No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
---|---|---|---|---|---|---|---|---|
1 | 00850037694105 | SC301XL | The Stronghold SMS Reinforced Gown is a device that is intended to be worn by op The Stronghold SMS Reinforced Gown is a device that is intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material. It is made from SMS material, and is full length, constructed with raglan sleeves, hook and loop neck closures, and tie waist closures. The reinforcement has the following structural features: (a) The chest area is reinforced with additional layer of SMS material. (b) The sleeve area is reinforced with additional layer of SMS material. The gowns are sterilized with EtO sterilization IAW ISO 11135. | FYA | Gown, Surgical | 2 | Stronghold SMS Reinforced Surgical Gown (Sterile)-XL | |
2 | 00850037694037 | SC300XXL | The Stronghold SMS Reinforced Gown is a device that is intended to be worn by op The Stronghold SMS Reinforced Gown is a device that is intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material. It is made from SMS material, and is full length, constructed with raglan sleeves, hook and loop neck closures, and tie waist closures. The reinforcement has the following structural features: (a) The chest area is reinforced with additional layer of SMS material. (b) The sleeve area is reinforced with additional layer of SMS material. Non-sterile surgical gowns are to be sold to OEMs for EtO sterilization according to ISO 11135. Sterile Surgical Gowns are to be sold directly to users after EtO sterilization validation to ISO 11135. | FYA | Gown, Surgical | 2 | Stronghold SMS Reinforced Surgical Gown (Non-Sterile)-XXL | |
3 | 00711583361104 | FRSNS-LYDUSNTRL | Patient examination glove made from nitrile compound, blue color, powder free an Patient examination glove made from nitrile compound, blue color, powder free and non-sterile (Per 21 CFR 880.6250, Class I). The device meets the specifications in ASTM D6319-19 Standard Specification for Nitrile Examination Gloves for Medical Application. See product packaging for size identification. Carton of 100 pieces/inner box. | LZA | Polymer Patient Examination Glove | 1 | LYDUS Nitrile Examination Gloves, Powder Free | |
4 | 00850037694778 | SC210U | This gown is intended to protect health care patients and health care personnel This gown is intended to protect health care patients and health care personnel from the transfer of microorganisms, body fluids and particulate materials. Not intended for use in the operating room. This gown is classified as Level 2 per AAMI Standard PB70 Liquid barrier performance and classification of protective apparel and drapes intended for use in healthcare facilities. Pack of 10. | OEA | Non-Surgical Isolation Gown | 1 | Stronghold SMS Isolation Gown (AAMI Level 2)-Unisize | |
5 | 00850037694761 | SC210XL | This gown is intended to protect health care patients and health care personnel This gown is intended to protect health care patients and health care personnel from the transfer of microorganisms, body fluids and particulate materials. Not intended for use in the operating room. This gown is classified as Level 2 per AAMI Standard PB70 Liquid barrier performance and classification of protective apparel and drapes intended for use in healthcare facilities. Pack of 10. | OEA | Non-Surgical Isolation Gown | 1 | Stronghold SMS Isolation Gown (AAMI Level 2)-XL | |
6 | 00850037694112 | SC301XXL | The Stronghold SMS Reinforced Gown is a device that is intended to be worn by op The Stronghold SMS Reinforced Gown is a device that is intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material. It is made from SMS material, and is full length, constructed with raglan sleeves, hook and loop neck closures, and tie waist closures. The reinforcement has the following structural features: (a) The chest area is reinforced with additional layer of SMS material. (b) The sleeve area is reinforced with additional layer of SMS material. The gowns are sterilized with EtO sterilization IAW ISO 11135. | FYA | Gown, Surgical | 2 | Stronghold SMS Reinforced Surgical Gown (Sterile)-XXL | |
7 | 00850037694020 | SC300XL | The Stronghold SMS Reinforced Gown is a device that is intended to be worn by op The Stronghold SMS Reinforced Gown is a device that is intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material. It is made from SMS material, and is full length, constructed with raglan sleeves, hook and loop neck closures, and tie waist closures. The reinforcement has the following structural features: (a) The chest area is reinforced with additional layer of SMS material. (b) The sleeve area is reinforced with additional layer of SMS material. Non-sterile surgical gowns are to be sold to OEMs for EtO sterilization according to ISO 11135. Sterile Surgical Gowns are to be sold directly to users after EtO sterilization validation to ISO 11135. | FYA | Gown, Surgical | 2 | Stronghold SMS Reinforced Surgical Gown (Non-Sterile)-XL | |
8 | 00860007372230 | SHFBSNS0603XL | Nitrile examination/treatment glove, non-powdered, non-antimicrobial Size: XL Pa Nitrile examination/treatment glove, non-powdered, non-antimicrobial Size: XL Pack: 100 pieces by weight / inner box. | LZA | Polymer Patient Examination Glove | 1 | Stronghold Group Nitrile Examination Glove, Powder Free-XL | |
9 | 00860007372216 | SHFBSNS0603M | Nitrile examination/treatment glove, non-powdered, non-antimicrobial Size: M Pac Nitrile examination/treatment glove, non-powdered, non-antimicrobial Size: M Pack: 100 pieces by weight / inner box. | LZA | Polymer Patient Examination Glove | 1 | Stronghold Group Nitrile Examination Glove, Powder Free-M | |
10 | 00850037694662 | SC200L | This gown is intended to protect health care patients and health care personnel This gown is intended to protect health care patients and health care personnel from the transfer of microorganisms, body fluids and particulate materials. Not intended for use in the operating room. This gown is classified as Level 2 per AAMI Standard PB70 Liquid barrier performance and classification of protective apparel and drapes intended for use in healthcare facilities. Pack of 10. | OEA | Non-Surgical Isolation Gown | 1 | Stronghold PP/PE Isolation Gown (AAMI Level 2)-L | |
11 | 00850037694013 | SC300L | The Stronghold SMS Reinforced Gown is a device that is intended to be worn by op The Stronghold SMS Reinforced Gown is a device that is intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material. It is made from SMS material, and is full length, constructed with raglan sleeves, hook and loop neck closures, and tie waist closures. The reinforcement has the following structural features: (a) The chest area is reinforced with additional layer of SMS material. (b) The sleeve area is reinforced with additional layer of SMS material. Non-sterile surgical gowns are to be sold to OEMs for EtO sterilization according to ISO 11135. Sterile Surgical Gowns are to be sold directly to users after EtO sterilization validation to ISO 11135. | FYA | Gown, Surgical | 2 | Stronghold SMS Reinforced Surgical Gown (Non-Sterile)-L | |
12 | 00850037694006 | SC300M | The Stronghold SMS Reinforced Gown is a device that is intended to be worn by op The Stronghold SMS Reinforced Gown is a device that is intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material. It is made from SMS material, and is full length, constructed with raglan sleeves, hook and loop neck closures, and tie waist closures. The reinforcement has the following structural features: (a) The chest area is reinforced with additional layer of SMS material. (b) The sleeve area is reinforced with additional layer of SMS material. Non-sterile surgical gowns are to be sold to OEMs for EtO sterilization according to ISO 11135. Sterile Surgical Gowns are to be sold directly to users after EtO sterilization validation to ISO 11135. | FYA | Gown, Surgical | 2 | Stronghold SMS Reinforced Surgical Gown (Non-Sterile)-M | |
13 | 00860007372223 | SHFBSNS0603L | Nitrile examination/treatment glove, non-powdered, non-antimicrobial Size: L Pac Nitrile examination/treatment glove, non-powdered, non-antimicrobial Size: L Pack: 100 pieces by weight / inner box. | LZA | Polymer Patient Examination Glove | 1 | Stronghold Group Nitrile Examination Glove, Powder Free-L | |
14 | 00850037694686 | SC200U | This gown is intended to protect health care patients and health care personnel This gown is intended to protect health care patients and health care personnel from the transfer of microorganisms, body fluids and particulate materials. Not intended for use in the operating room. This gown is classified as Level 2 per AAMI Standard PB70 Liquid barrier performance and classification of protective apparel and drapes intended for use in healthcare facilities. Pack of 10. | OEA | Non-Surgical Isolation Gown | 1 | Stronghold PP/PE Isolation Gown (AAMI Level 2)-Unisize | |
15 | 00850037694082 | SC301M | The Stronghold SMS Reinforced Gown is a device that is intended to be worn by op The Stronghold SMS Reinforced Gown is a device that is intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material. It is made from SMS material, and is full length, constructed with raglan sleeves, hook and loop neck closures, and tie waist closures. The reinforcement has the following structural features: (a) The chest area is reinforced with additional layer of SMS material. (b) The sleeve area is reinforced with additional layer of SMS material. The gowns are sterilized with EtO sterilization IAW ISO 11135. | FYA | Gown, Surgical | 2 | Stronghold SMS Reinforced Surgical Gown (Sterile)-M | |
16 | 00860007372209 | SHFBSNS0603S | Nitrile examination/treatment glove, non-powdered, non-antimicrobial Size: S Pac Nitrile examination/treatment glove, non-powdered, non-antimicrobial Size: S Pack: 100 pieces by weight / inner box. | LZA | Polymer Patient Examination Glove | 1 | Stronghold Group Nitrile Examination Glove, Powder Free-S | |
17 | 00850037694730 | SC210S | This gown is intended to protect health care patients and health care personnel This gown is intended to protect health care patients and health care personnel from the transfer of microorganisms, body fluids and particulate materials. Not intended for use in the operating room. This gown is classified as Level 2 per AAMI Standard PB70 Liquid barrier performance and classification of protective apparel and drapes intended for use in healthcare facilities. Pack of 10. | OEA | Non-Surgical Isolation Gown | 1 | Stronghold SMS Isolation Gown (AAMI Level 2)-S | |
18 | 00850037694655 | SC200M | This gown is intended to protect health care patients and health care personnel This gown is intended to protect health care patients and health care personnel from the transfer of microorganisms, body fluids and particulate materials. Not intended for use in the operating room. This gown is classified as Level 2 per AAMI Standard PB70 Liquid barrier performance and classification of protective apparel and drapes intended for use in healthcare facilities. Pack of 10. | OEA | Non-Surgical Isolation Gown | 1 | Stronghold PP/PE Isolation Gown (AAMI Level 2)-M | |
19 | 00850037694648 | SC200S | This gown is intended to protect health care patients and health care personnel This gown is intended to protect health care patients and health care personnel from the transfer of microorganisms, body fluids and particulate materials. Not intended for use in the operating room. This gown is classified as Level 2 per AAMI Standard PB70 Liquid barrier performance and classification of protective apparel and drapes intended for use in healthcare facilities. Pack of 10. | OEA | Non-Surgical Isolation Gown | 1 | Stronghold PP/PE Isolation Gown (AAMI Level 2)-S | |
20 | 00850037694747 | SC210M | This gown is intended to protect health care patients and health care personnel This gown is intended to protect health care patients and health care personnel from the transfer of microorganisms, body fluids and particulate materials. Not intended for use in the operating room. This gown is classified as Level 2 per AAMI Standard PB70 Liquid barrier performance and classification of protective apparel and drapes intended for use in healthcare facilities. Pack of 10. | OEA | Non-Surgical Isolation Gown | 1 | Stronghold SMS Isolation Gown (AAMI Level 2)-M | |
21 | 00850037694679 | SC200XL | This gown is intended to protect health care patients and health care personnel This gown is intended to protect health care patients and health care personnel from the transfer of microorganisms, body fluids and particulate materials. Not intended for use in the operating room. This gown is classified as Level 2 per AAMI Standard PB70 Liquid barrier performance and classification of protective apparel and drapes intended for use in healthcare facilities. Pack of 10. | OEA | Non-Surgical Isolation Gown | 1 | Stronghold PP/PE Isolation Gown (AAMI Level 2)-XL | |
22 | 00850037694099 | SC301L | The Stronghold SMS Reinforced Gown is a device that is intended to be worn by op The Stronghold SMS Reinforced Gown is a device that is intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material. It is made from SMS material, and is full length, constructed with raglan sleeves, hook and loop neck closures, and tie waist closures. The reinforcement has the following structural features: (a) The chest area is reinforced with additional layer of SMS material. (b) The sleeve area is reinforced with additional layer of SMS material. The gowns are sterilized with EtO sterilization IAW ISO 11135. | FYA | Gown, Surgical | 2 | Stronghold SMS Reinforced Surgical Gown (Sterile)-L |
No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
---|---|---|---|---|---|---|
1 | 00816703023006 | 315748REG | Not Applicable | Isolation Gown, Yellow | MedSource Isolation Gown | MEDSOURCE INTERNATIONAL LLC |
2 | 00815555023745 | 38-05 | GOWN ISOLATION PREMIUM YEL | Cypress | MCKESSON MEDICAL-SURGICAL INC. | |
3 | 00815555023714 | 34-380 | LAB COAT WHT XL SPP | Cypress | MCKESSON MEDICAL-SURGICAL INC. | |
4 | 00815555023684 | 34-120 | LAB COAT SM KNIT COLLAR/CUFF B | Cypress | MCKESSON MEDICAL-SURGICAL INC. | |
5 | 00815555023653 | 33-140 | LAB JACKET MD KNIT COLLAR/CUFF | Cypress | MCKESSON MEDICAL-SURGICAL INC. | |
6 | 00814639024968 | GWN-D02 | SUPERFIT Surgical Disposable Isolation Gown. Level II. | SUPERFIT | APPLIED DENTAL, INC. | |
7 | 00813360021727 | RR-500 | RR-500 | Chemotherapy Gown,AAMI Level 2, ASTM F739 Tested, Purple, Velcro Tab, Knit Cuffs Chemotherapy Gown,AAMI Level 2, ASTM F739 Tested, Purple, Velcro Tab, Knit Cuffs, Purple, Universal | Protexer | ICP MEDICAL, LLC |
8 | 00813360021611 | 1 | ICP-8700 | Isolation Gown, White, AAMI Level 2, SMS, Over the Head, Full Coverage, Thumbloo Isolation Gown, White, AAMI Level 2, SMS, Over the Head, Full Coverage, Thumbloop, Universal | Protexer | ICP MEDICAL, LLC |
9 | 00813360021598 | 1 | ICP-8150FC | Isolation gown, SMS, AAMI Level II, Yellow, Over the Head, Full Coverage, Thumb Isolation gown, SMS, AAMI Level II, Yellow, Over the Head, Full Coverage, Thumb Loop with Elastic Wrist, Universal | Protexter | ICP MEDICAL, LLC |
10 | 00813360021581 | ICP-8300 | ICP-8300 | Open Back Gown, SMS, Yellow, Over the Head, Thumb Loop with Elastic Wrist, 3XL | Protexer | ICP MEDICAL, LLC |
11 | 00813360021574 | ICP-7052FCC | ICP-7052FCC | Procedure Gown, PE Coating, White, Over the Head, Knit Cuffs, Full Coverage, XL | Protexer | ICP MEDICAL, LLC |
12 | 00813360021567 | 1 | ICP-7053FCC | Procedure Gown, PE Coating White, Over the Head, Knit Cuffs, Full Coverage, Universal | Protexter | ICP MEDICAL, LLC |
13 | 00813360021550 | 1 | ICP-7050C | Procedure Gown, Tested for Chemotherapy Drugs, White, Over the Head, Knit Cuffs, Procedure Gown, Tested for Chemotherapy Drugs, White, Over the Head, Knit Cuffs, Open Back, Universal | Protexer | ICP MEDICAL, LLC |
14 | 00813360021536 | 1 | ICP-5050Y | Open Back Gown - Polycoated, Yellow, Over the Head, Open Back, Thumb Loop and El Open Back Gown - Polycoated, Yellow, Over the Head, Open Back, Thumb Loop and Elastic Wrist, Universal | Protexer | ICP MEDICAL, LLC |
15 | 00813360021505 | 1 | 8150 | Universal Comfort Gown | Protexter | ICP MEDICAL, LLC |
16 | 00813360021376 | ICP-8250 | ICP-8250 | Dental Gown, SMS, Velcro Neck Closure, AAMI II, Yellow, Full Coverage, Knit Cuffs, 2XL | Protexer | ICP MEDICAL, LLC |
17 | 00813360021369 | ICP-8200 | ICP-8200 | Dental Gown, SMS, Velcro Neck Closure, AAMI II, Yellow, Full Coverage, Knit Cuff Dental Gown, SMS, Velcro Neck Closure, AAMI II, Yellow, Full Coverage, Knit Cuffs, Universal | Protexer | ICP MEDICAL, LLC |
18 | 00812460028124 | IGS01 | IGS01 | ISOLATION GOWN. EA. | Rospital Productos Medicos | ATLAS MEDICAL PRODUCTS LLC |
19 | 00811220033606 | D23467 | D23467 | PremierPro Isolation Gown, AAMI 2, Yellow, Over Head, Full Back, Thumbloops, X-L PremierPro Isolation Gown, AAMI 2, Yellow, Over Head, Full Back, Thumbloops, X-Large, 10/bg | PremierPro | SVS LLC |
20 | 00811220033545 | D23466 | D23466 | PremierPro Isolation Gown, AAMI 2, Yellow, Over Head, Full Back, Thumbloops, Uni PremierPro Isolation Gown, AAMI 2, Yellow, Over Head, Full Back, Thumbloops, Universal, 10/bg | PremierPro | SVS LLC |
21 | 00811220033477 | 2372 | 2372 | PremierPro Chemo Tested Cover Gown Universal 10/bg | PremierPro | SVS LLC |
22 | 00811220031282 | 2349 | 2349 | PremierPro PE Isolation Gown AAMI 2 OTH Elastic Cuff, X-Large, 10/bg | PremierPro | SVS LLC |
23 | 00810107330470 | 31004XL | Isolation Gown, AAMI Level 3, Model 31004XL, Size XLarge | Hilo Fit | HILO INDUSTRIES LLC | |
24 | 00810107330456 | 21003L | Isolation Gown, AAMI Level 2, Model 21003L, Size Large | Hilo Fit | HILO INDUSTRIES LLC | |
25 | 00810107330449 | 31003L | Isolation Gown, AAMI Level 3, Model 31003L, Size Large | Hilo Fit | HILO INDUSTRIES LLC | |
26 | 00810107330418 | 21004XL | Isolation Gown, AAMI Level 2, Model 21004XL, Size XLarge | Hilo Fit | HILO INDUSTRIES LLC | |
27 | 00810107330395 | 11004XL | Isolation Gown, AAMI Level 1, Model 11004XL, Size XLarge | Hilo Fit | HILO INDUSTRIES LLC | |
28 | 00810107330371 | 11003L | Isolation Gown, AAMI Level 1, Model 11003L, Size Large | Hilo Fit | HILO INDUSTRIES LLC | |
29 | 00810107330357 | 22704XL | Isolation Gown (raglan sleeves), AAMI Level 2, Model 22704XL, Size XLarge | Hilo Fit | HILO INDUSTRIES LLC | |
30 | 00810107330340 | 22703L | Isolation Gown (raglan sleeves), AAMI Level 2, Model 22703L, Size Large | Hilo Fit | HILO INDUSTRIES LLC | |
31 | 00810107330333 | 12704XL | Isolation Gown (raglan sleeves), AAMI Level 1, Model 12704XL, Size XLarge | Hilo Fit | HILO INDUSTRIES LLC | |
32 | 00810107330326 | 12703L | Isolation Gown (raglan sleeves), AAMI Level 1, Model 12703L, Size Large | Hilo Fit | HILO INDUSTRIES LLC | |
33 | 00810107330319 | 32703L | Isolation Gown (raglan sleeves), AAMI Level 3, Model 32703L, Size Large | Hilo Fit | HILO INDUSTRIES LLC | |
34 | 00810107330302 | 32704XL | Isolation Gown (raglan sleeves), AAMI Level 3, Model 32704XL, Size XLarge | Hilo Fit | HILO INDUSTRIES LLC | |
35 | 00810107330234 | 22004XL | Hilo Fit Isolation Gown, Size X-LARGE, SINGLE USE ONLY, LEVEL 2 AAMI PB70, Meets Hilo Fit Isolation Gown, Size X-LARGE, SINGLE USE ONLY, LEVEL 2 AAMI PB70, Meets requirement of Specification F3352. Available in colors blue or yellow. | Hilo Fit | HILO INDUSTRIES LLC | |
36 | 00810107330227 | 22003L | Hilo Fit Isolation Gown, Size LARGE, SINGLE USE ONLY, LEVEL 2 AAMI PB70, Meets r Hilo Fit Isolation Gown, Size LARGE, SINGLE USE ONLY, LEVEL 2 AAMI PB70, Meets requirement of Specification F3352. Available in colors blue or yellow. | Hilo Fit | HILO INDUSTRIES LLC | |
37 | 00810069260174 | 1325 | AMG | ARROW MEDSOURCE GROUP LIMITED | ||
38 | 00810019801181 | 129060 | 129060 | Gown, Isolation, XL 20-Pk NS | NOVO Health Services, LLC | NOVO HEALTH SERVICES, LLC |
39 | 00810019801174 | 129059 | 129059 | Gown, Isolation, S 20-Pk NS | NOVO Health Services, LLC | NOVO HEALTH SERVICES, LLC |
40 | 00690521018105 | SF-202-XXL | SF-202-XXL | Level 2 Protective Gowns, XX-Large, Blue | Batrik Level 2 Ultrasonically Welded Seam\Blue Gown\Size XXL | BATRIK MEDICAL MANUFACTURING INC |
41 | 00690521018099 | SF-202-XL | SF-202-XL | Level 2 Protective Gowns, X-Large, Blue | Batrik Level 2 Ultrasonically Welded Seam\Blue Gown\Size XL | BATRIK MEDICAL MANUFACTURING INC |
42 | 00690521018082 | SF-202-L | SF-202-L | Level 2 Protective Gowns, Large, Blue | Batrik Level 2 Ultrasonically Welded Seam\Blue Gown\Size L | BATRIK MEDICAL MANUFACTURING INC |
43 | 00690521018075 | SF-202-M | SF-202-M | Level 2 Protective Gowns, Medium, Blue | Batrik Level 2 Ultrasonically WeldedSeam\Blue Gown\Size M | BATRIK MEDICAL MANUFACTURING INC |
44 | 00683534060520 | 1 | 68-6201-B | PE FILM GOWN A garment made of natural and/or synthetic materials intended to be PE FILM GOWN A garment made of natural and/or synthetic materials intended to be worn over a scrub suit to cover the arms, trunk, and upper legs, during a surgical procedure; it may be fluid resistant or impervious to fluids. Also known as an operating room (OR) gown, it is used during surgical procedures to help protect both the patient and operating room personnel from the transfer of microorganisms, body fluids, and particulate material. This is a single-use garment. | SURGIPLUS | A PLUS INTERNATIONAL INC. |
45 | 00677964067839 | 200352 | 200352 | Impervious Gown | Impervious Gown | MEDIVATORS INC. |
46 | 00677964067822 | 200351 | 200351 | Impervious Gown | Impervious Gown | MEDIVATORS INC. |
47 | 00677964067815 | 200350 | 200350 | Impervious Gown | Impervious Gown | MEDIVATORS INC. |
48 | 00653160146448 | IFC340 | IFC340 | PPE KIT | Centurion | CENTURION MEDICAL PRODUCTS CORPORATION |
49 | 00653160024708 | AG150XST | AG150XST | STERILE GOWN | Centurion | CENTURION MEDICAL PRODUCTS CORPORATION |
50 | 00647921630017 | 6300-50 | 6300-50 | ISOLATION KIT, 50/CS | MORRISON MEDICAL | MORRISON MEDICAL, LTD |