Other products from "THE STRONGHOLD GROUP LLC"
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 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
8 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
9 00850037694754 SC210L 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)-L
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
Other products with the same Product Code "FYA"
No Primary DI Version or Model Catalog Number Device Description Brand Name Organization Name
1 00854150007323 HF-XXL HF-XXL HaloFit XX-Large with Face Shield AAMI 4 ORI OPERATING ROOM INNOVATIONS, INC.
2 00854150007309 HF-XL HF-XL HaloFit X-Large with Face Shield AAMI 4 ORI OPERATING ROOM INNOVATIONS, INC.
3 00854150007248 SF-4XXXL-EL SF-4XXXL-EL Solofit Critical Zone AAMI IV Gown, XXXL, Extra Long SoloFit OPERATING ROOM INNOVATIONS, INC.
4 00854150007187 SF-4XXL SF-4XXL SF-4XXL ORI OPERATING ROOM INNOVATIONS, INC.
5 00854150007163 SF-4XL SF-4XL Solofit AAMI IV SMS Gown L4 Reinforced, x-Large ORI OPERATING ROOM INNOVATIONS, INC.
6 00854150007156 SF-4PL SF-4PL Solofit AAMI IV SMS Gown L4 Reinforced, Large ORI OPERATING ROOM INNOVATIONS, INC.
7 00854150007132 SF-SDT-1 SF-SDT-1 Surgical Gown ORI Self Donning Tabs Kit ORI Self Donning Tabs Kit OPERATING ROOM INNOVATIONS, INC.
8 00854150007095 SF-3PXXL SF-3PXXL SF-3PXXL Solofit AAMI III SMS Gown Poly Reinforced XX-Large OPERATING ROOM INNOVATIONS, INC.
9 00854150007071 SF-3XXL SF-3XXL SF-3XXL Solofit AAMI III SMS Gown XX-Large OPERATING ROOM INNOVATIONS, INC.
10 00854150007064 SF-3PXL SF-3PXL SF-3PXL Solofit AAMI III SMS Gown Poly Reinforced X-Large OPERATING ROOM INNOVATIONS, INC.
11 00854150007040 SF-3XL SF-3XL SF-3XL Solofit AAMI III SMS Gown X-Large OPERATING ROOM INNOVATIONS, INC.
12 00854150007026 SF-3L SF-3L SF-3L Solofit AAMI III SMS Gown Large OPERATING ROOM INNOVATIONS, INC.
13 00854150007002 SF-3PL SF-3PL SF-3PL Solofit AAMI III SMS Gown Poly Reinforced Large OPERATING ROOM INNOVATIONS, INC.
14 00852205007854 10601006 10601006 10601006 Dual Fenestrated Drape, Sterile EXACT MEDICAL MANUFACTURING, INC.
15 00852205007823 E103170 E103170 C-Core Surgical Soft SMS Gown w/ Standard SMS Rein. XX-Large EXACT MEDICAL MANUFACTURING, INC.
16 00852205007809 E103150 E103150 C-Core Surgical Soft SMS Gown w/ Standard SMS Rein. Large EXACT MEDICAL MANUFACTURING, INC.
17 00852205007687 E103160 E103160 C-Core Surgical Soft SMS Gown w/ Standard SMS Rein. X-Large EXACT MEDICAL MANUFACTURING, INC.
18 00852205007120 E6552N E6552N E6552N SMS Shorts for Colonoscopy Extra Large EXACT MEDICAL MANUFACTURING, INC.
19 00852205007106 E6551N E6551N E6551N SMS Shorts for Colonoscopy Large EXACT MEDICAL MANUFACTURING, INC.
20 00850337007414 00403 00403 Gown, Surgical, Reinforced AAMI Level 4 XX-Large w/ Towel POSS EXACT MEDICAL MANUFACTURING, INC.
21 00850337007339 00403 E104180 Gown, Surgical Haloguard AAMI Level 4 XX-Large w/ Towel POSS EXACT MEDICAL MANUFACTURING, INC.
22 00850337007315 00402 E104170 Gown, Surgical Haloguard AAMI Level 4 X-Large w/ Towel POSS EXACT MEDICAL MANUFACTURING, INC.
23 00850337007292 00401 E104160 Gown, Surgical Haloguard AAMI Level 4 Large w/ Towel POSS EXACT MEDICAL MANUFACTURING, INC.
24 00850337007278 E104170S 00401 Gown, Surgical AAMI Level 4, Large w/ Towel POSS EXACT MEDICAL MANUFACTURING, INC.
25 00850337007193 E313101 E313101 Drape, Extremity 89" x 128", SMS, Sterile POSS EXACT MEDICAL MANUFACTURING, INC.
26 00850337007070 E104160PS 00402 Gown, Surgical AAMI Level 4, X-Large w/ Towel POSS EXACT MEDICAL MANUFACTURING, INC.
27 00850044458899 SG011 SG011 Surgical Gown, AAMI LV3, Reinforced XL CALICO CALICO MEDICAL GROUP LLC
28 00850044458882 SG010 SG010 Surgical Gown, AAMI LV3, Reinforced L CALICO CALICO MEDICAL GROUP LLC
29 00850044458875 SG009 SG009 Surgical Gown, AAMI LV2, Non-Reinforced, XL CALICO CALICO MEDICAL GROUP LLC
30 00850044458868 SG008 SG008 Surgical Gown, AAMI LV2, Non-Reinforced, L CALICO CALICO MEDICAL GROUP LLC
31 00850038889098 MDSurg4-XXL Surgical Gown, Double Extra Large, AAMI Level 4 Maddox Defense MADDOX DEFENSE INC.
32 00850038889081 MDSurg4-XL Surgical Gown, Extra Large, AAMI Level 4 Maddox Defense MADDOX DEFENSE INC.
33 00850038889074 MDSurg4-L Surgical Gown, Large, AAMI Level 4 Maddox Defense MADDOX DEFENSE INC.
34 00850038889067 MDSurg4-M Surgical Gown, Medium, AAMI Level 4 Maddox Defense MADDOX DEFENSE INC.
35 00850038889050 MDSurg4-S Surgical Gown, Small, AAMI Level 4 Maddox Defense MADDOX DEFENSE INC.
36 00850038889043 MDSurg3-XXL Surgical Gown, Double Extra Large, AAMI Level 3 Maddox Defense MADDOX DEFENSE INC.
37 00850038889036 MDSurg3-XL Surgical Gown, Extra Large, AAMI Level 3 Maddox Defense MADDOX DEFENSE INC.
38 00850038889029 MDSurg3-L Surgical Gown, Large, AAMI Level 3 Maddox Defense MADDOX DEFENSE INC.
39 00850038889012 MDSurg3-M Surgical Gown, Medium, AAMI Level 3 Maddox Defense MADDOX DEFENSE INC.
40 00850038889005 MDSurg3-S Surgical Gown, Small, AAMI Level 3 Maddox Defense MADDOX DEFENSE INC.
41 00850038608095 S4005 Ultra Reinforced Surgical Gown with Poly Reinforcement, Size XX-LARGE, SINGLE US Ultra Reinforced Surgical Gown with Poly Reinforcement, Size XX-LARGE, SINGLE USE ONLY, LEVEL 4 AAMI PB70,Meets requirement of ASTM F2407. Color: Blue. Case Hilo HILO ENTERPRISES LLC
42 00850038608088 S4004 Ultra Reinforced Surgical Gown with Poly Reinforcement, Size X-LARGE, SINGLE USE Ultra Reinforced Surgical Gown with Poly Reinforcement, Size X-LARGE, SINGLE USE ONLY, LEVEL 4 AAMI PB70,Meets requirement of ASTM F2407. Color: Blue. Case Hilo HILO ENTERPRISES LLC
43 00850038608071 S4003 Ultra Reinforced Surgical Gown with Poly Reinforcement, Size LARGE, SINGLE USE O Ultra Reinforced Surgical Gown with Poly Reinforcement, Size LARGE, SINGLE USE ONLY, LEVEL 4 AAMI PB70,Meets requirement of ASTM F2407. Color: Blue. Case Hilo HILO ENTERPRISES LLC
44 00850038608064 S4002 Ultra Reinforced Surgical Gown with Poly Reinforcement, Size MEDIUM, SINGLE USE Ultra Reinforced Surgical Gown with Poly Reinforcement, Size MEDIUM, SINGLE USE ONLY, LEVEL 4 AAMI PB70,Meets requirement of ASTM F2407. Color: Blue. Case Hilo HILO ENTERPRISES LLC
45 00850038608057 S4001 Ultra Reinforced Surgical Gown with Poly Reinforcement, Size SMALL, SINGLE USE O Ultra Reinforced Surgical Gown with Poly Reinforcement, Size SMALL, SINGLE USE ONLY, LEVEL 4 AAMI PB70,Meets requirement of ASTM F2407. Color: Blue. Case Hilo HILO ENTERPRISES LLC
46 00850038608040 S3005 Standard Surgical gown, Size XX-LARGE, SINGLE USE ONLY, LEVEL 3 AAMI PB70,Meets Standard Surgical gown, Size XX-LARGE, SINGLE USE ONLY, LEVEL 3 AAMI PB70,Meets requirement of ASTM F2407. Color: Blue. Case Hilo HILO ENTERPRISES LLC
47 00850038608033 S3004 Standard Surgical gown, Size X-LARGE, SINGLE USE ONLY, LEVEL 3 AAMI PB70,Meets r Standard Surgical gown, Size X-LARGE, SINGLE USE ONLY, LEVEL 3 AAMI PB70,Meets requirement of ASTM F2407. Color: Blue. Case Hilo HILO ENTERPRISES LLC
48 00850038608026 S3003 Standard Surgical gown, Size LARGE, SINGLE USE ONLY, LEVEL 3 AAMI PB70,Meets req Standard Surgical gown, Size LARGE, SINGLE USE ONLY, LEVEL 3 AAMI PB70,Meets requirement of ASTM F2407. Color: Blue. Case Hilo HILO ENTERPRISES LLC
49 00850038608019 S3002 Standard Surgical gown, Size MEDIUM, SINGLE USE ONLY, LEVEL 3 AAMI PB70,Meets re Standard Surgical gown, Size MEDIUM, SINGLE USE ONLY, LEVEL 3 AAMI PB70,Meets requirement of ASTM F2407. Color: Blue. Case Hilo HILO ENTERPRISES LLC
50 00850038608002 S3001 Standard Surgical gown, Size SMALL, SINGLE USE ONLY, LEVEL 3 AAMI PB70,Meets req Standard Surgical gown, Size SMALL, SINGLE USE ONLY, LEVEL 3 AAMI PB70,Meets requirement of ASTM F2407. Color: Blue. Case Hilo HILO ENTERPRISES LLC