MEDTECS (TAIWAN) CORP.

Spunlace Reinforced Surgical Gown (Sterile)-XXL - 04710415369291 Catalog Number :

Device Description : The Spunlace Reinforced Gown is a device that is intended to be worn by operatin The Spunlace 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. The Spunlace Reinforced Gown is made from Spunlace 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 come with sterile.

Device Class : 2

Duns Number: 658023890

Premarket Exempt : No

Product Code : FYA

Prescription Use : No

Device Count : 1

Spunlace Reinforced Surgical Gown (Non-Sterile)-M - 04710415369307 Catalog Number :

Device Description : The Spunlace Reinforced Gown is a device that is intended to be worn by operatin The Spunlace 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. The Spunlace Reinforced Gown is made from Spunlace 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.

Device Class : 2

Duns Number: 658023890

Premarket Exempt : No

Product Code : FYA

Prescription Use : No

Device Count : 1

Spunlace Reinforced Surgical Gown (Non-Sterile)-L - 04710415369314 Catalog Number :

Device Description : The Spunlace Reinforced Gown is a device that is intended to be worn by operatin The Spunlace 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. The Spunlace Reinforced Gown is made from Spunlace 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.

Device Class : 2

Duns Number: 658023890

Premarket Exempt : No

Product Code : FYA

Prescription Use : No

Device Count : 1

Spunlace Reinforced Surgical Gown (Non-Sterile)-XL - 04710415369321 Catalog Number :

Device Description : The Spunlace Reinforced Gown is a device that is intended to be worn by operatin The Spunlace 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. The Spunlace Reinforced Gown is made from Spunlace 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.

Device Class : 2

Duns Number: 658023890

Premarket Exempt : No

Product Code : FYA

Prescription Use : No

Device Count : 1

Spunlace Reinforced Surgical Gown (Non-Sterile)-XXL - 04710415369338 Catalog Number :

Device Description : The Spunlace Reinforced Gown is a device that is intended to be worn by operatin The Spunlace 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. The Spunlace Reinforced Gown is made from Spunlace 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.

Device Class : 2

Duns Number: 658023890

Premarket Exempt : No

Product Code : FYA

Prescription Use : No

Device Count : 1

SFT Surgical Gown (Sterile)-M - 04710415369345 Catalog Number :

Device Description : The SFT Surgical Gown is a device that is intended to be worn by operating room The SFT Surgical 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. The SFT Surgical Gown is is made from SPF material, and is full length, constructed with raglan sleeves, hook and loop neck closures, and tie waist closures. The gowns come with sterile.

Device Class : 2

Duns Number: 658023890

Premarket Exempt : No

Product Code : FYA

Prescription Use : No

Device Count : 1

SFT Surgical Gown (Sterile)-L - 04710415369352 Catalog Number :

Device Description : The SFT Surgical Gown is a device that is intended to be worn by operating room The SFT Surgical 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. The SFT Surgical Gown is is made from SPF material, and is full length, constructed with raglan sleeves, hook and loop neck closures, and tie waist closures. The gowns come with sterile.

Device Class : 2

Duns Number: 658023890

Premarket Exempt : No

Product Code : FYA

Prescription Use : No

Device Count : 1

SFT Surgical Gown (Sterile)-XL - 04710415369369 Catalog Number :

Device Description : The SFT Surgical Gown is a device that is intended to be worn by operating room The SFT Surgical 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. The SFT Surgical Gown is is made from SPF material, and is full length, constructed with raglan sleeves, hook and loop neck closures, and tie waist closures. The gowns come with sterile.

Device Class : 2

Duns Number: 658023890

Premarket Exempt : No

Product Code : FYA

Prescription Use : No

Device Count : 1

SFT Surgical Gown (Sterile)-XXL - 04710415369376 Catalog Number :

Device Description : The SFT Surgical Gown is a device that is intended to be worn by operating room The SFT Surgical 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. The SFT Surgical Gown is is made from SPF material, and is full length, constructed with raglan sleeves, hook and loop neck closures, and tie waist closures. The gowns come with sterile.

Device Class : 2

Duns Number: 658023890

Premarket Exempt : No

Product Code : FYA

Prescription Use : No

Device Count : 1

SFT Surgical Gown (Non-Sterile)-M - 04710415369383 Catalog Number :

Device Description : "The SFT Surgical Gown is a device that is intended to be worn by operating room "The SFT Surgical 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. The SFT Surgical Gown is is made from SPF material, and is full length, constructed with raglan sleeves, hook and loop neck closures, and tie waist closures. 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."

Device Class : 2

Duns Number: 658023890

Premarket Exempt : No

Product Code : FYA

Prescription Use : No

Device Count : 1

MEDTECS (TAIWAN) CORP.

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