MEDTECS (TAIWAN) CORP.

Address:11F, No. 9, Songgao Road,Taipei City,TW

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Device Description : ASTM Level 1/EN14683 Type IIR 3-Ply disposable Surgical Mask, Model number: FM-1 ASTM Level 1/EN14683 Type IIR 3-Ply disposable Surgical Mask, Model number: FM-140G are 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 face masks are single use, disposable device, provided non-sterile.

Device Class :

Duns Number: 658023890

Premarket Exempt : No

Product Code : FXX

Prescription Use : No

Device Count : 50

Device Description : The SMS Reinforced Gown is a device that is intended to be worn by operating roo The 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 come with sterile.

Device Class : 2

Duns Number: 658023890

Premarket Exempt : No

Product Code : FYA

Prescription Use : No

Device Count : 1

Device Description : The SMS Reinforced Gown is a device that is intended to be worn by operating roo The 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 come with sterile.

Device Class : 2

Duns Number: 658023890

Premarket Exempt : No

Product Code : FYA

Prescription Use : No

Device Count : 1

Device Description : The SMS Reinforced Gown is a device that is intended to be worn by operating roo The 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 come with sterile.

Device Class : 2

Duns Number: 658023890

Premarket Exempt : No

Product Code : FYA

Prescription Use : No

Device Count : 1

Device Description : The SMS Reinforced Gown is a device that is intended to be worn by operating roo The 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 come with sterile.

Device Class : 2

Duns Number: 658023890

Premarket Exempt : No

Product Code : FYA

Prescription Use : No

Device Count : 1

Device Description : The SMS Reinforced Gown is a device that is intended to be worn by operating roo The 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.

Device Class : 2

Duns Number: 658023890

Premarket Exempt : No

Product Code : FYA

Prescription Use : No

Device Count : 1

Device Description : The SMS Reinforced Gown is a device that is intended to be worn by operating roo The 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.

Device Class : 2

Duns Number: 658023890

Premarket Exempt : No

Product Code : FYA

Prescription Use : No

Device Count : 1

Device Description : The SMS Reinforced Gown is a device that is intended to be worn by operating roo The 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.

Device Class : 2

Duns Number: 658023890

Premarket Exempt : No

Product Code : FYA

Prescription Use : No

Device Count : 1

Device Description : The SMS Reinforced Gown is a device that is intended to be worn by operating roo The 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.

Device Class : 2

Duns Number: 658023890

Premarket Exempt : No

Product Code : FYA

Prescription Use : No

Device Count : 1

Device Description : The SPUNLACE Regular Gown is a device that is intended to be worn by operating r The SPUNLACE Regular 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 Regular Gown is made from SPUNLACE 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