KENPAX INTERNATIONAL LIMITED

Address:Flat 5, 5/F., Wing On Plaza,Kowloon,HK

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- Catalog Number : 68-8600-B

Device Description : Procedure Mask

Device Class :

Duns Number: 686206765

Premarket Exempt : No

Product Code : FXX

Prescription Use : No

Device Count : 1000

- Catalog Number : 68-6201-B

Device Description : PE Film Gown

Device Class :

Duns Number: 686206765

Premarket Exempt : Yes

Product Code : OEA

Prescription Use : No

Device Count : 1

- Catalog Number : 1003092

Device Description : Gown Reinforced Chest & Sleeve

Device Class : 2

Duns Number: 686206765

Premarket Exempt : No

Product Code : FYA

Prescription Use : No

Device Count : 1

- Catalog Number : 1004292

Device Description : Gown Reinforced Chest & Sleeve

Device Class : 2

Duns Number: 686206765

Premarket Exempt : No

Product Code : FYA

Prescription Use : No

Device Count : 1

- Catalog Number : 1004293

Device Description : Gown Reinforced Chest & Sleeve

Device Class : 2

Duns Number: 686206765

Premarket Exempt : No

Product Code : FYA

Prescription Use : No

Device Count : 1

- Catalog Number : 100780

Device Description : Gown No Reinforced

Device Class : 2

Duns Number: 686206765

Premarket Exempt : No

Product Code : FYA

Prescription Use : No

Device Count : 1

- Catalog Number : 100770

Device Description : Gown Reinforced Chest & SleeveA garment made of natural and/or synthetic materia Gown Reinforced Chest & SleeveA 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.

Device Class : 2

Duns Number: 686206765

Premarket Exempt : No

Product Code : FYA

Prescription Use : No

Device Count : 1

- Catalog Number : 1005572

Device Description : GOWN SURGICAL POLY-REINFORCED SOFT A garment made of natural and/or synthetic ma GOWN SURGICAL POLY-REINFORCED SOFT 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.

Device Class : 2

Duns Number: 686206765

Premarket Exempt : No

Product Code : FYA

Prescription Use : No

Device Count : 1

- Catalog Number : 1005567

Device Description : GOWN SURGICAL POLY-REINFORCED SOFT A garment made of natural and/or synthetic ma GOWN SURGICAL POLY-REINFORCED SOFT 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.

Device Class : 2

Duns Number: 686206765

Premarket Exempt : No

Product Code : FYA

Prescription Use : No

Device Count : 1

- Catalog Number : 68-101B-UC

Device Description : Shoe coverA non-sterile device made of a non-conductive material intended to be Shoe coverA non-sterile device made of a non-conductive material intended to be used as a physical barrier on a shoe to prevent cross-contamination between the shoe and the environment. This is a single-use device.

Device Class : 1

Duns Number: 686206765

Premarket Exempt : Yes

Product Code : FXP

Prescription Use : No

Device Count : 1