Protective Gown AAMI Level 4
Kenpax International Limited
KENPAX INTERNATIONAL LIMITED
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3015820879 | 3015820879 | KENPAX INTERNATIONAL LIMITED | 1 | N | 2026-01-01 | Flat 5, 5/F., Wing On Plaza 62 Mody Road, Tsim Sha Tsui Kowloon HK 999077 |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 239911 | 1564398743 | K222151 | Sterilization Wrap | FRG | 2023-03-23 |
| 239911 | 1853415333 | K222128 | Protective Gown AAMI Level 4 | QPC | 2023-08-08 |
| 239911 | 1839192511 | K212504 | Isolation Gown AAMI Level 3 | FYC | 2021-11-07 |
| 239911 | 1917005362 | K202899 | Procedure Mask, Surgical Mask | FXX | 2021-05-20 |
| 239911 | 1740341215 | K031353 | SOLUTION FACE MASKS | FXX | 2003-06-19 |
| 239911 | 1151551759 |
Product Codes Associated With Registrations#
PMN#
Sterilization Wrap
Kenpax International Limited
Isolation Gown AAMI Level 3
Kenpax International Limited
Procedure Mask, Surgical Mask
Kenpax International Limited
GUDID#
CustoMed - Bouffant capA non-sterile head covering designed as a cap intended to be worn by surgical staff during an operation to protect both the patient and themselves from the transfer of microorganisms, body fluids, and particulate material. It is usually made of reinforced paper or non-woven materials. This is a single-use device.
2020-07-16
CustoMed - Bouffant capA non-sterile head covering designed as a cap intended to be worn by surgical staff during an operation to protect both the patient and themselves from the transfer of microorganisms, body fluids, and particulate material. It is usually made of reinforced paper or non-woven materials. This is a single-use device.
2020-07-16
CustoMed - Surgical capA non-sterile head covering designed as a cap intended to be worn by surgical staff during an operation to protect both the patient and themselves from the transfer of microorganisms, body fluids, and particulate material. It is usually made of reinforced paper or non-woven materials. This is a single-use device.
2020-07-16
SOURCE SURGICAL INC. - Bouffant capA non-sterile head covering designed as a cap intended to be worn by surgical staff during an operation to protect both the patient and themselves from the transfer of microorganisms, body fluids, and particulate material. It is usually made of reinforced paper or non-woven materials. This is a single-use device.
2021-03-15
SOURCE SURGICAL INC. - Bouffant capA non-sterile head covering designed as a cap intended to be worn by surgical staff during an operation to protect both the patient and themselves from the transfer of microorganisms, body fluids, and particulate material. It is usually made of reinforced paper or non-woven materials. This is a single-use device.
2021-03-15
Customed - 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.
2020-07-16
SURGIPLUS - Scrub Shirt, LA non-sterile, two-piece garment designed to be worn by healthcare staff to facilitate hygienic conditions typically in areas where surgery is performed. It typically consists of a shirt and pants composed of disposable materials and is intended to provide a barrier to help prevent cross-contamination of infectious agents between staff and patients. This is a single-use garment.
2020-07-22
SURGIPLUS - Scrub Shirt, XLA non-sterile, two-piece garment designed to be worn by healthcare staff to facilitate hygienic conditions typically in areas where surgery is performed. It typically consists of a shirt and pants composed of disposable materials and is intended to provide a barrier to help prevent cross-contamination of infectious agents between staff and patients. This is a single-use garment.
2020-07-22
SURGIPLUS - Scrub Shirt, 2XLA non-sterile, two-piece garment designed to be worn by healthcare staff to facilitate hygienic conditions typically in areas where surgery is performed. It typically consists of a shirt and pants composed of disposable materials and is intended to provide a barrier to help prevent cross-contamination of infectious agents between staff and patients. This is a single-use garment.
2020-07-22
SURGIPLUS - Scrub Pant, LA non-sterile, two-piece garment designed to be worn by healthcare staff to facilitate hygienic conditions typically in areas where surgery is performed. It typically consists of a shirt and pants composed of disposable materials and is intended to provide a barrier to help prevent cross-contamination of infectious agents between staff and patients. This is a single-use garment.
2020-07-22
SURGIPLUS - Scrub Pant, XLA non-sterile, two-piece garment designed to be worn by healthcare staff to facilitate hygienic conditions typically in areas where surgery is performed. It typically consists of a shirt and pants composed of disposable materials and is intended to provide a barrier to help prevent cross-contamination of infectious agents between staff and patients. This is a single-use garment.
2020-07-22
SURGIPLUS - Scrub Shirt, MA non-sterile, two-piece garment designed to be worn by healthcare staff to facilitate hygienic conditions typically in areas where surgery is performed. It typically consists of a shirt and pants composed of disposable materials and is intended to provide a barrier to help prevent cross-contamination of infectious agents between staff and patients. This is a single-use garment.
2020-07-29
SURGIPLUS - Scrub Pant, 2XLA non-sterile, two-piece garment designed to be worn by healthcare staff to facilitate hygienic conditions typically in areas where surgery is performed. It typically consists of a shirt and pants composed of disposable materials and is intended to provide a barrier to help prevent cross-contamination of infectious agents between staff and patients. This is a single-use garment.
2020-07-22
SURGIPLUS - Scrub Pant, MA non-sterile, two-piece garment designed to be worn by healthcare staff to facilitate hygienic conditions typically in areas where surgery is performed. It typically consists of a shirt and pants composed of disposable materials and is intended to provide a barrier to help prevent cross-contamination of infectious agents between staff and patients. This is a single-use garment.
2020-07-29
SOURCE SURGICAL INC. - 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.
2021-03-15
SURGIPLUS - Warm-up Jacket, Blue, LA non-sterile garment designed to be worn by healthcare staff to facilitate hygienic conditions typically in areas where surgery is performed. It typically a shirt composed of disposable materials and is intended to provide a barrier to help prevent cross-contamination of infectious agents between staff and patients. This is a single-use garment.
2021-03-15
SURGIPLUS - Warm-up Jacket, Blue, XLA non-sterile garment designed to be worn by healthcare staff to facilitate hygienic conditions typically in areas where surgery is performed. It typically a shirt composed of disposable materials and is intended to provide a barrier to help prevent cross-contamination of infectious agents between staff and patients. This is a single-use garment.
2021-03-15
CustoMed - Gown Reinforced Chest & Sleeve
2020-07-16
CustoMed - Gown Reinforced Chest & Sleeve
2020-07-16
CustoMed - Gown Reinforced Chest & Sleeve
2020-07-16
CustoMed - Gown No Reinforced
2020-07-16
CustoMed - 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.
2020-07-16
CustoMed - 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.
2020-07-16
CustoMed - 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.
2020-07-16
SURGIPLUS - Warm-up Jacket, BlueA non-sterile garment designed to be worn by healthcare staff to facilitate hygienic conditions typically in areas where surgery is performed. It typically a shirt composed of disposable materials and is intended to provide a barrier to help prevent cross-contamination of infectious agents between staff and patients. This is a single-use garment.
2021-03-15
CustoMed - Shoe cover A 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.
2020-07-16
SOURCE SURGICAL INC. - Bouffant cap A non-sterile head covering designed as a cap intended to be worn by surgical staff during an operation to protect both the patient and themselves from the transfer of microorganisms, body fluids, and particulate material. It is usually made of reinforced paper or non-woven materials. This is a single-use device.
2021-03-15
SOURCE SURGICAL INC. - Bouffant cap A non-sterile head covering designed as a cap intended to be worn by surgical staff during an operation to protect both the patient and themselves from the transfer of microorganisms, body fluids, and particulate material. It is usually made of reinforced paper or non-woven materials. This is a single-use device.
2021-03-15
SOURCE SURGICAL INC. - Shoe cover A 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.
2021-03-15
SURGIPLUS - Warm-up Jacket, Blue, L A non-sterile garment designed to be worn by healthcare staff to facilitate hygienic conditions typically in areas where surgery is performed. It typically a shirt composed of disposable materials and is intended to provide a barrier to help prevent cross-contamination of infectious agents between staff and patients. This is a single-use garment.
2021-03-15
SURGIPLUS - Warm-up Jacket, Blue, XL A non-sterile garment designed to be worn by healthcare staff to facilitate hygienic conditions typically in areas where surgery is performed. It typically a shirt composed of disposable materials and is intended to provide a barrier to help prevent cross-contamination of infectious agents between staff and patients. This is a single-use garment.
2021-03-15
SURGIPLUS - Scrub Shirt, M A non-sterile, two-piece garment designed to be worn by healthcare staff to facilitate hygienic conditions typically in areas where surgery is performed. It typically consists of a shirt and pants composed of disposable materials and is intended to provide a barrier to help prevent cross-contamination of infectious agents between staff and patients. This is a single-use garment.
2020-07-29
SURGIPLUS - Scrub Pant, M A non-sterile, two-piece garment designed to be worn by healthcare staff to facilitate hygienic conditions typically in areas where surgery is performed. It typically consists of a shirt and pants composed of disposable materials and is intended to provide a barrier to help prevent cross-contamination of infectious agents between staff and patients. This is a single-use garment.
2020-07-29
SURGIPLUS - Scrub Shirt, L A non-sterile, two-piece garment designed to be worn by healthcare staff to facilitate hygienic conditions typically in areas where surgery is performed. It typically consists of a shirt and pants composed of disposable materials and is intended to provide a barrier to help prevent cross-contamination of infectious agents between staff and patients. This is a single-use garment.
2020-07-22
SURGIPLUS - Scrub Shirt, XL A non-sterile, two-piece garment designed to be worn by healthcare staff to facilitate hygienic conditions typically in areas where surgery is performed. It typically consists of a shirt and pants composed of disposable materials and is intended to provide a barrier to help prevent cross-contamination of infectious agents between staff and patients. This is a single-use garment.
2020-07-22
SURGIPLUS - Scrub Shirt, 2XL A non-sterile, two-piece garment designed to be worn by healthcare staff to facilitate hygienic conditions typically in areas where surgery is performed. It typically consists of a shirt and pants composed of disposable materials and is intended to provide a barrier to help prevent cross-contamination of infectious agents between staff and patients. This is a single-use garment.
2020-07-22
SURGIPLUS - Scrub Pant, L A non-sterile, two-piece garment designed to be worn by healthcare staff to facilitate hygienic conditions typically in areas where surgery is performed. It typically consists of a shirt and pants composed of disposable materials and is intended to provide a barrier to help prevent cross-contamination of infectious agents between staff and patients. This is a single-use garment.
2020-07-22
SURGIPLUS - Scrub Pant, XL A non-sterile, two-piece garment designed to be worn by healthcare staff to facilitate hygienic conditions typically in areas where surgery is performed. It typically consists of a shirt and pants composed of disposable materials and is intended to provide a barrier to help prevent cross-contamination of infectious agents between staff and patients. This is a single-use garment.
2020-07-22
SURGIPLUS - Scrub Pant, 2XL A non-sterile, two-piece garment designed to be worn by healthcare staff to facilitate hygienic conditions typically in areas where surgery is performed. It typically consists of a shirt and pants composed of disposable materials and is intended to provide a barrier to help prevent cross-contamination of infectious agents between staff and patients. This is a single-use garment.
2020-07-22
SURGIPLUS - PE Film Gown
2020-07-02