Data / Medical devices / Hong Kong / Kenpax International Limited
Kenpax International Limited: FDA-registered device maker in Kowloon, Hong Kong, 5 510(k) clearances
Kenpax International Limited is registered with the FDA (registration 3015820879) in Kowloon, Hong Kong. It lists 5 device types. The FDA files 5 510(k) clearances under its listings, the newest dated August 8, 2023. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3015820879
- Address
- Flat 5, 5/F., Wing On Plaza 62 Mody Road, Tsim Sha Tsui, Kowloon, Hong Kong, 999077
- Owner or operator
- Kenpax International Limited (10062935)
- Roles
- Exporter to the US, Specification developer
- First device listed
- March 13, 2020
- Registered through
- 2026
- Brand names listed
- Isolation Gown AAMI Level 3, PE Film Gown
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Gown, Isolation, Surgical | FYC | 2 | Specification developer | accessdata.fda.gov |
| Gown, Non-Sterile, Non-Isolation, Intended To Provide Moderate Or High Barrier Protection | QPC | 2 | Specification developer | accessdata.fda.gov |
| Mask, Surgical | FXX | 2 | Exporter to the US, Specification developer | accessdata.fda.gov |
| Non-Surgical Gown | OEA | 1 | Exporter to the US | accessdata.fda.gov |
| Wrap, Sterilization | FRG | 2 | Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| August 8, 2023 | K222128 | Protective Gown AAMI Level 4 | QPC | Substantially Equivalent | Kenpax International Limited | accessdata.fda.gov |
| March 23, 2023 | K222151 | Sterilization Wrap | FRG | Substantially Equivalent | Kenpax International Limited | accessdata.fda.gov |
| November 7, 2021 | K212504 | Isolation Gown AAMI Level 3 | FYC | Substantially Equivalent | Kenpax International Limited | accessdata.fda.gov |
| May 20, 2021 | K202899 | Procedure Mask, Surgical Mask | FXX | Substantially Equivalent | Kenpax International Limited | accessdata.fda.gov |
| June 19, 2003 | K031353 | SOLUTION FACE MASKS | FXX | Substantially Equivalent | A Plus International, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Gown, Non-Sterile, Non-Isolation, Intended To Provide Moderate Or High Barrier Protection
- All makers of Mask, Surgical
- All makers of Wrap, Sterilization
- All makers of Non-Surgical Gown
- All makers of Gown, Isolation, Surgical
Updated August 8, 2023. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.