510(k) K222128
- Device
- Protective Gown AAMI Level 4
- Applicant
- Kenpax International Limited
- 510(k) number
- K222128
- Product code
- QPC
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2023-08-08
- Date received
- 2022-07-18
- Regulation
- 878.4040
- Classification name
- Gown, Non-Sterile, Non-Isolation, Intended To Provide Moderate Or High Barrier Protection
- Medical specialty
- General, Plastic Surgery
- Review panel
- General, Plastic Surgery
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- Solomon Chen
- Address
- Flat 5, 5/F, Wing On Plz., 62 Mody Rd. Tsim Sha Tsui, Kowloon Hong Kong CN 999077 999077
FDA Registration Numbers#
- 1417592
- 3015960676
- 3013557562
- 3015820879
- 3011547453
- 3013410562
- 3038356900
- 3004513970
- 3008959420
- 1423537
- 3013502418
- 3015499242
- 3042129477
- 1043644
- 1423205
- 1921846
- 3007339875
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code QPC#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K252940 | VR® Personal Protective Level 3 Gown (VR Gowns) | PolyConversions, Inc. | 2025-12-16 |
| K242689 | AAMI Level 4 Protective; Gown | Azac Group | 2025-01-13 |
| K233526 | Medline Open-back Level 3 Protective Gown | Medline Industries, LP | 2024-03-05 |
| K230384 | PolyWear® Personal Protective Level 3 Gown | PolyConversions, Inc. | 2023-08-11 |
| K212464 | Dukal Corporation AAMI Level 4 Open-Back Protective Gown | Dukal Corporation | 2022-03-30 |
| K203821 | Donagamex Blue Performance Protective Gown | Dong Nai Garment Corporation (Donagamex) | 2021-12-17 |
| K210405 | ProTEC-USA EZDoff Gown | Cadillac Products, Inc. | 2021-12-15 |
| K182830 | Cardinal HealthTM Poly-Coated Open-Back Protective Gown | Cardinal Health200, LLC | 2019-04-26 |
| K160337 | Safecare Open Back Protective Gowns and ValueCare Open Back Protective Gowns | Bam Corporation Limited | 2017-07-07 |