AAMI Level 4 Protective; Gown
FDA 510(k) clearance K242689 · decided 2025-01-13
Clearance details
- K-number
- K242689
- Device name
- AAMI Level 4 Protective; Gown
- Applicant
- Azac Group
- Decision
- Substantially Equivalent
- Date received
- 2024-09-06
- Decision date
- 2025-01-13
- Days to decision
- 129 days
- Clearance type
- Traditional
- Product code
- QPC
- Device class
- 2
- Regulation number
- 878.4040
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- City Of Industry, CA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| VR® Personal Protective Level 3 Gown (VR Gowns) (K252940) | PolyConversions, Inc. | 2025-12-16 |
| Medline Open-back Level 3 Protective Gown (K233526) | Medline Industries, LP | 2024-03-05 |
| PolyWear® Personal Protective Level 3 Gown (K230384) | PolyConversions, Inc. | 2023-08-11 |
| Protective Gown AAMI Level 4 (K222128) | Kenpax International Limited | 2023-08-08 |
| Dukal Corporation AAMI Level 4 Open-Back Protective Gown (K212464) | Dukal Corporation | 2022-03-30 |
| Donagamex Blue Performance Protective Gown (K203821) | Dong Nai Garment Corporation (Donagamex) | 2021-12-17 |
| ProTEC-USA EZDoff Gown (K210405) | Cadillac Products, Inc. | 2021-12-15 |
| Cardinal HealthTM Poly-Coated Open-Back Protective Gown (K182830) | Cardinal Health200, LLC | 2019-04-26 |
| Safecare Open Back Protective Gowns and ValueCare Open Back Protective Gowns (K160337) | Bam Corporation Limited | 2017-07-07 |
Recalls involving this device
No recalls on record reference this clearance.