FDA Product Code
FDA Product Code QPC — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- General, Plastic Surgery
- 21 CFR Citation
- 878.4040
510(k) Clearances — 12 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K262007 | PRIMED AAMI Level 3 Open Back Gowns | PRIMED Medical Products, Inc. | 2026-09-11 | Traditional | PDF ↗ |
| K261115 | VR® Personal Protective Level 4 Gown (VR Gowns) | PolyConversions, Inc. | 2026-08-11 | Traditional | PDF ↗ |
| K252940 | VR® Personal Protective Level 3 Gown (VR Gowns) | PolyConversions, Inc. | 2025-12-16 | Traditional | PDF ↗ |
| K242689 | AAMI Level 4 Protective; Gown | Azac Group | 2025-01-13 | Traditional | PDF ↗ |
| K233526 | Medline Open-back Level 3 Protective Gown | Medline Industries, LP | 2024-03-05 | Traditional | PDF ↗ |
| K230384 | PolyWear® Personal Protective Level 3 Gown | PolyConversions, Inc. | 2023-08-11 | Traditional | PDF ↗ |
| K222128 | Protective Gown AAMI Level 4 | Kenpax International Limited | 2023-08-08 | Traditional | PDF ↗ |
| K212464 | Dukal Corporation AAMI Level 4 Open-Back Protective Gown | Dukal Corporation | 2022-03-30 | Traditional | PDF ↗ |
| K203821 | Donagamex Blue Performance Protective Gown | Dong Nai Garment Corporation (Donagamex) | 2021-12-17 | Traditional | PDF ↗ |
| K210405 | ProTEC-USA EZDoff Gown | Cadillac Products, Inc. | 2021-12-15 | Traditional | PDF ↗ |
| K182830 | Cardinal HealthTM Poly-Coated Open-Back Protective Gown | Cardinal Health200, LLC | 2019-04-26 | Traditional | PDF ↗ |
| K160337 | Safecare Open Back Protective Gowns and ValueCare Open Back Protective Gowns | Bam Corporation Limited | 2017-07-07 | Traditional | PDF ↗ |
Product code QPC · Class II · General, Plastic Surgery. Data: openFDA.