Donagamex Blue Performance Protective Gown
FDA 510(k) clearance K203821 · decided 2021-12-17
Clearance details
- K-number
- K203821
- Device name
- Donagamex Blue Performance Protective Gown
- Applicant
- Dong Nai Garment Corporation (Donagamex)
- Decision
- Substantially Equivalent
- Date received
- 2020-12-29
- Decision date
- 2021-12-17
- Days to decision
- 353 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
- Bien Hoa City, VN
- Third-party review
- No
- Expedited review
- No
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| Dukal Corporation AAMI Level 4 Open-Back Protective Gown (K212464) | Dukal Corporation | 2022-03-30 |
| 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 |
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Recalls involving this device
No recalls on record reference this clearance.