FDA 510(k)
FDA class 2
Substantially Equivalent
🇻🇳 Vietnam
Donagamex Blue Performance Protective Gown
K Number: K203821
·
Decision Dec 17, 2021
Classifications
1
FEI Numbers
18
Registration Numbers
18
Same Product Code
9
Applicant Total
1
Review Days
353
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- Donagamex Blue Performance Protective Gown
- K Number
- K203821
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4040
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Dong Nai Garment Corporation (Donagamex)
- Date Received
- December 29, 2020
- Decision Date
- December 17, 2021
- Product Code
- QPC
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- HO
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| QPC | Gown, Non-Sterile, Non-Isolation, Intended To Provide Moderate Or High Barrier Protection | FDA class 2 | General, Plastic Surgery |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (QPC), ordered by most recent decision date.
VR® Personal Protective Level 3 Gown (VR Gowns)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
AAMI Level 4 Protective; Gown
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Medline Open-back Level 3 Protective Gown
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
PolyWear® Personal Protective Level 3 Gown
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Protective Gown AAMI Level 4
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Dukal Corporation AAMI Level 4 Open-Back Protective Gown
FDA 510(k)
FDA Class 2
·General, Plastic Surgery