FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇳 China
Surgical Gown
K Number: K211809
·
Decision Oct 18, 2021
Classifications
1
FEI Numbers
222
Registration Numbers
222
Same Product Code
294
Applicant Total
4
Review Days
129
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
- Surgical Gown
- K Number
- K211809
- 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
- Wuhan Dymex Healthcare Co., Ltd.
- Date Received
- June 11, 2021
- Decision Date
- October 18, 2021
- Product Code
- FYA
- 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 |
|---|---|---|---|
| FYA | Gown, Surgical | FDA class 2 | General, Plastic Surgery |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (FYA), ordered by most recent decision date.
Tuff Cuff Disposable Surgical Gowns AAMI L4 Sterile-Large (ML-L4-STL-DC-L)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
BAÜMER Surgical Gowns (COP01, COP04, COP05, COP10)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Cardinal Health Poly Reinforced Surgical Gown
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Non-sterile Level 3 Surgical Gown (4025); Sterile Level 3 Surgical Gown (M4025); Non-sterile Reinforced Level 4 Surgical Gown (G4025); Reinforced Sterile Level 4 Surgical Gown (GM4025)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Copioumed AAMI 3 Surgical Gown
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Henan Yadu Level 4 Surgical Gowns (Reinforced)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery