FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇳 China
Disposable Surgical Gowns (S,M,L,XL,XXL,XXXL)
K Number: K223401
·
Decision Mar 7, 2023
Classifications
1
FEI Numbers
218
Registration Numbers
218
Same Product Code
287
Applicant Total
3
Review Days
118
Basic Information
- Device Name
- Disposable Surgical Gowns (S,M,L,XL,XXL,XXXL)
- K Number
- K223401
- 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
- Xiamen Probtain Medical Techology Co., Ltd
- Date Received
- November 9, 2022
- Decision Date
- March 7, 2023
- 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 |
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