FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇳 China
Protective Gown AAMI Level 4
K Number: K222128
·
Decision Aug 8, 2023
Classifications
1
FEI Numbers
18
Registration Numbers
18
Same Product Code
9
Applicant Total
4
Review Days
386
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Basic Information
- Device Name
- Protective Gown AAMI Level 4
- K Number
- K222128
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4040
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Kenpax International Limited
- Date Received
- July 18, 2022
- Decision Date
- August 8, 2023
- 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 |
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