FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Tuff Cuff Disposable Surgical Gowns AAMI L4 Sterile-Large (ML-L4-STL-DC-L)
K Number: K252575
·
Decision Jun 4, 2026
Classifications
1
FEI Numbers
222
Registration Numbers
222
Same Product Code
294
Applicant Total
1
Review Days
294
Basic Information
- Device Name
- Tuff Cuff Disposable Surgical Gowns AAMI L4 Sterile-Large (ML-L4-STL-DC-L)
- K Number
- K252575
- 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
- New York Embroidery Studio (NYES)
- Date Received
- August 14, 2025
- Decision Date
- June 4, 2026
- 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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