Sterile Latex Powder Free Surgical Gloves
FDA 510(k) clearance K253060 · decided 2026-05-22
Clearance details
- K-number
- K253060
- Device name
- Sterile Latex Powder Free Surgical Gloves
- Applicant
- Protect Gloves Company Limited
- Decision
- Substantially Equivalent
- Date received
- 2025-09-22
- Decision date
- 2026-05-22
- Days to decision
- 242 days
- Clearance type
- Traditional
- Product code
- KGO
- Device class
- 1
- Regulation number
- 878.4460
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Rayong, TH
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
Recalls involving this device
No recalls on record reference this clearance.