Sterile Latex Powder Free Surgical Gloves— 510(k) K253060
Substantially EquivalentProtect Gloves Company Limited
FDA 510(k) clearance K253060 for Sterile Latex Powder Free Surgical Gloves, Substantially Equivalent on 2026-05-22. Applicant: Protect Gloves Company Limited. Device class: 1.
Summary
Protect Gloves Company's Sterile Latex Powder Free Surgical Gloves are filed under KGO, surgeon's gloves. The device name is generic.
Class I, 21 CFR 878.4460. The General Hospital review panel handled it as a Traditional 510(k), though the record lists General and Plastic Surgery as the classification panel.
The company filed from Rayong, Thailand. Review took 242 calendar days (September 22, 2025 to May 22, 2026).
Clearance details
- Applicant
- Protect Gloves Company Limited
- Product code
- Product code KGO
- Device class
- Class 1
- Regulation
- 21 CFR 878.4460
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Rayong, TH
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Data sourced from openFDA. This site is unofficial and independent of the FDA.