Sterile Latex Powder Free Surgical Gloves— 510(k) K253060

Name: FDA 510(k) clearance K253060
Creator: U.S. Food and Drug Administration
Published: 2026-05-22

Substantially Equivalent

Protect 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.

Clearance details

Applicant: Protect Gloves Company Limited
Product code: Code KGO
Device class: Class 1
Regulation: 21 CFR 878.4460
Advisory panel: General, Plastic Surgery
Date received: 2025-09-22
Decision date: 2026-05-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rayong, TH

Download summary PDF View on FDA.gov ↗

Recent devices under product code KGO

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K240790 — Polyisoprene Surgical gloves2024-08-23
K232079 — Natural Rubber Latex Surgical Glove, Powder Free, Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl (Green) +1 more2024-03-28
K232444 — Sterile Powder Free Latex Surgical Gloves, Tested for Use with Chemotherapy Drugs2023-12-20

Data sourced from openFDA. This site is unofficial and independent of the FDA.