Single-Use Latex Sterile Surgical Gloves (SG100)— 510(k) K231446

Name: FDA 510(k) clearance K231446
Creator: U.S. Food and Drug Administration
Published: 2023-09-22

Substantially Equivalent

Fitone Latex Products Co., Ltd. Guangdong

FDA 510(k) clearance K231446 for Single-Use Latex Sterile Surgical Gloves (SG100), Substantially Equivalent on 2023-09-22. Applicant: Fitone Latex Products Co., Ltd. Guangdong. Device class: 1.

Clearance details

Applicant: Fitone Latex Products Co., Ltd. Guangdong
Product code: Code KGO
Device class: Class 1
Regulation: 21 CFR 878.4460
Advisory panel: General, Plastic Surgery
Date received: 2023-05-18
Decision date: 2023-09-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Zhanjiang, CN

Download summary PDF View on FDA.gov ↗

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