Sterile Latex Surgical Gloves Powder Free— 510(k) K212848

Name: FDA 510(k) clearance K212848
Creator: U.S. Food and Drug Administration
Published: 2021-12-27

Substantially Equivalent

Pentavest Holdings Sdn Bhd

FDA 510(k) clearance K212848 for Sterile Latex Surgical Gloves Powder Free, Substantially Equivalent on 2021-12-27. Applicant: Pentavest Holdings Sdn Bhd. Device class: 1.

Clearance details

Applicant: Pentavest Holdings Sdn Bhd
Product code: Code KGO
Device class: Class 1
Regulation: 21 CFR 878.4460
Advisory panel: General, Plastic Surgery
Date received: 2021-09-07
Decision date: 2021-12-27
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Batu, MY

Download summary PDF View on FDA.gov ↗

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