Sterile Surgical Powder Free Latex Glove— 510(k) K221424

Name: FDA 510(k) clearance K221424
Creator: U.S. Food and Drug Administration
Published: 2023-01-26

Substantially Equivalent

New Era Medicare Sdn. Bhd.

FDA 510(k) clearance K221424 for Sterile Surgical Powder Free Latex Glove, Substantially Equivalent on 2023-01-26. Applicant: New Era Medicare Sdn. Bhd.. Device class: 1.

Clearance details

Applicant: New Era Medicare Sdn. Bhd.
Product code: Code KGO
Device class: Class 1
Regulation: 21 CFR 878.4460
Advisory panel: General, Plastic Surgery
Date received: 2022-05-16
Decision date: 2023-01-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Teluk Intan, 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.