SUPERGLOVES, POLYMER COATED POWDER FREE LATEX EXAMINATION GLOVES— 510(k) K991415

Name: FDA 510(k) clearance K991415
Creator: U.S. Food and Drug Administration
Published: 1999-05-26

Substantially Equivalent

Supermax Sdn Bhd

FDA 510(k) clearance K991415 for SUPERGLOVES, POLYMER COATED POWDER FREE LATEX EXAMINATION GLOVES, Substantially Equivalent on 1999-05-26. Applicant: Supermax Sdn Bhd. Device class: 1.

Clearance details

Applicant: Supermax Sdn Bhd
Product code: Code LYY
Device class: Class 1
Regulation: 21 CFR 880.6250
Advisory panel: General Hospital
Date received: 1999-04-23
Decision date: 1999-05-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sungai Pelong, Selangor, 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.