COLORED AND FLAVORED POWDER FREE LATEX EXAMINATION GLOVES— 510(k) K993864

Name: FDA 510(k) clearance K993864
Creator: U.S. Food and Drug Administration
Published: 2000-01-20

Substantially Equivalent

Supermax Sdn Bhd

FDA 510(k) clearance K993864 for COLORED AND FLAVORED POWDER FREE LATEX EXAMINATION GLOVES, Substantially Equivalent on 2000-01-20. 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: 1999-11-15
Decision date: 2000-01-20
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.