ARMOR, LATEX EXAMINATION GLOVES— 510(k) K894499

Name: FDA 510(k) clearance K894499
Creator: U.S. Food and Drug Administration
Published: 1989-09-21

Substantially Equivalent

Prestige Manufacturing Snd Bhd

FDA 510(k) clearance K894499 for ARMOR, LATEX EXAMINATION GLOVES, Substantially Equivalent on 1989-09-21. Applicant: Prestige Manufacturing Snd Bhd. Device class: 1.

Clearance details

Applicant: Prestige Manufacturing Snd Bhd
Product code: Code LYY
Device class: Class 1
Regulation: 21 CFR 880.6250
Advisory panel: General Hospital
Date received: 1989-07-19
Decision date: 1989-09-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: 58200 Kuala Lumpur Malays, MY

Download summary PDF View on FDA.gov ↗

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