HEALTH-PLUS, SANITEX, RELIANCE STERILE POWDER-FREE NITRILE SURGICAL GLOVES— 510(k) K993756

Name: FDA 510(k) clearance K993756
Creator: U.S. Food and Drug Administration
Published: 2000-04-28

Substantially Equivalent

Pamitex Industries Sdn Bhd

FDA 510(k) clearance K993756 for HEALTH-PLUS, SANITEX, RELIANCE STERILE POWDER-FREE NITRILE SURGICAL GLOVES, Substantially Equivalent on 2000-04-28. Applicant: Pamitex Industries Sdn Bhd. Device class: 1.

Clearance details

Applicant: Pamitex Industries Sdn Bhd
Product code: Code KGO
Device class: Class 1
Regulation: 21 CFR 878.4460
Advisory panel: General, Plastic Surgery
Date received: 1999-11-05
Decision date: 2000-04-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Darul Khusus, 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.