NUZONE NITRILE SURGICAL GLOVES POWDER FREE— 510(k) K000179

Name: FDA 510(k) clearance K000179
Creator: U.S. Food and Drug Administration
Published: 2000-05-15

Substantially Equivalent

Terang Nusa Sdn Bhd

FDA 510(k) clearance K000179 for NUZONE NITRILE SURGICAL GLOVES POWDER FREE, Substantially Equivalent on 2000-05-15. Applicant: Terang Nusa Sdn Bhd. Device class: 1.

Clearance details

Applicant: Terang Nusa Sdn Bhd
Product code: Code KGO
Device class: Class 1
Regulation: 21 CFR 878.4460
Advisory panel: General, Plastic Surgery
Date received: 2000-01-20
Decision date: 2000-05-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Kota Bharu, 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.