STERILE POWDERED LATEX SURGICAL GLOVES WITH PROTEIN LABELING CLAIM (200 MICROGRAMS OR LESS)— 510(k) K012896

Name: FDA 510(k) clearance K012896
Creator: U.S. Food and Drug Administration
Published: 2001-11-16

Substantially Equivalent

Ssn Gloves (M) Sdn Bhd

FDA 510(k) clearance K012896 for STERILE POWDERED LATEX SURGICAL GLOVES WITH PROTEIN LABELING CLAIM (200 MICROGRAMS OR LESS), Substantially Equivalent on 2001-11-16. Applicant: Ssn Gloves (M) Sdn Bhd. Device class: 1.

Clearance details

Applicant: Ssn Gloves (M) Sdn Bhd
Product code: Code KGO
Device class: Class 1
Regulation: 21 CFR 878.4460
Advisory panel: General, Plastic Surgery
Date received: 2001-08-28
Decision date: 2001-11-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Petaling Jaya, Selangor, MY

Download summary PDF View on FDA.gov ↗

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