SURGIFIT STERILE SURGICAL GLOVES— 510(k) K913215

Name: FDA 510(k) clearance K913215
Creator: U.S. Food and Drug Administration
Published: 1991-09-23

Substantially Equivalent

Hevealactics Intl. Sdn Bhd

FDA 510(k) clearance K913215 for SURGIFIT STERILE SURGICAL GLOVES, Substantially Equivalent on 1991-09-23. Applicant: Hevealactics Intl. Sdn Bhd. Device class: 1.

Clearance details

Applicant: Hevealactics Intl. Sdn Bhd
Product code: Code KGO
Device class: Class 1
Regulation: 21 CFR 878.4460
Advisory panel: General, Plastic Surgery
Date received: 1991-07-19
Decision date: 1991-09-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Klang, Selangor Darul Ehsan, 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.