SAFEMED LATEX SURGICAL GLOVES— 510(k) K914097

Name: FDA 510(k) clearance K914097
Creator: U.S. Food and Drug Administration
Published: 1992-08-14

Substantially Equivalent

Safetytech Sdn. Bhd.

FDA 510(k) clearance K914097 for SAFEMED LATEX SURGICAL GLOVES, Substantially Equivalent on 1992-08-14. Applicant: Safetytech Sdn. Bhd.. Device class: 1.

Clearance details

Applicant: Safetytech Sdn. Bhd.
Product code: Code KGO
Device class: Class 1
Regulation: 21 CFR 878.4460
Advisory panel: General, Plastic Surgery
Date received: 1991-09-12
Decision date: 1992-08-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Jalan Ipoh, 68100 Selang., 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.