PB PLUS LEAD LATEX GLOVES— 510(k) K896759

Name: FDA 510(k) clearance K896759
Creator: U.S. Food and Drug Administration
Published: 1990-03-27

Substantially Equivalent

Sistem Med-Pro (M) Sdn Bhd

FDA 510(k) clearance K896759 for PB PLUS LEAD LATEX GLOVES, Substantially Equivalent on 1990-03-27. Applicant: Sistem Med-Pro (M) Sdn Bhd. Device class: 1.

Clearance details

Applicant: Sistem Med-Pro (M) Sdn Bhd
Product code: Code LZC
Device class: Class 1
Regulation: 21 CFR 880.6250
Advisory panel: General Hospital
Date received: 1989-12-01
Decision date: 1990-03-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Santa Rosa, CA, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.