POWDER FREE LATEX EXAM GLOVES— 510(k) K031335

Name: FDA 510(k) clearance K031335
Creator: U.S. Food and Drug Administration
Published: 2003-10-16

Substantially Equivalent

Tan Sin Lian Industries Sdn. Bhd.

FDA 510(k) clearance K031335 for POWDER FREE LATEX EXAM GLOVES, Substantially Equivalent on 2003-10-16. Applicant: Tan Sin Lian Industries Sdn. Bhd.. Device class: 1.

Clearance details

Applicant: Tan Sin Lian Industries Sdn. Bhd.
Product code: Code LYY
Device class: Class 1
Regulation: 21 CFR 880.6250
Advisory panel: General Hospital
Date received: 2003-04-28
Decision date: 2003-10-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Philadephia, PA, US

Download summary PDF View on FDA.gov ↗

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