FLEXISKIN LATEX EXAMINATION GLOVES, POWDERED, NON STERILE— 510(k) K031020

Name: FDA 510(k) clearance K031020
Creator: U.S. Food and Drug Administration
Published: 2003-05-21

Substantially Equivalent

Pt. Mandiri Inti Buana

FDA 510(k) clearance K031020 for FLEXISKIN LATEX EXAMINATION GLOVES, POWDERED, NON STERILE, Substantially Equivalent on 2003-05-21. Applicant: Pt. Mandiri Inti Buana. Device class: 1.

Clearance details

Applicant: Pt. Mandiri Inti Buana
Product code: Code LYY
Device class: Class 1
Regulation: 21 CFR 880.6250
Advisory panel: General Hospital
Date received: 2003-03-31
Decision date: 2003-05-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Medan, ID

Download summary PDF View on FDA.gov ↗

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K051987 — FLEXISKIN POLYMER COATED LATEX EXAMINATION GLOVES, POWDER FREE, NON-STERILE2005-10-06
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Data sourced from openFDA. This site is unofficial and independent of the FDA.