VINYL EXAM GLOVES (MFG. JM GLOVES CO. LTD.)— 510(k) K891568

Name: FDA 510(k) clearance K891568
Creator: U.S. Food and Drug Administration
Published: 1989-04-11

Substantially Equivalent

Neo-Sigma, Inc.

FDA 510(k) clearance K891568 for VINYL EXAM GLOVES (MFG. JM GLOVES CO. LTD.), Substantially Equivalent on 1989-04-11. Applicant: Neo-Sigma, Inc.. Device class: 1.

Clearance details

Applicant: Neo-Sigma, Inc.
Product code: Code LYZ
Device class: Class 1
Regulation: 21 CFR 880.6250
Advisory panel: General Hospital
Date received: 1989-03-17
Decision date: 1989-04-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Dallas, TX, 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.