LATEX EXAMINATION GLOVES-POWDERED, NONSTERILE— 510(k) K010347

Substantially Equivalent

Enzymic Technologies Sdn Bhd

FDA 510(k) clearance K010347 for LATEX EXAMINATION GLOVES-POWDERED, NONSTERILE, Substantially Equivalent on 2001-03-27. Applicant: Enzymic Technologies Sdn Bhd. Device class: 1.

Clearance details

Applicant
Enzymic Technologies Sdn Bhd
Product code
Code LYY
Device class
Class 1
Regulation
21 CFR 880.6250
Advisory panel
General Hospital
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Melaka, MY
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