MAXIKLEEN-LATEX EXAMINATION GLOVE POWDER FREE— 510(k) K983827

Substantially Equivalent

Sinetimed Latex Sdn Bhd

FDA 510(k) clearance K983827 for MAXIKLEEN-LATEX EXAMINATION GLOVE POWDER FREE, Substantially Equivalent on 1999-01-14. Applicant: Sinetimed Latex Sdn Bhd. Device class: 1.

Clearance details

Applicant
Sinetimed Latex 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
Taiping, Perak, MY
Download summary PDFView on FDA.gov ↗

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