POWDER-FREE LATEX EXAMINATION GLOVE WITH PROTEIN LABELING CLAIM (200 MICROGRAM PER GRAM OF GLOVE OR LESS)— 510(k) K023262

Substantially Equivalent

Perusahaan Getah Asas Sdn. Bhd.

FDA 510(k) clearance K023262 for POWDER-FREE LATEX EXAMINATION GLOVE WITH PROTEIN LABELING CLAIM (200 MICROGRAM PER GRAM OF GLOVE OR LESS), Substantially Equivalent on 2002-10-28. Applicant: Perusahaan Getah Asas Sdn. Bhd.. Device class: 1.

Clearance details

Applicant
Perusahaan Getah Asas 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
Selangor, Darul Ehsan, MY
Download summary PDFView on FDA.gov ↗

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