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


Device Classification Name

latex patient examination glove

510(k) Number K023262
Device Name POWDER-FREE LATEX EXAMINATION GLOVE WITH PROTEIN LABELING CLAIM (200 MICROGRAM PER GRAM OF GLOVE OR LESS)
Original Applicant
PERUSAHAAN GETAH ASAS SDN BHD
41720 klang,
p.o. box 188, 41720 klang
selangor, darul ehsan, 

MY

42100

Original Contact tan kong chang
Regulation Number 880.6250
Classification Product Code
LYY  
Date Received 09/30/2002
Decision Date 10/28/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General Hospital

510k Review Panel

General Hospital

statement

statement

Type Traditional
Reviewed by Third Party No

Combination Product

No