ON-LINE POWDER-FREE LATEX EXAMINATION GLOVE, TYPE II,LOW MODULUS, WITH PROTEIN LABELING CLAIM


Device Classification Name

latex patient examination glove

510(k) Number K030331
Device Name ON-LINE POWDER-FREE LATEX EXAMINATION GLOVE, TYPE II,LOW MODULUS, WITH PROTEIN LABELING CLAIM
Original Applicant
PERUSAHAAN GETAH ASAS SDN BHD
1301 defense highway
gambrills, 
MD 
21054 -1928

Original Contact james f logan
Regulation Number 880.6250
Classification Product Code
LYY  
Date Received 01/31/2003
Decision Date 03/21/2003
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