LATEX EXAMINATION GLOVE,POWEDERED TYPE II, LOW MODULUS,WITH PROTEIN LABLING CLAIM


Device Classification Name

latex patient examination glove

510(k) Number K030333
Device Name LATEX EXAMINATION GLOVE,POWEDERED TYPE II, LOW MODULUS,WITH PROTEIN LABLING 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