LATEX EXAMINATION GLOVES POWDER-FREE WITH PROTEIN LABELING CLAIM (50 MICROGRAMS OR LESS TOTAL EXTRACTABLE PROTEIN)


Device Classification Name

latex patient examination glove

510(k) Number K991777
Device Name LATEX EXAMINATION GLOVES POWDER-FREE WITH PROTEIN LABELING CLAIM (50 MICROGRAMS OR LESS TOTAL EXTRACTABLE PROTEIN)
Applicant
SELTOM PACIFIC SDN. BHD.
lot 25, jalan pjs 7/17
sunway industrial park
petaling jaya, selangor, 

MY

46150

Applicant Contact s. segaran
Correspondent
SELTOM PACIFIC SDN. BHD.
lot 25, jalan pjs 7/17
sunway industrial park
petaling jaya, selangor, 

MY

46150

Correspodent Contact s. segaran
Regulation Number 880.6250
Classification Product Code
LYY  
Date Received 05/25/1999
Decision Date 08/31/1999
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