CASHMERE NON-STERILE, POLYMER COATED POWDER FREE LATEX EXAMINATION GLOVES CONTAINS 50 MCGM OR LESS OF TOTAL WATER EXTRAM


Device Classification Name

latex patient examination glove

510(k) Number K021388
Device Name CASHMERE NON-STERILE, POLYMER COATED POWDER FREE LATEX EXAMINATION GLOVES CONTAINS 50 MCGM OR LESS OF TOTAL WATER EXTRAM
Original Applicant
SEAL POLYMER INDUSTRIES BHD.
lot 72706,jalan lahat,kawasan
perindustrian bukit merah
lahat, perak, 

MY

31500

Original Contact chun chooi fong
Regulation Number 880.6250
Classification Product Code
LYY  
Date Received 05/02/2002
Decision Date 06/10/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General Hospital

510k Review Panel

General Hospital

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No