BLUE LATEX EXAM GLOVES NON STERILE CHLORINATED POWDER FREE


Device Classification Name

latex patient examination glove

510(k) Number K073299
Device Name BLUE LATEX EXAM GLOVES NON STERILE CHLORINATED POWDER FREE
Applicant
BETELCARE SDN BHD
lot 3342, jalan keretapi lama
7 1/2 mi off jalan kapar
selangor, darul ehsan, 

MY

42200

Applicant Contact keng beng siah
Correspondent
BETELCARE SDN BHD
lot 3342, jalan keretapi lama
7 1/2 mi off jalan kapar
selangor, darul ehsan, 

MY

42200

Correspodent Contact keng beng siah
Regulation Number 880.6250
Classification Product Code
LYY  
Date Received 11/23/2007
Decision Date 03/05/2008
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