POWDER FREE NATURAL RUBBER LOW MODULUS LATEX PATIENT EXAMINATION GLOVES WITH A PROTEIN LABELING CLAIM


Device Classification Name

latex patient examination glove

510(k) Number K072300
Device Name POWDER FREE NATURAL RUBBER LOW MODULUS LATEX PATIENT EXAMINATION GLOVES WITH A PROTEIN LABELING CLAIM
Applicant
PERUSAHAAN PELINDUNG GETAH (M) SDN BHD
2000 cold spring road
dixville notch, 
NH 
03576

Applicant Contact thomas n tillotson
Regulation Number 880.6250
Classification Product Code
LYY  
Date Received 08/17/2007
Decision Date 05/16/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General Hospital

510k Review Panel

General Hospital

statement

statement

Type Traditional
Reviewed by Third Party Yes

Combination Product

No