DERMAGRIP POWDER FREE POLYMER COATED LATEX EXAMINATION GLOVE STERILE, CONTAINS 50 MICROGRAMS OR LESS OF TOTAL EXTRACTABL


codes

Device Classification Name

latex patient examination glove

510(k) Number K002975
Device Name DERMAGRIP POWDER FREE POLYMER COATED LATEX EXAMINATION GLOVE STERILE, CONTAINS 50 MICROGRAMS OR LESS OF TOTAL EXTRACTABL
Original Applicant
WRP SPECIALTY PRODUCTS SDN. BHD.
lot11, jl.2,kawasan perusahaan
bandar baru slak tinggi
selangor daurl ehsan, sepang, 

MY

43900

Original Contact mohd haizan hussein
Regulation Number 880.6250
Classification Product Code
LYY  
Date Received 09/22/2000
Decision Date 10/24/2000
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General Hospital

510k Review Panel

General Hospital

Type Traditional
Reviewed by Third Party No

Combination Product

No