DERMAGRIP POWDERFREE POLYMER COATED LATEX EXAMINATION GLOVE WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAM OR LESS)


definition

Device Classification Name

latex patient examination glove

510(k) Number K002579
Device Name DERMAGRIP POWDERFREE POLYMER COATED LATEX EXAMINATION GLOVE WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAM OR LESS)
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 08/18/2000
Decision Date 09/08/2000
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General Hospital

510k Review Panel

General Hospital

Type Traditional
Reviewed by Third Party No

Combination Product

No