POWDER FREE GREEN LATEX SURGICAL GLOVES, STERILE WITH ALOE VERA AND PROTEIN CONTENT LABELING CLAIM (50 MICROGRAM LESS)


Device Classification Name

surgeon’s gloves

510(k) Number K022442
Device Name POWDER FREE GREEN LATEX SURGICAL GLOVES, STERILE WITH ALOE VERA AND PROTEIN CONTENT LABELING CLAIM (50 MICROGRAM LESS)
Original Applicant
WRP ASIA PACIFIC SDN. BHD.
lot 1, jalan 3,
kawasan perusahaan bandar baru
salak tinggi, sepang selangor, 

MY

43900

Original Contact yue wah chow
Regulation Number 878.4460
Classification Product Code
KGO  
Date Received 07/25/2002
Decision Date 09/05/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General & Plastic Surgery

510k Review Panel

General Hospital

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No