POWDERED STERILE LATEX SURGICAL GLOVE, WITH PROTEIN CONTENT LABELING CLAIM (200 MICROGRAMS OR LESS)


definition

Device Classification Name

surgeon’s gloves

510(k) Number K001959
Device Name POWDERED STERILE LATEX SURGICAL GLOVE, WITH PROTEIN CONTENT LABELING CLAIM (200 MICROGRAMS OR LESS)
Original Applicant
HARTALEGA SDN BHD
9 jalan kuang bulan taman
kepong industrial estate
kuala lumpur, 

MY

52100

Original Contact nuru aisyah kong
Regulation Number 878.4460
Classification Product Code
KGO  
Date Received 06/27/2000
Decision Date 07/26/2000
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General & Plastic Surgery

510k Review Panel

General Hospital

Type Traditional
Reviewed by Third Party No

Combination Product

No