TEXTURED POWDER-FREE LATEX EXAMINATION GLOVES CONTAINS 50 MICROGRAMS OR LESS OF TOTAL WATER EXTRACTABLE PROTEIN PER GRAM


Device Classification Name

latex patient examination glove

510(k) Number K011045
Device Name TEXTURED POWDER-FREE LATEX EXAMINATION GLOVES CONTAINS 50 MICROGRAMS OR LESS OF TOTAL WATER EXTRACTABLE PROTEIN PER GRAM
Original Applicant
SHEN WEI (USA), INC.
2845 whipple rd.
union city, 
CA 
94587

Original Contact belle chou
Regulation Number 880.6250
Classification Product Code
LYY  
Date Received 04/05/2001
Decision Date 09/11/2001
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General Hospital

510k Review Panel

General Hospital

Type Traditional
Reviewed by Third Party No

Combination Product

No