LAXTEX EXAMINATION GLOVES, POWDERED CONTAINS 180 MCGM OR LESS OF TOTAL WATER EXTRACTABLE PROTEIN PER GRAM


Device Classification Name

latex patient examination glove

510(k) Number K022987
Device Name LAXTEX EXAMINATION GLOVES, POWDERED CONTAINS 180 MCGM OR LESS OF TOTAL WATER EXTRACTABLE PROTEIN PER GRAM
Original Applicant
ARISTA LATINDO INDUSTRIAL, LTD. P.T.
jl: k.h.moh mansyur no. 128
jakarta, 

ID

11210

Original Contact linga sumarta
Regulation Number 880.6250
Classification Product Code
LYY  
Date Received 09/09/2002
Decision Date 10/21/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General Hospital

510k Review Panel

General Hospital

statement

statement

Type Traditional
Reviewed by Third Party No

Combination Product

No