LAXTEX POWDERED EXAMINATION GLOVE WITH PROTEIN LABELING CLAIM (100 MICROGRAMS OR LESS)— 510(k) K001557

Clearance details

Applicant

Kossan Latex Industries(M)Sdn Bhd

Product code

Code LYY

Device class

Class 1

Regulation

21 CFR 880.6250

Advisory panel

General Hospital

Date received

2000-05-19

Decision date

2000-06-09

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Klang, Selangor, MY

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