POWDER FREE POLYMER COATED LATEX EXAMINATION GLOVES, NON-STERILE, WITH PROTEIN LABELING CLAIM OF 50 MICROGRAMS PER DM2 O— 510(k) K092492

Clearance details

Applicant

Wear Safe (Malaysia) Sdn. Bhd.

Product code

Code LYY

Device class

Class 1

Regulation

21 CFR 880.6250

Advisory panel

General Hospital

Date received

2009-08-13

Decision date

2009-10-21

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Klang, Selangor Darul Ehsan, MY

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