POWDER FREE POLYMER COATED LATEX SURGICAL GLOVES, STERILE, WITH PROTEIN LABELING CLAIM OF 50 MICROGRAMS PER DM2 OF GLOVE— 510(k) K090066

Clearance details

Applicant

Wear Safe (Malaysia) Sdn. Bhd.

Product code

Code KGO

Device class

Class 1

Regulation

21 CFR 878.4460

Advisory panel

General, Plastic Surgery

Date received

2009-01-09

Decision date

2009-05-15

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Klang, Selangor Darul Ehsan, MY

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