POWDER FREE POLYMER COATED LATEX EXAMINATION GLOVES, STERILE, WITH PROTEIN LABELING CLAIM OF 50 UG PER DM2 OF GLOVE— 510(k) K090327

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

2009-02-09

Decision date

2009-04-03

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Klang, Selangor, MY

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