LATEX EXAMINATION GLOVES (POWDERED)— 510(k) K120693

Clearance details

Applicant

Top Calibre Sdn Bhd

Product code

Code LYY

Device class

Class 1

Regulation

21 CFR 880.6250

Advisory panel

General Hospital

Date received

2012-03-07

Decision date

2012-05-08

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Shah Alam, MY

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