POWDER-FREE LATEX EXAMINATION GLOVES (BLUE)— 510(k) K980318

Clearance details

Applicant

Hartalega Sdn Bhd

Product code

Code LYY

Device class

Class 1

Regulation

21 CFR 880.6250

Advisory panel

General Hospital

Date received

1998-01-27

Decision date

1998-03-11

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Kuala Lumpur, MY

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