LOW POWDER POLYMER LATEX EXAMINATION GLOVES (WITH PROTEIN LABELING CLAIM)— 510(k) K973871

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

1997-10-10

Decision date

1997-12-11

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Kuala Lumpur, MY

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