POWDER FREE STERILE LATEX SURGICAL GLOVES, CONTAINS 50 MICROGRAM OR LESS OF TOTAL WATER EXTRACTABLE PROTEIN PER GRAM— 510(k) K002593

Clearance details

Applicant

Hartalega Sdn Bhd

Product code

Code KGO

Device class

Class 1

Regulation

21 CFR 878.4460

Advisory panel

General, Plastic Surgery

Date received

2000-08-21

Decision date

2000-11-29

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Kuala Lumpur, MY

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