POWDER FREE POLYMER COATED LATEX SURGICAL GLOVES, STERILE (PROTEIN LABELING CLAIM)— 510(k) K020019

Clearance details

Applicant

Wrp Asia Pacific Sdn. Bhd.

Product code

Code KGO

Device class

Class 1

Regulation

21 CFR 878.4460

Advisory panel

General, Plastic Surgery

Date received

2002-01-03

Decision date

2002-01-23

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Salak Tinggi, Sepang Selangor, MY

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Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K020019.