ALOETOUCH POWDER FREE, POLYMER COATED POLYISOPRENE SURGICAL GLOVES, STERILE, COATED WITH ALOE VERA, NATURAL COLOUR— 510(k) K040503

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

2004-02-27

Decision date

2004-03-16

Decision

Substantially Equivalent

Clearance type

Special

Location

Sepang, MY

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Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K040503.