COMFORT RUBBER GLOVES INDUSTRIES SDN BHD— 510(k) K974424

Clearance details

Applicant

Comfort Rubber Gloves Industries Sdn. Bhd.

Product code

Code LYY

Device class

Class 1

Regulation

21 CFR 880.6250

Advisory panel

General Hospital

Date received

1997-11-24

Decision date

1998-04-23

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Matang, MY

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Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K974424.