GLOVETEX POWDER FREE NITRILE EXAMINATION GLOVES, BLUE, NON-STERILE— 510(k) K032010

Clearance details

Applicant

Pt. Wrp Buana Multicorpora

Product code

Code LZA

Device class

Class 1

Regulation

21 CFR 880.6250

Advisory panel

General Hospital

Date received

2003-06-30

Decision date

2003-08-19

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Medan, ID

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• K022343 — GLOVETEX POWDER FREE LATEX EXAMINATION GLOVES, NON STERILE (PROTEIN CONTENT LABELING CLAIM 50UG/G OR LESS)2002-09-16
• K994426 — GLOVETEX, LATEX EXAMINATION GLOVES, POWDERED NON-STERILE.(PROTEIN CONTENT LABELING)2000-05-23

Other

1

Total

1

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →