NITRILE PATIENT EXAMINATION GLOVES, POWDER-FREE AND YELLOWISH WHITE— 510(k) K014284

Substantially Equivalent

Formosa Glove Industrial Co., Ltd.

FDA 510(k) clearance K014284 for NITRILE PATIENT EXAMINATION GLOVES, POWDER-FREE AND YELLOWISH WHITE, Substantially Equivalent on 2002-02-15. Applicant: Formosa Glove Industrial Co., Ltd.. Device class: 1.

Clearance details

Applicant
Formosa Glove Industrial Co., Ltd.
Product code
Code LZA
Device class
Class 1
Regulation
21 CFR 880.6250
Advisory panel
General Hospital
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Westfield, NJ, US
Download summary PDFView on FDA.gov ↗

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Adverse events under product code LZA

product code LZA
Other
1
Total
1

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.