OMNI GRACE NITRILE, GREEN, EXAMINATION GLOVE, POWDER-FREE, POLYMER COATED— 510(k) K993050

Substantially Equivalent

Omnigrace , Ltd.

FDA 510(k) clearance K993050 for OMNI GRACE NITRILE, GREEN, EXAMINATION GLOVE, POWDER-FREE, POLYMER COATED, Substantially Equivalent on 1999-11-09. Applicant: Omnigrace , Ltd..

Clearance details

Applicant: Omnigrace , Ltd.
Product code: Code LZA
Advisory panel: General Hospital
Date received: 1999-09-10
Decision date: 1999-11-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: North Canton, OH, US

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Adverse events under product code LZA

product code LZA

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 →

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