OMNI FLEX NITRILE EXAMINATION GLOVE, POWDER-FREE, BLUE— 510(k) K983730

Substantially Equivalent

Omnigrace , Ltd.

FDA 510(k) clearance K983730 for OMNI FLEX NITRILE EXAMINATION GLOVE, POWDER-FREE, BLUE, Substantially Equivalent on 1998-12-11. Applicant: Omnigrace , Ltd..

Clearance details

Applicant: Omnigrace , Ltd.
Product code: Code LZA
Advisory panel: General Hospital
Date received: 1998-10-22
Decision date: 1998-12-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hatyai, Songkhla, TH

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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.