PATIENT EXAMINATION GLOVES, NITRILE POWDER FREE, TURQUOISE,NON-STERILE.— 510(k) K991845

Substantially Equivalent

Omnigrace , Ltd.

FDA 510(k) clearance K991845 for PATIENT EXAMINATION GLOVES, NITRILE POWDER FREE, TURQUOISE,NON-STERILE., Substantially Equivalent on 1999-08-05. Applicant: Omnigrace , Ltd..

Clearance details

Applicant: Omnigrace , Ltd.
Product code: Code LZA
Advisory panel: General Hospital
Date received: 1999-05-28
Decision date: 1999-08-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hatyai, Songkhla, TH

Download summary PDF View on FDA.gov ↗

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.