PATIENT EXAMINATION GLOVES (POLY)— 510(k) K892768

Substantially Equivalent

Promedica Products, Inc.

FDA 510(k) clearance K892768 for PATIENT EXAMINATION GLOVES (POLY), Substantially Equivalent on 1989-06-14. Applicant: Promedica Products, Inc..

Clearance details

Applicant: Promedica Products, Inc.
Product code: Code LZA
Advisory panel: General Hospital
Date received: 1989-04-11
Decision date: 1989-06-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Newport Beach, CA, 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.