Powder Free Nitrile Examination Gloves (White, Blue and Black)— 510(k) K212998

Substantially Equivalent

Alcatron Gloves Factory

FDA 510(k) clearance K212998 for Powder Free Nitrile Examination Gloves (White, Blue and Black), Substantially Equivalent on 2022-02-19. Applicant: Alcatron Gloves Factory.

Clearance details

Applicant: Alcatron Gloves Factory
Product code: Code LZA
Advisory panel: General Hospital
Date received: 2021-09-20
Decision date: 2022-02-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Weifang, CN

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.