BLUE NITRILE EXAMINATION GLOVES - POWDER FREE— 510(k) K994064

Substantially Equivalent

Glove Source, Inc.

FDA 510(k) clearance K994064 for BLUE NITRILE EXAMINATION GLOVES - POWDER FREE, Substantially Equivalent on 2000-01-28. Applicant: Glove Source, Inc..

Clearance details

Applicant: Glove Source, Inc.
Product code: Code LZA
Advisory panel: General Hospital
Date received: 1999-12-01
Decision date: 2000-01-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: City Of Industry, CA, US

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.