POWDER FREE NITRILE EXAMINATION GLOVES, BLACK— 510(k) K092034

Substantially Equivalent

Pt. Smartglove Indonesia

FDA 510(k) clearance K092034 for POWDER FREE NITRILE EXAMINATION GLOVES, BLACK, Substantially Equivalent on 2009-10-19. Applicant: Pt. Smartglove Indonesia.

Clearance details

Applicant: Pt. Smartglove Indonesia
Product code: Code LZA
Advisory panel: General Hospital
Date received: 2009-07-06
Decision date: 2009-10-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Morawa,Deli Serdang,Sumatera U, ID

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.