POLYMER COAT, POWDER FREE NITRILE EXAMINATION GLOVE (BLUE)— 510(k) K040791

Substantially Equivalent

Pt. Smartglove Indonesia

FDA 510(k) clearance K040791 for POLYMER COAT, POWDER FREE NITRILE EXAMINATION GLOVE (BLUE), Substantially Equivalent on 2004-06-03. Applicant: Pt. Smartglove Indonesia.

Clearance details

Applicant: Pt. Smartglove Indonesia
Product code: Code LZA
Advisory panel: General Hospital
Date received: 2004-03-29
Decision date: 2004-06-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tg Morawa-Deli Serdang Utara, 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.