POWDER FREE NITRILE EXAMINATION GLOVES (6MIL), TESTED FOR USE WITH CHEMOTHERAPY DRUGS (BLUE— 510(k) K101630

Substantially Equivalent

Pt. Smartglove Indonesia

FDA 510(k) clearance K101630 for POWDER FREE NITRILE EXAMINATION GLOVES (6MIL), TESTED FOR USE WITH CHEMOTHERAPY DRUGS (BLUE, Substantially Equivalent on 2010-09-07. Applicant: Pt. Smartglove Indonesia.

Clearance details

Applicant: Pt. Smartglove Indonesia
Product code: Code LZA
Advisory panel: General Hospital
Date received: 2010-06-10
Decision date: 2010-09-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Morawa,Deli Serdang,Sumatera U, ID

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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.