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

Clearance details

Applicant

Pt. Smartglove Indonesia

Product code

Code LZA

Device class

Class 1

Regulation

21 CFR 880.6250

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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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 →