ABLE GLOVE NITRILE BLUE POWDER FREE EXAMINATION GLOVE— 510(k) K063777

Clearance details

Applicant

Bright Element Sdn Bhd

Product code

Product code LZA

Device class

Class 1

Regulation

21 CFR 880.6250

Advisory panel

General Hospital

Date received

2006-12-22

Decision date

2007-02-23

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Subang Jaya, Selangor, MY

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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 →