POWDERFREE COLORED AND FLAVORED CHLOROPRENE PATIENT EXAMINATION GLOVES— 510(k) K981064

Clearance details

Applicant

P.T. Irama Dinamika Latex

Product code

Product code LZA

Device class

Class 1

Regulation

21 CFR 880.6250

Advisory panel

General Hospital

Date received

1998-03-23

Decision date

1998-11-05

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Indonesia, 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 →