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

Substantially Equivalent

P.T. Irama Dinamika Latex

FDA 510(k) clearance K981064 for POWDERFREE COLORED AND FLAVORED CHLOROPRENE PATIENT EXAMINATION GLOVES, Substantially Equivalent on 1998-11-05. Applicant: P.T. Irama Dinamika Latex.

Clearance details

Applicant: P.T. Irama Dinamika Latex
Product code: Code LZA
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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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.