PRE-POWDERED NITRILE EXAMINATION GLOVES— 510(k) K010232

Substantially Equivalent

P.T. Healthcare Glovindo

FDA 510(k) clearance K010232 for PRE-POWDERED NITRILE EXAMINATION GLOVES, Substantially Equivalent on 2001-09-21. Applicant: P.T. Healthcare Glovindo.

Clearance details

Applicant: P.T. Healthcare Glovindo
Product code: Code LZA
Advisory panel: General Hospital
Date received: 2001-01-24
Decision date: 2001-09-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Medan 10340, 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.