NITRILE EXAMINATION GLOVES- PRE-POWDERED, SMALL, MEDIUM, AND LARGE— 510(k) K992177

Substantially Equivalent

Pt. Berlian Glovindo

FDA 510(k) clearance K992177 for NITRILE EXAMINATION GLOVES- PRE-POWDERED, SMALL, MEDIUM, AND LARGE, Substantially Equivalent on 1999-07-29. Applicant: Pt. Berlian Glovindo.

Clearance details

Applicant: Pt. Berlian Glovindo
Product code: Code LZA
Advisory panel: General Hospital
Date received: 1999-06-28
Decision date: 1999-07-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Kec. Labuhan Batu - N. Sumatra, 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.