PRE-POWDERED NITRILE EXAMINATION GLOVES— 510(k) K974442

Name: FDA 510(k) clearance K974442
Creator: U.S. Food and Drug Administration
Published: 1998-01-05

Substantially Equivalent

P.T. Latexindo Tobaperkasa

FDA 510(k) clearance K974442 for PRE-POWDERED NITRILE EXAMINATION GLOVES, Substantially Equivalent on 1998-01-05. Applicant: P.T. Latexindo Tobaperkasa. Device class: 2.

Clearance details

Applicant: P.T. Latexindo Tobaperkasa
Product code: Code LZY
Device class: Class 2
Regulation: 21 CFR 888.3360
Advisory panel: Orthopedic
Date received: 1997-11-25
Decision date: 1998-01-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Medan, ID

Download summary PDF View on FDA.gov ↗

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Adverse events under product code LZY

product code LZY

Injury: 431
Total: 431

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.