NITRILE PRE-POWDERED EXAMINATION GLOVES— 510(k) K974907

Substantially Equivalent

Smart Glove Corp. Sdn Bhd

FDA 510(k) clearance K974907 for NITRILE PRE-POWDERED EXAMINATION GLOVES, Substantially Equivalent on 1998-03-13. Applicant: Smart Glove Corp. Sdn Bhd.

Clearance details

Applicant: Smart Glove Corp. Sdn Bhd
Product code: Code LZA
Advisory panel: General Hospital
Date received: 1997-12-31
Decision date: 1998-03-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Selangor Darul Eshan, MY

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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.