NITRIKLEEN- NITRILE EXAMINATION GLOVE POWDER FREE— 510(k) K983828

Substantially Equivalent

Sinetimed Latex Sdn Bhd

FDA 510(k) clearance K983828 for NITRIKLEEN- NITRILE EXAMINATION GLOVE POWDER FREE, Substantially Equivalent on 1999-01-21. Applicant: Sinetimed Latex Sdn Bhd.

Clearance details

Applicant: Sinetimed Latex Sdn Bhd
Product code: Code LZA
Advisory panel: General Hospital
Date received: 1998-10-30
Decision date: 1999-01-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Taiping, Perak, 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.