NITRILE EXAMINATION GLOVES (WHITE, BLUE AND BLACK)— 510(k) K121192

Substantially Equivalent

Tekmedic (M) Sdn Bhd

FDA 510(k) clearance K121192 for NITRILE EXAMINATION GLOVES (WHITE, BLUE AND BLACK), Substantially Equivalent on 2012-08-03. Applicant: Tekmedic (M) Sdn Bhd.

Clearance details

Applicant: Tekmedic (M) Sdn Bhd
Product code: Code LZA
Advisory panel: General Hospital
Date received: 2012-04-19
Decision date: 2012-08-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tanjung Bruas Jetty, Tanjung Kling, 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.