BIOPRO, NITRILON, CORRECT TOUCH- NITRILE POWDERED EXAMINATION GLOVES (GREEN/ PURPLE)— 510(k) K994276

Substantially Equivalent

Biopro (M) Sdn Bhd

FDA 510(k) clearance K994276 for BIOPRO, NITRILON, CORRECT TOUCH- NITRILE POWDERED EXAMINATION GLOVES (GREEN/ PURPLE), Substantially Equivalent on 2000-10-20. Applicant: Biopro (M) Sdn Bhd.

Clearance details

Applicant: Biopro (M) Sdn Bhd
Product code: Code LZA
Advisory panel: General Hospital
Date received: 1999-12-20
Decision date: 2000-10-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Port Klang, 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.