SCINITREX (POWDERED NITRILE EXAMINATION GLOVESD)— 510(k) K952052

Substantially Equivalent

Wembley Rubber Products (M) Sdn Bhd

FDA 510(k) clearance K952052 for SCINITREX (POWDERED NITRILE EXAMINATION GLOVESD), Substantially Equivalent on 1995-10-30. Applicant: Wembley Rubber Products (M) Sdn Bhd.

Clearance details

Applicant: Wembley Rubber Products (M) Sdn Bhd
Product code: Code LZA
Advisory panel: General Hospital
Date received: 1995-05-01
Decision date: 1995-10-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Salak Tinggi, Sepang Selangor, 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.