Glovmaster Nitrile Examination Glove Powder Free— 510(k) K212914

Substantially Equivalent

Glovmaster Sdn. Bhd.

FDA 510(k) clearance K212914 for Glovmaster Nitrile Examination Glove Powder Free, Substantially Equivalent on 2021-12-22. Applicant: Glovmaster Sdn. Bhd..

Clearance details

Applicant: Glovmaster Sdn. Bhd.
Product code: Code LZA
Advisory panel: General Hospital
Date received: 2021-09-13
Decision date: 2021-12-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Banting, MY

Download summary PDF View on FDA.gov ↗

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.