Blue Nitrile Examination Glove Powder Free— 510(k) K211479

Substantially Equivalent

Aspen Glove Sdn. Bhd.

FDA 510(k) clearance K211479 for Blue Nitrile Examination Glove Powder Free, Substantially Equivalent on 2021-09-16. Applicant: Aspen Glove Sdn. Bhd..

Clearance details

Applicant: Aspen Glove Sdn. Bhd.
Product code: Code LZA
Advisory panel: General Hospital
Date received: 2021-05-12
Decision date: 2021-09-16
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Georgetown, 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.