Powder Free Chloroprene Examination Glove Coloured (Blue, Green)— 510(k) K213993

Substantially Equivalent

Careglove Global Sdn. Bhd.

FDA 510(k) clearance K213993 for Powder Free Chloroprene Examination Glove Coloured (Blue, Green), Substantially Equivalent on 2022-08-05. Applicant: Careglove Global Sdn. Bhd..

Clearance details

Applicant: Careglove Global Sdn. Bhd.
Product code: Code LZA
Advisory panel: General Hospital
Date received: 2021-12-21
Decision date: 2022-08-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Seremban, 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.