Nitrile Powder Free Examination Gloves, Chemotherapy Nitrile Powder Free Examination Gloves— 510(k) K220118

Substantially Equivalent

Kl-Kepong Rubber Products Sdn. Bhd.

FDA 510(k) clearance K220118 for Nitrile Powder Free Examination Gloves, Chemotherapy Nitrile Powder Free Examination Gloves, Substantially Equivalent on 2022-05-12. Applicant: Kl-Kepong Rubber Products Sdn. Bhd..

Clearance details

Applicant: Kl-Kepong Rubber Products Sdn. Bhd.
Product code: Code LZA
Advisory panel: General Hospital
Date received: 2022-01-14
Decision date: 2022-05-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ipoh, 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.