Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim (Blue)— 510(k) K162646

Substantially Equivalent

Hartalega NGC Sdn. Bhd.

FDA 510(k) clearance K162646 for Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim (Blue), Substantially Equivalent on 2017-03-03. Applicant: Hartalega NGC Sdn. Bhd..

Clearance details

Applicant: Hartalega NGC Sdn. Bhd.
Product code: Code LZA
Advisory panel: General Hospital
Date received: 2016-09-22
Decision date: 2017-03-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sepang, 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.