ELAZ Nitrile Powder Free Examination Glove— 510(k) K213604

Substantially Equivalent

Protect Gloves Co., Ltd.

FDA 510(k) clearance K213604 for ELAZ Nitrile Powder Free Examination Glove, Substantially Equivalent on 2022-04-03. Applicant: Protect Gloves Co., Ltd..

Clearance details

Applicant
Protect Gloves Co., Ltd.
Product code
Code LZA
Advisory panel
General Hospital
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Pluakdang, TH
Download summary PDFView on FDA.gov ↗

Adverse events under product code LZA

product code LZA
Other
1
Total
1

Source: openFDA MAUDE database, through . 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.