Nitrile Patient Examination Powder Free Glove, Textured, Black— 510(k) K161085

Substantially Equivalent

Multisafe Sdn. Bhd.

FDA 510(k) clearance K161085 for Nitrile Patient Examination Powder Free Glove, Textured, Black, Substantially Equivalent on 2018-07-05. Applicant: Multisafe Sdn. Bhd..

Clearance details

Applicant
Multisafe Sdn. Bhd.
Product code
Code LZA
Advisory panel
General Hospital
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Bidor, MY
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.