Powder Free Nitrile Examination Glove (Blue) with Low Dermatitis claim and with tested for Use with Chemotherapy Drugs Claims— 510(k) K181066

Substantially Equivalent

Eco Medi Glove Sdn. Bhd.

FDA 510(k) clearance K181066 for Powder Free Nitrile Examination Glove (Blue) with Low Dermatitis claim and with tested for Use with Chemotherapy Drugs Claims, Substantially Equivalent on 2018-09-26. Applicant: Eco Medi Glove Sdn. Bhd..

Clearance details

Applicant
Eco Medi Glove Sdn. Bhd.
Product code
Code LZA
Advisory panel
General Hospital
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Perak, 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.