SBG Blue Nitrile Powder Free Medical Examination Glove— 510(k) K180467

Substantially Equivalent

Showa Best Glove, Inc.

FDA 510(k) clearance K180467 for SBG Blue Nitrile Powder Free Medical Examination Glove, Substantially Equivalent on 2018-10-10. Applicant: Showa Best Glove, Inc..

Clearance details

Applicant
Showa Best Glove, Inc.
Product code
Code LZA
Advisory panel
General Hospital
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Menlo, GA, US
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.