Black Nitrile Powder Free Patient Examination Glove, Non Sterile— 510(k) K212916

Substantially Equivalent

Rimba Glove Sdn Bhd

FDA 510(k) clearance K212916 for Black Nitrile Powder Free Patient Examination Glove, Non Sterile, Substantially Equivalent on 2022-03-24. Applicant: Rimba Glove Sdn Bhd.

Clearance details

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