FDA.report

510(k) K211390

Device
Nitrile Blue Powder-free Examination Glove
Applicant
Cardinal Health 200, LLC
510(k) number
K211390
Product code
LZA  
Decision
Substantially Equivalent (SESE)
Decision date
2021-08-28
Date received
2021-05-05
Regulation
880.6250
Classification name
Polymer Patient Examination Glove
Medical specialty
General Hospital
Review panel
General Hospital
Device class
1
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No
Source
FDA openFDA 510(k) dataset plus migrated FDA.report data

Related Records

Applicant Contact

Contact
William Cisneros
Address
3651 Birchwood Dr. Waukegan IL US 60085 60085

FDA Registration Numbers

Source Documents

FDA 510(k) Premarket Notification Database · 510(k) summary PDF not indicated by FDA · openFDA JSON

Legacy Summary

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FDA Review

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