FDA.report

510(k) K201592

Device
Cardinal Health Protexis PI Blue With Neu-Thera Surgical Glove
Applicant
Cardinal Health 200, LLC
510(k) number
K201592
Product code
KGO  
Decision
Substantially Equivalent (SESE)
Decision date
2021-09-26
Date received
2020-06-12
Regulation
878.4460
Classification name
Surgeon's Gloves
Medical specialty
General & Plastic Surgery
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
Padmini Sahoo
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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