FDA.report

510(k) K192988

Device
Dermasure Green Sterile SyntheticPolychloroprene Powder-Free Surgical Glove Tested For Use
Applicant
Medline Industries, Inc.
510(k) number
K192988
Product code
KGO  
Decision
Substantially Equivalent (SESE)
Decision date
2020-04-01
Date received
2019-10-25
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
Jennifer Mason
Address
Three Lakes Dr. Northfield IL US 60030 60030

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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