FDA.report

510(k) K191753

Device
Medline Sterile Powder-Free Nitrile Examination Gloves - Green (Tested For Use With Chemotherapy Drugs)
Applicant
Medline Industries, Inc.
510(k) number
K191753
Product code
LZA  
Decision
Substantially Equivalent (SESE)
Decision date
2020-03-17
Date received
2019-07-01
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
Claire Pigman
Address
Three Lakes Dr. Northfiled IL US 60093 60093

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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