Powder Free Nitrile Examination Glove, Tested For Use With Chemoterapy Drugs (Blue)

Polymer Patient Examination Glove

Harbour Health LLC

The following data is part of a premarket notification filed by Harbour Health Llc with the FDA for Powder Free Nitrile Examination Glove, Tested For Use With Chemoterapy Drugs (blue).

Pre-market Notification Details

Device IDK210944
510k NumberK210944
Device Name:Powder Free Nitrile Examination Glove, Tested For Use With Chemoterapy Drugs (Blue)
ClassificationPolymer Patient Examination Glove
Applicant Harbour Health LLC 4590 MacArthur Boulevard, Suite 500 Newport Beach,  CA  92660
ContactJared Koenig
CorrespondentDave Yungvirt
THIRD PARTY REVIEW GROUP, LLC 25 Independence Blvd Warren,  NJ  07059
Product CodeLZA  
Subsequent Product CodeLZC
Subsequent Product CodeOPJ
CFR Regulation Number880.6250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedYes
Combination ProductNo
Date Received2021-03-30
Decision Date2021-04-29

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