PureZero MARIN Nitrile Powder-Free Exam Gloves, PureZero MARIN-XTRA Nitrile Powder-Free Exam Gloves

Polymer Patient Examination Glove

O&M Halyard, Inc.

The following data is part of a premarket notification filed by O&m Halyard, Inc. with the FDA for Purezero Marin Nitrile Powder-free Exam Gloves, Purezero Marin-xtra Nitrile Powder-free Exam Gloves.

Pre-market Notification Details

Device IDK220547
510k NumberK220547
Device Name:PureZero MARIN Nitrile Powder-Free Exam Gloves, PureZero MARIN-XTRA Nitrile Powder-Free Exam Gloves
ClassificationPolymer Patient Examination Glove
Applicant O&M Halyard, Inc. 1 Edison Drive Alpharetta,  GA  30005
ContactAngela L. Bunn
CorrespondentAngela L. Bunn
O&M Halyard, Inc. 1 Edison Drive Alpharetta,  GA  30005
Product CodeLZA  
Subsequent Product CodeLZC
Subsequent Product CodeQDO
CFR Regulation Number880.6250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-02-25
Decision Date2022-06-02

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
30680651488818 K220547 000
30680651487620 K220547 000
30680651487637 K220547 000
30680651487644 K220547 000
30680651487651 K220547 000
30680651487668 K220547 000
30680651487675 K220547 000
30680651487682 K220547 000
30680651487699 K220547 000
30680651487705 K220547 000
30680651488771 K220547 000
30680651488788 K220547 000
30680651488795 K220547 000
30680651488801 K220547 000
30680651487613 K220547 000

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