PureZero LIMON Nitrile Powder-Free Exam Gloves, PureZero LIMON-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 Limon Nitrile Powder-free Exam Gloves, Purezero Limon-xtra Nitrile Powder-free Exam Gloves.

Pre-market Notification Details

Device IDK220541
510k NumberK220541
Device Name:PureZero LIMON Nitrile Powder-Free Exam Gloves, PureZero LIMON-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
30680651488016 K220541 000
30680651487514 K220541 000
30680651487521 K220541 000
30680651487538 K220541 000
30680651487545 K220541 000
30680651487972 K220541 000
30680651487989 K220541 000
30680651487996 K220541 000
30680651488009 K220541 000
30680651487507 K220541 000

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