Halyard Pink Underguard Nitrile Powder-Free Exam Glove Tested For Use With Chemotherapy Drugs

Patient Examination Glove, Specialty

O & M Halyard, Inc.

The following data is part of a premarket notification filed by O & M Halyard, Inc. with the FDA for Halyard Pink Underguard Nitrile Powder-free Exam Glove Tested For Use With Chemotherapy Drugs.

Pre-market Notification Details

Device IDK183132
510k NumberK183132
Device Name:Halyard Pink Underguard Nitrile Powder-Free Exam Glove Tested For Use With Chemotherapy Drugs
ClassificationPatient Examination Glove, Specialty
Applicant O & M Halyard, Inc. 5405 Windward Parkway Alpharetta,  GA  30004
ContactAngela L. Bunn
CorrespondentAngela L. Bunn
O & M Halyard, Inc. 5405 Windward Parkway Alpharetta,  GA  30004
Product CodeLZC  
CFR Regulation Number880.6250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeAbbreviated
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-11-13
Decision Date2019-02-05
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
30680651474569 K183132 000
30680651474552 K183132 000
30680651474545 K183132 000
30680651474538 K183132 000
30680651474521 K183132 000

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.