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510(k) K243604

Halyard Purple Nitrile-XTRA* Powder-Free Exam Gloves, Low Dermatitis Potential, Tested for Use with Chemotherapy Drugs, Fentanyl Citrate and Fentanyl Citrate in Simulated Gastric Acid by O&M Halyard, Inc. — Product Code LZA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 18, 2025
Date Received
November 21, 2024
Clearance Type
Abbreviated
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Polymer Patient Examination Glove
Device Class
Class I
Regulation Number
880.6250
Review Panel
HO
Submission Type

A nitrile (or polymer) patient examination glove is a disposable device made of nitrile rubber or synthetic polymers that may or may not bear a trace amount of residual powder, and is intended to be worn on the hand for medical purposes to provide a barrier against potentially infectious materials and other contaminants.

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