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510(k) K171737

Micro Touch Denta Glove Nitrile Hydrasoft Patient Examination Gloves by Ansell Healthcare Products, LLC — Product Code LZA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 29, 2017
Date Received
June 12, 2017
Clearance Type
Traditional
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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