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510(k) K202081

Biodegradable DriTek Powder Free Nitrile Examination Glove, Low Dermatitis Potential Claim, Blue by Shen Wei USA, Inc. — Product Code LZA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 19, 2021
Date Received
July 27, 2020
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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  • K202086 — Biodegradable Powder Free Nitrile Examination Glove, Low Dermatitis,Potential Cl (March 16, 2021)

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