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510(k) K220055

Disposable, vinyl examination gloves, Yellow by Dezhou Hengchang Medical Technology Co., Ltd. — Product Code LYZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 25, 2022
Date Received
January 6, 2022
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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

A vinyl patient examination glove is a disposable device made of poly(vinyl chloride) 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.

Other clearances by Dezhou Hengchang Medical Technology Co., Ltd.

  • K213634 — Vinyl/Nitrile Blend Exam Glove (February 18, 2022)
  • K213625 — Vinyl Examination Gloves (February 17, 2022)

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  • K220992 — Disposable Powder Free Vinyl Exam Glove, Black/Blue/Purple (October 19, 2022)
  • K223008 — Disposable Vinyl Examination Gloves (October 8, 2022)
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  • K220240 — Vinyl Co-Polymer Powder-free Examination Gloves, Black (March 31, 2022)