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510(k) K191292

Powder Free Vinyl Patient Examination Gloves, Clear (non-colored) by Anhui Powerguard Technology Co., Ltd. — Product Code LYZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 5, 2019
Date Received
May 14, 2019
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 Anhui Powerguard Technology Co., Ltd.

  • K233520 — Powder free, Non-sterile, Blue Nitrile Examination Gloves, Tested for Use with C (January 12, 2024)
  • K211860 — Powder Free Nitrile Patient Examination Gloves, Blue Color (August 13, 2021)

Other clearances for product code LYZ

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  • K252505 — Powder-Free Vinyl Exam Gloves, clear (August 28, 2025)
  • K241252 — Disposable Vinyl Examination Gloves (May 20, 2024)
  • K230046 — Vinyl examination gloves (March 25, 2023)
  • K221980 — Disposable Powder Free Vinyl Examination Gloves, Beige/Clear (February 6, 2023)
  • K220992 — Disposable Powder Free Vinyl Exam Glove, Black/Blue/Purple (October 19, 2022)
  • K223008 — Disposable Vinyl Examination Gloves (October 8, 2022)
  • K222442 — DISPOSABLE VINYL EXAMINATION GLOVES (Pink, Black, Blue) (September 28, 2022)
  • K220055 — Disposable, vinyl examination gloves, Yellow (August 25, 2022)