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510(k) K201504

Single-use medical poly (vinyl chloride) examination glove by Anhui Bytech Medical Supplies Co., Ltd. — Product Code LYZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 10, 2021
Date Received
June 5, 2020
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 Bytech Medical Supplies Co., Ltd.

  • K222442 — DISPOSABLE VINYL EXAMINATION GLOVES (Pink, Black, Blue) (September 28, 2022)

Other clearances for product code LYZ

  • K252467 — Disposable Vinyl Examination Gloves (October 27, 2025)
  • 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)
  • K220469 — Disposable Vinyl Examination Glove (June 16, 2022)