510(k) K011186

POWDER-FREE STERILE SYNTHETIC VINYL EXAMINATION GLOVES by Allegiance Healthcare Corp. — Product Code LYZ

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: May 25, 2001
Date Received: April 18, 2001
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 Allegiance Healthcare Corp.

K023673 — AIRLIFE DEMAND NASAL CANNULA (May 2, 2003)
K023419 — TRILAMINATE DRAPES/TIBURON (February 11, 2003)
K024120 — MODIFICATION TO TEMNO BIOPSY NEEDLES (January 15, 2003)
K024292 — MODIFICATION TO POSITIVE TOUCH POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN (January 9, 2003)
K024102 — DENTAL POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM (December 18, 2002)
K023425 — DRAPES WITH ABSORBENT REINFORCEMENT (November 6, 2002)
K022765 — NITRILE POWDER-FREE EXAMINATION GLOVES (October 11, 2002)
K023170 — NITRILE POWDER-FREE EXAMINATION GLOVES (October 9, 2002)
K023167 — BREATHABLE SURGICAL GOWN (October 2, 2002)
K012931 — GENESIS STERRAD COMPATIBLE REUSABLE STERILIZATION CONTAINER SYSTEM (August 20, 2002)

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)