510(k) K971316

POLY (VINYL) EXAM GLOVE, POWDERED by Copioumed Intl., Inc. — Product Code LYZ

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: August 27, 1997
Date Received: April 9, 1997
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 Copioumed Intl., Inc.

K030927 — POWDERED VINYL EXAM GLOVES, WHITE (April 17, 2003)
K021961 — POWDER-FREE POLY-VINYL EXAM GLOVES, COLOR: WHITE (July 2, 2002)
K021743 — (MULTIPLE LABELS) POWDER-FREE POLY-VINYL EXAM GLOVES, COLOR: YELLOW (June 10, 2002)
K972624 — POLY (VINYL) EXAM GLOVE, POWDER-FREE (November 6, 1997)
K965237 — NURSES BOUFFANT CAP (August 27, 1997)
K961342 — SHOE COVER, NON-STERILE (December 30, 1996)
K960999 — ISOLATION GOWN (December 30, 1996)

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)