510(k) K945767

POWDER FREE, HYPOALLERGENIC AMBIDEXTROUS PATIENT EXAMINATION GLOVES by Ansell, Inc. — Product Code LYY

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: March 2, 1995
Date Received: November 21, 1994
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

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

A latex patient examination glove is a disposable device made of natural rubber latex 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 Ansell, Inc.

K984392 — ANSELL CONDOMS (July 21, 1999)
K983518 — LIFESTYLES XTRA PLEASURE (July 6, 1999)
K940047 — SPERMICIDALLY LUBRICATED CONDOM (December 19, 1995)
K953379 — HYPOALLERGENIC POWDERED AMBIDEXTROUS COAGULATN DIPPED LATEX EXAMINATION GLOVE (September 27, 1995)
K945766 — HYPOALLERGENIC POWDERED AMBIDEXTROUS PATIENT EXAMINATION GLOVES (August 7, 1995)
K940045 — CONDOM (January 30, 1995)
K940046 — NON-LUBRICATED CONDOM (January 30, 1995)
K913766 — ANSELL NO POWDER AMBI PATIENT EXAMINATION GLOVES (March 11, 1993)
K914760 — LATEX EXAMINATION GLOVES (January 17, 1992)
K903107 — PATIENT EXAM GLOVES (DUSTED W/USP STARCH POWDER) (August 29, 1990)

Other clearances for product code LYY

K250069 — Powder Free Natural Rubber Latex Examination Gloves Blue, Non-Sterile and Prot (April 29, 2025)
K240266 — Latex Examination Glove Powder Free (Ocean Blue and Natural White) (September 9, 2024)
K230573 — Powder Free Latex Patient Examination Glove, Black Colored, Non-sterile, with Pr (June 13, 2023)
K223298 — Sterile Latex Examination Gloves Powder Free (S, M, L, Extra L) (February 22, 2023)
K222612 — Powder-Free Latex examination gloves (November 25, 2022)
K221667 — Non Sterile Powder Free Latex Examination Glove (October 28, 2022)
K222348 — JR MEDIC (October 27, 2022)
K221374 — Disposable Medical Rubber Examination Gloves (XS/S/M/L/XL) (October 26, 2022)
K222693 — Single-use medical latex examination gloves (LG100) (September 24, 2022)
K221648 — Iconic Latex Glove (August 25, 2022)