Home / 510(k) Clearances / K953379

510(k) K953379

HYPOALLERGENIC POWDERED AMBIDEXTROUS COAGULATN DIPPED LATEX EXAMINATION GLOVE by Ansell, Inc. — Product Code LYY

K953379 is an FDA 510(k) premarket notification submitted by Ansell, Inc. for the device "HYPOALLERGENIC POWDERED AMBIDEXTROUS COAGULATN DIPPED LATEX EXAMINATION GLOVE". The FDA issued a decision of Substantially Equivalent on September 27, 1995. The device falls under product code LYY (Latex Patient Examination Glove), a Class I device regulated under 21 CFR 880.6250. Ansell, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 27, 1995
Date Received
July 19, 1995
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)
  • K945766 — HYPOALLERGENIC POWDERED AMBIDEXTROUS PATIENT EXAMINATION GLOVES (August 7, 1995)
  • K945767 — POWDER FREE, HYPOALLERGENIC AMBIDEXTROUS PATIENT EXAMINATION GLOVES (March 2, 1995)
  • K940046 — NON-LUBRICATED CONDOM (January 30, 1995)
  • K940045 — 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)

FDA data resources