Home / 510(k) Clearances / K081464

510(k) K081464

STERILE, POWDER-FREE, LATEX EXAM GLOVES, MODELS 2D7018PF SERIES, 2D7028PF SERIES by Cardinalhealth — Product Code LYY

K081464 is an FDA 510(k) premarket notification submitted by Cardinalhealth for the device "STERILE, POWDER-FREE, LATEX EXAM GLOVES, MODELS 2D7018PF SERIES, 2D7028PF SERIES". The FDA issued a decision of Substantially Equivalent on August 28, 2008. The device falls under product code LYY (Latex Patient Examination Glove), a Class I device regulated under 21 CFR 880.6250. Cardinalhealth has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 28, 2008
Date Received
May 27, 2008
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 Cardinalhealth

  • K261749 — Cardinal Health Nitrile Blue Examination Gloves Tested for Use with Chemotherapy (September 2, 2026)
  • K252313 — Cardinal Health Nitrile Examination Gloves Extended Cuff (January 14, 2026)
  • K243660 — Monoject™ 1mL Tuberculin Syringe Luer-Lock Tip (1180100777); Monoject™ 3mL Syri (August 22, 2025)
  • K243652 — Monoject™ Enteral Syringe with ENFit Connector (401SE); Monoject™ Enteral Syring (December 19, 2024)
  • K230569 — Cardinal Health Surgical Mask With Anti-fog Hydrogel (Level 3 ); Cardinal Healt (July 3, 2023)
  • K213174 — Salem Sump Silicone Dual Lumen Stomach Tube with ENFit Connection (May 19, 2022)
  • K202217 — Kendall NPWT Incision Management Device (June 4, 2021)
  • K191101 — Kendall NPWT Incision Management Dressing Kit (July 31, 2020)
  • K190923 — Salem Sump Dual Lumen Stomach Tube with ENFit Connection (November 7, 2019)
  • K171499 — Occlusion Detection Dressing Kit (September 22, 2017)

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