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510(k) K252313

Cardinal Health Nitrile Examination Gloves Extended Cuff by Cardinalhealth — Product Code LZC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 14, 2026
Date Received
July 25, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Medical Glove, Specialty
Device Class
Class I
Regulation Number
880.6250
Review Panel
HO
Submission Type

A disposable medical glove (examination or surgeon’s) is a device that may or may not bear a trace amount of residual powder and is intended to be worn on the hand or finger(s) for medical purposes to prevent contamination. In addition, these gloves may have specialty claims such as chemotherapy, etc.

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Other clearances for product code LZC

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  • K220545 — Powder Free Nitrile Examination Gloves, Blue, Tested for use with Chemotherapy D (May 26, 2022)
  • K220491 — Disposable Medical Nitrile Examination Gloves -Tested for Use with Chemotherapy (May 14, 2022)
  • K220353 — Disposal Medical Nitrile Examination Gloves-Tested for Use with Chemotherapy Dru (March 31, 2022)
  • K213910 — Disposable Medical Nitrile Examination Gloves- Tested for Use with Chemotherapy (March 10, 2022)
  • K213325 — Disposable Medical Nitrile Examination Gloves- Tested for Use With Chemotherapy (January 28, 2022)
  • K213076 — AspenMed+ (December 20, 2021)
  • K212639 — Disposable Medical Nitrile Examination Gloves (Non sterile) (December 8, 2021)