510(k) K252313
K252313 is an FDA 510(k) premarket notification submitted by Cardinalhealth for the device "Cardinal Health Nitrile Examination Gloves Extended Cuff". The FDA issued a decision of Substantially Equivalent on January 14, 2026. The device falls under product code LZC (Medical Glove, Specialty), 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
- 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 surgeons) 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.