510(k) clearance
Cardinal Health Nitrile Blue Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate
- 510(k) number
- K261749
- Applicant
- Cardinalhealth
- Decision date
- Sep 2, 2026
- Date received
- May 28, 2026
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Product code
- LZA
- Device type
- Polymer Patient Examination Glove
- Device class
- Class I
- Regulation
- 21 CFR 880.6250
- Advisory committee
- General Hospital
- Statement or summary
- Statement
- Third party
- N
- Location
- Waukegan, IL, US