Cardinal Health Nitrile Examination Gloves Extended Cuff
FDA 510(k) clearance K252313 · decided 2026-01-14
Clearance details
- K-number
- K252313
- Device name
- Cardinal Health Nitrile Examination Gloves Extended Cuff
- Applicant
- Cardinalhealth
- Decision
- Substantially Equivalent
- Date received
- 2025-07-25
- Decision date
- 2026-01-14
- Days to decision
- 173 days
- Clearance type
- Traditional
- Product code
- LZC
- Device class
- 1
- Regulation number
- 880.6250
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Waukegan, IL, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Cardinalhealth
The Builder collects up to 8 candidate devices side by side with yours, then exports the substantial-equivalence comparison scaffold. How it works
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| Cardinal Health Multifunctional Defibrillation Electrode (P190007) | Cardinalhealth | 2020-08-07 |