STERILE, POWDER-FREE, LATEX EXAM GLOVES, MODELS 2D7018PF SERIES, 2D7028PF SERIES
FDA 510(k) clearance K081464 · decided 2008-08-28
Clearance details
- K-number
- K081464
- Device name
- STERILE, POWDER-FREE, LATEX EXAM GLOVES, MODELS 2D7018PF SERIES, 2D7028PF SERIES
- Applicant
- Cardinalhealth
- Decision
- Substantially Equivalent
- Date received
- 2008-05-27
- Decision date
- 2008-08-28
- Days to decision
- 93 days
- Clearance type
- Traditional
- Product code
- LYY
- 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
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Similar devices under this product code
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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 |