MemorialTM Gloves
FDA 510(k) clearance K231740 · decided 2023-07-04
Clearance details
- K-number
- K231740
- Device name
- MemorialTM Gloves
- Applicant
- Us Glove Supply
- Decision
- Substantially Equivalent
- Date received
- 2023-06-14
- Decision date
- 2023-07-04
- Days to decision
- 20 days
- Clearance type
- Traditional
- Product code
- LZA
- Device class
- 1
- Regulation number
- 880.6250
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Buffalo, NY, US
- Third-party review
- Yes
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.