Nitrile Examination Gloves Powder Free Tested for Use With Chemotherapy Drugs & Fentanyl Citrate (Blue & Black)
FDA 510(k) clearance K250578 · decided 2025-04-01
Clearance details
- K-number
- K250578
- Device name
- Nitrile Examination Gloves Powder Free Tested for Use With Chemotherapy Drugs & Fentanyl Citrate (Blue & Black)
- Applicant
- Careglove Global Sdn. Bhd.
- Decision
- Substantially Equivalent
- Date received
- 2025-02-27
- Decision date
- 2025-04-01
- Days to decision
- 33 days
- Clearance type
- Special
- Product code
- LZA
- Device class
- 1
- Regulation number
- 880.6250
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Seremban, MY
- 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.