Powder Free Nitrile Patient Examination Gloves, Blue Colored, Non Sterile, Low Dermatitis Potential. Tested for Use with Chemotherapy Drugs and Fentanyl Citrate
FDA 510(k) clearance K242533 · decided 2025-03-18
Clearance details
- K-number
- K242533
- Device name
- Powder Free Nitrile Patient Examination Gloves, Blue Colored, Non Sterile, Low Dermatitis Potential. Tested for Use with Chemotherapy Drugs and Fentanyl Citrate
- Applicant
- Better Care Plastic Technology Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2024-08-26
- Decision date
- 2025-03-18
- Days to decision
- 204 days
- Clearance type
- Traditional
- Product code
- LZA
- Device class
- 1
- Regulation number
- 880.6250
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Shenze County, CN
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.