Nitrile Exam Glove, Extended cuff, Tested For Use With Chemotherapy Drugs, Fentanyl Citrate, And Select Other Drugs
FDA 510(k) clearance K230662 · decided 2023-10-26
Clearance details
- K-number
- K230662
- Device name
- Nitrile Exam Glove, Extended cuff, Tested For Use With Chemotherapy Drugs, Fentanyl Citrate, And Select Other Drugs
- Applicant
- Zhonghong Pulin Medical Products Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2023-03-10
- Decision date
- 2023-10-26
- Days to decision
- 230 days
- Clearance type
- Traditional
- Product code
- LZA
- Device class
- 1
- Regulation number
- 880.6250
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Tangshan, CN
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.