FDA 510(k)
FDA class 1
Substantially Equivalent
🇨🇳 China
Nitrile Disposable Examination Gloves, Tested for Use with Chemotherapy Drugs and Fentanyl
K Number: K240629
·
Decision May 28, 2024
Classifications
1
FEI Numbers
380
Registration Numbers
380
Same Product Code
1171
Applicant Total
4
Review Days
83
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Basic Information
- Device Name
- Nitrile Disposable Examination Gloves, Tested for Use with Chemotherapy Drugs and Fentanyl
- K Number
- K240629
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 880.6250
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Xingyu Medical Tech Co., Ltd.
- Date Received
- March 6, 2024
- Decision Date
- May 28, 2024
- Product Code
- LZA
- Advisory Committee
- General Hospital
- Review Advisory Committee
- HO
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| LZA | Polymer Patient Examination Glove | FDA class 1 | General Hospital |
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