FDA 510(k)
FDA class 1
Substantially Equivalent
🇨🇳 China
Disposal Medical Nitrile Examination Gloves-Tested for Use with Chemotherapy Drugs
K Number: K220353
·
Decision Mar 31, 2022
Classifications
1
FEI Numbers
269
Registration Numbers
269
Same Product Code
78
Applicant Total
3
Review Days
51
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Basic Information
- Device Name
- Disposal Medical Nitrile Examination Gloves-Tested for Use with Chemotherapy Drugs
- K Number
- K220353
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 880.6250
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Niujian Technology Co., Ltd.
- Date Received
- February 8, 2022
- Decision Date
- March 31, 2022
- Product Code
- LZC
- 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 |
|---|---|---|---|
| LZC | Medical Glove, Specialty | FDA class 1 | General Hospital |
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