FDA 510(k)
FDA class 1
Substantially Equivalent
🇨🇳 China
Disposable Nitrile Inspection Gloves (Tested for Use with Chemotherapy Drugs)
K Number: K214056
·
Decision Sep 20, 2022
Classifications
1
FEI Numbers
380
Registration Numbers
380
Same Product Code
1171
Applicant Total
1
Review Days
267
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Basic Information
- Device Name
- Disposable Nitrile Inspection Gloves (Tested for Use with Chemotherapy Drugs)
- K Number
- K214056
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 880.6250
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Mezorrison Medical Technology (Dongying) Co., Ltd.
- Date Received
- December 27, 2021
- Decision Date
- September 20, 2022
- 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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