FDA 510(k)
FDA class 1
Substantially Equivalent
🇨🇳 China
YUSHENG
K Number: K141108
·
Decision Sep 16, 2014
Classifications
1
FEI Numbers
131
Registration Numbers
131
Same Product Code
798
Applicant Total
2
Review Days
140
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Basic Information
- Device Name
- YUSHENG
- K Number
- K141108
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 880.6250
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Zibo Yusheng Plastic Products Co., Ltd.
- Date Received
- April 29, 2014
- Decision Date
- September 16, 2014
- Product Code
- LYZ
- 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 |
|---|---|---|---|
| LYZ | Vinyl Patient Examination Glove | FDA class 1 | General Hospital |
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Other Clearances by Zibo Yusheng Plastic Products Co., Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K091431 | POWDER-FREE, YELLOW VINYL PATIENT EXAMINATION GLOVES | Jul 8, 2009 | Substantially Equivalent |