FDA 510(k)
FDA class 1
Substantially Equivalent
🇨🇳 China
TOP GLOVE VINYL EXAMINATION GLOVE
K Number: K024216
·
Decision Feb 27, 2003
Classifications
1
FEI Numbers
131
Registration Numbers
131
Same Product Code
798
Applicant Total
2
Review Days
66
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Basic Information
- Device Name
- TOP GLOVE VINYL EXAMINATION GLOVE
- K Number
- K024216
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 880.6250
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Top Glove (Zhangjiagang) Co. , Ltd.
- Date Received
- December 23, 2002
- Decision Date
- February 27, 2003
- 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 Top Glove (Zhangjiagang) Co. , Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K024016 | POWDERED VINYL EXAMINATION GLOVES | Feb 3, 2003 | Substantially Equivalent |