FDA 510(k)
FDA class 1
Substantially Equivalent
🇨🇳 China
POWDERED VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED)
K Number: K100856
·
Decision May 19, 2010
Classifications
1
FEI Numbers
151
Registration Numbers
151
Same Product Code
795
Applicant Total
2
Review Days
54
Basic Information
- Device Name
- POWDERED VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED)
- K Number
- K100856
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 880.6250
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- SUZHOU SHENGYUDA PLASTIC PRODUCTS CO., LTD.
- Date Received
- March 26, 2010
- Decision Date
- May 19, 2010
- 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 SUZHOU SHENGYUDA PLASTIC PRODUCTS CO., LTD.
| K Number | Device Name | ||
|---|---|---|---|
| K100855 | POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED) | Apr 22, 2010 | Substantially Equivalent |