FDA 510(k)
FDA class 1
Substantially Equivalent
🇨🇳 China
SHANGHAI CHINA STAR CORP POWDERED BLUE NITRILE PATIENT EXAMINATION GLOVES
K Number: K003675
·
Decision Jan 9, 2001
Classifications
1
FEI Numbers
380
Registration Numbers
380
Same Product Code
1171
Applicant Total
5
Review Days
41
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Basic Information
- Device Name
- SHANGHAI CHINA STAR CORP POWDERED BLUE NITRILE PATIENT EXAMINATION GLOVES
- K Number
- K003675
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 880.6250
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Shanghai China Star Corp
- Date Received
- November 29, 2000
- Decision Date
- January 9, 2001
- Product Code
- LZA
- Advisory Committee
- General Hospital
- Review Advisory Committee
- HO
- Third Party
- Y
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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Other Clearances by Shanghai China Star Corp
| K Number | Device Name | ||
|---|---|---|---|
| K071072 | SHANGHAI CHINA STAR CORP. POWDER FREE BLUE NITRILE PATIENT EXAMINATION GLOVE | Aug 30, 2007 | Substantially Equivalent |
| K010247 | SHANGHAI CHINASTAR POWER-FREE BLUE NITRIL EXAMINATION GLOVES | Feb 6, 2001 | Substantially Equivalent |
| K992206 | POWDER-FREE VINYL PATIENT EXAMINATION GLOVES | Jul 29, 1999 | Substantially Equivalent |
| K992205 | PRE-POWDERED VINYL PATIENT EXAMINATION GLOVES | Jul 23, 1999 | Substantially Equivalent |