FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
SYNTHETIC (WHITE) VINYL PATIENT EXAMINATION GLOVES-POWDER FREE
K Number: K031108
·
Decision Sep 8, 2003
Classifications
1
FEI Numbers
151
Registration Numbers
151
Same Product Code
795
Applicant Total
10
Review Days
153
Basic Information
- Device Name
- SYNTHETIC (WHITE) VINYL PATIENT EXAMINATION GLOVES-POWDER FREE
- K Number
- K031108
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 880.6250
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- SHIJIAZHUANG GREAT VISION PLASTIC PRODUCTS CO., LT
- Date Received
- April 8, 2003
- Decision Date
- September 8, 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 SHIJIAZHUANG GREAT VISION PLASTIC PRODUCTS CO., LT
| K Number | Device Name | ||
|---|---|---|---|
| K102097 | POWDER FREE VINYL PATIENT EXAMINATION GLOVES | Nov 17, 2010 | Substantially Equivalent |
| K102093 | POWDER FREE VINYL PATIENT EXAMINATION GLOVES | Nov 3, 2010 | Substantially Equivalent |
| K021506 | POWDERED (BLUE) NITRILE PATIENT EXAMINATION GLOVES | Jun 6, 2002 | Substantially Equivalent |
| K014077 | POWDER FREE (BLUE) NITRILE PATIENT EXAMINATION GLOVES | Feb 4, 2002 | Substantially Equivalent |
| K002012 | SYNTHETIC POWDERED (YELLOW) VINYL PATIENT EXAMINATION GLOVES | Aug 9, 2000 | Substantially Equivalent |
| K002015 | SYNTHETIC POWDER FREE (YELLOW) VINYL PATIENT EXAMINATION GLOVES | Aug 9, 2000 | Substantially Equivalent |
| K992554 | SYNTHETIC POWDERED VINYL PATIENT EXAMINATION GLOVES | Mar 29, 2000 | Substantially Equivalent |
| K992862 | SYNTHETIC POWDERED (YELLOW) VINYL PATIENT EXAMINATION GLOVES | Nov 29, 1999 | Substantially Equivalent |
| K992555 | SYNTHETIC POWDER-FREE VINYL PATIENT EXAMINATION GLOVES | Oct 14, 1999 | Substantially Equivalent |