FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
POWDERED SYNTHETIC VINYL PATIENT EXAMINATION GLOVES
K Number: K011884
·
Decision Jul 17, 2001
Classifications
1
FEI Numbers
151
Registration Numbers
151
Same Product Code
795
Applicant Total
5
Review Days
29
Basic Information
- Device Name
- POWDERED SYNTHETIC VINYL PATIENT EXAMINATION GLOVES
- K Number
- K011884
- 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 EVERSHARP PLASTIC PRODUCTS CO., LTD.
- Date Received
- June 18, 2001
- Decision Date
- July 17, 2001
- 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 EVERSHARP PLASTIC PRODUCTS CO., LTD.
| K Number | Device Name | ||
|---|---|---|---|
| K031293 | SYNTHETIC (WHITE) VINYL PATIENT EXAMINATION GLOVES-POWDER FREE | May 9, 2003 | Substantially Equivalent |
| K011883 | POWDERED SYNTHETIC (YELLOW) VINYL PATIENT EXAMINATION GLOVES | Jul 17, 2001 | Substantially Equivalent |
| K011885 | SYNTHETIC POWDER FREE VINYL PATIENT EXAMINATION GLOVES | Jul 16, 2001 | Substantially Equivalent |
| K011882 | SYNTHETIC POWDER FREE (YELLOW) VINYL PATIENT EXAMINATION GLOVES | Jul 10, 2001 | Substantially Equivalent |