FDA 510(k)
FDA class 1
Substantially Equivalent
🇨🇳 China
VINYL PATIENT EXAMINATION GLOVE, POWDER-FREE
K Number: K971415
·
Decision May 23, 1997
Classifications
1
FEI Numbers
151
Registration Numbers
151
Same Product Code
795
Applicant Total
4
Review Days
36
Basic Information
- Device Name
- VINYL PATIENT EXAMINATION GLOVE, POWDER-FREE
- K Number
- K971415
- 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 FOREMOST PLASTIC INDUSTRIAL CO., LTD.
- Date Received
- April 17, 1997
- Decision Date
- May 23, 1997
- Product Code
- LYZ
- 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 |
|---|---|---|---|
| LYZ | Vinyl Patient Examination Glove | FDA class 1 | General Hospital |
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Other Clearances by SHANGHAI FOREMOST PLASTIC INDUSTRIAL CO., LTD.
| K Number | Device Name | ||
|---|---|---|---|
| K041041 | NON STERILE SYNTHETIC POWDER FREE (YELLOW) VINYL PATIENT EXAMINATION GLOVES | Jun 8, 2004 | Substantially Equivalent |
| K032071 | POWDER FREE VINYL EXAMINATION GLOVE | Oct 10, 2003 | Substantially Equivalent |
| K971423 | VINYL PATIENT EXAMINATION GLOVE, POWDERED | May 23, 1997 | Substantially Equivalent |