FDA 510(k)
FDA class 1
Substantially Equivalent
🇨🇳 China
JIAWANG PRE-POWDERED VINYL EXAMINATION GLOVES
K Number: K964800
·
Decision Feb 14, 1997
Classifications
1
FEI Numbers
131
Registration Numbers
131
Same Product Code
798
Applicant Total
5
Review Days
77
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- JIAWANG PRE-POWDERED VINYL EXAMINATION GLOVES
- K Number
- K964800
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 880.6250
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Shanghai Jiawang Industrial Co. , Ltd.
- Date Received
- November 29, 1996
- Decision Date
- February 14, 1997
- 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 |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (LYZ), ordered by most recent decision date.
Powder Free Synthetic Vinyl Exam Gloves (Blue, Black)
FDA 510(k)
FDA Class 1
·General Hospital
Disposable Vinyl Examination Gloves
FDA 510(k)
FDA Class 1
·General Hospital
Powder-Free Vinyl Exam Gloves, clear
FDA 510(k)
FDA Class 1
·General Hospital
Disposable Vinyl Examination Gloves
FDA 510(k)
FDA Class 1
·General Hospital
Vinyl examination gloves
FDA 510(k)
FDA Class 1
·General Hospital
Disposable Powder Free Vinyl Examination Gloves, Beige/Clear
FDA 510(k)
FDA Class 1
·General Hospital
Other Clearances by Shanghai Jiawang Industrial Co. , Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K032792 | PRE-POWDERED, NON-STERILE, VINYL EXAM GLOVES, YELLOW | Oct 15, 2003 | Substantially Equivalent |
| K031854 | VINYL EXAM GLOVES, POWDER-FREE, YELLOW | Jul 25, 2003 | Substantially Equivalent |
| K023428 | VINYL EXAMINATION GLOVE, POWDER-FREE, WHITE | Oct 25, 2002 | Substantially Equivalent |
| K970111 | JIAWANG POWDER-FREE VINYL EXAMINATION GLOVES | Mar 27, 1997 | Substantially Equivalent |