FDA 510(k)
FDA class 1
Substantially Equivalent
🇮🇩 Indonesia
POWDER-FREE EXAM GLOVES
K Number: K970773
·
Decision Dec 4, 1997
Classifications
1
FEI Numbers
151
Registration Numbers
151
Same Product Code
1953
Applicant Total
4
Review Days
275
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Basic Information
- Device Name
- POWDER-FREE EXAM GLOVES
- K Number
- K970773
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 880.6250
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Pt. Sarana Indoprotex
- Date Received
- March 4, 1997
- Decision Date
- December 4, 1997
- Product Code
- LYY
- 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 |
|---|---|---|---|
| LYY | Latex Patient Examination Glove | FDA class 1 | General Hospital |
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