FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
VINYL EXAMINATION GLOVE, POWDER-FREE
K Number: K944510
·
Decision Oct 18, 1994
Classifications
1
FEI Numbers
151
Registration Numbers
151
Same Product Code
795
Applicant Total
1
Review Days
33
Basic Information
- Device Name
- VINYL EXAMINATION GLOVE, POWDER-FREE
- K Number
- K944510
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 880.6250
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- AMERICAN GEMINI, INC.
- Date Received
- September 15, 1994
- Decision Date
- October 18, 1994
- 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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