FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
EXAM GLOVES
K Number: K771757
·
Decision Oct 13, 1977
Classifications
1
FEI Numbers
11
Registration Numbers
11
Same Product Code
33
Applicant Total
3
Review Days
27
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Basic Information
- Device Name
- EXAM GLOVES
- K Number
- K771757
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 880.6250
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Applicant
- Jamar Health Products
- Date Received
- September 16, 1977
- Decision Date
- October 13, 1977
- Product Code
- FMC
- 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 |
|---|---|---|---|
| FMC | Patient Examination Glove | FDA class 1 | General Hospital |
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