FDA 510(k)
FDA class 1
Substantially Equivalent
🇲🇹 Malta
ANSELL E.P. EXTRA-PROTECTION EXAMINATION GLOVES
K Number: K895781
·
Decision Mar 9, 1990
Classifications
1
FEI Numbers
269
Registration Numbers
269
Same Product Code
78
Applicant Total
4
Review Days
163
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Basic Information
- Device Name
- ANSELL E.P. EXTRA-PROTECTION EXAMINATION GLOVES
- K Number
- K895781
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 880.6250
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Applicant
- Ansell Intl.
- Date Received
- September 27, 1989
- Decision Date
- March 9, 1990
- Product Code
- LZC
- 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 |
|---|---|---|---|
| LZC | Medical Glove, Specialty | FDA class 1 | General Hospital |
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