FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
SURGICAL GLOVES
K Number: K894010
·
Decision Oct 27, 1989
Classifications
1
FEI Numbers
138
Registration Numbers
138
Same Product Code
558
Applicant Total
3
Review Days
147
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Basic Information
- Device Name
- SURGICAL GLOVES
- K Number
- K894010
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4460
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Green Cross Medical Supplies Corp.
- Date Received
- June 2, 1989
- Decision Date
- October 27, 1989
- Product Code
- KGO
- Advisory Committee
- General, Plastic Surgery
- 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 |
|---|---|---|---|
| KGO | Surgeon'S Gloves | FDA class 1 | General, Plastic Surgery |
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