FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
CUT RESISTANT GLOVES OR SURGICAL GLOVE LINER
K Number: K920876
·
Decision Dec 11, 1992
Classifications
1
FEI Numbers
138
Registration Numbers
138
Same Product Code
558
Applicant Total
6
Review Days
289
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Basic Information
- Device Name
- CUT RESISTANT GLOVES OR SURGICAL GLOVE LINER
- K Number
- K920876
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4460
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Medtech Intl., Inc.
- Date Received
- February 26, 1992
- Decision Date
- December 11, 1992
- 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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Other Clearances by Medtech Intl., Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K853843 | IV MATE | Jan 9, 1986 | Substantially Equivalent |
| K791462 | HYPERDERMIC NEEDLE WITH SENSOR #514 | Sep 24, 1979 | Substantially Equivalent |
| K790467 | SURGICAL EYE SPONGE | Mar 26, 1979 | Substantially Equivalent |
| K790389 | GAUZE & COTTON SPONGES | Mar 26, 1979 | Substantially Equivalent |
| K781157 | STIMULATOR, NERVE, TRANSCUTANEOUS | Sep 20, 1978 | Substantially Equivalent |