FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
PROTEKT GLOVES
K Number: K910920
·
Decision May 15, 1991
Classifications
1
FEI Numbers
114
Registration Numbers
114
Same Product Code
6
Applicant Total
108
Review Days
71
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Basic Information
- Device Name
- PROTEKT GLOVES
- K Number
- K910920
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4040
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Intermedics Orthopedics
- Date Received
- March 5, 1991
- Decision Date
- May 15, 1991
- Product Code
- FYE
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- SU
- 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 |
|---|---|---|---|
| FYE | Dress, Surgical | FDA class 1 | General, Plastic Surgery |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (FYE), ordered by most recent decision date.
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CLOTHINGUARD
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Other Clearances by Intermedics Orthopedics
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|---|---|---|---|
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| K964357 | NATURAL-HIP SYSTEM COCR STEM | Jan 27, 1997 | Substantially Equivalent |
| K964350 | MODULA OPTIONS FOR SEVERE BONE LOSS AND TRAUMA | Jan 16, 1997 | Substantially Equivalent |
| K962190 | PATELLOFEMORAL JOINT PROSTHESIS | Oct 28, 1996 | Substantially Equivalent |
| K963266 | NATURAL HIP SYSTEM POROUS STEM - COLLARLESS, COLLARED | Oct 15, 1996 | Substantially Equivalent |
| K963155 | INTERMOORE FRACTURE HIP STEM (MODIFY) | Oct 1, 1996 | Substantially Equivalent |
| K962315 | SELECT SHOULDER COCR HUMERAL STEM COMPONENT | Sep 3, 1996 | Substantially Equivalent |