FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PROTOUCH OVERGLOVE
K Number: K952241
·
Decision Aug 7, 1995
Classifications
1
FEI Numbers
55
Registration Numbers
55
Same Product Code
14
Applicant Total
9
Review Days
87
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Basic Information
- Device Name
- PROTOUCH OVERGLOVE
- K Number
- K952241
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4370
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Cottrell, Ltd.
- Date Received
- May 12, 1995
- Decision Date
- August 7, 1995
- Product Code
- MMP
- 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 |
|---|---|---|---|
| MMP | Cover, Barrier, Protective | FDA class 2 | General, Plastic Surgery |
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Other Clearances by Cottrell, Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K972708 | ENDO-SPOR PLUS / HYPROCIDE | Sep 13, 1999 | Substantially Equivalent |
| K970726 | VAPOCIDE | May 18, 1998 | Substantially Equivalent |
| K960089 | PROCHEK G GLUTARALDEHYDE CONCENTRATION LEVEL INDICATOR | Apr 4, 1996 | Substantially Equivalent |
| K952234 | BARRIER ALL FILM | Jul 31, 1995 | Substantially Equivalent |
| K932922 | PROCIDE 14 N.S., OMNICIDE/LIQUID & PLUS LIQ ACTIVATOR | Jul 3, 1995 | Substantially Equivalent |
| K951983 | IMNI-II | Jun 20, 1995 | Substantially Equivalent |
| K945575 | PRO BARRIER(TM) TUBE SOX(TM) | Mar 6, 1995 | Substantially Equivalent |
| K893802 | PROVIEW SELF-SEALING STERILIZATION POUCH | Apr 4, 1990 | Substantially Equivalent |