FXP — Cover, Shoe, Operating-Room Class I
FDA Device Classification
Classification Details
- Product Code
- FXP
- Device Class
- Class I
- Regulation Number
- 878.4040
- Submission Type
- Review Panel
- HO
- Medical Specialty
- General, Plastic Surgery
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|
| K971076 | primeline medical products | PRIMED SHOE COVERS, PRIMED HEAD COVERS | January 13, 1998 |
| K971191 | far east science and technology development co | FAR-EAST SHOE COVERS | July 10, 1997 |
| K970815 | allegiance healthcare | CONVERTORS IMPERVIOUS SHOE COVERS | March 27, 1997 |
| K961342 | copioumed intl | SHOE COVER, NON-STERILE | December 30, 1996 |
| K955835 | instrument makar | FLUID BARRIER BOOT KNEE & ANKLE-HIGH | November 19, 1996 |
| K952937 | amerasia | NIOMED NON-SKID SHOE COVERS | October 23, 1995 |
| K952897 | amerasia | NIOMED SHOE COVERS | October 23, 1995 |
| K943034 | thantex specialties | OREX SHOE COVERS | January 2, 1995 |
| K932738 | kappler | KAPPLER PRO/VENT BOOT | March 29, 1994 |
| K925815 | amsco sterile recoveries | REUSABLE LIQUIDPROOF BOOTIE | July 9, 1993 |
| K914702 | depuy | STERILE VIEW(TM) KNEE-HIGH BOOTS/DEPUY SHOE BOOTS | January 29, 1993 |
| K913628 | gem nonwovews | DISPOSABLE SHOE COVER | October 4, 1991 |
| K894383 | american threshold industries | DISPOSABLE SHOE COVER | September 12, 1989 |
| K893702 | tecnol new jersey wound care | TECNOL GAITERS PRODUCT NUMBER 47725-010 | June 23, 1989 |
| K883657 | james river | SKID RESISTANT, LONG LASTING SHOE COVERS | September 15, 1988 |
| K882280 | a plus international | COVER, SHOE OPERATING ROOM | June 23, 1988 |
| K882128 | tecnol new jersey wound care | TECNOL TIGER PAWS PRODUCT NUMBER 47705-010 | June 15, 1988 |
| K880093 | james river | CARETEX SKID RESISTANT SHOE COVERS | January 29, 1988 |
| K874064 | interpro intl | SHOE COVERS | November 4, 1987 |
| K872797 | abco dealers | NON-SKID SHOE COVERS | August 4, 1987 |