Non-Skid Shoe Covers
FDA 510(k) K872797 · Abco Dealers, Inc.
510(k) numberK872797
Submission
- Device name
- Non-Skid Shoe Covers
- Applicant
- Abco Dealers, Inc.
Milwaukee, WI, US - Received
- July 15, 1987
- Decision date
- August 4, 1987
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- FXP – Cover, Shoe, Operating-Room
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4040
- Specialty
- General, Plastic Surgery
Other 510(k)s with product code FXP
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K971076 | Primed Shoe Covers, Primed Head CoversFXP · Traditional | Primeline Medical Products, Inc. | 01/13/1998SE |
| K971191 | Far-East Shoe CoversFXP · Traditional | Far East Science & Technology Development Co.… | 07/10/1997SE |
| K970815 | Convertors Impervious Shoe CoversFXP · Traditional | Allegiance Healthcare Corp. | 03/27/1997SE |
| K961342 | Shoe Cover, Non-SterileFXP · Traditional | Copioumed Intl., Inc. | 12/30/1996SE |
| K955835 | Fluid Barrier Boot Knee & Ankle-HighFXP · Traditional | Instrument Makar, Inc. | 11/19/1996SE |
| K952937 | Niomed Non-Skid Shoe CoversFXP · Traditional | Amerasia Corp. | 10/23/1995SE |
| K952897 | Niomed Shoe CoversFXP · Traditional | Amerasia Corp. | 10/23/1995SE |
| K943034 | Orex Shoe CoversFXP · Traditional | Thantex Specialties, Inc. | 01/02/1995SE |
| K932738 | Kappler Pro/Vent BootFXP · Traditional | Kappler, Inc. | 03/29/1994SE |
| K925815 | Reusable Liquidproof BootieFXP · Traditional | Amsco Sterile Recoveries, Inc. | 07/09/1993SE |
More from Amsco Sterile Recoveries, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K905025 | Digital Thermometer KitsFLL · Traditional | 02/07/1991SE |
| K882304 | Digital Thermometer Sheaths (Oral and Rectal)FLL · Traditional | 07/12/1988SE |
| K880892 | Blood Collecting Needle and HoldersFMI · Traditional | 04/21/1988SE |
| K880894 | Allergist SyringesFMF · Traditional | 03/31/1988SE |
| K872875 | Stretch Gauze BandagesNAD · Traditional | 09/04/1987SE |
| K872874 | Microscope Cover GlassesKES · Traditional | 08/10/1987SE |
| K871465 | Thermometer SheathsFLL · Traditional | 05/11/1987SE |
| K862726 | Disposable Shoe Covers and Nurses CapsFXP · Traditional | 08/01/1986SE |
| K862111 | Armboards, Reusable and Disposable · Traditional | 07/08/1986SE |
| K862112 | Microscope SlidesLIB · Traditional | 06/13/1986SE |
Questions and answers
When was Non-Skid Shoe Covers cleared by the FDA?
Non-Skid Shoe Covers (K872797) received a 510(k) decision of Substantially Equivalent on August 4, 1987, 20 days after the submission was received.
What is the product code of K872797?
The FDA product code is FXP – Cover, Shoe, Operating-Room, a Class I (low risk) device regulated under 21 CFR 878.4040.