Disposable Shoe Cover
FDA 510(k) K894383 · American Threshold Industries, Inc.
510(k) numberK894383
Submission
- Device name
- Disposable Shoe Cover
- Applicant
- American Threshold Industries, Inc.
Enka, NC, US - Received
- July 17, 1989
- Decision date
- September 12, 1989
- 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 |
|---|---|---|
| K971483 | Secure-Wrap (TM) Sterilization WrapFRG · Traditional | 06/24/1997SE |
| K953879 | Surgeon's CapFYF · Traditional | 01/05/1996SE |
| K953878 | Bouffant CapFYF · Traditional | 01/05/1996SE |
| K952115 | Barrier Gown, Kool-Gard Backless GownFYC · Traditional | 09/25/1995SE |
| K952114 | Kool Gard Singles GownFYC · Traditional | 09/25/1995SE |
| K952116 | Cover GownFYC · Traditional | 09/05/1995SE |
| K934085 | Modification of Surgical Eyeshield MaskHOY · Traditional | 11/12/1993SE |
| K915530 | Nova Gauze(R) Disposable Nonwoven Sponges, SterileHAX · Traditional | 08/17/1992SE |
| K915740 | Disposable O.R. Towel, SterileKKX · Traditional | 06/22/1992SE |
| K912110 | Disposable O.R. TowelKKX · Traditional | 07/25/1991SE |
Questions and answers
When was Disposable Shoe Cover cleared by the FDA?
Disposable Shoe Cover (K894383) received a 510(k) decision of Substantially Equivalent on September 12, 1989, 57 days after the submission was received.
What is the product code of K894383?
The FDA product code is FXP – Cover, Shoe, Operating-Room, a Class I (low risk) device regulated under 21 CFR 878.4040.