Cover, Shoe, Operating-Room
FDA product code FXP · Class I (low risk) · 21 CFR 878.4040 · General, Plastic Surgery
36510(k) clearances
0PMA approvals
0recalls
Manufacturers
- Abco Dealers, Inc. 3
- James River Corp. 3
- Amerasia Corp. 2
- Procter & Gamble Mfg. Co. 2
- Tecnol New Jersey Wound Care, Inc. 2
- Technol, Inc. 1
- Primeline Medical Products, Inc. 1
- Gem Nonwovews, Inc. 1
- American Threshold Industries, Inc. 1
- A Plus International, Inc. 1
- Interpro Intl., Inc. 1
- Ulti-Med Intl., Inc. 1
- Kimberly-Clark Corp. 1
- Surgikos, Inc. 1
- Roseburg SA 1
- Medicon, Inc. 1
- Zimmar Consulting , Ltd. 1
- CooperVision, Inc. 1
- Flare Products, Inc. 1
- American Convertors Div., American Pharmaseal 1
510(k) clearances
| 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 |
| K914702 | Sterile View(Tm) Knee-High Boots/Depuy Shoe BootsFXP · Traditional | Depuy, Inc. | 01/29/1993SE |
| K913628 | Disposable Shoe CoverFXP · Traditional | Gem Nonwovews, Inc. | 10/04/1991SE |
| K894383 | Disposable Shoe CoverFXP · Traditional | American Threshold Industries, Inc. | 09/12/1989SE |
| K893702 | Tecnol Gaiters Product Number 47725-010FXP · Traditional | Tecnol New Jersey Wound Care, Inc. | 06/23/1989SE |
| K883657 | Skid Resistant, Long Lasting Shoe CoversFXP · Traditional | James River Corp. | 09/15/1988SE |
| K882280 | Cover, Shoe Operating RoomFXP · Traditional | A Plus International, Inc. | 06/23/1988SE |
| K882128 | Tecnol Tiger Paws Product Number 47705-010FXP · Traditional | Tecnol New Jersey Wound Care, Inc. | 06/15/1988SE |
| K880093 | Caretex Skid Resistant Shoe CoversFXP · Traditional | James River Corp. | 01/29/1988SE |
| K874064 | Shoe CoversFXP · Traditional | Interpro Intl., Inc. | 11/04/1987SE |
| K872797 | Non-Skid Shoe CoversFXP · Traditional | Abco Dealers, Inc. | 08/04/1987SE |
| K865023 | Cover, Shoe Operating RoomFXP · Traditional | Ulti-Med Intl., Inc. | 01/12/1987SE |
| K864550 | Caretex Shoe CoversFXP · Traditional | James River Corp. | 12/24/1986SE |
| K864026 | Nonconductive Shoe CoverFXP · Traditional | Kimberly-Clark Corp. | 10/30/1986SE |
| K862726 | Disposable Shoe Covers and Nurses CapsFXP · Traditional | Abco Dealers, Inc. | 08/01/1986SE |
| K861528 | Tecnol Personal Shoe CoverFXP · Traditional | Technol, Inc. | 05/12/1986SE |
| K851554 | Overshoes (SurchaussuresFXP · Traditional | Roseburg SA | 04/30/1985SE |
| K844705 | Shoe CoversFXP · Traditional | Medicon, Inc. | 01/10/1985SE |
| K843475 | Pharma-Plast Single Use OvershoesFXP · Traditional | Zimmar Consulting , Ltd. | 10/31/1984SE |
| K830821 | Micro-MittFXP · Traditional | CooperVision, Inc. | 04/27/1983SE |
| K801617 | Conductive Shoe CoversFXP · Traditional | Procter & Gamble Mfg. Co. | 08/04/1980SE |
| K801616 | Non-Conductive Shoe CoversFXP · Traditional | Procter & Gamble Mfg. Co. | 08/04/1980SE |
| K800809 | Flare Dis. Conductive&Non. Shoe CoversFXP · Traditional | Flare Products, Inc. | 05/20/1980SE |
| K800528 | Shield Perfect Fit; Dura-Fit, Dispos.FXP · Traditional | American Convertors Div., American Pharmaseal | 04/16/1980SE |
| K780590 | Shoe CoversFXP · Traditional | Abco Dealers, Inc. | 05/09/1978SE |
| K761072 | P.S.M. Justa CoverFXP · Traditional | The Owenby Co. | 12/02/1976SE |
| K760779 | Barner Shoe Covers & CoverbootsFXP · Traditional | Surgikos, Inc. | 11/02/1976SE |