Convertors Impervious Shoe Covers
FDA 510(k) K970815 · Allegiance Healthcare Corp.
510(k) numberK970815
Submission
- Device name
- Convertors Impervious Shoe Covers
- Applicant
- Allegiance Healthcare Corp.
Mcgraw Park, IL, US - Received
- March 6, 1997
- Decision date
- March 27, 1997
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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 |
| 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 |
More from Depuy, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K023673 | Airlife Demand Nasal CannulaNFB · Traditional | 05/02/2003SE |
| K023602 | Small Volume NebulizerCAF · Special | 05/01/2003SE |
| K023419 | Trilaminate Drapes/TiburonKKX · Traditional | 02/11/2003SE |
| K024120 | Modification to Temno Biopsy NeedlesFCG · Special | 01/15/2003SE |
| K024292 | Modification to Positive Touch Powder-Free Latex Examination Gloves with Protein and…LYY · Special | 01/09/2003SE |
| K024102 | Dental Powder-Free Latex Examination Gloves with Protein Labeling ClaimLYY · Special | 12/18/2002SE |
| K023425 | Drapes with Absorbent ReinforcementKKX · Special | 11/06/2002SE |
| K022765 | Nitrile Powder-Free Examination GlovesLZA · Traditional | 10/11/2002SE |
| K023170 | Nitrile Powder-Free Examination GlovesLZA · Special | 10/09/2002SE |
| K023167 | Breathable Surgical GownFYA · Special | 10/02/2002SE |
Questions and answers
When was Convertors Impervious Shoe Covers cleared by the FDA?
Convertors Impervious Shoe Covers (K970815) received a 510(k) decision of Substantially Equivalent on March 27, 1997, 21 days after the submission was received.
What is the product code of K970815?
The FDA product code is FXP – Cover, Shoe, Operating-Room, a Class I (low risk) device regulated under 21 CFR 878.4040.