Caretex Shoe Covers
FDA 510(k) K864550 · James River Corp.
510(k) numberK864550
Submission
- Device name
- Caretex Shoe Covers
- Applicant
- James River Corp.
Neenah, WI, US - Received
- November 19, 1986
- Decision date
- December 24, 1986
- 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 |
|---|---|---|
| K894505 | Cotolin Drain Sponge and Dressing SpongeEFQ · Traditional | 09/15/1989SE |
| K894147 | Visulin Transparent Adhesive DressingKGX · Traditional | 08/09/1989SN |
| K894034 | Modified Labeling of Surgical GlovesKGO · Traditional | 07/14/1989SE |
| K893939 | Isolation MasksFXX · Traditional | 07/14/1989SE |
| K892580 | Caretouch Examination GlovesLYY · Traditional | 07/14/1989SE |
| K890459 | James River Biogel Powderless Surgical GlovesKGO · Traditional | 04/20/1989SE |
| K883802 | Caretex Central Supply WrapFRG · Traditional | 10/21/1988SE |
| K884112 | Caretex or TowelKKX · Traditional | 10/13/1988SE |
| K883657 | Skid Resistant, Long Lasting Shoe CoversFXP · Traditional | 09/15/1988SE |
| K880481 | Caretex Surgeon's CapsFYF · Traditional | 02/24/1988SE |
Questions and answers
When was Caretex Shoe Covers cleared by the FDA?
Caretex Shoe Covers (K864550) received a 510(k) decision of Substantially Equivalent on December 24, 1986, 35 days after the submission was received.
What is the product code of K864550?
The FDA product code is FXP – Cover, Shoe, Operating-Room, a Class I (low risk) device regulated under 21 CFR 878.4040.