Shoe Cover, Non-Sterile
FDA 510(k) K961342 · Copioumed Intl., Inc.
510(k) numberK961342
Submission
- Device name
- Shoe Cover, Non-Sterile
- Applicant
- Copioumed Intl., Inc.
Green Valley, AZ, US - Received
- March 20, 1996
- Decision date
- December 30, 1996
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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 |
| K970815 | Convertors Impervious Shoe CoversFXP · Traditional | Allegiance Healthcare Corp. | 03/27/1997SE |
| 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 |
|---|---|---|
| K030927 | Powdered Vinyl Exam Gloves, WhiteLYZ · Traditional | 04/17/2003SE |
| K021961 | Powder-Free Poly-Vinyl Exam Gloves, Color: WhiteLYZ · Traditional | 07/02/2002SE |
| K021743 | (Multiple Labels) Powder-Free Poly-Vinyl Exam Gloves, Color: YellowLZA · Traditional | 06/10/2002SE |
| K972624 | Poly (Vinyl) Exam Glove, Powder-FreeLYZ · Traditional | 11/06/1997SE |
| K971316 | Poly (Vinyl) Exam Glove, PowderedLYZ · Traditional | 08/27/1997SE |
| K965237 | Nurses Bouffant CapLYU · Traditional | 08/27/1997SE |
| K960999 | Isolation GownFYC · Traditional | 12/30/1996SE |
Questions and answers
When was Shoe Cover, Non-Sterile cleared by the FDA?
Shoe Cover, Non-Sterile (K961342) received a 510(k) decision of Substantially Equivalent on December 30, 1996, 285 days after the submission was received.
What is the product code of K961342?
The FDA product code is FXP – Cover, Shoe, Operating-Room, a Class I (low risk) device regulated under 21 CFR 878.4040.