Niomed Shoe Covers
FDA 510(k) K952897 · Amerasia Corp.
510(k) numberK952897
Submission
- Device name
- Niomed Shoe Covers
- Applicant
- Amerasia Corp.
Baldwin Park, CA, US - Received
- June 23, 1995
- Decision date
- October 23, 1995
- 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 |
| 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 |
| 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 |
|---|---|---|
| K955833 | Niomed Surgical CapsFYF · Traditional | 03/15/1996SE |
| K954747 | Niomed Barrier GownsFYC · Traditional | 03/06/1996SE |
| K954455 | Niomed Bouffant CapsFYF · Traditional | 01/23/1996SE |
| K954454 | Niomed Surgical HoodFYF · Traditional | 01/23/1996SE |
| K952937 | Niomed Non-Skid Shoe CoversFXP · Traditional | 10/23/1995SE |
Questions and answers
When was Niomed Shoe Covers cleared by the FDA?
Niomed Shoe Covers (K952897) received a 510(k) decision of Substantially Equivalent on October 23, 1995, 122 days after the submission was received.
What is the product code of K952897?
The FDA product code is FXP – Cover, Shoe, Operating-Room, a Class I (low risk) device regulated under 21 CFR 878.4040.