Primed Shoe Covers, Primed Head Covers
FDA 510(k) K971076 · Primeline Medical Products, Inc.
510(k) numberK971076
Submission
- Device name
- Primed Shoe Covers, Primed Head Covers
- Applicant
- Primeline Medical Products, Inc.
Alberta, CA - Received
- March 24, 1997
- Decision date
- January 13, 1998
- 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 |
|---|---|---|---|
| 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 |
More from Depuy, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K023266 | Primagard Surgical GownsFYA · Traditional | 11/08/2002SE |
| K023117 | Primagard Surgical GownsKKX · Traditional | 11/08/2002SE |
| K022868 | Primagard Surgical Equipment DrapesKKX · Traditional | 11/08/2002SE |
| K021864 | Primagard Nonsterile Femoral Angiography Drapes (Models PM1-0136, PM1-0119, PM1-0142)KKX · Traditional | 09/23/2002SE |
| K021076 | Primagard Yellow Surgical Mask, Pleated, Tie-On, PM4-307; Primagard Yellow Surgical…FXX · Special | 04/16/2002SE |
| K011789 | Procedure Masks: PM4-301 and PM4-304FXX · Special | 06/22/2001SE |
| K001951 | Primed Pleated Tie-Back, Procedure Mask PM4-305, Primed Pleated Ear-Loop, Procedure Mask…FXX · Traditional | 09/08/2000SE |
| K971075 | Primed Prime-Plus Cotton Gauze SpongesEFQ · Traditional | 06/22/1997SE |
Questions and answers
When was Primed Shoe Covers, Primed Head Covers cleared by the FDA?
Primed Shoe Covers, Primed Head Covers (K971076) received a 510(k) decision of Substantially Equivalent on January 13, 1998, 295 days after the submission was received.
What is the product code of K971076?
The FDA product code is FXP – Cover, Shoe, Operating-Room, a Class I (low risk) device regulated under 21 CFR 878.4040.