Product code FXP
- Device name
- Cover, Shoe, Operating-Room
- Medical specialty
- General, Plastic Surgery
- Device class
- 1
- Regulation number
- 878.4040
- Review panel
- HO
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K971076 | PRIMED SHOE COVERS, PRIMED HEAD COVERS | Primeline Medical Products, Inc. | 1998-01-13 |
| K971191 | FAR-EAST SHOE COVERS | Far East Science & Technology Development Co., Ltd. | 1997-07-10 |
| K970815 | CONVERTORS IMPERVIOUS SHOE COVERS | Allegiance Healthcare Corp. | 1997-03-27 |
| K961342 | SHOE COVER, NON-STERILE | Copioumed Intl., Inc. | 1996-12-30 |
| K955835 | FLUID BARRIER BOOT KNEE & ANKLE-HIGH | Instrument Makar, Inc. | 1996-11-19 |
| K952937 | NIOMED NON-SKID SHOE COVERS | Amerasia Corp. | 1995-10-23 |
| K952897 | NIOMED SHOE COVERS | Amerasia Corp. | 1995-10-23 |
| K943034 | OREX SHOE COVERS | Thantex Specialties, Inc. | 1995-01-02 |
| K932738 | KAPPLER PRO/VENT BOOT | Kappler, Inc. | 1994-03-29 |
| K925815 | REUSABLE LIQUIDPROOF BOOTIE | Amsco Sterile Recoveries, Inc. | 1993-07-09 |
| K914702 | STERILE VIEW(TM) KNEE-HIGH BOOTS/DEPUY SHOE BOOTS | Depuy, Inc. | 1993-01-29 |
| K913628 | DISPOSABLE SHOE COVER | Gem Nonwovews, Inc. | 1991-10-04 |
| K894383 | DISPOSABLE SHOE COVER | American Threshold Industries, Inc. | 1989-09-12 |
| K893702 | TECNOL GAITERS PRODUCT NUMBER 47725-010 | Tecnol New Jersey Wound Care, Inc. | 1989-06-23 |
| K883657 | SKID RESISTANT, LONG LASTING SHOE COVERS | James River Corp. | 1988-09-15 |
| K882280 | COVER, SHOE OPERATING ROOM | A Plus International, Inc. | 1988-06-23 |
| K882128 | TECNOL TIGER PAWS PRODUCT NUMBER 47705-010 | Tecnol New Jersey Wound Care, Inc. | 1988-06-15 |
| K880093 | CARETEX SKID RESISTANT SHOE COVERS | James River Corp. | 1988-01-29 |
| K874064 | SHOE COVERS | Interpro Intl., Inc. | 1987-11-04 |
| K872797 | NON-SKID SHOE COVERS | Abco Dealers, Inc. | 1987-08-04 |
| K865023 | COVER, SHOE OPERATING ROOM | Ulti-Med Intl., Inc. | 1987-01-12 |
| K864550 | CARETEX SHOE COVERS | James River Corp. | 1986-12-24 |
| K864026 | NONCONDUCTIVE SHOE COVER | Kimberly-Clark Corp. | 1986-10-30 |
| K862726 | DISPOSABLE SHOE COVERS AND NURSES CAPS | Abco Dealers, Inc. | 1986-08-01 |
| K861528 | TECNOL PERSONAL SHOE COVER | Technol, Inc. | 1986-05-12 |
| K851554 | OVERSHOES (SURCHAUSSURES | Roseburg SA | 1985-04-30 |
| K844705 | SHOE COVERS | Medicon, Inc. | 1985-01-10 |
| K843475 | PHARMA-PLAST SINGLE USE OVERSHOES | Zimmar Consulting , Ltd. | 1984-10-31 |
| K830821 | MICRO-MITT | CooperVision, Inc. | 1983-04-27 |
| K801617 | CONDUCTIVE SHOE COVERS | Procter & Gamble Mfg. Co. | 1980-08-04 |
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| 10097604474754 | Tronex International, Inc. | TRONEX INTERNATIONAL, INC. | 2023-04-10 |
| 10182921000745 | ALLCARE | ALLCARE, INC | 2022-12-08 |
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| 10097604488256 | Tronex International, Inc. | TRONEX INTERNATIONAL, INC. | 2022-10-28 |
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| M220P7020103 | PRO ADVANTAGE | NATIONAL DISTRIBUTION & CONTRACTING, INC. | 2019-09-09 |