FDA Product Code
FDA Product Code FXP — Clearance Directory
- Device Class
- Class I
- Assigned Panel
- General, Plastic Surgery
- 21 CFR Citation
- 878.4040
510(k) Clearances — 36 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K971076 | PRIMED SHOE COVERS, PRIMED HEAD COVERS | Primeline Medical Products, Inc. | 1998-01-13 | Traditional | PDF ↗ |
| K971191 | FAR-EAST SHOE COVERS | Far East Science & Technology Development Co., Ltd. | 1997-07-10 | Traditional | PDF ↗ |
| K970815 | CONVERTORS IMPERVIOUS SHOE COVERS | Allegiance Healthcare Corp. | 1997-03-27 | Traditional | PDF ↗ |
| K961342 | SHOE COVER, NON-STERILE | Copioumed Intl., Inc. | 1996-12-30 | Traditional | PDF ↗ |
| K955835 | FLUID BARRIER BOOT KNEE & ANKLE-HIGH | Instrument Makar, Inc. | 1996-11-19 | Traditional | PDF ↗ |
| K952937 | NIOMED NON-SKID SHOE COVERS | Amerasia Corp. | 1995-10-23 | Traditional | PDF ↗ |
| K952897 | NIOMED SHOE COVERS | Amerasia Corp. | 1995-10-23 | Traditional | PDF ↗ |
| K943034 | OREX SHOE COVERS | Thantex Specialties, Inc. | 1995-01-02 | Traditional | PDF ↗ |
| K932738 | KAPPLER PRO/VENT BOOT | Kappler, Inc. | 1994-03-29 | Traditional | PDF ↗ |
| K925815 | REUSABLE LIQUIDPROOF BOOTIE | Amsco Sterile Recoveries, Inc. | 1993-07-09 | Traditional | PDF ↗ |
| K914702 | STERILE VIEW(TM) KNEE-HIGH BOOTS/DEPUY SHOE BOOTS | Depuy, Inc. | 1993-01-29 | Traditional | PDF ↗ |
| K913628 | DISPOSABLE SHOE COVER | Gem Nonwovews, Inc. | 1991-10-04 | Traditional | PDF ↗ |
| K894383 | DISPOSABLE SHOE COVER | American Threshold Industries, Inc. | 1989-09-12 | Traditional | PDF ↗ |
| K893702 | TECNOL GAITERS PRODUCT NUMBER 47725-010 | Tecnol New Jersey Wound Care, Inc. | 1989-06-23 | Traditional | PDF ↗ |
| K883657 | SKID RESISTANT, LONG LASTING SHOE COVERS | James River Corp. | 1988-09-15 | Traditional | PDF ↗ |
| K882280 | COVER, SHOE OPERATING ROOM | A Plus International, Inc. | 1988-06-23 | Traditional | PDF ↗ |
| K882128 | TECNOL TIGER PAWS PRODUCT NUMBER 47705-010 | Tecnol New Jersey Wound Care, Inc. | 1988-06-15 | Traditional | PDF ↗ |
| K880093 | CARETEX SKID RESISTANT SHOE COVERS | James River Corp. | 1988-01-29 | Traditional | PDF ↗ |
| K874064 | SHOE COVERS | Interpro Intl., Inc. | 1987-11-04 | Traditional | PDF ↗ |
| K872797 | NON-SKID SHOE COVERS | Abco Dealers, Inc. | 1987-08-04 | Traditional | PDF ↗ |
| K865023 | COVER, SHOE OPERATING ROOM | Ulti-Med Intl., Inc. | 1987-01-12 | Traditional | PDF ↗ |
| K864550 | CARETEX SHOE COVERS | James River Corp. | 1986-12-24 | Traditional | PDF ↗ |
| K864026 | NONCONDUCTIVE SHOE COVER | Kimberly-Clark Corp. | 1986-10-30 | Traditional | PDF ↗ |
| K862726 | DISPOSABLE SHOE COVERS AND NURSES CAPS | Abco Dealers, Inc. | 1986-08-01 | Traditional | PDF ↗ |
| K861528 | TECNOL PERSONAL SHOE COVER | Technol, Inc. | 1986-05-12 | Traditional | PDF ↗ |
| K851554 | OVERSHOES (SURCHAUSSURES | Roseburg SA | 1985-04-30 | Traditional | PDF ↗ |
| K844705 | SHOE COVERS | Medicon, Inc. | 1985-01-10 | Traditional | PDF ↗ |
| K843475 | PHARMA-PLAST SINGLE USE OVERSHOES | Zimmar Consulting , Ltd. | 1984-10-31 | Traditional | PDF ↗ |
| K830821 | MICRO-MITT | CooperVision, Inc. | 1983-04-27 | Traditional | PDF ↗ |
| K801617 | CONDUCTIVE SHOE COVERS | Procter & Gamble Mfg. Co. | 1980-08-04 | Traditional | PDF ↗ |
| K801616 | NON-CONDUCTIVE SHOE COVERS | Procter & Gamble Mfg. Co. | 1980-08-04 | Traditional | PDF ↗ |
| K800809 | FLARE DIS. CONDUCTIVE&NON. SHOE COVERS | Flare Products, Inc. | 1980-05-20 | Traditional | PDF ↗ |
| K800528 | SHIELD PERFECT FIT; DURA-FIT, DISPOS. | American Convertors Div., American Pharmaseal | 1980-04-16 | Traditional | PDF ↗ |
| K780590 | SHOE COVERS | Abco Dealers, Inc. | 1978-05-09 | Traditional | PDF ↗ |
| K761072 | P.S.M. JUSTA COVER | The Owenby Co. | 1976-12-02 | Traditional | PDF ↗ |
| K760779 | BARNER SHOE COVERS & COVERBOOTS | Surgikos, Inc. | 1976-11-02 | Traditional | PDF ↗ |
Product code FXP · Class I · General, Plastic Surgery. Data: openFDA.