FXP · Cover, Shoe, Operating-Room
General, Plastic Surgery · 21 CFR 878.4040 · Class 1
Overview
| Product Code | FXP |
|---|---|
| Device Name | Cover, Shoe, Operating-Room |
| Regulation | 21 CFR 878.4040 |
| Device Class | Class 1 |
| Review Panel | General, Plastic Surgery |
Identification
Surgical apparel are devices that are intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material. Examples include surgical caps, hoods, masks, gowns, operating room shoes and shoe covers, and isolation masks and gowns. Surgical suits and dresses, commonly known as scrub suits, are excluded.
Classification Rationale
Class II (special controls) for surgical gowns and surgical masks. A surgical N95 respirator or N95 filtering facepiece respirator is not exempt if it is intended to prevent specific diseases or infections, or it is labeled or otherwise represented as filtering surgical smoke or plumes, filtering specific amounts of viruses or bacteria, reducing the amount of and/or killing viruses, bacteria, or fungi, or affecting allergenicity, or it contains coating technologies unrelated to filtration (e.g., to reduce and or kill microorganisms). Surgical N95 respirators and N95 filtering facepiece respirators are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 878.9, and the following conditions for exemption: (i) The user contacting components of the device must be demonstrated to be biocompatible. (ii) Analysis and nonclinical testing must: (A) Characterize flammability and be demonstrated to be appropriate for the intended environment of use; and (B) Demonstrate the ability of the device to resist penetration by fluids, such as blood and body fluids, at a velocity consistent with the intended use of the device. (iii) NIOSH approved under its regulation. (2) Class I (general controls) for surgical apparel other than surgical gowns and surgical masks. The class I device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 878.9.
Special Controls
*Classification.* (1) Class II (special controls) for surgical gowns and surgical masks. A surgical N95 respirator or N95 filtering facepiece respirator is not exempt if it is intended to prevent specific diseases or infections, or it is labeled or otherwise represented as filtering surgical smoke or plumes, filtering specific amounts of viruses or bacteria, reducing the amount of and/or killing viruses, bacteria, or fungi, or affecting allergenicity, or it contains coating technologies unrelated to filtration (e.g., to reduce and or kill microorganisms). Surgical N95 respirators and N95 filtering facepiece respirators are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 878.9, and the following conditions for exemption:(i) The user contacting components of the device must be demonstrated to be biocompatible. (ii) Analysis and nonclinical testing must: (A) Characterize flammability and be demonstrated to be appropriate for the intended environment of use; and (B) Demonstrate the ability of the device to resist penetration by fluids, such as blood and body fluids, at a velocity consistent with the intended use of the device. (iii) NIOSH approved under its regulation. (2) Class I (general controls) for surgical apparel other than surgical gowns and surgical masks. The class I device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 878.9.
Recent Cleared Devices (20 of 36)
Showing 20 most recent of 36 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K971076 | PRIMED SHOE COVERS, PRIMED HEAD COVERS | Primeline Medical Products, Inc. | Jan 13, 1998 | SESE |
| K971191 | FAR-EAST SHOE COVERS | Far East Science & Technology Development Co., Ltd. | Jul 10, 1997 | SESE |
| K970815 | CONVERTORS IMPERVIOUS SHOE COVERS | Allegiance Healthcare Corp. | Mar 27, 1997 | SESE |
| K961342 | SHOE COVER, NON-STERILE | Copioumed Intl., Inc. | Dec 30, 1996 | SESE |
| K955835 | FLUID BARRIER BOOT KNEE & ANKLE-HIGH | Instrument Makar, Inc. | Nov 19, 1996 | SESE |
| K952937 | NIOMED NON-SKID SHOE COVERS | Amerasia Corp. | Oct 23, 1995 | SESE |
| K952897 | NIOMED SHOE COVERS | Amerasia Corp. | Oct 23, 1995 | SESE |
| K943034 | OREX SHOE COVERS | Thantex Specialties, Inc. | Jan 2, 1995 | SESE |
| K932738 | KAPPLER PRO/VENT BOOT | Kappler, Inc. | Mar 29, 1994 | SESE |
| K925815 | REUSABLE LIQUIDPROOF BOOTIE | Amsco Sterile Recoveries, Inc. | Jul 9, 1993 | SESE |
| K914702 | STERILE VIEW(TM) KNEE-HIGH BOOTS/DEPUY SHOE BOOTS | Depuy, Inc. | Jan 29, 1993 | SESE |
| K913628 | DISPOSABLE SHOE COVER | Gem Nonwovews, Inc. | Oct 4, 1991 | SESE |
| K894383 | DISPOSABLE SHOE COVER | American Threshold Industries, Inc. | Sep 12, 1989 | SESE |
| K893702 | TECNOL GAITERS PRODUCT NUMBER 47725-010 | Tecnol New Jersey Wound Care, Inc. | Jun 23, 1989 | SESE |
| K883657 | SKID RESISTANT, LONG LASTING SHOE COVERS | James River Corp. | Sep 15, 1988 | SESE |
| K882280 | COVER, SHOE OPERATING ROOM | A Plus International, Inc. | Jun 23, 1988 | SESE |
| K882128 | TECNOL TIGER PAWS PRODUCT NUMBER 47705-010 | Tecnol New Jersey Wound Care, Inc. | Jun 15, 1988 | SESE |
| K880093 | CARETEX SKID RESISTANT SHOE COVERS | James River Corp. | Jan 29, 1988 | SESE |
| K874064 | SHOE COVERS | Interpro Intl., Inc. | Nov 4, 1987 | SESE |
| K872797 | NON-SKID SHOE COVERS | Abco Dealers, Inc. | Aug 4, 1987 | SESE |
Top Applicants
- James River Corp. — 3 clearances
- Abco Dealers, Inc. — 3 clearances
- Tecnol New Jersey Wound Care, Inc. — 2 clearances
- Procter & Gamble Mfg. Co. — 2 clearances
- Amerasia Corp. — 2 clearances
