RACAL N95 RESIRATOR
Device Facts
| Record ID | K964723 |
|---|---|
| Device Name | RACAL N95 RESIRATOR |
| Applicant | Racal Filter Technologies, Inc. |
| Product Code | FXX · General, Plastic Surgery |
| Decision Date | Feb 7, 1997 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 878.4040 |
| Device Class | Class 2 |
Indications for Use
The Racal N95 Respirator and Surgical Mask will be used for the protection of the health care practitioner from blood and body fluids and particulates and to meet the NIOSH / CDC TB Prevention Guidelines.
Device Story
Disposable, lightweight, one-piece half-mask respirator and surgical mask. Constructed with multi-layer filtering media, including inner/outer scrim layers, netting, and a meltblown protection layer. Features a wire nose clip, foam nose piece, and elastic headbands to ensure a secure face-to-mask seal. Used by healthcare practitioners in clinical settings to provide a fluid-resistant barrier and 95% filtration efficiency against non-oil-based particulate aerosols. Protects the wearer from exposure to blood, body fluids, and airborne pathogens, specifically aiding in the prevention of Mycobacterium tuberculosis transmission.
Clinical Evidence
Bench testing only. Device is NIOSH approved (TC-84A-0008) with 95% filtration efficiency against particulate aerosols free of oil, meeting 42 CFR Part 84 standards and CDC guidelines for Mycobacterium tuberculosis transmission prevention.
Technological Characteristics
N95-class particulate respirator. Materials: multi-layer filtering media (inner/outer scrim, netting, meltblown layer), wire nose clip, foam nose piece, elastic headband. Dimensions: four sizes (XS, S, M, L). Performance: 95% filtration efficiency against non-oil aerosols. NIOSH approved (TC-84A-0008).
Indications for Use
Indicated for health care practitioners to provide respiratory protection against particulates, blood, and body fluids, and to assist in compliance with NIOSH/CDC tuberculosis prevention guidelines.
Regulatory Classification
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.
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.
Predicate Devices
- 3M Model 1860 Health Care Respirators (K955382)
- Louis M Gerson Isolair APR Type N95 Respirators (K960778)
