RACAL N95 RESIRATOR

K964723 · Racal Filter Technologies, Inc. · FXX · Feb 7, 1997 · General, Plastic Surgery

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

Intended 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)

Submission Summary (Full Text)

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FILE.No. 708 01/29 '97 16:06 ID:RACAL HEALTH & SAFETY 301 695 3017 PAGE 2

RACAL HEALTH & SAFETY INC. PREMARKET SUBMISSION

RACAL N95 RESPIRATOR AND SURGICAL MASK 510(K) K964723

510(k) SUMMARY - K96 4723

FEB - 7 1997

RACAL N95 RESPIRATOR & SURGICAL MASK

January 29, 1997

This summary is provided in accordance with the Safe Medical Devices Act of 1990 (SMDA). The information provided in the 510(k), Premarket Notification, was in accordance with 21 CFR 807.87.

1. Submitter of 510(k):

Company Name: Racal Health & Safety Inc.
7305 Executive Way
Frederick, Maryland
U.S.A. 21704-8368

Contact Person (U.S.A.): Mr. J. Randall Hoggle
Telephone: [phone]
Fax: [phone]

Contact Person (Canada): John Campbell
Telephone: [phone]
Fax: [phone]

2. Name of Device

Trade/Proprietary Name: RACAL N95 RESPIRATOR AND SURGICAL MASK

Common/Usual Name: Masks, Surgical

Classification Name: 21 CFR 878.4040 "Surgical Apparel", Class II

3. Legally Marketed Predicate Devices

RACAL N95 RESPIRATOR AND SURGICAL MASK is substantially equivalent to many legally marketed Surgical masks, including those listed in Table I below.

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FILE No. 708 01/29 '97 16:06 ID:RACAL HEALTH & SAFETY 301 695 3017 PAGE 3

RACAL HEALTH & SAFETY INC. PREMARKET SUBMISSION

RACAL N95 RESPIRATOR AND SURGICAL MASK 510(K) K964723

# 510(k) SUMMARY

TABLE 1 COMPARISON OF TECHNOLOGICAL CHARACTERISTICS PREDICATE DEVICES AND DELTA N95 RESPIRATOR AND SURGICAL MASK

| Manufacturers | Racal Health & Safety | 3M | Louis M Gerson |
| --- | --- | --- | --- |
| Device | RACAL N95 Respirators | Model 1860 Health Care Respirators | Isolair APR Type N95 Respirators |
| 510(k) Number | K964723 | K955382 | K960778 |
| Standards Met | Performance Code of Federal Regulations Title 42 Part 84 for N95-class of Respiratory Protective Devices
Meets CDC guidelines for preventing transmission of Mycobacterium tuberculosis | Performance Code of Federal Regulations Title 42,Part 84 for N95-class of Respiratory Protective Devices
Meets CDC guidelines for preventing transmission of Mycobacterium tuberculosis | Performance Code of Federal Regulations Title 42, Part 84 for N95 - class of Respiratory Protective Devices
Meets CDC guidelines for preventing transmission of Mycobacterium tuberculosis |
| NIOSH Approval Number | TC-84A-008 | TC-84A-006 | TC-84A-160 |
| Device Description | • N95 Class particulate Respirator
• Multi-Layer Filtering media
• Fluid resistant barrier
• Wire nose clip
• Foam nose piece inside mask
• Elastic Headband
• Peach colored | • N95 Class particulate Respirator
• Multi-Layer Filtering media
• Fluid resistant barrier
• Wire nose clip
• Foam nose piece inside mask
• Elastic Headband
• Blue colored | • N95 Class particulate Respirator
• Multi-Layer Filtering media
• Fluid resistant barrier
• Wire nose clip
• Foam nose piece inside mask
• Elastic Headband
• Blue-green colored |
| Intended Use | Respiratory Protection of Health Care workers | Respiratory Protection of Health Care of workers | Respiratory Protection of Health Care workers |

## 4. Device Description

RACAL N95 RESPIRATOR AND SURGICAL MASK is indicated for respiratory protective device. This disposable Surgical mask is a one-piece, light weight half mask with filter material forming the mask. The component includes an inner scrim layer, netting material forming the mask. The component includes an inner scrim layer, netting layer, meltblown protection layer, outer scrim layer and elastic band. RACAL

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FILE No. 708 01/29 '97 16:06 ID:RACAL HEALTH & SAFETY 301 695 3017 PAGE 4

RACAL HEALTH & SAFETY INC. PREMARKET SUBMISSION

RACAL N95 RESPIRATOR AND SURGICAL MASK 510(K) K964723

N95 RESPIRATOR AND SURGICAL MASK is NIOSH approved (Approval #TC-84A-0008) and has a filtration efficiency level of 95% and is effective against particulate aerosols free of oil. RACAL N95 RESPIRATOR AND SURGICAL MASK is available in four sizes, extra small, small, medium and large. The nose clip and elastic headband ensures effective face to mask seal. Based on the information provided, RACAL N95 RESPIRATOR AND SURGICAL MASK is substantially equivalent to legally marketed predicate devices.

5. 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.

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