ISOLAIR APR TYPE N95

K960778 · Louis M. Gerson Co., Inc. · MSH · May 9, 1996 · General, Plastic Surgery

Device Facts

• Record ID: K960778
• Device Name: ISOLAIR APR TYPE N95
• Applicant: Louis M. Gerson Co., Inc.
• Product Code: MSH · General, Plastic Surgery
• Decision Date: May 9, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4040
• Device Class: Class 2

Intended Use

The Gerson Isolair APR Type N95 Healthcare Particulate Respirator and Surgical Mask Model 2735 is 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. This device also meets CDC Guidelines for "B Exposure Control.

Device Story

Healthcare particulate respirator and surgical mask; worn by operating room personnel. Constructed of nonwoven inner/outer shells with polypropylene melt-blown filter media; rubber headband; aluminum nosepiece. Provides barrier protection against microorganisms, body fluids, and particulates. NIOSH-certified (TC-84A-160) as N95 respirator; 95% filtration efficiency against 0.3-micron particles. Fluid resistant per ASTM D583-65; resistant to synthetic blood. Used in clinical/surgical settings to reduce cross-contamination risk.

Clinical Evidence

Bench testing only. Device certified by NIOSH (TC-84A-160) per 42 CFR 84 requirements. Performance validated via synthetic blood penetration resistance (Protocol 9602202-01), breathing resistance (30 CFR 11), fluid resistance (ASTM D583-65), filtration efficiency (NIOSH 42 CFR 1), and primary dermal irritation testing.

Technological Characteristics

Nonwoven inner/outer shell; polypropylene melt-blown filter media; rubber headband; aluminum nosepiece. NIOSH N95 certified (TC-84A-160). Fluid resistance per ASTM D583-65. Mechanical filtration principle.

Indications for Use

Indicated for operating room personnel during surgical procedures to provide protection against transfer of microorganisms, body fluids, and particulate material.

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

• Gerson Isolair SMF (K922507)

Submission Summary (Full Text)

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# 510(K) Summary

K960778

MAY - 9 1996

## Submitter

Louis M. Gerson Co., Inc.
15 Sproat Street
Middleboro, MA 02346

## Contact:

Joseph Z. Zdrok
Technical Director
Respiratory Protection

Telephone: [phone] or 508-947-4000
Fax: [phone]

Date: January 5, 1996

## Trade Name:

Gerson Isolair APR Type N95 Healthcare Particulate Respirator and Surgical Mask Model 2735

## Common Name:

Healthcare Particulate Respirator and Surgical Mask

## Classification

Device Class - Class II
CFR Section - 21 CFR 878.4040

## Substantial Equivalency:

The Gerson Isolair APR Type N95 Healthcare Particulate Respirator and Surgical Mask Model 2735 is found to be substantially equivalent to the Gerson Isolair SMF 510 (k) number K922507. The product is manufactured in the same manner but utilizes more efficient filter media.

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# 510(K) Summary (Continued)

## Description:

The Gerson Isolair APR Type N95 Healthcare Particulate Respirator and Surgical Mask Model 2735 is constructed from a white nonwoven material used in the inner and outer shell. The polypropylene melt blown filter media is layered between the inner and outer shell. The headband is made of rubber stapled to the mask. The inside nosepiece utilizes a closed cell foam and the outside nosepiece which conforms to the nose is made of aluminum.

The Gerson Isolair APR Type N95 Healthcare Particulate Respirator and Surgical Mask Model 2735 is approved by NIOSH as per 42 CFR 84. The certification number assigned is TC-84A-160 for a type N95 Particulate Respirator. The Type N95 must meet the prescribed test criteria which specifies the use of 0.3 micron diameter challenge and requiring a 95% efficiency. This mask is also fluid resistant as per (ASTM D583 65 Method) and is resistant to synthetic blood as per Protocol number 9602202-01 conducted by Nelson Laboratories. Breathing resistance was tested as per NIOSH 30 CFR11 section 11.140-9.

## Intended Use:

The Gerson Isolair APR Type N95 Healthcare Particulate Respirator and Surgical Mask Model 2735 is 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.

This device also meets CDC Guidelines for "B Exposure Control.

## Limitations:

This product does not eliminate the wearer from any risk of contracting any type of disease or infection. The mask should be changed immediately if contaminated with blood or body fluids.

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# 510(K) Summary (Continued)

## Comparison of Predicate Device

The outside cover stock color of the previously cleared device is blue. The Gerson Isolair APR Type N95 Healthcare Particulate Respirator and Surgical Mask Model 2735 is white. The headband color of the cleared device is white and the Isolair APR Type N95 is green.

The Gerson Isolair APR Type N95 Healthcare Particulate Respirator and Surgical Mask Model 2735 incorporates a highly efficient filter media and is 95% efficient against a .3 micron particulate which was scientifically established as the most penetrating particle size. The legally marketed device previously cleared 510 (k) K922507 is manufactured from similar materials, but does not have the high efficiency characteristics as the new Isolair APR Type N95

## Performance Tests:

This product was tested and certified by NIOSH as an approved N95 respirator. It meets all the requirements prescribed in 42 CFR 84 and is assigned TC-84A-160.

| Tests Performed | Laboratory |
| --- | --- |
| 1. Department of Health and Human Services 42 CFR 84 Type N95 Requirements | NIOSH |
| 2. Resistance to Liquid (Synthetic Blood Penetration Resistance) Protocol No. 9602202-01 | Nelson Laboratories |
| 3. Breathing Resistance 30 CFR 11 | NIOSH |
| 4. Fluid Resistance (ASTM D583-65 Method 1) | Gerson |
| 5. Filtration Efficiency NIOSH 42 CFR 1 | NIOSH |
| 6. Primary Skin Irritation | Gerson |
| 7. FHSA Primary Dermal Irritation | Nelson Laboratories |

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# 510(K) Summary (Continued)

## Conclusion:

Since the basic construction is used in the cleared device as in the new device except for incorporation of a highly efficient filter media tested and approved by NIOSH, the Gerson Isolair APR Type N95 Healthcare Particulate Respirator and Surgical Mask Model 2735 is substantially equivalent to the Gerson SMF product.

## Safety/Effectiveness

The device has a filtration much greater than the previously cleared Gerson SMF Surgical Mask Respirator. It is NIOSH approved and meets the CDC guidelines for TB Exposure Control.