INOVEL HEALTH CARE N95 PARTICULATE RESPIRATORS AND SURGICAL MASKS, MODELS MFRN95-S, MFRN95-XS, MFRN95-ML, MFRN95-A

K063747 · Inovel, LLC · MSH · Jan 12, 2007 · General, Plastic Surgery

Device Facts

• Record ID: K063747
• Device Name: INOVEL HEALTH CARE N95 PARTICULATE RESPIRATORS AND SURGICAL MASKS, MODELS MFRN95-S, MFRN95-XS, MFRN95-ML, MFRN95-A
• Applicant: Inovel, LLC
• Product Code: MSH · General, Plastic Surgery
• Decision Date: Jan 12, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4040
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

Intended Use

The various models of Inovel Type N95 Healthcare Particulate Respirators and Surgical Masks meet CDC Guidelines for TB Exposure Control within healthcare facilities. These devices are also intended to be worn by healthcare personnel during surgical procedures to protect both the patient and healthcare personnel from the transfer of microorganisms, body fluids and particulate material.

Device Story

Inovel N95 Healthcare Particulate Respirators and Surgical Masks are molded cup-style masks designed for use by healthcare personnel. The device acts as a physical barrier to protect both the wearer and the patient from the transfer of microorganisms, body fluids, and particulate material. It also serves as a respirator for TB exposure control. The mask is constructed with an outer cover of extruded plastic mesh (ethylene-vinyl acetate copolymer) or polypropylene spunbond, a polypropylene melt-blown filter media, and an inner cover of nonwoven spunbond. It features a closed-cell polyethylene foam nosepiece and non-latex rubber head straps. The device is used in clinical settings during surgical procedures. It provides a filtration efficiency of at least 95% against aerosols with a count median diameter of 0.055-0.095 microns. The mask is intended to be changed immediately if contaminated with blood or body fluids.

Clinical Evidence

Bench testing only. Performance evaluated per NIOSH 42 CFR Part 84 and ASTM F1862. Filter efficiency averaged 99.46% (n=40). Breathing resistance averaged 12.5 mm H2O at 85 lpm (n=18). Fluid resistance testing showed 32/32 pass for most models, 31/32 for model MFRN95-SZ. Flammability met Class I requirements (16 CFR 1610). Bacterial Filtration Efficiency >99.9% using Modified Green and Vesley Method.

Technological Characteristics

Molded cup-style respirator/mask. Materials: Extruded ethylene-vinyl acetate copolymer or polypropylene spunbond outer cover; polypropylene melt-blown filter; nonwoven spunbond inner cover; polyethylene foam nosepiece; non-latex rubber head straps. Dimensions: 4 5/8 - 7 3/4 inches width, 4 3/4 - 5 12 inches height. NIOSH-certified (TC-84A-4100, TC-84A-4101). Fluid resistance per ASTM F1862. Flammability per 16 CFR 1610.

Indications for Use

Indicated for healthcare personnel during surgical procedures and for TB exposure control in healthcare facilities to protect patients and personnel from 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

• Inovel Health Care N95 Particulate Respirators and Surgical Masks models 1510 (K062665), 1511, 1512, 1513, 1517 (K061859), 3000N95-XS, 3001N95-S, 3002N95-M, 3003N95-L, 3004N95-LP, 3101N95-S, 3102N95-M/L, and 3104N95-LP (K051182)

Submission Summary (Full Text)

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K063747

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10111 WEST JEFFERSON BOULEVARD, CULVER CITY, CALIFORNIA 90232 FELEPHONE 866-546-6835 FAX [phone] www.inovelmerical co

October 31, 2006

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### 510(k) Summary

Submitter: Inovel LLC 10111 W. Jefferson Blvd. Culver City, CA 90232-3509

JAN 1 2 2007

### Contact:

William Wawrzyniak Director Quality Assurance Telephone: [phone] Ext. 705 Fax: [phone] E-mail: [e-mail].

#### Trade Name:

Inovel Health Care N95 Particulate Respirators and Surgical Masks, various models.

#### Common Name:

Health Care N95 Particulate Respirators and Surgical Masks.

#### Classification:

Name - Surgical Apparel, as described in 21 CFR 878.4040. Device Class - Class II Product Code - MSH CFR Section - 21 CFR 878.4040

### Substantial Equivalency:

Inovel Health Care N95 Particulate Respirators and Surgical Masks are found to be substantially equivalent to Inovel Health Care N95 Particulate Respirators and Surgical Masks models 1510 (K062665), 1511,1512,1513,1517(K061859), 3000N95-XS, 3001N95-S, 3002N95-M, 3003N95-L, 3004N95-LP, 3101N95-S, 3102N95-M/L, and 3104N95-LP (K051182), These products have also been tested and approved by NIOSH as N95 Respirators

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### 510(k) Summary (Continued)

Description:

The Inovel type N95 Healthcare Particulate Respirators and Surgical Masks are constructed from an extruded plastic mesh used in the outer cover and a nonwoven spunbond used in the inner and outer cover. The polypropylene melt blown filter media is layered between the inner and outer cover. The head strap is made of a non-latex rubber stapled to the mask. The inside nosepiece is a closed cell foam.

The Inovel type N95 Healthcare Particulate Respirators and Surgical Masks are approved by NIOSH in accordance with 42 CFR Part 84. The certification numbers are TC-84A-4100 and TC-84A-4101.

The type N95 must meet the prescribed test criteria which specifies the use of 0.055 to 0.095 micron diameter challenge and requiring a 95% efficiency or better. The masks are resistant to synthetic blood as per ASTM F 1862 Standard Test method for Resistance of Medical Face Mask to Penetration by Synthetic Blood. Breathing resistance was tested by NIOSH in accordance to 42 CFR Part 84. The devices have a Bacterial Filtration Efficiency greater than 99.9%. Testing was conducted by Nelson Laboratories using the Modified Green and Vesley Mcthod for evaluation of bacterial filtration efficiency of surgical masks.

### Intended Use:

The various models of Inovel Type N95 Healthcare Particulate Respirators and Surgical Masks meet CDC Guidelines for TB Exposure Control within healthcare facilities. These devices are also intended to be worn by healthcare personnel during surgical procedures to protect both the patient and healtheare personnel from the transfer of microorganisms, body fluids and particulate material.

- I imitations:
These products do 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.

### Comparison of Predicate Devices:

The configuration, materials and components are the same for both the previously cleared device and the Inovel device models for which clearance is being requested including the same color of straps.

The Inovel type N95 Healthcare Particulate Respirators and Surgical Masks incorporate a highly efficient filter media and is 95% efficiency or better against aerosols that have a count median diameter of 0.055 - 0.095 microns which was scientifically established as the most penetrating particle size. The legally marketed devices previously cleared 510(k) are manufactured from identical materials.

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1011 WLS FJEFFFRSON BOOLEVARD, CULVER CITY, CALIFORNIA 90232
TELEPHONE - 866 546 6835 - FAX [phone] - - www.movesmedical com

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## 510(k) Summary (continued)

## Device and Predicate Devices Descriptions/ Comparisons

| Description | | | |
|-------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Inovel Health Care N95<br>Particulate Respirators and<br>Surgical Masks, models<br>MFRN95-S, MFRN95-XS,<br>MFRN95-ML, MFRN95-A,<br>MFRN95-SZ, MFRN95-<br>MLZ | Inovel Health Care N95<br>Particulate Respirators and<br>Surgical Masks, models 1510<br>1511, 1512, 1513, 1517,<br>3211N95-S, 3212N95-M/L | Inovel Health Care N95<br>Particulate Respirators and<br>Surgical Masks, models<br>3000N95-XS, 3001N95-S,<br>3002N95-M, 3003N95-L,<br>3004N95-LP, 3101N95-S,<br>3102N95-M/L, 3104N95-LP |
| Materials | | | |
| Outer Cover<br>Fabrics | Ethylene-Vinyl Acetate<br>Copolymer, extruded | Ethylene-Vinyl Acetate<br>Copolymer, extruded | Polypropylene Spunbond and<br>Ethylene-Vinyl Acetate<br>Copolymer, extruded |
| Nosepiece | Polyethylene foam | Polyethylene foam | Polyethylene foam |
| Headband | Various colors elastic, latex<br>free | Various colors elastic, latex free | Various colors elastic, latex free |
| Specification &<br>Dimensions | Overall width: $4 5/8 - 7 3/4$<br>inches | Overall width: $4 5/8 - 7 3/4$<br>inches | Overall width: $4 5/8 - 7 3/4$<br>inches |
| | Overall height: $4 3/4 - 5 1/2$<br>inches | Overall height: $4 3/4 - 5 1/2$<br>inches | Overall height: $4 3/4 - 5 1/2$<br>inches |
| Mask Style | Molded Cup | Molded Cup | Molded Cup |
| Design Features | Dual synthetic rubber or<br>single elastic head strap | Dual synthetic rubber or single<br>elastic head strap | Dual synthetic rubber or single<br>elastic head strap |
| NIOSH Certification# | TC-84A-4100<br>TC-84A-4101 | TC-84A-4333<br>TC-84A-4338<br>TC-84A-0013 | TC-84A-4102<br>TC-84A-4103 |

## Risks to Health

| Performance<br>Characteristics | Test Method | Acceptance criteria/ Results | Predicate Device Results | Predicate Device Results |
|---------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------|-------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Inovel Health Care N95<br>Particulate Respirators and<br>Surgical Masks models<br>MFRN95-S, MFRN95-XS,<br>MFRN95-ML, MFRN95-A,<br>MFRN95-SZ, MFRN95-MLZ | | | Inovel Health Care N95<br>Particulate Respirators and<br>Surgical Masks models 1510,<br>1511, 1512, 1513, 1517,<br>3211N95-S, 3212N95-M/L | Inovel Health Care N95<br>Particulate Respirators and<br>Surgical Masks models<br>3000N95-XS, 3001N95-S,<br>3002N95-M, 3003N95-L,<br>3004N95-LP, 3101N95-S,<br>3102N95-M/L, 3104N95-LP |
| Fluid Resistance<br>Performance | ASTM 1862 - 00a | Models MFRN95-S, MFRN95-XS,<br>MFRN95-ML, MFRN95-A, ,<br>MFRN95-MLZ: 32 of 32 pass<br>Model MFRN95-SZ:<br>31 of 32 pass | Models 1510, 1511, 1513 and<br>1517, 3211N95-S,<br>3212N95-M/L: 32 of 32 pass<br>Model 1512<br>31 of 32 pass | 32 of 32 pass |
| Flammability<br>Class | 16 CFR 1610 | Flame spread must be within<br>upper and lower limits/ No flame<br>spread on 10 of 10 samples,<br>meets Class I | Flame spread must be within<br>upper and lower limits/ No<br>flame spread on 10 of 10<br>samples, meets Class I | Flame spread must be within<br>upper and lower limits/ No flame<br>spread on 10 of 10 samples,<br>meets Class I |
| Filter Efficiency<br>(%) | NIOSH, 42 CFR<br>Part 84 | > 95% Efficient/ average<br>99.46% efficient of 40 samples | > 95% Efficient/ average<br>98.58% efficient of 17 samples | > 95% Efficient/ average<br>99.11% efficient of 20 samples |
| Breathing<br>Resistance<br>(mm H2O) | NIOSH, 42 CFR<br>Part 84 | ≤ 35.0 mm H2O @ 85 lpm/<br>average 12.5 mm H2O @ 85 lpm<br>of 18 samples | ≤ 35.0 mm H2O @ 85 lpm/<br>average 10.3 mm H2O @ 85<br>lpm of 3 samples | ≤ 35.0 mm H2O @ 85 lpm/<br>average 11.3 mm H2O @ 85 Ipm<br>of 3 samples |

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Image /page/3/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized eagle with its wings spread, symbolizing protection and service. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Inovel, LLC C/O Mr. Daniel W. Lehtonen Responsible Third Party Official Intertek Testing Services NA, Incorporated 2307 East Aurora Road, Unit B7 Twinsburg, Ohio 44087

JAN 1 2 2007

Re: K063747

Trade/Device Name: Health Care N95 Particulate Respirators and Surgical Masks, Models MFRN95-S, MFRN95-XS, MFRN95-ML, MFRN95-A, MFRN95-SZ, MFRN95-MLZ Regulation Number: 878.4040 Regulation Name: Surgical Apparel Regulatory Class: II Product Code: MSH Dated: January 2, 20067 Received: January 3, 2007

Dear Mr. Lehtonen:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 ta2898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2 - Mr. Lehtonen

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807): labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Suttey. Michian Omd

Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use

# 510(k) Number (if known): KO63747

### Device Name: Health Care N95 Particulate Respirators and Surgical Masks, models Health Caro 1059 Functions ML, MFRN95-ML, MFRN95-A, MFRN95-SZ, MFRN95-MLZ

Indications for Use:

The various models of Inovel Type N95 Healthcare Particulate Respirators and The Various Intodess of mover 17per for TB Exposure Control within healthcare facilities. These devices are also intended to be worn by healthcare personnel during surgical procedures to protect both the patient and healthcare personnel during "Surgiour" procedures eanisms, body fluids and particulate material.

AND/OR Prescription Use _ (Part 21 CFR 801 Subpart D)

Over-The-Counter Use X (21 CFR 801 Subpart C)

### (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

### Concurrence of CDRH, Office of Device Evaluation (ODE)

Shala H. Murphy, D

on of Anesthesiology. General H tion Control, Dental E

K063747

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