WILLSON ONE-FIT HEALTHCARE PARTICLE RESPIRATOR AND SURGICAL MASK, HC-NB095

K070139 · Survivair, Inc. · MSH · Mar 2, 2007 · General, Plastic Surgery

Device Facts

• Record ID: K070139
• Device Name: WILLSON ONE-FIT HEALTHCARE PARTICLE RESPIRATOR AND SURGICAL MASK, HC-NB095
• Applicant: Survivair, Inc.
• Product Code: MSH · General, Plastic Surgery
• Decision Date: Mar 2, 2007
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 878.4040
• Device Class: Class 2

Intended Use

The Willson® ONE-Fit™ HC-NB095 Healthcare Particulate Respirator and Surgical Mask is a NIOSH-approved N95 single use respirator intended for use by healthcare personnel during medical/surgical procedures to protect both the wearer and the patient by protecting the wearer against the spatter of blood and other potentially infectious materials and reducing the transfer of microorganisms and other airborne particulate matter. The Willson ONE-Fit also meets the CDC guidelines for TB exposure control within healthcare facilities and is intended for use as an isolation mask.

Device Story

Cup-type, single-use, disposable N95 particulate respirator and surgical mask; worn by healthcare personnel during medical/surgical procedures. Protects wearer from blood spatter/infectious materials; reduces transfer of microorganisms/particulates between wearer and patient. Meets CDC guidelines for TB exposure control. Device features thermoformed cup, heat-sealed perimeter flange, and two latex-free synthetic elastic straps for secure fit. NIOSH-certified (TC-84A-4357).

Clinical Evidence

Bench testing only. Device passed standardized performance tests for fluid resistance, filter efficiency, bacterial and viral filtration efficiency, flammability, and breathing resistance. Biocompatibility confirmed via cytotoxicity, sensitization, and skin irritation testing.

Technological Characteristics

Cup-type respirator; inner layer polypropylene, middle filtration layer polypropylene, outer layer non-woven polyester. Thermoformed cup with heat-sealed perimeter. Two latex-free synthetic elastic straps. NIOSH-certified N95 (42 CFR Part 84).

Indications for Use

Indicated for healthcare personnel during medical/surgical procedures to protect wearer and patient from blood spatter, infectious materials, and airborne particulates; also indicated for TB exposure control and as an isolation mask.

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's N95 Particulate Respirators and Surgical Masks (K051182)
• Aearo Co. Pleats Plus 1050 and 1050S (K041855)

Submission Summary (Full Text)

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K070/39

# MAR 92 2007

## 5. 510(k) Summary

| Submitter/Contact<br>Person | Richard O. Wood<br>The Wood Burditt Group<br>FDA Regulatory Counseling<br>1025 W. Everett Rd., Suite 100<br>Lake Forest, IL 60045 |
|------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Applicant | Survivair Respirators LLC<br>3001 S. Susan St.<br>Santa Ana, CA 92704 |
| Manufacturer | Bacou Dalloz Plaintel (SAS)<br>Gare<br>22940 Plaintel, France |
| Device Name | Willson® ONE-Fit™ HC-NB095 Healthcare Particulate<br>Respirator and Surgical Mask |
| Common Name | Surgical N95 NIOSH-certified Respirator |
| Classification | Class II<br>Procode MSH<br>21 C.F.R. §878.4040 |
| Identification of<br>Predicates and Summary<br>of Substantial<br>Equivalence | The Willson® ONE-Fit™ HC-NB095 is substantially<br>equivalent to Inovel Health Care's N95 Particulate<br>Respirators and Surgical Masks (K051182) and Aearo Co.<br>Pleats Plus 1050 and 1050S (K041855). Like the predicates,<br>it has been performance tested and passed standardized tests<br>for fluid resistance, filter efficiency, bacterial and viral<br>filtration efficiency, flammability and breathing resistance.<br>The materials used in the mask are the same as used on the<br>cited predicates, but were also determined to be biocompatible<br>by cytotoxicity, sensitization and skin irritation testing. |
| Device Description | The Willson ONE-Fit HC-NB095 Healthcare Particulate<br>Respirator and Surgical Mask is a one size fits all, cup type,<br>particulate respirator and surgical mask. The inner layer is<br>constructed of polypropylene; the middle layer is a filtration<br>layer made of polypropylene; and the outer layer is a covering<br>of non woven polyester. The cup is thermoformed while the<br>perimeter layers are heat sealed to form a small flange around<br>the perimeter of the mask. Two latex free, synthetic elastic<br>straps are stapled to the flange and are used to secure the mask<br>to the wearer's face.<br>The Willson ONE-Fit HC-NB095 is approved by NIOSH in<br>accordance with 42 CFR Part 84. NIOSH has issued<br>certification number TC-84A-4357 as a type N95 Particulate<br>Respirator. It is a single use, disposable device. |
| Intended Use and<br>Indications | The Willson® ONE-Fit™ HC-NB095 Healthcare<br>Particulate Respirator and Surgical Mask is a NIOSH-<br>approved N95 single use respirator intended for use by<br>healthcare personnel during medical/surgical<br>procedures to protect both the wearer and the patient<br>by protecting the wearer against the spatter of blood<br>and other potentially infectious materials and reducing<br>the transfer of microorganisms and other airborne<br>particulate matter. |
| | The Willson ONE-Fit also meets the CDC guidelines<br>for TB exposure control within healthcare facilities<br>and is intended for use as an isolation mask. |

K070139 510(k) -- Willson® ONE-Fit™ HC-NB095 Healthcare Particle Respirator and Surgical Mask

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the eagle. The logo is black and white.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 0 2 2007

Survivair, Incorporated C/O Mr. Richard O. Wood Official Correspondent The Wood Burditt Group LLC 1025 West Everett Road Lake Forest, Illinois 60045

Re: K070139

Trade/Device Name: Willson® ONE-Fit™ HC-NB095 Healthcare Particulate Respirator and Surgical Mask Regulation Number: 878.4040 Regulation Name: Surgical Apparel Regulatory Class: II Product Code: MSH Dated: February 23, 2007 Received: February 26, 2007

Dear Mr. Wood:

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 to 898, In addition, FDA may publish further announcements concerning your device in the Federal Register.

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### Page 2 - Mr. Wood

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 (OS) 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.

Sujata Y. Michael m.d.

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): K070139

Willson® ONE-Fit™ HC-NB095 Healthcare Particulate Device Name: Respirator and Surgical Mask

Indications For Use:

The Willson® ONE-Fit™ HC-NB095 Healthcare Particulate Respirator and Surgical Mask is a NIOSHapproved N95 single use respirator intended for use by healthcare personnel during medical/surgical procedures to protect both the wearer and the patient by protecting the wearer against the spatter of blood and other potentially infectious materials and reducing the transfer of microorganisms and other airborne particulate matter.

The Willson ONE-Fit also meets the CDC guidelines for TB exposure control within healthcare facilities and is intended for use as an isolation mask.

ਸ Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (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)

Shule A. Murphy, M.D.

Control, Evidence

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