WILLSON ONE-FIT FLAT-FOLD HEALTHCARE PARTICULATE RESPIRATOR AND SURGICAL MASK, MODELS HC-NB095F AND HC-NB295F

K070782 · Survivair Respirators, LLC · MSH · Apr 11, 2007 · General, Plastic Surgery

Device Facts

• Record ID: K070782
• Device Name: WILLSON ONE-FIT FLAT-FOLD HEALTHCARE PARTICULATE RESPIRATOR AND SURGICAL MASK, MODELS HC-NB095F AND HC-NB295F
• Applicant: Survivair Respirators, LLC
• Product Code: MSH · General, Plastic Surgery
• Decision Date: Apr 11, 2007
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 878.4040
• Device Class: Class 2

Intended Use

The Willson® ONE-Fit™ Flat-Fold™ Healthcare Particulate Respirator and Surgical Masks (Models HC-NB095F and HC-NB295F) are NIOSH-approved N95 single use respirators 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 Flat-Fold masks also meet the CDC guidelines for TB exposure control within healthcare facilities and are intended for use as an isolation mask.

Device Story

Flat-fold style particulate respirator and surgical mask; single or dual strap configurations. Construction: inner/outer layers of spunbonded polypropylene; middle filtration layer of melt-blown polypropylene. Ultrasonically sealed facepiece halves and perimeter edges. Used by healthcare personnel in clinical settings to reduce transfer of microorganisms and protect against blood spatter/infectious materials. NIOSH-approved N95 (TC-84A-4372, TC-84A-4371).

Clinical Evidence

Bench testing only. Performance testing included fluid resistance, filter efficiency, bacterial filtration efficiency, flammability, and breathing resistance. Biocompatibility testing included cytotoxicity, sensitization, and skin irritation.

Technological Characteristics

Flat-fold particulate respirator. Materials: spunbonded polypropylene (inner/outer), melt-blown polypropylene (filtration). Construction: ultrasonically welded/sealed. NIOSH N95 certified (42 CFR 84).

Indications for Use

Indicated for healthcare personnel during medical/surgical procedures to protect wearer and patient from blood spatter, infectious materials, and airborne particulate matter; 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

• Willson® ONE-Fit™ HC-NB095 Cup-style Healthcare Particle Respirator and Surgical Mask (K070139)

Submission Summary (Full Text)

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X070782

## 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>APR 11 2007<br>Lake Forest, IL 60045<br>[phone] x 203<br>[e-mail]<br>[phone] (fax) |
|------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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™ Flat-Fold™ Healthcare Particulate<br>Respirator and Surgical Masks, Models HC-NB095F and HC-<br>NB295F |
| 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™ Flat-Fold masks are substantially<br>equivalent to Survivair's own and recently cleared Willson®<br>ONE-Fit™ HC-NB095 Cup-style Healthcare<br>Particle<br>Respirator and Surgical Mask (K070139). The Flat-Fold<br>masks have been performance tested in an identical manner to<br>the predicate, and passed standardized tests for fluid<br>resistance, filter efficiency, bacterial filtration efficiency,<br>flammability and breathing resistance. The materials used in<br>the mask are virtually identical to the ones used on the cited<br>predicate, and were also determined to be biocompatible by<br>cytotoxicity, sensitization and skin irritation testing. |
| Device Description | The Willson ONE-Fit Flat-Fold Healthcare Particulate<br>Respirator and Surgical Masks are flat-fold style particulate<br>respirator and surgical masks. The only difference between<br>the two models is the number of straps; one has a single strap,<br>the other a double strap.<br>The inner layer of the mask is constructed of spunbonded<br>polypropylene, the middle layer is a filtration layer made of<br>melt blown polypropylene and the outer layer is a covering of<br>spunbonded polypropylene. The two halves that comprise<br>the flat-fold facepiece are ultrasonically sealed together. The |
| | lower halves and is/are ultrasonically welded into the corners<br>of the mask. The perimeter edges of the mask that contact the<br>wearer's face are also ultrasonically sealed to provide<br>reinforcement of the edges. |
| | The Willson ONE-Fit Flat-Fold Healthcare Particulate<br>Respirator and Surgical Masks are approved by NIOSH in<br>accordance with 42 CFR 84 as N95 particulate respirators.<br>NIOSH has issued approvals TC-84A-4372 (single strap) and<br>TC-84A-4371 (dual strap). |
| Intended Use and<br>Indications | The Willson® ONE-Fit™ Flat-Fold™ Healthcare Particulate<br>Respirator and Surgical Masks (Models HC-NB095F and HC-<br>NB295F) are NIOSH-approved N95 single use respirators<br>intended for use by healthcare personnel during<br>medical/surgical procedures to protect both the wearer and the<br>patient by protecting the wearer against the spatter of blood<br>and other potentially infectious materials and reducing the<br>transfer of microorganisms and other airborne particulate<br>matter.<br>The Willson ONE-Fit Flat-Fold masks also meet the CDC<br>guidelines for TB exposure control within healthcare facilities<br>and are intended for use as an isolation mask. |

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510(k) -- Willson® ONE-Fit™ Flat Fold Healthcare Particle Respirator and Surgical Masks

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Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized eagle with three lines representing its wings and body. The eagle faces to the left. Encircling the eagle is the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" in a circular arrangement.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Survivair Respirators, LLC C/O Mr. Richard O. Wood The Wood Burditt Group 1025 W. Everett Road Lake Forest, Illinois 60045

APR 1 1 2007

Re: K070782

Trade/Device Name: Willson® ONE-Fit Flat-Fold™ Healthcare Particulate Respirator and Surgical Mask, HC-NB095F & HC-NB295F Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: II Product Code: MSH Dated: April 3, 2007 Received: April 4, 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 misbrandi, no 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, EDA coach 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 (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.

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);

Willson® ONE-Fit™ Flat-Fold™ Healthcare Particulate Device Name: Respirator and Surgical Masks, HC-NB095F & HC-NB295F

Indications For Use:

The Willson® ONE-Fit™ Flat-Fold™ Healthcare Particulate Respirator and Surgical Masks (HC-NB095F & HC-NB295F) are NIOSH-approved N95 single use respirators 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 Flat-Fold masks also meet the CDC guidelines for TB exposure control within healthcare facilities and are intended for use as an isolation mask.

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)

Sheila P. Murphy, MD

f Anesthesiology, General Hospital,
-ion Control, Central Services

Page 1 of 1

c(k) Number: K010/82

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