ACTIPROTECT UF N95 RESPIRATOR, DOUBLE STRAP, FLAT FOLD

K081923 · Glaxosmithkline Consumer Healthcare · ONT · Jul 1, 2009 · General, Plastic Surgery

Device Facts

• Record ID: K081923
• Device Name: ACTIPROTECT UF N95 RESPIRATOR, DOUBLE STRAP, FLAT FOLD
• Applicant: Glaxosmithkline Consumer Healthcare
• Product Code: ONT · General, Plastic Surgery
• Decision Date: Jul 1, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4040
• Device Class: Class 2

Indications for Use

Actiprotect™ UF N95 Respirator is a single use, disposable respirator coated with Virucoat™ on the outer layer (active ingredient: citric acid, 1.8%, a pH lowering agent) and is not an antiviral drug. Actiprotect kills (inactivates) 99.99% of influenza A viruses (tested against influenza A subtypes H1N1 (2009 pandemic strains not tested)) within one minute of contact with the surface of the respirator. In vitro testing has demonstrated 99.99% kill (inactivation) on the surface of the outer laver when tested in vitro against the following influenza viruses (tested against Influenza A subtypes (and strains): H1N1(JPN/35/2007, JPN/36/2007, 2009 pandemic strains not tested), H2N2 (A2/JP/305/57), H3N2 (Hong Kong 8/68) and including bird flu subtypes: H5N1 (VNH5N1-PR8/CDCRG), H5N9 (Turkey A/Wisc/68, Myna A/Mass/71), and an Influenza B strain (JPN/85/2007)) under tested contact conditions. Correlation between in vitro activity and any clinical event has not been tested. Actiprotect™ is intended for occupational use during seasonal influenza A or an influenza A pandemic. It is intended to cover the nose and mouth of the wearer to help reduce wearer exposure to pathogenic biological airborne particulates during seasonal influenza A or an influenza A pandemic. Actiprotect™ UF N95 Respirator also helps to protect the wearer from splash and spray of body fluids.

Device Story

Double-strap, flat-fold filtering facepiece respirator; consists of multiple non-woven fabric layers. Filtration achieved via mechanical entrapment and electrostatic surface attraction. Outer layer coated with Virucoat™ (1.8% citric acid) to inactivate 99.99% of influenza A viruses upon contact. Used in occupational settings by healthcare workers. Protects wearer from airborne particulates and fluid splashes. Benefits include reduced exposure to pathogens during influenza outbreaks. No clinical correlation between in vitro inactivation and clinical events established.

Clinical Evidence

No clinical efficacy data provided. Clinical safety evidence limited to Human Repeated Insult Patch Tests (HRIPT) on respirator materials; study showed no evidence of sensitization or irritation. Bench testing confirmed efficacy for fluid penetration resistance (ASTM F1862), particulate filtration (NIOSH 42 CFR 84.181), bacterial/viral filtration (MIL M36954C, ASTM F2101), flammability (16 CFR 1610), and breathing resistance (NIOSH 42 CFR 84.180).

Technological Characteristics

Non-woven fabric layers; ultrasonically sealed perimeter. Two synthetic elastic straps. Active ingredient: 1.8% citric acid coating. Filtration via mechanical entrapment and electrostatic forces. Standards: ASTM F1862 (fluid), NIOSH 42 CFR 84.181 (particulate), MIL M36954C/ASTM F2101 (BFE/VFE), 16 CFR 1610 (flammability), NIOSH 42 CFR 84.180 (breathing resistance). Biocompatible per cytotoxicity and HRIPT.

Indications for Use

Indicated for occupational use by healthcare workers during seasonal influenza A or pandemic influenza A. Intended to cover nose and mouth to reduce wearer exposure to pathogenic biological airborne particulates and protect against splash and spray of body fluids.

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 Flat Folded Healthcare Particulate Respirator and Surgical Mask Model HC-NB095F & HC-NB295F (K070782)

Submission Summary (Full Text)

{0}------------------------------------------------

K081923/S2 Supplement 4

ctiprotect UF N95 Respirator GlaxoSmithKline Consumer Healthcare, L.P.

JUL - 1 2009

4

Image /page/0/Picture/3 description: The image contains the logo for GlaxoSmithKline. The logo consists of the letters "gsk" in a stylized font, placed inside of a dark, circular shape. To the right of the circular shape, the words "GlaxoSmithKline" are written in a smaller, sans-serif font.

## GlaxoSmithKline

1500 Littleton Road Parsippany, NJ 07054-3884

Tel. [phone] Fax. [phone] www.gsk.com

#### 6. 510(k) Summary

#### 6.1 Applicant and Correspondent:

Name:

# GlaxoSmithKline Consumer Healthcare

Address: 1500 Littleton Road Parsippany, NJ 07054-3884

Contact Person: Zinatara A. Manji, M.S., Pharm.D. Director, Regulatory Affairs

V

Phone: [phone]

Date of Preparation: June 24, 2009

#### 6.2 Manufacturer:

Sperian Protection Armor SAS Zl de la Gare 22940 Plaintel France

Doc ID 0b00233c807674db

{1}------------------------------------------------

#### 6.3 Name of Device:

Trade/Proprietary/Model Name:

Common Name:

Actiprotect™ UF N95 Respirator Double Strap, Flat Fold

Filtering Facepiece Respirator

Classification Name:

Filtering Facepiece Respirator for Use by Healthcare Workers (21 CFR 878.4040) Product Code MSH

#### Devices to Which New Device is Substantially Equivalent: 6.4

Willson ONE-Fit Flat Folded Healthcare Particulate Respirator and Surgical Mask Model HC-NB095F & HC-NB295F (K070782).

#### 6.5 Device Description:

Actiprotect™ UF N95 Respirator is a double strap, flat-fold style filtering facepiece respirator. It consists of multiple layers of non-woven fabric. A filtration layer provides a barrier to particles of various sizes through mechanical entrapment in a tortuous pathway and by surface attraction by electrostatic forces. The outer layer contains a coating to capture and inactivate viruses. The layers of non-woven fabric are ultrasonically sealed together at the outer perimeter. Two synthetic clastic strips are stapled or welded to the edge of the respirator and are used to secure the mask to the user's face.

#### ર્ણ વિશ્વર ભાગમાં આવેલું એક ગામનાં છે. આ ગામનાં લોકોનો મુખ્ય વ્યવસાય ખેતી ખેતી કરવામાં આવેલું એક ગામનાં છે. આ ગામનાં લોકોનો મુખ્ય વ્યવસાય ખેતી ખેતી કરવામાં આવેલું એક ગામના Statement of Intended Use:

Actiprotect™ UF N95 Respirator is a single use, disposable respirator coated with Virucoat™ on the outer layer (active ingredient: citric acid, 1.8%, a pH lowering agent) and is not an antiviral drug. Actiprotect kills (inactivates) 99.99% of influenza A viruses (tested against influenza A subtypes HIN1 (2009 pandemic strains not tested)) within one minute of contact with the surface of the respirator. In vitro testing has demonstrated 99.99% kill (inactivation) on the surface of the outer laver when tested in vitro against the following influenza viruses (tested against Influenza A subtypes (and strains): H1N1(JPN/35/2007, JPN/36/2007, 2009 pandemic strains not tested), H2N2 (A2/JP/305/57), H3N2 (Hong Kong 8/68) and including bird flu subtypes: H5N1 (VNH5N1-PR8/CDCRG), H5N9 (Turkey A/Wisc/68, Myna

5

{2}------------------------------------------------

A/Mass/71), and an Influenza B strain (JPN/85/2007)) under tested contact conditions. Correlation between in vitro activity and any clinical event has not been tested. Actiprotect™ is intended for occupational use during seasonal influenza A or an influenza A pandemic. It is intended to cover the nose and mouth of the wearer to help reduce wearer exposure to pathogenic biological airborne particulates during seasonal influenza A or an influenza A pandemic. Actiprotect™ UF N95 Respirator also helps to protect the wearer from splash and spray of body fluids.

#### 6.7 Summary of the Technological Characteristics:

Actiprotect™ UF N95 Respirator has the same filtering and barrier properties as the predicate device, Willson ONE-Fit Flat Folded Healthcare Particulate Respirator and Surgical Mask. In addition, Actiprotect™ UF N95 Respirator offers the protection of a coating on its outermost surface to capture and inactivate influenza viruses on contact with the surface.

Actiprotect™ UF N95 Respirator has been tested for and passed standardized tests for fluid penetration resistance, particulate filtration efficiency, bacterial filtration efficiency (BFE), virus filtration efficiency (VFE), flammability, and breathing resistance.

The materials of construction used in Actiprotect™ UF N95 Respirator are substantially equivalent to those of the predicate device. The device as a whole has been demonstrated to be biocompatible by cytotoxicity and human repeated insult patch testing.

### 6.8 Brief discussion of the nonclinical tests submitted, referenced, or relied on in the premarket notification submission for a determination of substantial equivalence:

- . Fluid Penetration Resistance - ASTM F1862
- Particulate Filtration Efficiency NIOSH 42 CFR 84.181 .
- Bacterial Filtration Efficiency MIL M36954C. ASTM F2101 ●
- . Virus Filtration Efficiency - MIL M36954C, ASTM F2101
- Flammability 16 CFR 1610 .
- Breathing Resistance NIOSH 42 CFR 84.180

{3}------------------------------------------------

### 6.9 Brief discussion of the clinical tests submitted, referenced, or relied on in the premarket notification submission for a determination of substantial equivalence:

Human Repeated Insult Patch Tests were conducted using samples of the respirator materials held under occlusive patches. There were no adverse reactions reported during the studies. The outcome of these tests revealed no evidence of sensitization or irritation.

## 6.10 Conclusions drawn from the nonclinical and clinical tests:

Cytotoxicity and human repeated insult patch tests plus a toxicological review of data on the product's ingredients indicates the product is safe for use in the intended application. Bench testing demonstrated the product's efficacy. Actiprotect™ UF N95 Respirator has been shown to be substantially equivalent to the predicate device.

Doc ID 0b00233c807674db

{4}------------------------------------------------

## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an emblem featuring a stylized eagle with its wings spread, clutching a staff with a snake wrapped around it, which is a symbol of medicine and healing.

Public Health Service

JUI - 1 2009

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Zinatara A. Manji, M.S., PharmaD Director of Regulatory Affairs GlaxoSmithKline Consumer Healthcare LP 1500 Littleton Road Parsippany, New Jersey 07054

Re: K081923

Trade/Device Name: Actiprotect™ UF N95 Respirator, Double Strap Flat Fold Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: II Product Code: ONT Dated: June 17, 2009 Received: June 17, 2009

Dear Dr. Manji:

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 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.

{5}------------------------------------------------

### Page 2 - Dr. Manji

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/ CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/cdrh/mdr/ for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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 vours.

Anthony D. Anton her

Susan Runner, D.D.S., M.A. Acting Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{6}------------------------------------------------

## Indications for Use

### 510(k) Number (if known): K081923

Device Name: Actiprotect™ UF N95 Respirator, Double Strap Flat Fold

Indications For Use:)".

Actiprotect™ UF N95 Respirator is a single use, disposable respirator coated with Virucoat™ on the outer layer (active ingredient: citric acid, 1.8%, a pH lowering agent) and is not an antiviral drug. Actiprotect kills (inactivates) 99.99% of influenza A viruses (tested against influenza A subtypes H1N1 (2009 pandemic strains not tested)) within one minute of contact with the surface of the respirator. In vitro testing has demonstrated 99.99% kill (inactivation) on the surface of the outer layer when tested in vitro against the following influenza viruses (tested against Influenza A subtypes (and strains): H1N1(JPN/35/2007, JPN/36/2007, 2009 pandemic strains not tested), H2N2 (A2JJP/305/57), H3N2 (Hong Kong 8/68) and including bird flu subtypes: H5N1 (VNH5N1-PR8/CDCRG), H5N9 (Turkey A/Wisc/68, Myna A/Mass/71), and an Influenza B strain (JPN/85/2007)) under tested contact conditions. Correlation between in vitro activity and any clinical event has not been tested. Actiprotect™ is intended for occupational use during seasonal influenza A or an influenza A pandemic. It is intended to cover the nose and mouth of the wearer to help reduce wearer exposure to pathogenic biological airborne particulates during seasonal influenza A or an influenza A pandemic. Actiprotect™ UF N95 Respirator also helps to protect the wearer from splash and spray of body fluids.

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)

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

Page 1 of

510(k) Number: