N95 RESPIRATOR MASK, POSITIVE FACIAL LOCK WITH MAGIC ARCH, MODEL 695

K092824 · Alpha Protech, Inc. · MSH · Oct 21, 2009 · General, Plastic Surgery

Device Facts

• Record ID: K092824
• Device Name: N95 RESPIRATOR MASK, POSITIVE FACIAL LOCK WITH MAGIC ARCH, MODEL 695
• Applicant: Alpha Protech, Inc.
• Product Code: MSH · General, Plastic Surgery
• Decision Date: Oct 21, 2009
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 878.4040
• Device Class: Class 2

Intended Use

Alpha Pro Tech's 695 N95 Respirator Mask meets the 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. It is intended to be a single use, disposable device. This would also include use as a procedure mask, isolation mask and/or dental face mask.

Device Story

Single-use, disposable N95 respirator mask; constructed of polypropylene meltblown filter media between non-woven wetlaid covers; secured via dual polyester-covered non-latex rubber headbands; features aluminum nose and chin wires for facial fit. Used in healthcare settings (surgical, dental, isolation) by personnel to reduce exposure to microorganisms, body fluids, and particulates. NIOSH-approved design.

Clinical Evidence

No clinical data; device relies on NIOSH approval and bench testing of material characteristics.

Technological Characteristics

Nonwoven meltblown polypropylene filter media; non-woven wetlaid outer/inner covers; aluminum nose and chin wires; dual polyester-covered non-latex rubber headbands; flat pleated form factor; NIOSH-approved.

Indications for Use

Indicated for healthcare personnel during surgical procedures, TB exposure control, and as a procedure, isolation, or dental mask to protect patients and personnel from microorganisms, body fluids, and particulates.

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

• Aearo Company's Pleats Plus 1050 Respirator Masks

Submission Summary (Full Text)

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K092824

OCT 2 1 2009

# Abbreviated 510(k) For Alpha Pro Tech, Inc 695 N95 Respirator Mask with Positive Facial Lock and Magic Arch

# SECTION 5 510(k) SUMMARY

## Submitter:

Alpha Pro Tech, Inc. 236 North 2200 West Salt Lake City, Utah 84116 Registration Number 1721663

#### Contact:

David Kitchen Corporate QA/RA Manager Telephone: [phone] Fax: [phone] E-mail: [e-mail]

#### Trade Name:

Alpha Pro Tech 695 N95 Respirator Mask, Positive Facial Lock with Magic Arch

#### Model Numbers:

ക്കട

#### Common Name:

Healthcare N95 Particulate Respirator Mask

#### Predicate Device:

Alpha Pro Tech's 695 N95 Respirator Mask has the same technological characteristics as Aearo Company's Pleats Plus 1050 Respirator Masks in that both are NIOSH approved; both are made of nonwoven meltblown polypropylene; both incorporate a forming nosepiece, both employee a flat pleated style; and both are secured using dual elastic head straps.

#### Classification:

Device Class - Class II Product Code - MSH - Surgical N95 Respirator CFR Section - 21 CFR 878.4040

#### Device Description:

Alpha Pro Tech's 695 N95 Respirator Masks consists of a polypropylene meltblown filter media sandwiched between non-woven wetlaid outer and inner covers. The mask is secured using two polyester covered non-latex rubber headbands. Fitting around the face is facilitated using a nose wire and an adjustable chin wire made from aluminum. No fiberglass media is used in this product.

#### Intended Use:

Alpha Pro Tech's 695 N95 Respirator Masks meet the CDC guidelines for TB Exposure Control within healthcare facilities. These devices are intended to be worn by healthcare personnel during surgical procedures to protect both the patient and healthcare personnel from the transfer of

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# AlphaProTec

# Abbreviated 510(k) For Alpha Pro Tech, Inc 695 N95 Respirator Mask with Positive Facial Lock and Magic Arch

microorganisms, body fluids, and particulate material. Intended use includes use as a procedure mask, isolation mask and/or dental face mask. The 695 mask is a single use, disposable device.

## Limitations:

The application of the 695 mask does not eliminate the risk to the wearer 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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Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized eagle-like symbol with three human profiles incorporated into its design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-066-0609 Silver Spring, MD 20993-0002

Mr. David Kitchen Corporate Ouality Assurance/Regulatory Affairs AlphaProTech, Incorporated 236 North 2200 West Salt Lake City, Utah 84116

OCT 2 1 2009

Re: K092824

Trade/Device Name: Alpha Pro Tech 695 N95 Respirator Mask, Positive Facial Lock with Magic Arch Regulation Number: 21CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: II Product Code: MSH Dated: October 1, 2009 Received: October 7, 2009

Dear Mr. Kitchen:

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.

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## Page 2- Mr. Kitchen

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/MedicalDevices/Safety/ReportaProblem/default.htm 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/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely vours.

Century D. mark for

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

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# Abbreviated 510(k) For Alpha Pro Tech, Inc 695 N95 Respirator Mask with Positive Facial Lock and Magic Arch

# SECTION 4 INDICATION FOR USE STATEMENT

510(k) Number (if known):

Device Name: Alpha Pro Tech 695 N95 Respirator Mask, Positive Facial Lock with Magic Arch

Indications for Use:

Alpha Pro Tech's 695 N95 Respirator Mask meets the 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. It is intended to be a single use, disposable device. This would also include use as a procedure mask, isolation mask and/or dental face 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)

Shule A. Murphy Co

ence of CDRH, Office of Device Evaluation (ODE)

Division Sign-Off) Division of Anesthesiology. General Horpits! Infection Control, Dental Devices

510(k) Number: K092824

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