SAFE LIFE N95 RESPIRATOR AND SURGICAL MASK, MODELS B130 AND B150

K100139 · Safelife Corp. · MSH · May 4, 2010 · General, Plastic Surgery

Device Facts

• Record ID: K100139
• Device Name: SAFE LIFE N95 RESPIRATOR AND SURGICAL MASK, MODELS B130 AND B150
• Applicant: Safelife Corp.
• Product Code: MSH · General, Plastic Surgery
• Decision Date: May 4, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4040
• Device Class: Class 2

Intended Use

The Safe Life B130 and B150 N95 Respirators and Surgical Masks are single-use disposable devices intended to protect healthcare workers and patients from the transfer of microorganisms, blood, body fluids, and airborne particulate materials. These respirators/surgical masks may be used during medical, surgical and dental procedures, and may also be used as isolation masks.

Device Story

Safe Life B130 and B150 are single-use, disposable N95 respirators and surgical masks. Designed for use by healthcare professionals in medical, surgical, and dental settings to provide a physical barrier against microorganisms, blood, body fluids, and airborne particulates. Function as both respiratory protection and surgical masks; used as isolation masks to reduce cross-contamination risk between patients and clinicians. No electronic components, software, or automated processing involved.

Clinical Evidence

Bench testing only.

Technological Characteristics

Single-use, disposable N95 respirator and surgical mask. Mechanical barrier design. No electronic, software, or energy-based components.

Indications for Use

Indicated for healthcare workers and patients to provide protection against transfer of microorganisms, blood, body fluids, and airborne particulates during medical, surgical, and dental procedures, or as isolation masks.

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.

Submission Summary (Full Text)

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name arranged in a circular fashion around the perimeter. In the center is a stylized emblem consisting of three abstract shapes that resemble a person with outstretched arms.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Dr. Albert Rego, Ph.D. Vice President Regulatory Affairs, Quality Assurance and Scientific Applications Safelife Corporation 12250 El Camino Real, Suite 350 MAY - 4 2010 San Diego, California 92130

Re: K100139

Trade/Device Name: Safe Life N95 Respirator and Surgical Mask, Models B130 and B150

Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: II Product Code: MSH Dated: March 31, 2010 Received: April 8, 2010

Dear Dr. Rego:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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- Dr. Albert Rego, Ph.D.

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.

Susan Ranner

Anthony D. Watson, B.S., M.S., M.B.A. 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):

Device Name:__________________________________________________________________________________________________________________________________________________________________

Indications for Use:

The Safe Life B130 and B150 N95 Respirators and Surgical Masks are single-use disposable devices intended to protect healthcare workers and patients from the transfer of microorganisms, blood, body fluids, and airborne particulate materials. These respirators/surgical masks may be used during medical, surgical and dental procedures, and may also be used as isolation masks.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 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

510(k) Number: k100139

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