PFR95 PARTICULATE FILTER RESPIRATOR AND SURGICAL MASK REGULAR SIZE, PFR95 PARTICULATE FILTER RESPIRATOR AND SURGICAL

K974068 · Tecnol Medical Products, Inc. · MSH · Dec 22, 1997 · General, Plastic Surgery

Device Facts

• Record ID: K974068
• Device Name: PFR95 PARTICULATE FILTER RESPIRATOR AND SURGICAL MASK REGULAR SIZE, PFR95 PARTICULATE FILTER RESPIRATOR AND SURGICAL
• Applicant: Tecnol Medical Products, Inc.
• Product Code: MSH · General, Plastic Surgery
• Decision Date: Dec 22, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4040
• Device Class: Class 2

Intended Use

The PFR95TM Particulate Filter Respirator and Surgical Masks are intended for use by operating room personnel and other health care workers to protect both the patients and the health care workers from transfer of microorganisms, blood and body fluids, and airborne particulate materials.

Device Story

Respirator and surgical mask; consists of nonwoven inner facing, filter media, and outer facing; covers nose and mouth; secured by two synthetic elastic headbands; includes malleable nosepiece. Used by healthcare workers and OR personnel to provide fluid resistance against blood/body fluid splash/splatter and filtration of airborne particulates. Provides 95% filtration efficiency against solid aerosols (NIOSH N95).

Clinical Evidence

Bench testing only. Filtration efficiency tested against 0.3 micron particles (>=95% efficiency). Fluid resistance tested with 2cc synthetic blood at arterial pressure. Face fit evaluated via qualitative fit test. Airflow resistance (inhalation) tested to be <35mm H2O. Biocompatibility verified per ISO-10993.

Technological Characteristics

Nonwoven fabric construction; synthetic elastic headbands; malleable nosepiece. NIOSH N95 filtration standard. Biocompatibility per ISO-10993. No electronic or software components.

Indications for Use

Indicated for operating room personnel and healthcare workers to provide protection against transfer of microorganisms, blood, body fluids, and airborne particulates. Meets CDC guidelines for TB exposure control and NIOSH N95 requirements.

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

• Gerson Isolair APR Type N95 Model 2735 Respirator and Surgical Mask

Submission Summary (Full Text)

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Tecnol Medical Products, Inc. 510(k) Premarket Notification PFR95TM Particulate Filter Respirator and Surgical Mask

K974068

Tab H
1 of 2 DEC 2 2 1997

## 510(k) SUMMARY

| (1) Submitter: | Tecnol Medical Products, Inc.<br>7201 Industrial Park Blvd.<br>Fort Worth, TX 76180 |
|-----------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Prepared By: | Ruth L. Jones |
| Date Submitted: | October 24, 1997 |
| (2) Device Name/Trade Name: | Tecnol PFR95TM Particulate Filter Respirator and Surgical Mask |
| Common Name: | Surgical Mask<br>Also sometimes referred to as a particulate respirator. |
| Classification Name: | Surgical Apparel, as described in 21 CFR 878.4040 |
| (3) Predicate Device: | Gerson Isolair APR Type N95 Model 2735 Respirator and Surgical Mask |
| (4) Device Description: | Respirator consisting of nonwoven inter facing, filter<br>media(s), and an outer facing. It covers the nose and mouth<br>of the wearer, and is held in place with two synthetic elastic<br>headbands, conforming to the curvature of the wearer's<br>nose with a malleable nosepiece. |
| (5) Intended Use: | Meets the CDC guidelines for TB exposure control.<br>Has a filter efficiency level of 95% against solid particulate<br>aerosols free of oil (NIOSH Type N95 respirator).<br>Designed to be fluid resistant to splash and splatter of blood<br>and body fluids. |
| (6) Technological Characteristics Comparison: | No new technological characteristics are used in the<br>PFR95TM mask. |

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K974068

Tab H 2 of 2

Performance Data: (7)

Tecnol Medical Products, Inc.

510(k) Premarket Notification

PFR95™ Particulate Filter Respirator and Surgical Mask

Filtration Efficiency: Subject device samples met the NIOSH required sodium chloride test with 0.3 micron particles. At no time can the filtration efficiency drop below 95%.

Fluid Resistance: Subject device samples were challenged with 2cc of synthetic blood at a speed simulating release of blood from an artery.

Face Fit: Subject device samples were tested using a qualitative fit test.

Ease of Breathing: Subject device samples met the requirements of the NIOSH airflow resistance test which requires initial resistance (inhalation) to be less than 35mm H2O.

Biocompatibility: Subject device meets the requirements of ISO-10993, "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing"

CONCLUSION: The results of these nonclinical tests, when compared with data available and/or claims made on the predicate device, demonstrate that the subject device is as safe and effective as the predicate device, and performs as well as the predicate device.

f\pfr510(k)/n-fs/tabh.doc

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 22 1997

Ms. Ruth L. Jones Director of Regulatory Affairs Tecnol Medical Products, Incorporated 7201 Industrial Park Boulevard Fort Worth, Texas 76180

Re: K974068 PFR95™ Particulate Filter Respirator and Trade Name: Surgical Mask Reqular Size Requlatory Class: II Product Code: MSH Dated: October 24, 1997 Received: October 28, 1997

Dear Ms. Jones:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does

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Page 2 - Ms. Jones

not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diaqnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Timothy A. Ulatowski

Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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TECNOL

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Tecnol Medical Products, Inc. 510(k) Premarket Notification PFR95TM Particulate Filter Respirator and Surgical Mask

> Tab D I of I

## Intended Use

510(k) Number: K974068

Device Name: PFR95TM Particulate Filter Respirator and Surgical Mask Type N95

Indications for Use:

The PFR95TM Particulate Filter Respirator and Surgical Masks are intended for use by operating room personnel and other health care workers to protect both the patients and the health care workers from transfer of microorganisms, blood and body fluids, and airborne particulate materials.

(PLEASE DO NOT WRITE BELOW THIS LINE--CONTINUE ON ANOTHER PAGE)

Concurrence of CDRH, Office of Device Evaluation (ODE)

| (Division Sign-Off) | George 1. Mille for |
|---------------------------------------------------------------------|------------------------------------|
| Division of Dental, Infection Control, and General Hospital Devices | Chiu S. Zin, Ph.D. |
| 510(k) Number | K974068 |
| Prescription Use (Per 21 CFR 801.109) | OR |
| | Over-the-Counter Use <span></span> |