FLOOR MASK-EAR LOOP(BMR-15011)/FLOOR MASK-TIE(BMR-1503)

K971744 · Berkley Medical Resources, Inc. · FXX · Jul 28, 1997 · General, Plastic Surgery

Device Facts

• Record ID: K971744
• Device Name: FLOOR MASK-EAR LOOP(BMR-15011)/FLOOR MASK-TIE(BMR-1503)
• Applicant: Berkley Medical Resources, Inc.
• Product Code: FXX · General, Plastic Surgery
• Decision Date: Jul 28, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4040
• Device Class: Class 2

Intended Use

The BMR - 1501, 1503 Surgical Face Mask is a surgical apparel device that is intended to be worn by operating personnel during surgical procedures to protect both the surgical patient and the operating room personnel from transfer of micro-organisms. body fluids, and particulate material. The BMR - 1501, 1503 Surgical Face Mask is intended to be used in the above application as a single use disposable device.

Device Story

Surgical face mask (BMR-1501/1503) designed as single-use disposable apparel. Worn by operating room personnel during surgical procedures. Functions as physical barrier to prevent transfer of microorganisms, body fluids, and particulate material between patient and staff. Used in clinical/surgical settings.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Single-use disposable surgical face mask. Materials and construction typical of surgical apparel for barrier protection.

Indications for Use

Indicated for use by operating room personnel during surgical procedures to provide a barrier against microorganisms, body fluids, and particulate material for both the patient and the wearer.

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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- Public Health Service
DATE?

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## JUL 28 1997

Berkley Medical Resources, Incorporated C/O Frank R. Dastoli Ph.D. & Associates LLC 31 Innsbrook Road Ashville, North Carolina 28804

K971744 Re: Surgical Face Mask-Ear Loop (BMR-1501) Trade Name: Mask-Tie (BMR-1503) Requlatory Class: II Product Code: FXX June 6, 1997 Dated: Received: June 6, 1997

Dear Dr. Dastoli:

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 aqainst 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 requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਜੇ 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 regulation 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 not affect any obligation you might have under sections 531 \

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through 542 of the Act for devices under the Electronic enrough Siz on Control provisions, or other Federal laws or requlations.

This letter will allow you to begin marketing your device as . described in your 510(k) premarket notification. The FDA debtired in for a four lence 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 requlation (21 CFR Part 801 and additionally 809.10 for in rogaradiagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact che office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). 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,

Patricia Cucentiflor

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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## BERKLEY MEDICAL RESOURCES INC.

| Indication for Use Statement (Rev. 7/14/97) | Page: 1 of 1 |
|---------------------------------------------|------------------------------------------------------|
| 510 (k) Number | K971744 |
| Device Name: | Surgical Face Mask, Code 1501, 1503 ( Rev. 7/14/97 ) |
| Indications For Use: | |

The BMR - 1501, 1503 Surgical Face Mask is a surgical apparel device that is intended to be worn by operating personnel during surgical procedures to protect both the surgical patient and the operating room personnel from transfer of micro-organisms. body fluids, and particulate material.

The BMR - 1501, 1503 Surgical Face Mask is intended to be used in the above application as a single use disposable device.

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

(Division Sign-Off)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Division of Dental, Infection Control, and General Hospital Devices

| 510(k) Number | K971744 OR |
|---------------------------------------|------------------------|
| Prescription Use (Pre 21 CFR 801.109) | Over-The-Counter Use X |

(Optional Format 1-2-96)

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