ISOSAFE EARLOOP PROCEDURE MASK (BLUE, YELLOW)

K972883 · Cypress Medical Products, Ltd. · FXX · Feb 26, 1998 · General, Plastic Surgery

Device Facts

• Record ID: K972883
• Device Name: ISOSAFE EARLOOP PROCEDURE MASK (BLUE, YELLOW)
• Applicant: Cypress Medical Products, Ltd.
• Product Code: FXX · General, Plastic Surgery
• Decision Date: Feb 26, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4040
• Device Class: Class 2

Intended Use

An Earloop Procedure Mask is a disposable device intended for medical purposes that is worn over the examiner's mouth and nose to prevent contamination between examiner and patient.

Device Story

Disposable earloop procedure mask; worn by medical examiners over mouth and nose; acts as physical barrier to prevent cross-contamination between examiner and patient; intended for general medical use.

Clinical Evidence

Bench testing only.

Technological Characteristics

Disposable, non-sterile earloop procedure mask. Materials and construction consistent with standard surgical/procedure masks for infection control.

Indications for Use

Indicated for use as a disposable face mask worn by examiners over the mouth and nose to prevent cross-contamination between the examiner and patient in medical settings.

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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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Anthony L. Giaccio Director, Quality Systems/Regulatory Affairs Cypress Medical Products, Ltd. 1202 S. Route 31 McHenry, Illinois 60050

FEB 26 1998

K972883 Re : Isosafe Earloop Procedure Mask (Blue), and Trade Name: Isolation Mask (Yellow), Disposable & Non Sterile Regulatory Class: II Product Code: FXX December 29, 1997 Dated: Received: December 30, 1997

Dear Mr. Giaccio:

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, Druq, 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 General regulation (21 CFR Part 820) and that, Devices: 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 action. In addition, FDA may publish further announcements concerning your device in the Federal Reqister. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531

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Page 2 - Mr. Giaccio

through 542 of the Act for devices under the Electronic Product Radiation 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 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic 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 requlation 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.qov/cdrh/dsmamain.html".

Sincerely yours

Timothy A. Ulatowski

A Timothi 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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## EXHIBIT IV

## STATEMENT OF INDICATIONS FOR USE

510(k) Number (if known:______________________________________________________________________________________________________________________________________________________

Device Name: Earloop Procedure Mask ( Yellow , Blu , Blu , Blu

An Earloop Procedure Mask is a disposable device intended for medical purposes that is worn over the examiner's mouth and nose to prevent contamination between examiner and patient.

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

| Concurrent of CDRH, Office of Device Evaluation (ODE) | |
|---------------------------------------------------------------------|--------|
| (Division Sign-Off) | |
| Division of Dental, Infection Control, and General Hospital Devices | |
| 510(k) Number | K92883 |

| Prescription Use<br>(Per 21 CFR 801.109) | OR | Over-The-Counter-Use |
|------------------------------------------|----|------------------------------------------------------------------|
| | | (Optional Format 1-2-96) <div style="text-align: right;">X</div> |