FACE MASK, SURGICAL MASK, NON-STERILE

K970835 · Tucker & Associates · FXX · Sep 3, 1997 · General, Plastic Surgery

Device Facts

• Record ID: K970835
• Device Name: FACE MASK, SURGICAL MASK, NON-STERILE
• Applicant: Tucker & Associates
• Product Code: FXX · General, Plastic Surgery
• Decision Date: Sep 3, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4040
• Device Class: Class 2

Intended Use

This device is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material.

Device Story

Surgical face mask designed to provide a physical barrier; worn by healthcare personnel and patients in clinical settings. Functions as personal protective equipment to reduce cross-contamination by filtering or blocking microorganisms, body fluids, and particulate matter. Device is non-sterile and intended for over-the-counter use.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Non-sterile surgical face mask; physical barrier construction; intended for single use.

Indications for Use

Indicated for use by healthcare personnel and patients to provide a barrier against the transfer of microorganisms, body fluids, and particulate material.

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
Public Health Service
Food and Drug Administration
9200 Corporate Boulevard
Rockville MD 20850

SEP - 3 1997

Ms. Janna P. Tucker
President
Janna Tucker & Associates
19001 S. Richfield #185
Green Valley, Arizona 85614

Re: K970835
Trade Name: Face Mask, Surgical Mask, Non-Sterile Regulatory Class: II
Product Code: FXX
Dated: August 4, 1997
Received: August 8, 1997

Dear Ms. Tucker:

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 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, 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 regulation may result in regulatory action. In addition, FDA may publish further announcements 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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Page 2 - Ms. Tucker

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 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 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,

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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SEP-02-97 TUE 08:23 AM JANNA TUCKER & ASSOC 5206253908 P.02

# INDICATIONS FOR USE

Applicant: COPIOUMED INTERNATIONAL, INC.
510(k) Number (if known): K970835
Device Name: FACE MASK, SURGICAL
Indications For Use:

This device is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material.

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

Concurrence of CDRH Office of Device Evaluation (ODE)

Clin S. Lin
(Division Sign-Off)
Division of Dental, Infection Control,
and General Hospital Devices
510(k) Number K970835

Prescription Use
Per 21 CFR 801.109

OR

Over-The-Counter ☑
(Optional Format 1-2-96)

(Division Sign-Off)
Division of Dental, Infection Control,
and General Hospital Devices
510(k) Number