MEDLINE PROHIBIT SERIES SURGICAL MASK WITH FLUID SHIELD

K991559 · Medline Industries, Inc. · FXX · Aug 23, 1999 · General, Plastic Surgery

Device Facts

• Record ID: K991559
• Device Name: MEDLINE PROHIBIT SERIES SURGICAL MASK WITH FLUID SHIELD
• Applicant: Medline Industries, Inc.
• Product Code: FXX · General, Plastic Surgery
• Decision Date: Aug 23, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4040
• Device Class: Class 2

Intended Use

A surgical mask is a device intended to be worn by operating room personnel / t surgiour rical procedures to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material.

Device Story

Medline Prohibit Series Surgical Mask with Face Shield is a personal protective equipment device. It is worn by operating room personnel during surgical procedures. The device acts as a physical barrier to prevent the transfer of microorganisms, body fluids, and particulate material between the surgical patient and the operating room staff. It is used in clinical settings, specifically the operating room, and is operated by healthcare professionals. The device provides protection to both the wearer and the patient, reducing the risk of cross-contamination during surgery.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Surgical mask with integrated face shield. Designed for use in operating room environments to provide barrier protection against fluids and particulates.

Indications for Use

Indicated for use by operating room personnel during surgical procedures to protect the patient and personnel from 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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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus or a representation of human figures.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 73 1000

Ms. Lara N. Simmons Corporate Director, Regulatory Affairs Medline Industries Incorporated One Medline Place Mundelein, Illinois 60060-4486

Re : K991559 Medline Prohibit Series Surgical Mask With Fluid Trade Name: Shield Regulatory Class: II Product Code: FXX July 23, 1999 Dated: Received: August 04,1999

Dear Ms. Simmons:

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 Good Manufacturing Practice for Medical Devices: General (GMP) requlation (21 CFR Part 820) and that, through periodic GMP 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. this response to your premarket notification Please note: submission does 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 requlations.

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Page 2 - Ms. Simmons

This letter will allow you to begin marketing your device as Info iceeer wire as 0 (k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed Or subbeantial equalits in a classification for your device and predicate as a read 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 xitro regulation (Sices), please contact the Office of Compliance at sele devices) promotions on the promotions on the promotion and (301) (Jor, Joing of your device, please contact the Office of advertising of your actros, p. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 Other general information on your responsibilities CFR 807.97) . under the Act may be obtained from the Division of Small ander choolist may 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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## 510(k) Number (if known): K991559

Device Name: Medline Prohibit Series Surgical Masks with Face Shield

Indications For Use:

A surgical mask is a device intended to be worn by operating room personnel / t surgiour rical procedures to protect both the surgical patient and the operating room 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)

OR

Prescription Use (Per 21 CFR 801.109)

Colin S. Lin

510(k) N

(Optional Format 1-2-96)

Over-The-Counter Use