PREVENTION BREATHABLE, IMPERVIOUS SURGICAL GOWNS

K043017 · Medline Industries, Inc. · FYA · Mar 8, 2005 · General, Plastic Surgery

Device Facts

• Record ID: K043017
• Device Name: PREVENTION BREATHABLE, IMPERVIOUS SURGICAL GOWNS
• Applicant: Medline Industries, Inc.
• Product Code: FYA · General, Plastic Surgery
• Decision Date: Mar 8, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4040
• Device Class: Class 2

Intended Use

Medline Prevention ™ Disposable Surgical Gowns are surgical apparel 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 body fluids, micro-organisms, and particulate material.

Device Story

Medline Prevention Disposable Surgical Gowns are protective apparel worn by operating room personnel. The gowns act as a physical barrier to prevent the transfer of body fluids, microorganisms, and particulate material between the patient and the surgical staff. Used in clinical operating room environments; worn by surgeons, nurses, and surgical staff. The device provides protection during surgical procedures, reducing the risk of cross-contamination and exposure to infectious agents.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Disposable surgical gown; non-sterile or sterile barrier material; form factor designed for full-body coverage of operating room personnel; intended for single use.

Indications for Use

Indicated for operating room personnel during surgical procedures to provide a barrier against body fluids, microorganisms, 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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Public Health Service

MAN 2 U LUUB

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Matt Clausen Regulatory Affairs Specialist Medline Industries, Incorporated One Medline Place Mundelein, Illinois 60060

Re: K043017

Trade/Device Name: Medline Prevention Surgical Gowns Regulation Number: 21 CFR 880.4040 Regulation Name: Surgical Apparel Regulatory Class: II Product Codes: FYA Dated: February 9, 2005 Received: February 10, 2005

Dear Mr. Clausen:

This letter corrects our substantially equivalent letter of March 8, 2005.

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval (PMA). 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 (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2 - Mr. Clausen

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to continue marketing your device as described in your Section 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). please contact the Office of Compliance at [phone] http://www.fda.gov/cdrh/organiz.html#OC for OC organization structure). Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Sutie Y. Michan, M.D.

Chiu S. Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

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510(k) Number (if known): __ K043017

Device Name: Medline Prevention Surgical Gowns Indications for Use:

Medline Prevention ™ Disposable Surgical Gowns are surgical apparel 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 body fluids, micro-organisms, and particulate material.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109) OR

× Over-the-Counter Use_

(Optional Format 12-96)

Aguilla Micheli Cms

toriology, General Hospit of Dental Devices

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