MEDLINE DISPOSABLE SURGICAL DRAPES AND GOWNS

K964142 · Medline Industries, Inc. · KKX · Feb 25, 1997 · General, Plastic Surgery

Device Facts

• Record ID: K964142
• Device Name: MEDLINE DISPOSABLE SURGICAL DRAPES AND GOWNS
• Applicant: Medline Industries, Inc.
• Product Code: KKX · General, Plastic Surgery
• Decision Date: Feb 25, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4370
• Device Class: Class 2

Device Story

Medline Disposable Surgical Drapes and Gowns are protective apparel and barrier devices used in clinical settings, such as operating rooms, to prevent the transfer of microorganisms, body fluids, and particulate matter between patients and healthcare personnel. These devices serve as a physical barrier to reduce the risk of infection during surgical procedures. They are intended for use by surgeons, nurses, and other clinical staff. The devices are disposable, single-use items.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Disposable surgical drapes and gowns; barrier material construction; single-use; non-sterile or sterile (as indicated by product labeling).

Regulatory Classification

Identification

A surgical drape and drape accessories is a device made of natural or synthetic materials intended to be used as a protective patient covering, such as to isolate a site of surgical incision from microbial and other contamination. The device includes a plastic wound protector that may adhere to the skin around a surgical incision or be placed in a wound to cover its exposed edges, and a latex drape with a self-retaining finger cot that is intended to allow repeated insertion of the surgeon's finger into the rectum during performance of a transurethral prostatectomy.

Special Controls

*Classification.* Class II (special controls). The device, when it is an ear, nose, and throat surgical drape, a latex sheet drape with self-retaining finger cot, a disposable urological drape, a Kelly pad, an ophthalmic patient drape, an ophthalmic microscope drape, an internal drape retention ring (wound protector), or a surgical drape that does not include an antimicrobial agent, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 878.9.

Submission Summary (Full Text)

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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
JUL 20 2006
Food and Drug Administration
9200 Corporate Boulevard
Rockville MD 20850

Lara N. Simmons
Corporate Director, QA/RA
Medline Industries, Incorporated
One Medline Place
Mundelein, Illinois 60060-4486

Re: K964142
Trade Name: Medline Disposable Surgical Drapes and Gowns
Regulation Number: 21 CFR 878.4370 and 878.4040
Regulation Name: Surgical Drapes and Accessories and Surgical Gowns
Regulatory Class: II
Product Code: KKX, FYA
Dated: February 4, 1997
Received: February 10, 1997

Dear Ms. Simmons:

This letter corrects our substantially equivalent letter of February 25, 1997.

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 – Ms. Simmons

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]. 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 toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,


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

Enclosure