PROMEDICAL SURGICAL MAYO STAND COVERS, BAND BAGS, TABLE COVERS AND EQUIPMENT COVERS

K042137 · Promedical Products Co., Ltd. · KKX · Oct 5, 2004 · General, Plastic Surgery

Device Facts

• Record ID: K042137
• Device Name: PROMEDICAL SURGICAL MAYO STAND COVERS, BAND BAGS, TABLE COVERS AND EQUIPMENT COVERS
• Applicant: Promedical Products Co., Ltd.
• Product Code: KKX · General, Plastic Surgery
• Decision Date: Oct 5, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4370
• Device Class: Class 2

Intended Use

proMedical Products Co. Ltd. intends to market Non-sterile surgical equipment covers which are protective barrier covers that are intended to cover equipment and provide a protective barrier for that equipment.

Device Story

Device consists of non-sterile surgical equipment covers; function as protective barriers for surgical equipment; used in clinical/surgical settings to prevent contamination of equipment; manual application by healthcare personnel; provides physical barrier between equipment and surgical environment; benefits patient by reducing risk of cross-contamination during surgical procedures.

Clinical Evidence

Bench testing only.

Technological Characteristics

Non-sterile protective barrier covers; material composition not specified; form factor designed for surgical equipment coverage; manual application; no electronic or software components.

Indications for Use

Indicated for use as protective barrier covers for surgical equipment to prevent contamination.

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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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OC1 5 - 2004

ProMedical Products Company Limited C/O Mr. Boyd Harris 125 Clements Avenue Starkville, Mississippi 39759

Re: K042137

Trade/Device Name: Promedical Surgical Equipment Covers Regulation Number: 878.4370 Regulation Name: Surgical Drape and Drape Accessories Regulatory Class: II Product Code: KKX Dated: September 28, 2004 Received: September 29, 2004

Dear Mr. Harris:

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 application (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 such 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. Harris

Please be advised that FDA's issuance of a substantial equivalence determination does not I lease be advised and a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. or the For of any 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 and fishing (21 CF 1 F rth in the quality systems (QS) regulation (21 CFR Part 820); and if requirence as betreoric product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin 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 vours.

Chiu Lin, Ph.D.

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

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## Indications for Use

510k Number (if known): k042137

Surgical Equipment Covers Device Name:

Indications For Use:

proMedical Products Co. Ltd. intends to market Non-sterile surgical promour r roually in read.org which are protective barrier covers that are intended to equipment 601010 which acquipment and provide a protective barrier for that equipment.

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Kei Muluy
(Division Sign-Off)

Division of Anesthesiology, General Hospital,
Infection Control, Dental Devices
510(k) Number: K042137

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