PRIMAGARD SURGICAL GOWNS

K023117 · Primeline Medical Products, Inc. · KKX · Nov 8, 2002 · General, Plastic Surgery

Device Facts

• Record ID: K023117
• Device Name: PRIMAGARD SURGICAL GOWNS
• Applicant: Primeline Medical Products, Inc.
• Product Code: KKX · General, Plastic Surgery
• Decision Date: Nov 8, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4370
• Device Class: Class 2

Intended Use

The primaGARD Surgical Drapes are Non-sterile Surgical Gowns, identified in 21 CFR, part 878.400, as a medical device intended to be worn by operating room personnel during surgical procedures to protect both the surgical patients and the operating room personnel from the transfer of microorganisms, body fluids, and particulate material.

Device Story

primaGARD Surgical Gowns are non-sterile protective apparel worn by operating room personnel. The device functions as a physical barrier to prevent cross-contamination of microorganisms, body fluids, and particulate matter between surgical patients and staff. Used in clinical surgical settings; operated by healthcare personnel. The gown design aims to mitigate infection risk during invasive procedures.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Non-sterile surgical gown; classified as surgical apparel (21 CFR 878.4040); product code FYA. Physical barrier construction.

Indications for Use

Indicated for use by operating room personnel during surgical procedures to provide a barrier against the transfer of microorganisms, body fluids, and particulate material between the patient and the personnel.

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

NOV 2 0 2002

Ms. Brenda Lee Manager of RA/QA PrimeLine Medical Products, Incorporated 10707-100th Avenue, Suite 300 Edmonton, Alberta T5J 3M1 CANADA

Re: K023117

Trade/Device Name: primaGARD Surgical Gowns Regulation Number: 878.4040 Regulation Name: Surgical Apparel Regulatory Class: II Product Code: FYA Dated: September 5, 2002 Received: September 11, 2002

Dear Ms. Lee:

This letter corrects our substantially equivalent letter of September 5, 2002 regarding the product code.

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). 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. Lee

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 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 and additionally Part 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]. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at their toll free number [phone] or at [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Timothy A. Ulatowski 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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## Statement of Indications for Use

## 510(k) Number:

Device Name: PrimeLine Medical Products Inc. primaGARD Surgical Gowns

The primaGARD Surgical Drapes are Non-sterile Surgical Gowns, identified in 21 CFR, part 878.400, as a medical device intended to be worn by operating room personnel during surgical procedures to protect both the surgical patients and the operating room personnel from the transfer of microorganisms, body fluids, and particulate material.

Blanch

Brenda Lee

September 5, 2002

Date

K023117

- Premarket Notification (510K Number)

hesiology, General Hospital.

510(k) Number: K023117

Pre-Market Notification: primaGARD Surgical Gowns

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PrimeLine Medical Products Inc