BOUFFANT CAP

K972187 · American Seal Co. · KKX · Sep 9, 1997 · General, Plastic Surgery

Device Facts

• Record ID: K972187
• Device Name: BOUFFANT CAP
• Applicant: American Seal Co.
• Product Code: KKX · General, Plastic Surgery
• Decision Date: Sep 9, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4370
• Device Class: Class 2

Intended Use

The Bouffant Cap is a device intended to be worn by hospital personnel during procedures to protect both the patient and the hospital personnel from transfer of microorganisms, body fluids and particulate materials.

Device Story

Bouffant cap; worn by hospital personnel during procedures; acts as physical barrier to prevent transfer of microorganisms, body fluids, and particulate materials between patient and staff; intended for over-the-counter use.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Disposable bouffant cap; physical barrier material; non-sterile or sterile (implied by infection control category); Class I device.

Indications for Use

Indicated for hospital personnel to protect patients and staff from transfer of microorganisms, body fluids, and particulate materials during procedures.

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

Mr. Joseph Tung President American Seal Company 25029 Viking Street Hayward, California 94545

9 1997 SEP

K972187 Re : Bouffant Cap Trade Name: Regulatory Class: I FYF Product Code: Dated: August 7, 1997 Received: August 14, 1997

Dear Mr. Tung:

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 Requlations, Title 21, Parts 800 to 895. ਰ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obliqation you miqht have under sections 531

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Page 2 - Mr. Tung

through 542 of the Act for devices under the Electronic chrough Siz Or Chorol provisions, or other Federal laws or requlations.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA deberibus in your in your device of your device to a legally marketed predicate device results in a classification for your markets and thus, permits your device 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 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]. Also, please note the regulation entitled, "Misbranding by reference to Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Tim A. Ulatowski

Timo 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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Page

510(k) Number (if known): K972187

Device Name:_Bouffant_Cap

Indications For Use:

The Bouffant Cap is a device intended to be worn by hospital personnel during procedures to protect both the patient and the hospital personnel from transfer of microorganisms, body fluids and particulate materials.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

*Chùm S. tìn*
(Division Sign-Off)

Unision of Dental, Info and General Hospita 510(k) Number

Prescription Use (Per 21 CFR 801.109)

CR

Over-The-Counter Use*X*

(Optional Format 1-2-96)

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