CARLO SURGICAL GOWN

K051426 · Sofilm Technology Co., Ltd. · FYA · Aug 2, 2005 · General, Plastic Surgery

Device Facts

• Record ID: K051426
• Device Name: CARLO SURGICAL GOWN
• Applicant: Sofilm Technology Co., Ltd.
• Product Code: FYA · General, Plastic Surgery
• Decision Date: Aug 2, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4040
• Device Class: Class 2

Intended Use

The Sofilm Technology Co., Ltd. Carlo Surgical Gown is a sterile, single-use surgical gown that is 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.

Device Story

Carlo Surgical Gown is a sterile, single-use protective garment. Worn by operating room personnel during surgical procedures. Functions as a physical barrier to prevent cross-contamination of microorganisms, body fluids, and particulate material between patient and staff. Used in clinical/surgical settings.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Sterile, single-use surgical gown. Classified as Class II, Product Code FYA under 21 CFR 878.4040.

Indications for Use

Indicated for operating room personnel during surgical procedures to provide a barrier against microorganisms, body fluids, 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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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus, which is a symbol of medicine, with three lines representing the branches of government. The caduceus is surrounded by the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" in a circular pattern.

AUG 2 - 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Jeffry O. Stull Sofilm Technology Company Limited 622. Sec. 3. Ankang Road Hsintien City, Taipei County 231 TAIWAN (R.O.C.)

Re: K051426

Trade/Device Name: Carlo Surgical Gown Disposable Sterile Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: II Product Code: FYA Dated: July 15, 2005 Received: July 25, 2005

Dear Mr. Stull:

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. Stull

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 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/industry/support/index.html.

Sincerely yours,

Quette Y. Michie MD.

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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#### 510(k) Number (if known): K051426

### Device Name: Carlo Surgical Gown. Disposable, Sterile

## Indications for Use:

.

The Sofilm Technology Co., Ltd. Carlo Surgical Gown is a sterile, single-use surgical gown that is 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.

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#### Concurrence of CDRH, Office of Device Evaluation (ODE)

Shule H. Murphy, D 7/2/05

(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices

510(k) Number K051426

Prescription Use (Per 21 CFR 801.109) OR

Over-The-Counter Use X _______________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)