DEROYAL POLY-REINFORCED SURGICAL GOWNS (STERILE, NON-STERILE)

K031408 · Deroyal · FYA · Oct 15, 2003 · General, Plastic Surgery

Device Facts

• Record ID: K031408
• Device Name: DEROYAL POLY-REINFORCED SURGICAL GOWNS (STERILE, NON-STERILE)
• Applicant: Deroyal
• Product Code: FYA · General, Plastic Surgery
• Decision Date: Oct 15, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4040
• Device Class: Class 2

Intended Use

DeRoyal Poly-Reinforced Surgical Gowns are surgical attire that is worn by operating room personnel to protect both operating room personnel and the patient from the transfer of microorganisms, body fluids and other particulate materials during surgical procedures.

Device Story

DeRoyal Poly-Reinforced Surgical Gowns function as protective apparel for operating room personnel. Device acts as physical barrier to prevent cross-contamination of microorganisms, body fluids, and particulates between patient and staff during surgical procedures. Used in clinical operating room environments. Provides protection via material composition; no electronic or active components.

Clinical Evidence

Bench testing only; no clinical data provided.

Technological Characteristics

Surgical gown constructed of poly-reinforced material. Designed as barrier apparel. Non-electronic, passive device. Sterilization method not specified.

Indications for Use

Indicated for use by operating room personnel as surgical attire to provide a barrier against microorganisms, body fluids, and particulate matter during surgical procedures.

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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## Public Health Service

OCT 1 5 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Sharon Cook Regulatory Affairs Group Manager DeRoyal Industries, Incorporated 200 DeBusk Lane Powell, Tennessee 37849

Re: K031408

Trade/Device Name: Deroyal Poly-Reinforced Surgical Gowns(Sterile, Non-Sterile) Regulation Number: 878.4040 Regulation Name: Surgical Apparel Regulatory Class: II Product Code: FYA Dated: September 15, 2003 Received: September 16, 2003

Dear Ms. Cook:

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 vour 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. Cook

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/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

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## Indications for Use Statement

510(k): K03140B Device Name: DeRoyal Poly-Reinforced Surgical Gowns

Intended Use: DeRoyal Poly-Reinforced Surgical Gowns are surgical attire that is worn by operating room personnel to protect both operating room personnel and the patient from the transfer of microorganisms, body fluids and other particulate materials during surgical procedures.

Patricia Day, Steven Brandt, IUCB/
(Division Sign Off) Clis/ N03

(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental D

510(k) Number: K031428

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Pcr 21 CFR 801.109) OR

Over-The-Counter Use -----

(Optional Format 1-2-96)