ROTECNO 2000 SURGICAL GOWN

K982059 · Encompass Group, LLC · FYA · Nov 30, 1998 · General, Plastic Surgery

Device Facts

• Record ID: K982059
• Device Name: ROTECNO 2000 SURGICAL GOWN
• Applicant: Encompass Group, LLC
• Product Code: FYA · General, Plastic Surgery
• Decision Date: Nov 30, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4040
• Device Class: Class 2

Indications for Use

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

Rotecno® 2000 is a reusable surgical gown; fabricated from 99% polyester and 1% carbon chemically treated fabric. Designed for use by operating room personnel during surgical procedures. Provides barrier protection against microorganisms, body fluids, and particulate material. Reusable for up to 150 laundry/sterilization cycles. Device is non-sterile upon distribution.

Clinical Evidence

No clinical data. Performance testing included breaking strength, tear resistance, air permeability, water repellency, impact penetration, hydrostatic head, flammability, and aqueous bacterial barrier testing. Toxicity testing also performed. All results found acceptable.

Technological Characteristics

Fabricated from 99% polyester and 1% carbon chemically treated fabric. Reusable design capable of withstanding 150 laundry/sterilization cycles. Class II device per 21 CFR 878.4040.

Indications for Use

Indicated for operating room personnel to provide a barrier against microorganisms, body fluids, and particulate material 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.

Predicate Devices

• SafeCare™ Reusable Surgical Gown

Submission Summary (Full Text)

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| Manufacturer: | Dowling Textile Company<br>615 Macon Road<br>McDonough, Georgia 30253<br>[phone] |
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| Regulatory Contact: | Tim Cummins |
| Common Name: | Reusable Surgical Gown, NON STERILE |
| Trade Name: | Rotecno® 2000 Surgical Gown |
| Classification Number: | 79FYA |
| Class, Regulation: | II per 21 CFR §878.4040 |
| Predicate Device: | SafeCare™ Reusable Surgical Gown |
| Device Description: | A reusable surgical gown fabricated from 99%<br>polyester, 1% carbon, chemically treated fabric and<br>designed to provide fluid protection through up to 150<br>laundry/sterilization cycles. |
| Intended Use: | "Intended to be worn by operating room personnel<br>during surgical procedures to protect both the surgical<br>patient and the operating room personnel from<br>transfer of microorganisms, body fluids, and<br>particulate material." |
| Substantial Equivalence: | The Rotecno® 2000 Surgical Gown is substantially<br>equivalent to the SafeCare™ Gown in material,<br>design, form, fit, and function. |
| Toxicity Testing Summary: | The material used in the fabrication of the Rotecno®<br>2000 Surgical Gown has been found acceptable for its<br>intended use. |
| Performance Testing Summary: | The Rotecno® 2000 Surgical Gown has been tested<br>for breaking strength, tear resistance, air permeability<br>water repellency, impact penetration, hydrostatic<br>head, flammability, and aqueous bacterial barrier and<br>found acceptable for its intended use. |

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## K982059 XVI. 510 (k) Summary

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines forming its body and wings. The eagle is positioned within a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper portion of the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 30 1998

Mr. Tim Cummins RA/QA Manager Dowling Textile Company 615 Macon Road McDonough, Georgia 30253

K982059 Re : Rotecno® 2000 Reusable Surgical Gown, Trade Name: Nonsterile Regulatory Class: II Product Code: FYA Dated: October 21, 1998 Received: October 27, 1998

Dear Mr. Cummins:

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 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 (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਕੇ substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Requlation (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 requlatory 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 obligation you might have under sections 531

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Page 2 - Mr. Cummins

through 542 of the Act for devices under the Electronic Product Radiation Control 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 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 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 premarket notification" (21CFR 807.97). Other qeneral 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/dsma/dsmamajin.html".

Sincerely yours,

Timothy A. Ulatowski

Director Infection Control, Division of Dental, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## K 982059 Indications for Use XVII.

Rotection 2000 Surgical Gown, NONSTERILE AND REUSHALE Device Name:

The Rotecno® 2000 Surgical Gown is "intended to be worn by operating room personnel during The Rolection 2000 Surgical Goth the surgical patient and the operating room personnel from the transfer of microorganisms, body fluids, and particulate material."

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Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off) ( Division of Dental, Infection Control, and General Hospital Devices 510(k) Number

Prescription Use (Per 21 CFR 801.109)

OR

Over-The-Counter Use X

(Optional Format 1-2-96).