CONVERTORS BREATHABLE SURGICAL GOWNS

K992514 · Allegiance Healthcare Corp. · FYA · Aug 12, 1999 · General, Plastic Surgery

Device Facts

• Record ID: K992514
• Device Name: CONVERTORS BREATHABLE SURGICAL GOWNS
• Applicant: Allegiance Healthcare Corp.
• Product Code: FYA · General, Plastic Surgery
• Decision Date: Aug 12, 1999
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.4040
• Device Class: Class 2

Intended Use

Surgical apparel are devices intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating room personnel from the transfer of microorganisms, body fluids and particulate material.

Device Story

Convertors® Breathable Gowns consist of single-layer spunlaced nonwoven fabric laminated to breathable impervious film. Worn by operating room personnel during surgical procedures; provides barrier protection against transfer of microorganisms, body fluids, and particulate material between patient and staff.

Clinical Evidence

Bench testing only. Materials evaluated for biocompatibility (cytotoxicity, sensitization, irritation/intracutaneous reactivity) per ISO 10993-1 and industry-recognized test methods.

Technological Characteristics

Single-layer spunlaced nonwoven fabric laminated to breathable impervious film. Biocompatibility tested per ISO 10993-1.

Indications for Use

Indicated for operating room personnel during surgical procedures to provide barrier protection against microorganisms, body fluids, and particulate material for both the patient and the wearer.

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

• Convertors® Breathable Gowns (K992514)

Submission Summary (Full Text)

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AUG 12 1999

Allegiance

Allegiance Healthcare Corporation 1500 Waukegan Road McGaw Park, Illinois 60085-6787 847.473.1500 FAX: [phone]

K992514

## XII. SMDA REQUIREMENTS

## 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

| Manufacturer: | Allegiance Healthcare Corporation<br>One Butterfield Trail<br>El Paso, Texas 79906 |
|-----------------------------|-------------------------------------------------------------------------------------------------------------------------|
| Regulatory Affairs Contact: | Sharon Robbins<br>1500 Waukegan Road MPWM<br>McGaw Park, IL 60085 |
| Telephone: | [phone] |
| Date Summary Prepared: | June, 1999 |
| Common Name: | Convertors® Breathable Gowns |
| Classification: | Class II per 21CFR § 878.4040 |
| Predicate Device: | Convertors® Breathable Gowns. |
| Description: | The gowns are comprised of a single layer of<br>spunlaced nonwoven fabric laminated to a<br>breathable impervious film. |

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Image /page/1/Picture/0 description: The image shows the word "Allegiance" in a stylized font. To the left of the word is a symbol that looks like a plus sign made up of small dots. The word is in black and the background is white.

Allegiance Healthcare Corporation 1500 Waukegan Road McGaw Park, Illinois 60085-6787 847.473.1500 FAX: [phone]

## SMDA REQUIREMENTS (continued) XII.

## 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS Convertors® Gowns

| Intended Use: | Surgical apparel are devices intended to be<br>worn by operating room personnel during<br>surgical procedures to protect both the surgical<br>patient and the operating room personnel from<br>the transfer of microorganisms, body fluids and<br>particulate material. |
|--------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Substantial Equivalence: | The Convertors® gowns are substantially<br>equivalent to the Convertors® Breathable<br>gowns in that: |
| | - the intended use is the same<br>- the performance attributes are the<br>similar |
| Summary of testing: | All materials used in the fabrication of this<br>Convertors® Breathable Gowns were evaluated<br>through biological qualification safety tests as<br>outlined in ISO 10993 Part-1 "Biological Evaluation<br>of Medical Devices". The biocompatibility tests<br>performed were cytotoxicity, sensitization, and<br>irritation/ intracutaneous reactivity. These<br>materials also were tested in accordance with<br>industry recognized test methods and were found<br>to be acceptable for the intended use. |

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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes forming its body and wings. The eagle is enclosed within a circular border, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is written around the border of the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 12 1999

Ms. Sharon Robbins Regulatory Affairs Manager Alleqiance Healthcare Corporation 1500 Waukegan Road, Building MP-WM McGaw Park, Illinois 60085

K992514 Re :

> Trade Name: Convertors® Breathable Surgical Gowns Requlatory Class: II Product Code: FYA Dated: July 27, 1999 Received: July 28, 1999

Dear Ms. Robbins:

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 reqistration, listing of devices, qood 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 Regulations, Title 21, Parts 800 to 895. A 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 - Ms. Robbins

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 regulation (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 genera 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/dsmamain.html".

Sincerely yours,

Timothy A. Ulatowski

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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Image /page/4/Picture/0 description: The image shows the word "Allegiance" in a stylized font. The word is written in black and appears to be the logo of a company or organization. To the left of the word is a graphic of a plus sign made up of small dots.

Allegiance Healthcare Corporation 1500 Waukegan Road McGaw Park, Illinois 60085-6787 847.473.1500 FAX: [phone]

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| 510(k) Number (if known): | Unknown K992514 |
|---------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name: | Convertors® Breathable Gowns |
| Indications For Use: | The Convertors® Breathable Gowns are devices intended to be worn by operating room personnel during surgical procedures to protect both 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) Over-The Counter Use Prescription Use or (Per 21 CFR 801.109) 19 (Division Sign-Off)

Stronon Sign-Off)
Vision of Dental, Infection Control,
d General Hospital, Devices and General Hospital Device 510(k) Number

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