CONVERTORS SURGICAL GOWNS

K991034 · Allegiance Healthcare Corp. · FYA · Apr 16, 1999 · General, Plastic Surgery

Device Facts

• Record ID: K991034
• Device Name: CONVERTORS SURGICAL GOWNS
• Applicant: Allegiance Healthcare Corp.
• Product Code: FYA · General, Plastic Surgery
• Decision Date: Apr 16, 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® Fabric-Reinforced Gowns consist of single-layer Optima® base fabric with nonwoven reinforcement in body area; worn by operating room personnel during surgical procedures; provides barrier protection against microorganisms, body fluids, and particulates; protects both patient and staff.

Clinical Evidence

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

Technological Characteristics

Single-layer Optima® base fabric with nonwoven reinforcement in body area. Biocompatibility testing performed per ISO 10993-1.

Indications for Use

Indicated for operating room personnel during surgical procedures to protect patients and personnel from transfer of 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.

Predicate Devices

• Convertors® Optima® Fabric-Reinforced Gowns

Submission Summary (Full Text)

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APR 16 999

Allegiance

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

K991034

## SMDA REQUIREMENTS XII.

## 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: | March 1999 |
| Common Name: | Convertors® Fabric-Reinforced Gowns |
| Classification: | Class II per 21CFR § 878.4040 |
| Predicate Device: | Convertors® Optima® Fabric-Reinforced<br>Gowns. |
| Description: | The gowns are comprised of a single layer of<br>Optima® as the base fabric. The gowns are<br>fabric-reinforced with a layer of nonwoven<br>in the body area. |
| 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. |

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Image /page/1/Picture/0 description: The image contains the word "Allegiance" in a stylized font. The word is written in black and appears to be the name 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]

## SMDA REQUIREMENTS (continued) XII.

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

| Substantial Equivalence: | The Convertors® gowns are substantially<br>equivalent to the Convertors® Optima®<br>fabric-reinforced gowns in that:<br><br>- the intended use is the same<br>- the performance attributes are<br>similar |
|--------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Summary of testing: | All materials used in the fabrication of this<br>Convertors® Gowns 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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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 16 1999

Ms. Sharon Robbins Allegiance Healthcare Corporation 1500 Waukeqan Road MPWM McGaw Park, Illinois 60085-6787

Re : K991034 Trade Name: Convertors® Surqical Gowns - Fabric -Reinforced Regulatory Class: II Product Code: FYA Dated: March 25, 1999 Received: March 29, 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 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. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements 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 through 542 of

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Page 2 - Ms. Robbins

the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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 ons 20gation" (21 CFR 807.97). 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,

Timothy A. Ulatowski

Timothy A 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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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 K991034 |
|---------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name: | Convertors® Fabric Reinforced Gowns |
| Indications For Use: | The Convertors® Fabric-Reinforced 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.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE)

Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use<br>(Per 21 CFR 801.109) | or | Over-The Counter Use <span style="text-decoration: overline;">X</span> |
|------------------------------------------|----|------------------------------------------------------------------------|
|------------------------------------------|----|------------------------------------------------------------------------|

| (Division Sign-Off) | |
|---------------------------------------------------------------------|---------|
| Division of Dental, Infection Control, and General Hospital Devices | |
| 510(k) Number | K991034 |