BREATHABLE SURGICAL GOWN

K023167 · Allegiance Healthcare Corp. · FYA · Oct 2, 2002 · General, Plastic Surgery

Device Facts

• Record ID: K023167
• Device Name: BREATHABLE SURGICAL GOWN
• Applicant: Allegiance Healthcare Corp.
• Product Code: FYA · General, Plastic Surgery
• Decision Date: Oct 2, 2002
• 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 Surgical Gowns and Breathable Sleeve Surgical Gowns are protective apparel for operating room personnel. Breathable Surgical Gowns consist of outer and inner layers of spunmelt polyolefin nonwoven fabric with a middle layer of breathable monolithic film. Breathable Sleeve Surgical Gowns feature sleeves with the same three-layer construction, while the gown body uses spunmelt nonwoven (SMS) with polyolefin-based film reinforcement. Worn by surgeons and staff during procedures to provide a barrier against microorganisms, body fluids, and particulates, reducing cross-contamination risk for both patient and wearer.

Clinical Evidence

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

Technological Characteristics

Materials: Spunmelt polyolefin nonwoven fabric, breathable monolithic film, SMS nonwoven. Construction: Multi-layer laminate. Biocompatibility: ISO 10993-1 compliant. Sterilization: Not specified.

Indications for Use

Indicated for operating room personnel during surgical procedures to protect patient 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® Breathable Surgical Gowns

Submission Summary (Full Text)

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OCT 02 2002

Allegiance

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

KO23167

# SMDA REQUIREMENTS

### 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS Convertors® Breathable Surgical Gowns and Breathable Sleeve Surgical Gowns

| Manufacturer: | Allegiance Healthcare Corporation<br>One Butterfield Trail<br>El Paso, Texas 79906 |
|-----------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Regulatory Affairs Contact: | Sharon Nichols<br>1500 Waukegan Road MPWM<br>McGaw Park, IL 60085 |
| Telephone: | [phone] |
| Date Summary Prepared: | September, 2002 |
| Common Name: | Convertors®Breathable Surgical Gowns<br>and Breathable Sleeve Surgical Gowns |
| Classification: | Class II per 21CFR § 878.4040 |
| Predicate Device: | Convertors® Breathable Surgical Gowns. |
| Description: | The Breathable Surgical Gown consists of an<br>outer and inner layer of spunmelt polyolefin<br>nonwoven fabric with a middle layer of<br>breathable monolithic film throughout the entire<br>gown. The Breathable Sleeve Surgical Gown<br>consists of sleeves containing a an outer and<br>inner layer of spunmelt polyolefin nonwoven<br>fabric with a middle layer of breathable<br>monolithic film with a gown body comprised of<br>spunmelt nonwoven (SMS) with a polyolefin-<br>based film reinforcement. |

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# Allegiance

Allegiance Healthcare Corporation 1500 Waukegan Road McGaw Park, Illinois 60085-6787 847 473 1500 FAX: [phone]

## SMDA REQUIREMENTS (continued)

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

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

- Substantial The Convertors® gowns are substantially Equivalence: equivalent to the Convertors® Breathable gowns in that:
- the intended use is the same
- the performance attributes are similar
- Summary of testing: All materials used in the fabrication of this Convertors®Breathable Gowns were evaluated through biological qualification safety tests as outlined in ISO 10993 Part-1 " Biological Evaluation of Medical Devices''. The biocompatibility tests performed were cytotoxicity, sensitization, and irritation/ intracutaneous reactivity. These materials also were tested in accordance with industry recognized test methods and were found to be acceptable for the intended use.

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## OCT 02 2002

Ms. Sharon Nichols Regulatory Affairs Manager Allegiance Healthcare Corporation 1500 Waukegan Road, Building WM McGaw Park, Illinois 60085-6787

Re: K023167

Trade/Device Name: Convertors® Breathable Surgical Gowns Regulation Number: 878.4040 Regulation Name: Surgical Apparel Regulatory Class: II Product Code: 79 FYA Dated: September 20, 2002 Received: September 23, 2002

Dear Ms. Nichols:

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 - Ms. Nichols

Please be advised that FDA's issuance of a substantial equivalence determination docs 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 and additionally 21 CFR Part 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 Part 807.97). Other general information on your responsibilities under the Act may be obtained 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.qov/cdrh/dsma/dsmamain.html

Sincerely yours,

Timothy A. Ulatowski Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

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Allegiance

Allegiance Healthcare 500 Waukenan Roa

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510(k) Number (if known):

KO23167 Накнөни

Device Name:

Indications For Use:

Convertors®Breathable Surgical Gowns

The Convertors®Breathable Surgical 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 _ (Per 21 CFR 801.109) or

Over-The Counter Use

Olia Sizin

General Hospital, ntrol Dental

510(k) Number: K023167