BREATHABLE IMPERVIOUS GOWNS

K012984 · Allegiance Healthcare Corp. · FYA · Sep 24, 2001 · General, Plastic Surgery

Device Facts

• Record ID: K012984
• Device Name: BREATHABLE IMPERVIOUS GOWNS
• Applicant: Allegiance Healthcare Corp.
• Product Code: FYA · General, Plastic Surgery
• Decision Date: Sep 24, 2001
• 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 are protective apparel worn by operating room personnel. The device consists of a composite fabric structure combining nonwoven layers with a monolithic breathable impervious film. Used in surgical settings, the gown acts as a physical barrier to prevent the cross-transfer of microorganisms, body fluids, and particulate matter between the patient and the surgical team. The device is a passive protective garment; it does not involve electronic inputs, algorithms, or software.

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

Composite fabric construction consisting of nonwoven fabric and monolithic breathable impervious film. Biocompatibility tested per ISO 10993-1.

Indications for Use

Indicated for operating room personnel to protect patients and staff from transfer of 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

• Convertors® Breathable Surgical Gowns (K012984)

Submission Summary (Full Text)

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SEP 2 4 2001

Allegiance

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

#### SMDA REQUIREMENTS XII.

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

Manufacturer:

Allegiance Healthcare Corporation One Butterfield Trail El Paso, Texas 79906

Regulatory Affairs Contact:

Telephone:

Common Name:

Classification:

Sharon Robbins 1500 Waukegan Road MPWM McGaw Park, IL 60085 [phone]

August, 2001 Date Summary Prepared:

Convertors®Breathable Surgical Gowns

Class II per 21CFR § 878.4040

Predicate Device: Convertors® Breathable Surgical Gowns.

Description:

The gowns are comprised of a composite fabric of nonwoven fabric, monolithic breathable impervious film and nonwoven fabric.

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Allegiance

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® Breathable Surgical Gowns

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.

Substantial Equivalence:

The Convertors® gowns are substantially 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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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 2 4 2001

Ms. Sharon Robbins Regulatory Affairs Manager Allegiance Healthcare Corporation 1500 Waukegan Road McGaw Park, Illinois 60085

Re: K012984

Trade/Device Name: Breathable Impervious Gowns Regulation Number: 878.4040 Regulation Name: Surgical Gowns Regulatory Class: II Product Code: FYA Dated: September 4, 2001 Received: September 6, 2001

Dear Ms. Robbins:

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.

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.

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### Page 2 - Ms. Robbins

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 (section 531-542 of the Act; 21); CFR 1000-1050.

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 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.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Timothy A. Ulatowski

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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Allegiance

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

Page 1 of 1

510(k) Number (if known):

Unknown

(K012984)

Device Name:

Convertors®Breathable Surgical Gowns

Indications For Use:

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

Olin S. Lòm

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