CONVERTORS SMS POLYOLEFIN GOWN

K020593 · Allegiance Healthcare Corp. · FYA · Mar 18, 2002 · General, Plastic Surgery

Device Facts

• Record ID: K020593
• Device Name: CONVERTORS SMS POLYOLEFIN GOWN
• Applicant: Allegiance Healthcare Corp.
• Product Code: FYA · General, Plastic Surgery
• Decision Date: Mar 18, 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 SMS Polyolefin Gowns are surgical apparel designed for use by operating room personnel. The device consists of a single layer of SMS (spunbond-meltblown-spunbond) polyolefin fabric. Fabric-reinforced versions include an additional layer of SMS fabric in the sleeve and body areas; poly-reinforced versions include an additional layer of polyolefin film in the sleeve and body areas. The gown acts as a physical barrier to prevent the transfer of microorganisms, body fluids, and particulate material between the surgical patient and operating room staff during procedures.

Clinical Evidence

No clinical data. Biocompatibility testing performed per ISO 10993-1 (cytotoxicity, sensitization, and irritation/intracutaneous reactivity).

Technological Characteristics

Materials: SMS (spunbond-meltblown-spunbond) polyolefin fabric; polyolefin film (reinforced versions). Biocompatibility: ISO 10993-1 compliant. Form factor: Surgical gown with optional fabric or poly-film reinforcement in sleeve and body areas.

Indications for Use

Indicated for operating room personnel during surgical procedures to provide a barrier against 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®SMS Polyolefin standard, fabric and poly-reinforced Gowns (K020593)

Submission Summary (Full Text)

{0}------------------------------------------------

### MAR 1 8 2002

Allegiance

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

K020593

## SMDA REQUIREMENTS

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

Manufacturer:

Allegiance Healthcare Corporation One Butterfield Trail El Paso, Texas 79906

Allegiance Healthcare Corporation 1500 Waukegan Road MPWM-1E

Requlatory Affairs Contact:

Telephone:

[phone]

Sharon Robbins

McGaw Park, IL 60085

Date Summary Prepared:

Common Name:

Classification:

Predicate Device:

Description:

February, 2002

Convertors®SMS Polyolefin Gowns

Class II per 21CFR § 878.4040

Convertors®SMS Polyolefin Standard, Fabric and Poly-reinforced Gowns

The standard, fabric- and poly-reinforced gowns are comprised of a single layer of SMS Polyolefin fabric. The fabric-reinforced gowns have an additional layer of SMS Polyolefin fabric in the sleeve and body areas; the poly-reinforced gowns have an additional layer of polyolefin film in the sleeve and body areas.

30

{1}------------------------------------------------

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®SMS Polyolefin Gowns

Intended Use:

Substantial Equivalence:

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.

The Convertors® SMS Polyolefin gown is substantially equivalent to the Convertors® SMS Polyolefin standard, fabric- and polyreinforced gowns in that:

- the intended use is the same
- the performance attributes are the same

All materials used in the fabrication of this Convertors® SMS Polyolefin gown were evaluated through biological qualification safety tests as outlined in in ISO 10993 Part-1 " Biological Evaluation of Medical Devices". The biocompatibility tests performed were cytotoxicity, sensitization, and irritation/ intracutaneous reactivity. These materials have met the requirements of the guidance and were found to be acceptable for the intended use.

Summary of testing:

{2}------------------------------------------------

# 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 is a circular emblem with the department's name encircling an abstract symbol. The symbol resembles a stylized eagle or bird in flight, composed of three curved lines. The text is arranged around the perimeter of the circle, with the department's name clearly visible.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 1 8 2002

Ms. Sharon Robbins Regulatory Affairs Manager Allegiance Healthcare Corporation 1500 Waukegan Road, MPWM-1E McGraw Park, Illinois 60085

Re: K020593

Trade/Device Name: Convertors® SMS Polyolefin Gown Regulation Number: 878.4040 Regulation Name: Surgical Gowns Regulatory Class: II Product Code: FYA Dated: February 21, 2002 Received: February 22, 2002

Dear Ms. Robbins:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your and have determined the device is substantially equivalent (for the rections 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 the Fodelar F ood, Drag, and Connenay, therefore, market the device, subject to the general approvisions of the Act. The general controls provisions of the Act include controls providents or a 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 If your device is clabelieve (such additional controls. Existing major regulations affecting (1 NET), it inch of our any of 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.

{3}------------------------------------------------

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 roquicable as 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 110(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.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

K. Wlatrust

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

Enclosure

{4}------------------------------------------------

**Allegiance**

*a Cardinal Health company*

rk. Illinois 60085-6

Page 1 of 1

510(k) Number (if known):

K020593 Waknown

Device Name:

Convertors®SMS Polyolefin Gown

Indications For Use:

The Convertors®SMS Polyolefin 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) Over-The Counter Use Prescription Use or (Per 21 CFR 801.109) 25