CONVERTORS, SPUNBONDED, FLASHSPUN POLYOLEFIN GOWNS

K982369 · Allegiance Healthcare Corp. · FYC · Aug 24, 1998 · General, Plastic Surgery

Device Facts

• Record ID: K982369
• Device Name: CONVERTORS, SPUNBONDED, FLASHSPUN POLYOLEFIN GOWNS
• Applicant: Allegiance Healthcare Corp.
• Product Code: FYC · General, Plastic Surgery
• Decision Date: Aug 24, 1998
• Decision: SESE
• Submission Type: Traditional
• 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. The Convertors® Spunbonded, Flashspun 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.

Device Story

Convertors® Spunbonded, Flashspun Polyolefin Gowns are sterile surgical apparel designed for use by operating room personnel. The device acts as a physical barrier to prevent the transfer of microorganisms, body fluids, and particulate material between the surgical patient and the operating room staff. The gowns are constructed from spunbonded, flashspun polyolefin fabric and are packaged with a towel. They are intended for use in clinical surgical settings to enhance infection control and maintain a sterile field.

Clinical Evidence

Bench testing only. Biocompatibility testing performed per ISO 10993 Part-1 (sensitization, cytotoxicity, and irritation/intracutaneous reactivity).

Technological Characteristics

Material: Spunbonded, flashspun polyolefin. Biocompatibility: Tested per ISO 10993 Part-1. Form factor: Surgical gown, sterile, packaged with a towel.

Indications for Use

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

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 standard, fabric- and poly-reinforced gowns

Submission Summary (Full Text)

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AUG 2 4 1998

**Allegiance**

Park, Illinois 60085-678

K982369

## SMDA REQUIREMENTS (continued) XII.

# 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS Convertors® Spunbonded, Flashspun Polyolefin Gowns

Intended Use:

Substantial Equivalence:

patient and the operating room personnel from the transfer of microorganisms, body fluids and particulate material. The Convertors® Spunbonded, Flashspun

surgical procedures to protect both the surgical

Surgical apparel are devices intended to be

worn by operating room personnel during

Polyolefin gowns are substantially equivalent to the Convertors® Optima standard, fabric- and poly-reinforced gowns in that:

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

All materials used in the fabrication of this Convertors® Spunbonded, Flashspun Polyolefin evaluated through biological aowns were qualification safety tests as outlined in ISO 10993 Part-1 "Biological Evaluation of Medical Devices". The biocompatibility tests performed were sensitization, cvtotoxicity, 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.

Summary of testing:

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#### XIII. SAMPLE

A drawing of the standard, fabric- and poly-reinforced gowns are enclosed to visually assist with the review. (See Appendix D).

#### XIV. KIT INFORMATION

Each gown is packaged with a towel. The towel is the same towel that is currently placed in our gown packs. This towel has been used safely and effectively for many years as a component of the gown This premarket notification (510(k)) is to introduce standard, pack. fabric and poly-reinforced gowns constructed of Spunbonded, Flashspun Polyolefin fabric. There is no change to the towel contained within this pack.

### XV. 21 CFR 807.95 -CONFIDENTIALITY

Allegiance Healthcare Corporation regards its intent to market the Convertors® Spunbonded, Flashspun Polyolefin gown as confidential commercial information. Allegiance Healthcare Corporation has not divulged this intent to market information to anyone other than Allegiance employees and even then on a need-to-know basis. Therefore, we request that FDA treat this information in a confidential manner.

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract design of a human figure with three arms.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 2 4 1998

Ms. Sharon Robbins Requlatory Affairs Manager Allegiance Healthcare Corporation 1500 Waukegan Road MPWM McGaw Park, Illinois 60085-6787

Re : K982369 Convertors® Spunbonded, Flashspun Trade Name: Polyolefin Gowns, Sterile Regulatory Class: II Product Code: FYC Dated: July 1, 1998 Received: July 7, 1998

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 reguirements 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 requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਰ substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical General regulation (21 CFR Part 820) and that, Devices: through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Reqister. 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 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/dsma/dsmamain.html".

Sincerely yours,

S. Butman for

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 7.473.1500 AX: 847.785.2461

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510(k) Number (if known):

K982369

Device Name:

Convertors® Spunbonded, Flashspun Polyolefin Gowns, Sterile

Indications For Use:

The Convertors® Spunbonded, Flashspun 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)

Prescription Use (Per 21 CFR 801.109) or

Over-The Counter Use

Chim S. f.

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