KIMBERLY-CLARK PROCEDURE GOWN

K052824 · Kimberly-Clark Corp. · FYA · May 2, 2006 · General, Plastic Surgery

Device Facts

• Record ID: K052824
• Device Name: KIMBERLY-CLARK PROCEDURE GOWN
• Applicant: Kimberly-Clark Corp.
• Product Code: FYA · General, Plastic Surgery
• Decision Date: May 2, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4040
• Device Class: Class 2

Intended Use

The Kimberly-Clark Procedure Gown is a non-sterile, disposable, single use item of apparel intended to be worn by healthcare professionals during the preparation and administration of selected chemotherapy drugs. The gown is not intended to be worn during surgical procedures.

Device Story

The Kimberly-Clark Procedure Gown is a non-sterile, disposable, single-use protective garment designed for healthcare professionals handling chemotherapy drugs. Constructed from polypropylene spunbond non-woven fabric with a polyethylene film laminate coating, the gown provides a barrier against fluid penetration and chemical permeation. It is worn in clinical settings during the preparation and administration of chemotherapy agents. The material is engineered to resist tearing and prevent drug permeation for up to four hours (240 minutes). The device is not intended for surgical use. It protects the wearer from exposure to hazardous chemotherapy drugs and blood-borne pathogens.

Clinical Evidence

No clinical data. Bench testing only: Dermal irritation and sensitization testing showed no adverse effects. Flammability testing met NFPA Standard #702-1980 Class I requirements. Liquid chemical permeation testing per ASTM F 739-99a demonstrated no permeation of various chemotherapy drugs for up to 240 minutes. Fluid penetration resistance verified per ASTM F 1670-03. Viral penetration resistance verified per ASTM F 1671-03.

Technological Characteristics

Non-woven polypropylene spunbond fabric with polyethylene film laminate coating. Open back design. Non-sterile, single-use. Tested per ASTM F 739-99a (chemical permeation), ASTM F 1670-03 (fluid penetration), and ASTM F 1671-03 (viral penetration). Meets NFPA 702-1980 Class I flammability standards.

Indications for Use

Indicated for healthcare professionals during the preparation and administration of selected chemotherapy drugs. Not for use 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

• Kimberly-Clark Impervious Open Back Gown (K880382)

Submission Summary (Full Text)

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K052824

### Premarket Notification [510(k)] Summary

| 1. | Submitted by: | Kimberly-Clark Corporation<br>1400 Holcomb Bridge Road<br>Roswell, GA 30076 | |
|----|-------------------------------------|-----------------------------------------------------------------------------|--|
| | Contact Person: | Cheryl M. Sanzare<br>Associate Director Regulatory Affairs | |
| | Telephone:<br>Facsimile:<br>e-mail: | [phone]<br>[phone]<br>[e-mail] | |

April 26, 2006 Date Prepared:

### 2. Device Name

Trade / Proprietary Name: Kimberly-Clark Procedure Gown Common / Usual name: Surqical gown Gown, surgical (per 21CFR 878.4040) Classification Name:

### 3. Predicate Device

Kimberly-Clark Procedure Gown is substantially equivalent to the The Kimberly-Clark Impervious Open Back Gown cleared under K880382.

#### 4. Intended Use of the Device

The Kimberly-Clark Procedure Gown is a non-sterile, disposable, single use item of apparel intended to be worn by healthcare professionals during the preparation and administration of selected chemotherapy drugs. The gown is not intended to be worn during surgical procedures.

#### 5. Description of the Device

The Kimberly-Clark Comfort Gown is an open back gown manufactured from a non-woven fabric with a film laminate coating. The non-woven fabric is a polypropylene spunbond with a polyethylene coating. The composition of the gown fabric resists tearing and permeation by various chemotherapy drugs for up to four hours of use.

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# Premarket Notification [510(k)] Summary (Continued)

### Summary of the technological characteristics of the device compared to 6. the predicate device

The Kimberly-Clark Procedure Gown and the Kimberly-Clark Impervious Open Back Gown (K880382) are manufactured with similar materials of construction. Neither gown is intended to be worn during surgical procedures as both gowns are provided as non-sterile. The K-C Procedure Gown is substantially equivalent to the K-C Imperious Open Back Gown in that they both provide the following characteristics: good tear resistance and fluid barrier.

| Summary of Testing: | |
|-----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Test | Result |
| Dermal Irritation & Sensitization | No evidence of dermal irritation<br>or allergic contact sensitization |
| Flammability | Meets Class I flammability<br>requirements per NFPA Standard<br>#702-1980. |
| Liquid Chemical Permeation | Permeation testing per ASTM F 739-<br>99a with the following chemotherapy<br>drugs: carmustine, cisplatin,<br>cyclophosphamide, dacarbazine,<br>doxorubicin hydrochloride,<br>etoposide, fluorouracil, paclitaxel,<br>thioTEPA and vincristine sulfate.<br>Results showed no permeation of<br>the drugs for up to 240 minutes. |
| Fluid Penetration | Penetration testing per ASTM-F<br>1670-03 with resistance of the gown<br>fabric to penetration by blood under<br>conditions of continuous liquid<br>contact. The 'pass' determination<br>was based on visual detection of<br>synthetic blood penetration. |
| Viral Penetration | Penetration testing per ASTM-F 1671-<br>03 with resistance of the gown fabric to<br>penetration by blood-borne pathogens<br>under conditions of continuous liquid<br>contact. The 'pass' determination was<br>based on detection of viral penetration. |

Section of the courses

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 2 2006

Ms. Cheryl M. Sanzare Associate Director Regulatory Affairs Kimberly-Clark Corporation 1400 Holcomb Bridge Road Roswell, Georgia 30076

Re: K052824

Trade/Device Name: Kimberly-Clark Procedure Gown Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: II Product Code: FYA Dated: April 10, 2006 Received: April 11, 2006

Dear Ms. Sanzare:

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. Sanzare

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. 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), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act 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/industry/support/index.html.

Sincerely yours.

Chiu-Ling, Ph.D.

Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications For Use

| Applicant: | Kimberly-Clark Corporation |
|----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number: | K052824 |
| Device Name: | Kimberly-Clark Procedure Gown |
| Indications for Use: | Based upon 21CFR§878.4040; Surgical apparel |
| | The Kimberly-Clark Procedure Gown is a non-sterile,<br>disposable, single use item of apparel intended to be<br>worn by healthcare professionals during the<br>preparation and administration of selected<br>chemotherapy drugs. The gown is not intended to be<br>worn during surgical procedures. |

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## Concurrence of CDRH Office of Device Evaluation (ODE)

| Prescription Use |
|------------------|
|------------------|

Over-the-Counter

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Shuli Hughes 5/1/66

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K 052824

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