MICROCOOL SURGICAL GOWN

K981393 · Kimberly-Clark Corp. · FYA · Jul 10, 1998 · General, Plastic Surgery

Device Facts

• Record ID: K981393
• Device Name: MICROCOOL SURGICAL GOWN
• Applicant: Kimberly-Clark Corp.
• Product Code: FYA · General, Plastic Surgery
• Decision Date: Jul 10, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4040
• Device Class: Class 2

Intended Use

The MicroCool gown is a single use item of surgical apparel intended to be worn by health care professionals to help protect both the patient and the healthcare worker from the transfer of microorganisms, body fluids and particulate matter. The MicroCool gown was designed to provide a barrier to fluids such as water, blood, sweat and isopropyl alcohol while allowing the wearer to remain comfortable.

Device Story

Disposable surgical and isolation gown; manufactured from breathable, repellent, three-layer laminated non-woven polypropylene fabric. Designed for use by healthcare professionals in clinical settings to provide a barrier against fluids (water, blood, sweat, isopropyl alcohol), microorganisms, and particulate matter. Protects both patient and wearer; enhances comfort during use. Supplied sterile or non-sterile.

Clinical Evidence

Bench testing only. Testing included cytotoxicity (USP XXIII), skin irritation, sterilant residue analysis (EO, EC, EG), flammability (16 CFR 1610 Class I), and fluid/viral penetration resistance (ASTM 1670-97, ASTM F 903-96, ASTM F 1671-97a).

Technological Characteristics

Three-layer laminated non-woven polypropylene fabric. Provides fluid barrier and tear resistance. Tested to ASTM 1670-97, ASTM F 903-96, and ASTM F 1671-97a for penetration resistance. Flammability meets 16 CFR 1610 Class I. Biocompatible per USP XXIII.

Indications for Use

Indicated for use by healthcare professionals as a single-use surgical or isolation gown to provide a barrier against microorganisms, body fluids, and particulate matter for both patient and wearer.

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

• 3M Prevention Fabric Surgical Gown

Submission Summary (Full Text)

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JUL | 0 |998

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## 510(k) Summary of Safety and Effectiveness

| Manufacturer: | Kimberly-Clark Corporation<br>1400 Holcomb Bridge Road<br>Roswell, GA 30076 |
|--------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Regulatory Affairs<br>Contact: | Larry R. Kludt<br>Manager Regulatory Affairs<br>1400 Holcomb Bridge Road<br>Roswell, GA 30076<br>[phone] |
| Summary Date: | July 1, 1998 |
| Product Trade<br>Name: | MicroCool™ Surgical Gown (sterile)<br>MicroCool™ Isolation Gown (nonsterile) |
| Common Name: | Surgical gown, Isolation gown |
| Classification: | Surgical apparel |
| Predicate Device: | 3M Prevention Fabric Surgical Gown |
| Description: | The MicroCool gown is manufactured from a breathable,<br>repellent, non-woven, polypropylene fabric, The fabric is a three-<br>layer lamination that resists tearing and penetration by liquids.<br>This disposable gown is supplied sterile or non-sterile. |
| Intended Use: | The MicroCool gown is a single use item of surgical apparel<br>intended to be worn by health care professionals to help protect<br>both the patient and the healthcare worker from the transfer of<br>microorganisms, body fluids and particulate matter. The<br>MicroCool gown was designed to provide a barrier to fluids such<br>as water, blood, sweat and isopropyl alcohol while allowing the<br>wearer to remain comfortable. |
| Substantial<br>Equivalence: | The MicroCool gown is substantially equivalent to the 3M<br>Prevention Fabric Gown manufactured by 3M Health Care in that<br>they both provide the following characteristics: |

- good tear resistance
fluid barrier 로 로
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## Summary of Testing;

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| Test | Result |
|--------------------|---------------------------------------------------------------------------------------------------------------------------|
| Cytotoxicity | No evidence of component<br>sensitizer (met USP XXIII<br>requirements) |
| Skin Irritation | No evidence of dermal<br>irritation |
| Sterilant residues | Levels of EO, EC and EG were<br>each within the proposed FDA<br>limits for medical devices that<br>contact skin |
| Flammability | Meets Class I flammability<br>requirements per 16 CFR Part<br>1610 |
| Fluid penetration | Resists visual penetration by blood<br>and viral penetration fluids<br>(met ASTM 1670-97 & ASTM F<br>903-96 requirements) |
| Viral penetration | Resists viral penetration<br>(met ASTM F 1671-97a<br>requirements) |

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

10 1 0 1398

Kimberly-Clark Corporation C/O Mr. Larry R. Kludt Manager Requlatory Affaris 1400 Holcomb Bridge Road Roswell, Georgia 30076

Re : K981393 MicroCool™ Nonsterile Disposable Isolation Trade Name: Gown and MicroCool™ Sterile Disposable Surgical Gown Regulatory Class: II FYC and FYA Product Code: Dated: April 16, 1998 Received: April 17, 1998

Dear Mr. Kludt:

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 requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions aqainst 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 regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. ਜੋ substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Failure to Administration (FDA) will verify such assumptions. comply with the GMP requlation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. 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 - Mr. Kludt

through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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 in a crassification for your

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 requires artition artition at [phone]. Also, please note the regulation entitled, "Misbranding by reference to a premarket notification" (21CFR 807.97) . 1 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,

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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| 510(k) Number (if known): | K981393 |
|---------------------------|---------|
|---------------------------|---------|

Sterile
Non Sterile

| Device Name: | Disposable MicroCool Surgical Gown, MicroCool Isolation Gown, DISPOSABLE |
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## Indications For Use:

The MicroCool Surgical Gown and the MicroCool Isolation Gown are single use items of surgical apparel intended to be worn by health are worker from the transfer of microorganisms, body fluids and particulate matter.

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Concurence of CDRH, Office of Device Evaluation (ODE)

*Chus. Lin*
(Division Sign-Off)
Division of Dental, Infection Control,
and General Hospital Devices
510(k) Number *k981393*

Prescription Use (Pct 21 CFR 801.109)

OR

Over-The-Counter Use X

(Optional Formal 1-2-96)