BARRIER SURGICAL GOWNS

K990395 · Johnson & Johnson Medical, Div. of Ethicon, Inc. · FYA · Apr 13, 1999 · General, Plastic Surgery

Device Facts

• Record ID: K990395
• Device Name: BARRIER SURGICAL GOWNS
• Applicant: Johnson & Johnson Medical, Div. of Ethicon, Inc.
• Product Code: FYA · General, Plastic Surgery
• Decision Date: Apr 13, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4040
• Device Class: Class 2

Intended Use

A BARRIER surgical gown is a single use article of surgical apparel 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.

Device Story

Single-use surgical gown; worn by operating room personnel during surgical procedures. Constructed with high-repellency zones on front and lower sleeves using breathable materials. Protects patient and staff from transfer of microorganisms, body fluids, and particulate material. Provides higher breathability, equivalent strength/repellency, and lower weight compared to predicate. High-repellency zones are dimensionally larger than predicate reinforced zones.

Clinical Evidence

Bench testing only. Materials tested per October 1993 FDA 510(k) Surgical Gown guidance. Passed ASTM 1671 (viral penetration) and 16CFR1610 (flammability). Biocompatibility confirmed per ISO 10993-1.

Technological Characteristics

Single-use surgical gown; non-woven fabric construction. High-repellency zones (front/sleeves). Materials meet ISO 10993-1 biocompatibility. Flammability: 16CFR1610 Class I. Viral penetration resistance: ASTM 1671.

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

• BARRIER Extra Protection Plus surgical gown

Submission Summary (Full Text)

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

4/13/99

# 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS for the new BARRIER* surgical gowns

Johnson & Johnson MedicalTM Division of Ethicon Inc. 2500 Arbrook Boulevard P.O. Box 90130 Arlington, Texas 76004-3130

## Date:

- Submitter Information: 1. Contact Person: Jane Ann Martin Phone: [phone] Fax: [phone]
#### 2. Device Name:

Trade Name: BARRIER* surgical gowns Common/Usual Name: surgical gown Classification Name: surgical gown Device Classification: Class II, 21CFR878.4040

#### Statement of Substantial Equivalence: 3.

BARRIER surgical gowns with the new non-wovens are substantially equivalent to the BARRIER Extra Protection Plus surgical gown.

#### 4. Intended Use:

A BARRIER surgical gown is a single use article of surgical apparel 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.

#### ട്. Device Description:

The new BARRIER surgical gowns have high repellency areas ( front and lower sleeves) constructed from new breathable repellent materials.

#### 6. Material Safety Testing Summary

The new materials meet ISO 10993-1 requirements for material safety and biocompatibility.

000023

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

### Performance Testing Summary: 7.

The new materials were tested versus the predicate materials in the applicable standard material evaluations as indicated in the October, 1993, FDA 510(k) Surgical Gown guidance document. The new materials have higher breathability with equivalent strength and repellency as compared to the predicate's. The new gowns meet the Class I flammability requirements of 16CFR1610 and pass the ASTM Standard Test Method 1671, Resistance of Protective Clothing Materials to Penetration by Bloodborne Pathogens Using Viral Penetration as a Test System. The new fabrics are also lighter in weight than the predicate materials, resulting in lower disposal costs where disposal cost is based on weight. The high repellency zones of the new gowns are also larger in area dimensionally than the reinforced zones in the predicate gown.

### 8. Conclusion:

The new BARRIER surgical gowns are safe and effective for their intended use and are substantially equivalent to the predicate device.

00024

^* TRADEMARK

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

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the top half of the circle. Inside the circle is a stylized image of three human profiles facing right, with flowing lines above them.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 1 3 1999

Ms. Jane Ann Martin Johnson & Johnson Medical™ Division of Ethicon, Incorporated 2500 Arbrook Boulevard P.O. Box 90130 Arlington, Texas 76004-3130

Re : K990395 BARRIER Surgical Gowns (Six) Sterile and Trade Name: Non-Sterile Disposable Regulatory Class: II Product Code: FYA February 5, 1999 Dated: February 9, 1999 Received:

Dear Ms. Martin

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 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 The general controls provisions of the Act 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 requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your

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

Page 2 - Ms. Martin

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 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" (21 CFR 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/dsmamain.html".

Sincerely yours,

Timothy A. Ulatowski

Directbr Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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

# Indications for Use Statement

Applicant: Johnson & Johnson Medical, Division of Ethicon, Inc.

510(k) Number (if known): 长990395

Device Name:

Indications For Use:

A BARRIER surgical gown is a single use article of surgical apparel 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.

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use: (Per 21 CFR 801.109) OR

Over-the-Counter Use: X

Qun S. Lin

(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices

510(k) Number K990395

* TRADEMARK