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 Description

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

AI/ML Overview

This document describes the acceptance criteria and the study conducted for the new BARRIER surgical gowns.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Material Safety/Biocompatibility	New materials meet ISO 10993-1 requirements.
Flammability	New gowns meet Class I flammability requirements of 16CFR1610.
Resistance to Penetration by Bloodborne Pathogens	New gowns pass ASTM Standard Test Method 1671 (Resistance of Protective Clothing Materials to Penetration by Bloodborne Pathogens Using Viral Penetration as a Test System).
Breathability (compared to predicate)	New materials have higher breathability.
Strength (compared to predicate)	New materials have equivalent strength.
Repellency (compared to predicate)	New materials have equivalent repellency.
Weight (compared to predicate)	New fabrics are lighter.
High Repellency Zone Area (compared to predicate)	High repellency zones are larger in area dimensionally.

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the specific sample sizes for each material test. It mentions that the "new materials were tested versus the predicate materials in the applicable standard material evaluations."

Test Set Sample Size: Not specified.
Data Provenance: The document implies that the testing was performed internally by the manufacturer (Johnson & Johnson Medical) or by third-party labs on behalf of the manufacturer, following established industry standards. The country of origin of the data is not specified, but the submission is to the US FDA, suggesting the data would comply with US regulatory standards. The testing is for a new product undergoing premarket notification, implying prospective testing for this specific device.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts

This document describes performance testing of a physical product (surgical gowns) based on established material science standards. The "ground truth" is determined by objective measurements and compliance with these standards, not by expert interpretation in a clinical context. Therefore, the concept of "experts establishing ground truth" as it applies to medical imaging or diagnostics is not directly relevant here. The experts involved would be material scientists, engineers, and technicians conducting the specified tests and interpreting results according to the standards. No specific number or qualifications of these testing personnel are provided.

4. Adjudication Method for the Test Set

Not applicable. The tests described are objective material performance tests, where results are measured against defined criteria within the standard. There is no subjective interpretation or adjudication process as would be seen in clinical or diagnostic studies.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Not applicable. This is a submission for a physical medical device (surgical gown) based on material performance, not a diagnostic or AI-assisted device that would involve human readers.

6. Standalone Performance Study

Yes, a standalone performance study was conducted. The "Performance Testing Summary" section describes the results of the new materials and gowns being tested against various standards (Class I flammability, ASTM 1671, ISO 10993-1) and compared to the predicate device for breathability, strength, and repellency. This represents the performance of the device itself (the surgical gown) without human interaction in a diagnostic or interpretive capacity.

7. Type of Ground Truth Used

The ground truth used is based on:

Objective Material Performance Standards: Compliance with recognized international and national standards (e.g., ISO 10993-1, 16CFR1610 Class I flammability, ASTM Standard Test Method 1671).
Direct Comparison to Predicate Device Performance: The new materials were compared to predicate materials for properties like breathability, strength, and repellency, where the predicate's established performance serves as a comparative benchmark.

8. Sample Size for the Training Set

Not applicable. This is not an AI/ML device that requires a training set. The performance is based on the physical properties of the materials and production processes.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set for this type of device.

Summary

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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: 817-262-4048 Fax: 817-262-5369

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:

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.

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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.

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* TRADEMARK

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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

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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 (301) 594-4692. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 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

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Indications for Use Statement

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

510(k) Number (if known): 长990395

Device Name:

Indications For Use:

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

Regulation Number and Section

§ 878.4040 Surgical apparel.

(a)
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.(b)
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.