The UltraGard™ Blue O. R. Gown with Impervious Reinforced Chest and Sleeves is composed of a single base layer of SMS non-woven material with reinforced areas of the chest and sleeves. The reinforced area contains an additional layer of polyester laminated to a film.

AI/ML Overview

The provided text describes a 510(k) submission for a surgical gown and therefore does not include information relevant to a medical device that utilizes AI/ML or requires a study with a test set, ground truth establish by experts, or training set as described in the prompt. The "device" in this context is a physical product (a surgical gown), not a software algorithm.

Therefore, most of the requested fields are not applicable.

Here's an analysis of the provided text based on the categories you've requested, highlighting why many are not present:

Acceptance Criteria and Device Performance for UltraGard™ Blue Operating Room Gown

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Test Standard)	Reported Device Performance
ASTM F1670-98 (Resistance to Penetration by Synthetic Blood)	Pass (in the reinforced gown areas)
ASTM F1671-97b (Viral Penetration)	Pass (in the reinforced gown areas)
National Fire Protection Association No. 702-1980, "Wearing Apparel Flammability"	Meets Class 1
ISO 10993 (Biocompatibility for surface devices, intact skin, limited duration (< 24 hours))	Meets requirements
Applicable industry recognized test methods	Found to be acceptable for the intended use

2. Sample size used for the test set and the data provenance:

Sample Size: Not specified for any of the performance tests. The text refers to "the material" being tested.
Data Provenance: Not specified (e.g., country of origin, retrospective/prospective). This type of information is typically not relevant for material performance testing of a physical product.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable. The "ground truth" for a physical product like a surgical gown is established by performance against standardized, objective test methods (e.g., ASTM, ISO) and laboratory measurements, not by expert consensus on clinical images or data.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not applicable. Adjudication methods are relevant for subjective assessments, particularly in clinical or image-based studies where different expert opinions need to be reconciled to establish a ground truth. Material performance testing relies on objective, quantifiable results from standardized laboratory procedures.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

Not applicable. This is a physical product (surgical gown), not a diagnostic or interpretive AI-driven device. There are no "human readers" interpreting data, nor is there an AI component.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not applicable. This refers to the performance of a software algorithm without human intervention, which is not relevant for a surgical gown.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

Ground Truth Type: Objective, standardized laboratory test results against established performance criteria (e.g., measurement of synthetic blood penetration, viral penetration, flammability, biocompatibility as defined by the respective ASTM, NFPA, and ISO standards).

8. The sample size for the training set:

Not applicable. This is a physical product, not an AI/ML algorithm that requires a training set.

9. How the ground truth for the training set was established:

Not applicable, as there is no training set for a physical product.

Summary

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MAY 2 2 2002

SMDA REQUIREMENTS 510(k)

2013846

SUMMARY OF SAFETY AND EFFECTIVENESS FOR THE UltraGard™ IMPERVIOUS REINFORCED GOWN

This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of SMDA 1990 and 21 CFR § 807.92.

	Submitter's Name: Precept Medical Products, Inc.
	370 Airport Road
	Arden, North Carolina 28704 USA
	Telephone: (828) 681-0209

Mary Ann Faulkner, V. P. Quality Assurance/Regulatory Affairs Contact Person:

Date of Summary: April 19, 2002

Device Name: UltraGard™ Blue Operating Room Gown with Impervious Reinforced Chest and Sleeves.

Device Classification: The legally marketed device has been classified as follows: Surgical gown drape and drape accessories; (79 FPH); 21 CFR § 878.4040.

Legally Marketed Devices To Which Equivalence Is Claimed: The legally marketed predicate device is the Kimberly-Clark ULTRA Zoned-Impervious Gown (K842115), determined to be substantially equivalent to a legally marketed device on June 11, 1984. The UltraGard™ Blue O. R. Gown with Impervious Reinforced Chest and Sleeves is substantially equivalent to the Kimberly-Clark ULTRA Zoned-Impervious Gown in the intended use and in the performance attributes.

Device Description: The UltraGard™ Blue O. R. Gown with Impervious Reinforced Chest and Sleeves is composed of a single base layer of SMS non-woven material with reinforced areas of the chest and sleeves. The reinforced area contains an additional layer of polyester laminated to a film.

Intended Use: The UltraGard™ Blue O. R. Gown with Impervious Reinforced Chest and Sleeves is a sterile, single use, disposable garment to be used during surgical procedures in the operating room to help protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material.

Descriptive Summary Of Technological Characteristics And Those Of Predicate Device: The UltraGard™ Blue O. R. Gown with Impervious Reinforced Chest and Sleeves is made of a composite of multiple layers of nonwoven material similar to the Kimberly-Clark ULTRA Zoned-Impervious Gown.

Performance Data: The material used in the manufacture of the UltraGard™ Blue O. R. Gown with Impervious Reinforced Chest and Sleeves was tested in accordance with applicable standards and was determined to pass the Resistance of Materials Used in Protective Clothing to Penetration by Synthetic Blood ASTM F1670-98 and the Viral Penetration testing, ASTM

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F1671-97b in the reinforced gown areas. The material was tested in accordance with the National Fire Protection Association No. 702-1980, "Wearing Apparel Flammability" and meets Class 1. These devices meet the requirements for biocompatibility per ISO 10993 for surface devices, intact skin, limited duration (< 24 hours). These materials also were tested in accerdance with applicable industry recognized test methods and were found to be acceptable for the intended use.

Gown Pack 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 pack.

Conclusion: The information and data provided in this 510(k) Notification establish that the UltraGard™ Blue O. R. Gown with Impervious Reinforced Chest and Sleeves is substantially equivalent to a legally marketed device.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 2 2 2002

Ms. Mary Ann Faulkner Vice President, QA/RA Precept Medical Products, Incorporated 370 Airport Road Arden, North Carolina 28704

Re: K013846

Trade/Device Name: Ultragard™ Blue Operating Room Gown with Impervious Reinforced Chest and Sleeves Regulation Number: 878.4040 Regulation Name: Surgical Gown Regulatory Class: II Product Code: FYA Dated: April 19, 2002 Received: April 23. 2002

Dear Ms. Faulkner:

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.

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

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Page 2 - Ms. Faulkner

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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4618. 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.qov/cdrh/dsma/dsmamain.html

Sincerely yours,

Timothy A. Ulatowski Director Division of Dental, Infection Control and (ieneral Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

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April 19, 2001

Page 1 of 1

510(k) Number: K013846

Device Name: UltraGard™ Blue O. R. Gown with Impervious Reinforced Chest and Sleeves.

Indications for Use: UltraGard™ Blue O. R. Gown with Impervious Reinforced Chest and Sleeves is indicated for use in operating room procedures as a sterile cover garment.

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

Prescription Use (Per 21 CFR 801.109) OR

Over-the-Counter Use_

Qiu Si Lin

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

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.