The 3M™ Basic Disposable Surgical Gowns, 3M™ Disposable Surgical Gowns and 3M™ HP Disposable Surgical Gowns are items of surgical apparel intended to be worn by health care professionals to help protect both the patient and health care worker from transfer of microorganisms, body fluids and particulate matter. These gowns meet level 2 of the AAMI Liquid Barrier Classification.

The 3M™ Reinforced Disposable Surgical Gowns and 3M™ HP Reinforced Disposable Surgical Gowns are items of surgical apparel intended to be worn by health care professionals to help protect both the patient and health care worker from transfer of microorganisms, body fluids and particulate matter. The extra reinforced material is non-permeable and therefore provides a 100% barrier to liquids and blood. These gowns meet level 4 of the AAMI Liquid Barrier Classification within the critical areas of the gowns. *

*To fulfill these requirements, extra reinforced material sheets are integrated into parts of the gown on the front panel and in both sleeves from the cuff to the elbow.

These gowns are for single use.

Device Description

The 3M surgical gowns are sterile, disposable and intended for single use. They come in a variety of sizes (M, L, XL and XXL). Their construction includes a blue nonwoven fabric consisting of either a SMMS or Spunlace. Those gowns that are labeled reinforce include extra reinforced material sheets integrated into parts of the gown within the front panel and on both sleeves from the cuff to the elbow. The gowns include a specific AAMI Liquid Barrier Performance and Classification (i.e. 2 or 4) Level. All gowns are easy to don and include a hook and loop to close the neck and ties for closing the back of the gown. They include functional cuffs constructed of a white knitted material.

AI/ML Overview

This appears to be a 510(k) premarket notification for surgical gowns, which are medical devices, but not an AI or algorithm-driven device. Therefore, many of the requested fields are not applicable.

Here's the information based on the provided text, with explanations for the non-applicable fields:

1. Table of Acceptance Criteria and Reported Device Performance

Feature/Test	Acceptance Criteria (Target)	Reported Device Performance
Intended Use	Same as predicate device (Kimberly Clark, Ultra Film-Reinforced Surgical Gown K080795)	3M™ Basic Disposable, 3M™ Disposable, 3M™ HP Disposable: Intended to protect patient and healthcare worker from transfer of microorganisms, body fluids and particulate matter. 3M™ Reinforced Disposable, 3M™ HP Reinforced Disposable: Intended to protect patient and healthcare worker from transfer of microorganisms, body fluids and particulate matter; extra reinforced material provides 100% barrier to liquids and blood.
Sterile	Yes	Yes
Single Use	Yes	Yes
Disposable	Yes	Yes
AAMI Fluid Barrier Protection Level	Predicate: Level 4 (for reinforced areas)	3M™ Basic Disposable, 3M™ Disposable, 3M™ HP Disposable: Level 2 3M™ Reinforced Disposable, 3M™ HP Reinforced Disposable: Level 4 (within critical areas of the gowns)
Flammability Level	Class 1 (Same as predicate)	Class 1
Materials	Comparable to predicate (Nonwoven SMS)	Nonwoven (SMMS or Spunlace)
Optional Sizes	Yes (e.g., L)	Yes
Hook-and-loop neck closure	Yes	Yes
Tie waist closure	Yes	Yes
Reinforcement	Yes (for reinforced models)	Yes* (Note: Includes a reinforced panel on the inside of the gown within the front panel and sleeves from the cuff to the elbow for reinforced models)
Cuffs	Yes	Yes
Gown Color	Blue	Blue
Biocompatibility	Met acceptable and/or required criteria	All results met acceptable and/or required criteria.
Linting and Cleanliness - Particulate Matter	Met acceptable and/or required criteria	All results met acceptable and/or required criteria.
Tensile Strength	Met acceptable and/or required criteria	All results met acceptable and/or required criteria.
ANSI/AAMI PB70:2003 Liquid Barrier Performance	Met acceptable and/or required criteria	All results met acceptable and/or required criteria.

Explanation of Findings: The study demonstrates substantial equivalence to the predicate device by comparing various physical characteristics and performance standards (like AAMI fluid barrier levels, flammability, and materials) as well as specific biocompatibility and material integrity tests. All tested parameters met the "acceptable and/or required criteria."

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

Sample Size for Test Set: The document states that "all results of the testing met acceptable and/or required criteria." However, it does not specify the sample sizes for the biocompatibility, linting, tensile strength, flammability, or ANSI/AAMI PB70:2003 liquid barrier performance tests.
Data Provenance: Not specified in the provided text. It's likely that such testing would be conducted in a laboratory setting by the manufacturer (3M Health Care, St. Paul, MN, USA) or a contract lab. The document does not indicate if the data is retrospective or prospective.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

This is not applicable to this type of device. The ground truth for surgical gowns is established through objective, standardized physical and chemical tests (e.g., AAMI standards for fluid barrier, flammability tests), not through expert consensus on qualitative assessments like image interpretation.

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

This is not applicable to this type of device, as it refers to methods for reconciling differences in qualitative assessments, typically by human readers in areas like medical imaging. The tests performed are objective and yield quantitative results.

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

This is not applicable. An MRMC study is relevant for evaluating the performance of AI-assisted diagnostic tools where human readers are interpreting cases. Surgical gowns are not AI-driven devices.

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

This is not applicable. This question refers to the performance of an AI algorithm operating independently, which is not relevant for a physical medical device like a surgical gown.

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

The "ground truth" for this device is based on established industry standards and objective physical/chemical test methods. Examples include:

ANSI/AAMI PB70:2003 Liquid Barrier Performance: This is a defined standard for liquid barrier protection levels.
Flammability Level (Class 1): A standard classification for material flammability.
Biocompatibility: Likely assessed against ISO standards (e.g., ISO 10993 series) which involve standardized tests for cytotoxicity, sensitization, irritation, etc.
Tensile Strength, Linting, Cleanliness: Assessed using established material science testing methodologies.

These are not based on expert consensus for diagnosis, pathology, or clinical outcomes data, but rather on meeting predefined physical and performance specifications.

8. The sample size for the training set

This is not applicable. Surgical gowns are physical products, not AI models that require a training set.

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

This is not applicable, as there is no training set for a physical surgical gown.

Summary

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Premarket Notification 510(k) Summary

101468

APR 1 4 2011

Sponsor Information:	3M Health Care3M Center, Bldg. 275-5W-06St. Paul, MN 55144-1000
Primary Contact Person:	Linda JohnsenRegulatory Affairs SpecialistPhone Number: (651) 737-4376FAX Number: (651) 737-5320
Date of Summary:	October 6, 2010
Device Common Name:	Sterile Disposable Surgical Gowns
Proprietary Name:	3M™ Basic Disposable Surgical Gown (REF 7492, 7493 & 7494)3M™ HP Disposable Surgical Gown (REF 7691C, 7692C,7693C & 7694C)3M™ Reinforced Disposable Surgical Gown (REF 7595C,7596C, 7597C & 7598C)3M™ Disposable Surgical Gown (REF 7591C, 7592C, 7593C,& 7594C)3M™ HP Reinforced Disposable Surgical Gown (REF 7695C,7696C, 7697C, & 7698C)
Classification Name:	Surgical Apparel (Class II, 21 CFR § 878.4040)
Product Code:	FYA
Performance Standards:	None
Predicate Device:	Kimberly Clark, Ultra Film-Reinforced Surgical Gown (K080795)

Intended Use:

*To fulfill these requirements, extra reinforced material sheets are integrated into parts of the gown on the front panel and in both sleeves from the cuff to the elbow.

These gowns are for single use.

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Description of Device:

Comparative Data for Determining Substantial Equivalence of New Device to Predicate Device:

Element	3M BasicDisposableSurgicalGown	3MDisposableSurgicalGown	3MReinforcedDisposableSurgicalGown	3M HPDisposableSurgicalGown	3M HPReinforcedDisposableSurgicalGown	K080795KC-Ultra FilmReinforceSurgical Gown
Cat #'s	749274937494	7591C7592C7593C7594C	7595C7596C7597C7598C	7691C7692C7693C7694C	7695C7696C7697C7698C
Intended Use	Same	Same	Same	Same	Same	Same
Sterile	Yes	Yes	Yes	Yes	Yes	Yes
Single Use	Yes	Yes	Yes	Yes	Yes	Yes
Disposable	Yes	Yes	Yes	Yes	Yes	Yes
AAMI FluidBarrierProtection Level	Level 2	Level 2	Level 4	Level 2	Level 4	Level 4
FlammabilityLevel	Class 1	Class 1	Class 1	Class 1	Class 1	Class 1
Materials	NonwovenSMMS	NonwovenSpunlace	NonwovenSpunlace	NonwovenSMMS	NonwovenSMMS	NonwovenSMS
Optional Sizes(i.e. L)	Yes	Yes	Yes	Yes	Yes	Yes
hook-and-loopneck closure	Yes	Yes	Yes	Yes	Yes	Yes
Tie waist closure	Yes	Yes	Yes	Yes	Yes	Yes
Reinforcement	No	No	Yes*	No	Yes*	Yes
Cuffs	Yes	Yes	Yes	Yes	Yes	Yes
Gown Color	Blue	Blue	Blue	Blue	Blue	Blue

*Note: Include a reinforced panel on the inside of the gown within the front panel and sleeves from the cuff to the elbow.

Summary of Testing:

The surgical qowns testing includes; biocompatibility, linting and cleanliness - particular matter, tensile strength, flammability and ANSI/AMMI PB70:2003 liquid barrier performance. All results of the testing met acceptable and/or required criteria.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the circle is an abstract symbol that resembles an eagle or bird in flight. The symbol is composed of three curved lines that form the body and wings of the bird.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Ms. Linda Johnson Regulatory Affairs Specialist 3M Company Corporation 3M Center, Building 275-5W-06 St Paul, Minnesota 55144-1000

APR 1 4 2011

Re: K101468

Trade/Device Name: 3M™ Surgical 3M™ Basic Disposable Surgical Gown (REF 7492, 7493 & 7494) 3MTM HP Disposable Surgical Gown (REF 7691C, 7693C & 7694C) 3M™ Reinforced Disposable Surgical Gown (REF 7595C, 7597C, & 7598C) 3MTM Disposable Surgical Gown (REF 7591C, 7592C, 7593C, & 7594C) 3M™ HP Reinforced Disposable Surgical Gown (REF7695C, 7696C 7697C & 7698C) Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: II Product Code: FYA Dated: April 5, 2011 Received: April 6, 2011

Dear Ms. Johnson:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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. Johnson

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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 (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industrv/default.htm.

Sincerely yours,

Anthony D. Watson, B.S., M.S., M.B.A. Division 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 Statement

510(k) Number (if Known):

Device Name: 3M™ Surgical Gowns

3M™ Basic Disposable Surgical Gown (REF 7492, 7493 & 7494) 3M™ HP Disposable Surgical Gown (REF 7691C, 7692C, 7693C & 7694C) 3M™ Reinforced Disposable Surgical Gown (REF 7595C, 7596C, 7597C, & 7598C) 3M™ Disposable Surgical Gown (REF 7591C, 7592C, 7593C, & 7594C) 3M™ HP Reinforced Disposable Surgical Gown (REF 7695C, 7696C 7697C, & 7698C)

Intended Use

*To fulfill these requirements, extra reinforced material sheets are integrated into parts of the gown on the front panel and in both sleeves from the cuff to the elbow.

These gowns are for single use.

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use X (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

				Concurrence of CDRH, Office of Device Evaluation (ODE)
2007	11 To Clawiter in .	110.18-	Career of the Property of Children

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

510(k) Number: K101468

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.