The reusable Maxima Surgical Gown is intended to be used by operating room personnel during surgical procedures to help protect both the patient and the health care worker from transfer of micro-organisms, body fluids, and particulate material.

The reusable Maxima Surgical Gown is provided non-sterile. Sterilization parameters are as follows: * Prevac Steam Sterilization - 135°C/274°F (temperature) / 3 minutes (exposure time) / 20 minutes (dry time)

Device Description

The Maxima® Surgical Gown is a reusable woven surgical gown for use in sterile conditions. It is made of 100% filament polyester that provides AAM PB70:2012 Level 3 Liquid Barrier Performance Barrier in the critical zone up to 75 reprocessing cycles. The back of the gown provides AAMI Level 3 Liquid Barrier Performance Barrier up to 75 reprocessing cycles. The seam in the sleeves are sealed with a permanent seam tape which seals the stitch area enabling it to perform as AAMI Level 3 up to 75 reprocessing cycles.

Maxima® Surgical Gown will be manufactured in small, medium, and larges sizes. Maxima® Surgical Gowns will be sold as non-sterile reusable surgical gowns that are to be laundered, sterilized and processed by health care facilities and or contract laundry and sterliization companies before first use and after each subsequent use.

AI/ML Overview

This document is a 510(k) Premarket Notification for a surgical gown, not an AI medical device. Therefore, the questions related to AI device performance, training sets, ground truth establishment, expert consensus, and MRMC studies are not applicable.

The document focuses on demonstrating that the Maxima Surgical Gown is substantially equivalent to a predicate device (Blockade Surgical Gown) by meeting relevant performance and safety standards.

Here's an analysis of the acceptance criteria and performance study as presented for this surgical gown:

1. A table of acceptance criteria and the reported device performance:

Test Conducted	Test Standard	Acceptance Criteria	Reported Device Performance
Cytotoxicity ISO MEM Elution Using L-929 Mouse Fibroblast Cells	ISO 10993-5 Cytotoxicity: Biological Evaluation Of Medical Devices - Part 5: Tests For In Vitro Cytotoxicity	non-cytotoxic	non-cytotoxic
Skin Irritation ISO Intracutaneous Irritation Test	ISO 10993-10 Irritation: Biological Evaluation of Medical Devices - Part 10: Tests For Skin Sensitization	non-irritating	non-irritating
Skin Sensitization ISO Guinea Pig Buehler Sensitization Test	ISO 10993-10 Sensitization: Biological Evaluation of Medical Devices - Part 10: Tests For Skin Sensitization	non-sensitizing	non-sensitizing
Water Resistance (Hydrostatic Pressure)	AATCC 127: Test Method for Water Resistance: Hydrostatic Pressure	>50 cm AQL 4.0	Avg. 70.3 cm
Water Resistance (Impact Penetration)	AATCC 42: Test Method for Water Resistance: Impact Penetration	<1.0 g AQL 4.0	Mean 0.01 g
Breaking Strength (Grab Test)	ASTM D5034: Standard Test Method For Breaking Strength And Elongation Of Textile Fabrics (Grab Test)	>30 lbf	Warp: 138.9 lbf, Fill: 82.01 lbf
Tear Strength (Trapezoid Procedure)	ASTM D 5587: Standard Test Method for Tearing Strength of Fabrics by Trapezoid Procedure	>1.5 lbf	Warp: 25.3 lbf, Fill: 7.4 lbf
Seam Strength (Failure In Sewn Seams)	ASTM D1683: Standard Test Method For Failure In Sewn Seams Of Woven Fabrics	>30 lbf	Warp: 78 lbf, Fill: 65.4 lbf
Weight	ASTM D3776/D3776M-09a: Standard Test Methods For Mass Per Unit Area (Weight) Of Fabric	Documentation Only	88 gsm
Flammability	16 CFR 1610: Standard for the Flammability of Clothing Textiles	Class 1	Class 1
Lint Generation	EN ISO 9073-10: Textiles - Test methods for nonwovens - Part 10: Lint and other particles generation in the dry state	Documentation Only	log10 (lint count) 1.89
Evaporative Resistance	ASTM F1868: Standard Test Method for Thermal and Evaporative Resistance of Clothing Materials Using a Sweating Hot Plate	Documentation Only	Ret Critical Zone 0.01193, Ret Noncritical Zone 0.01157

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

The document does not explicitly state the sample sizes (e.g., number of gowns or fabric samples) used for each specific test in the "Summary of Non-Clinical Testing" section. It refers to general "performance testing." The data provenance (country of origin, retrospective/prospective) is also not specified, as this is a laboratory performance testing rather than a clinical study with patient data.

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):

Not applicable. This is a physical product performance validation based on defined test standards, not an AI or diagnostic device requiring expert interpretation for ground truth.

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

Not applicable. This is not a study requiring adjudication of expert opinions.

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 surgical gown, not an AI-assisted diagnostic device.

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

Not applicable. This is a physical product.

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

The "ground truth" for this device is the adherence to established industry-wide performance standards and specifications for surgical gowns, such as those related to barrier protection (AAMI Level 3), biocompatibility (ISO 10993 series), and physical properties (ASTM standards). The tests themselves provide objective measurements against these predefined criteria.

8. The sample size for the training set:

Not applicable. This is not a machine learning model.

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

Not applicable. This is not a machine learning model.

In summary: The provided document is a 510(k) summary for a surgical gown, demonstrating substantial equivalence to a predicate device through detailed non-clinical performance testing against established industry standards. It does not involve AI, clinical data, expert consensus, or typical AI/software device evaluation metrics.

Summary

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March 11, 2022

Elevate Textiles Nathaniel Terry Technical Director 22 American Street Mt. Holly, North Carolina 28210

Re: K201351

Trade/Device Name: Maxima Surgical Gown Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical apparel Regulatory Class: Class II Product Code: FYA Dated: December 8, 2021 Received: December 13, 2021

Dear Nathaniel Terry:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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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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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

For Clarence W. Murray III, Ph.D. Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K201351

Device Name Maxima Surgical Gown

Indications for Use (Describe)

Elevate Textiles Item Numbers / gown color / liquid barrier protection / gown size MAXAL3S / Royal Blue B103 / AAMI Level 3 / Small MAXAL3M / Royal Blue B103 / AAMI Level 3 / Medium MAXAL3L / Royal Blue B103 / AAMI Level 3 / Large

Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CER 801 Subpart D)
	X Over-The-Counter Use (21 CER 801 Subpart C)

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510(k) Summary (K201351)

[As required by section 807.92(c)]

Submitter:

Elevate Textiles 22 American Street Mt Holly NC, 28120

Contact Person:

Nathaniel Terry Technical Director / Regulatory Affairs Telephone: 336-684-1683 Email: Nathaniel.terry@elevatetextiles.com

Summary Preparation Date

December 1, 2021

Type of Submission Traditional 510(k)

Device Name / Classification

Trade Name:	Maxima® Surgical Gown
Common Name:	Sterile Surgical Gown
Classification Name:	Surgical Gown, Class 2

Predicate Device - Maxima® Surgical Gown claims substantial equivalence to:

K150598 Blockade Surgical Gown manufactured by Medline Industries, Inc

Device Description

Indications for Use

The Maxima Surgical Gown is a reusable surgical gown intended to be used by operating room personnel during surgical procedures to help protect both the patient and the health care worker of micro-organisms, body fluids, and particulate material.

The Maxima Surgical Gown is provided non-sterilization parameters are as follows:

Prevac Steam Sterilization - 135°C/274°F (temperature) / 3 minutes (exposure time) / 20 minutes (dry time)

Elevate Textiles Item Numbers / Gown Color / Liquid Barrier Protection / Gown Size

MAXAL3S / Royal B103 / AAMI Level 3 / Small MAXAL3M MAXAL3L

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Summary of Technological Characteristics

DeviceCharacteristic	Proposed Device	Predicate Device	ComparisonAnalysis
Product Name	Maxima® Surgical Gown	Blockade Surgical Gown	N/A
510(k) Reference	K201351	K150598	N/A
Product Owner	Elevate Textiles	Medline Industries Inc.	N/A
Product Code	FYA	FYA	same
Intended Use	Intended to be used byoperating room personnelduring surgical procedures tohelp protect both the patientand the health care workerfrom transfer of micro-organisms, body fluids, andparticulate material.	Intended to be used byoperating room personnelduring surgical proceduresto help protect both thepatient and the health careworker from transfer ofmicro-organisms, bodyfluids, and particulatematerial.	same
Regulation Number	21 CFR 878.4040	21 CFR 878.4040	same
Color	Royal B103	Ceil, Jade	different
Design Features	belt tiesknit cuffsneck closure: metal snaps	belt tiesknit cuffsneck closure: metal snaps	same
Sizes	Small, Medium, Large	Large, X-Large XX-Large	similar
Materials	Woven polyester	Woven polyester	same
PerformanceSpecifications	Level 3 ANSI/AAMI PB70Barrier protection	Level 3 ANSI/AAMI PB70Barrier protection	same
Prescription vs. OTC	ОТС	OTC	same
Contact Durations	Surface, Breached orCompromised, < 24 hours	Surface, Breached orCompromised, < 24 hours	same
Sterile vs. non-sterile	Sterile when used	Sterile when used	same
Single Use vs.Reusable	reusable	reusable	same
Biocompatibility	Under the test conditions, thesubject device was shown tobe non-cytotoxic, non-irritatingand non-sensitizing per ISO10993-5 & ISO 10993-10.	Met requirements per: ISO10993-5 Cytotoxicity ISO10993-10 Irritation ISO10993-10 Sensitization	same
Flammability	Meets the requirements ofCPSC 16 CFR 1610 Class 1	Meets the requirements ofCPSC 16 CFR 1610 Class 1	same
Lint Level	Log10 (lint count) 1.89	Log10 (lint count) 1.89	same
Tensile Strength	Warp: 138.9 IbfFill: 82.01 Ibf	Warp: 138.9 IbfFill: 82.01 Ibf	same
Seam Strength	Warp: 78 IbfFill: 65.4 Ibf	Warp: 78 IbfFill: 65.4 Ibf	same
Tear Resistance	Warp: 25.3 IbfFill: 7.4 Ibf	Warp: 25.3 IbfFill: 7.4 Ibf	same
Sterilization Method	Prevac steam autoclave	Prevac steam autoclave	same

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Summary of Non-Clinical Testing

Performance testing was performed to verify that the acceptance criteria. The testing done on the Maxima® Surgical Gown was conducted to demonstrate the safety and effectiveness of the subject device with the relevant test methods cited below, including the appropriate biocompatibility test.

Test Conducted	Test Standard	Acceptance Criteria	Test Result
Cytotoxicity ISO MEMElution Using L-929Mouse Fibroblast Cells	ISO 10993-5 Cytotoxicity: Biological Evaluation Of MedicalDevices - Part 5: Tests For In Vitro Cytotoxicity	non-cytotoxic	non-cytotoxic
Skin Irritation ISOIntracutaneous IrritationTest	ISO 10993-10 Irritation: Biological Evaluation of MedicalDevices - Part 10: Tests For Skin Sensitization	non-irritating	non-irritating
Skin Sensitization ISOGuinea Pig BuehlerSensitization Test	ISO 10993-10 Sensitization: Biological Evaluation of MedicalDevices - Part 10: Tests For Skin Sensitization	non-sensitizing	non-sensitizing
Water Resistance	AATCC 127: Test Method for Water Resistance: HydrostaticPressure	>50 cm AQL 4.0	Avg. 70.3 cm
Water Resistance	AATCC 42: Test Method for Water Resistance: ImpactPenetration	<1.0 g AQL 4.0	Mean 0.01 g
Breaking Strength	ASTM D5034: Standard Test Method For Breaking StrengthAnd Elongation Of Textile Fabrics (Grab Test)	>30 lbf	Warp: 138.9 lbfFill: 82.01 lbf
Tear Strength	ASTM D 5587: Standard Test Method for Tearing Strength ofFabrics by Trapezoid Procedure	>1.5 lbf	Warp: 25.3 lbfFill: 7.4 lbf
Seam Strength	ASTM D1683: Standard Test Method For Failure In SewnSeams Of Woven Fabrics	>30 lbf	Warp: 78 lbfFill: 65.4 lbf
Weight	ASTM D3776/D3776M-09a: Standard Test Methods For MassPer Unit Area (Weight) Of Fabric	Documentation Only	88 gsm
Flammability	16 CFR 1610: Standard for the Flammability of ClothingTextiles	Class 1	Class 1
Lint Generation	EN ISO 9073-10: Textiles - Test methods for nonwovens -Part 10: Lint and other particles generation in the dry state	Documentation Only	log10 (lint count) 1.89
Evaporative Resistance	ASTM F1868: Standard Test Method for Thermal andEvaporative Resistance of Clothing Materials Using a SweatingHot Plate	Documentation Only	Ret Critical Zone 0.01193Ret Noncritical Zone 0.01157

Summary of Clinical Testing

Not applicable

Conclusion

Based on the information provided in this premarket notification, Elevate Textiles concludes that the Maxima® Surgical Gown is as safe, as effective, and performs as well as or better than the legally marketed predicate device K150598 Medline Blockade Surgical gown.

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.