The Paneffort AAMI Level 3 Isolation Gowns are intended to be worn by healthcare personnel in isolations to provide moderate barrier protection for health care personnel and patients from the transfer of microorganisms, body fluids, and particulate material. Paneffort AAM Level 3 Isolation Gowns meet the requirements of level 3 Liquid Barrier Performance as per AAMI PB70:2012 and are provided non-sterile and are single use only.

Device Description

The Paneffort AAMI Level 3 Isolation Gown is a surgical isolation gown with moderate barrier protection identified by Regulation 21 CFR 878.4040 under FDA product code FYC. The Paneffort AAMI Level 3 Isolation Gown is a single use, disposable medical device provided non-sterile. Paneffort AAMI Level 3 Isolation Gown is offered in one color (blue) and six different sizes of Small, Medium, Regular/Large, X-Large, 2X-Large, and 3X-Large. Each model is constructed of a nonwoven Spunbond-Meltblown-Spunbond (SMS) material that is tested according to ANSI/AAMI PB70:2012 Liquid Barrier and Performance Classification of Protective Apparel and Surgical Drapes Intended for Use in Health Care Facilities and meets AAMI Level 3.

The Paneffort AAMI Level 3 Isolation Gown consists of one critical zone throughout the entire gown including seams, but excluding cuffs, hems, and bindings as per AAMI PB70:2012. It is a protective tape sealed gown along with other design features like tieneck, elastic cuffs, and belt tie, that meets AAMI PB70 Level 3 barrier performance for protective apparel.

AI/ML Overview

This document describes the non-clinical testing performed on the Paneffort AAMI Level 3 Isolation Gown to demonstrate its substantial equivalence to a predicate device.

Here's an analysis of the provided information:

1. Table of Acceptance Criteria and Reported Device Performance:

S.No.	Test Performed	Acceptance Criteria	Reported Device Performance	Conclusion
1.	Bursting Strength	≥ 40 kPa (≥5.80 psi)	The test meets the Acceptance Criteria	The test meets the Acceptance Criteria
2.	Basis Weight	≥35 g/m²	The test meets the Acceptance Criteria	The test meets the Acceptance Criteria
3.	Linting Test	Co-coefficient of Linting ≤4.2	The test meets the Acceptance Criteria	The test meets the Acceptance Criteria
4.	Air Permeability	≥15 ft³/min/ft²	The test meets the Acceptance Criteria	The test meets the Acceptance Criteria
5.	Water Resistance: Hydrostatic Pressure	≥ 50cm H₂O (Ac: 3, Re: 4); AQL: 4% (Level 3 ANSI/AAMI PB70:2012)	Lot 1: 3 out of 32 samples failed. Lot 2: 3 out of 32 samples failed. Lot 3: 2 out of 32 samples failed. Despite these failures, the overall conclusion states: "The test meets the Acceptance Criteria."	The test meets the Acceptance Criteria
6.	Water Resistance: Impact Penetration	≤1.0g (Ac: 3, Re: 4); AQL: 4% (Level 3 ANSI/AAMI PB70:2012)	The test meets the Acceptance Criteria	The test meets the Acceptance Criteria
7.	Tensile Strength/Breaking Strength	≥30N (≥7 lbf)	The test meets the Acceptance Criteria	The test meets the Acceptance Criteria
8.	Tearing Strength	≥10N (≥2.3 lbf)	The test meets the Acceptance Criteria	The test meets the Acceptance Criteria
9.	Seam Strength	≥30N (≥7 lbf)	The test meets the Acceptance Criteria	The test meets the Acceptance Criteria
10.	Flammability	Class I. Textile exhibiting normal flammability.	The test meets the Acceptance Criteria	The test meets the Acceptance Criteria
11.	Water Vapour resistance	0,0-1,0 kPa.m²/W (This appears to be a range, but typically there would be a specific limit or target for water vapor resistance for PPE)	The test meets the Acceptance Criteria	The test meets the Acceptance Criteria
Biocompatibility: In Vitro Cytotoxicity	Non-cytotoxic	Under the conditions of the study, the device is non-cytotoxic.	The test meets the Acceptance Criteria
Biocompatibility: Skin Irritation	Not an irritant	Under the conditions of the study, not an irritant.	The test meets the Acceptance Criteria
Biocompatibility: Skin Sensitization	Not a sensitizer	Under the conditions of the study, not a sensitizer.	The test meets the Acceptance Criteria

Note on Water Resistance (Hydrostatic Pressure): The reported performance shows individual sample failures within each lot (3 out of 32 in Lot 1, 3 out of 32 in Lot 2, and 2 out of 32 in Lot 3). However, the "Conclusion" column for this test still states "The test meets the Acceptance Criteria." This implies that the passing condition is based on an Allowable Quality Level (AQL) or a specific sampling plan where a certain number of defects are permitted within the sample size while still meeting the overall acceptance criteria (Ac: 3, Re: 4; AQL: 4%).

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

Sample Sizes:
- Bursting Strength, Basis Weight, Linting Test, Air Permeability, Tensile Strength/Breaking Strength, Tearing Strength, Seam Strength, Flammability, Water Vapour resistance: 32 samples each from 3 different lots (total 96 samples per test).
- Water Resistance: Hydrostatic Pressure and Impact Penetration: Lot 1: 74 pieces; Lot 2: 72 pieces; Lot 3: 72 pieces (total 218 pieces across 3 lots for each test).
Data Provenance: The document does not explicitly state the country of origin for the testing data. However, the manufacturer is Paneffort (Cambodia) Garment Co. Ltd., and the specification developer is Paneffort, LLC (USA). The testing standards are international (ASTM, AATCC, ISO, CFR), suggesting tests were conducted in reputable labs, but the specific location of the test facilities is not provided. The data is retrospective, as it was collected to support a 510(k) submission for a device that has already been manufactured and tested.

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

Not Applicable. This study is a non-clinical performance testing of a physical medical device (isolation gown) against established engineering and material science standards. It does not involve human interpretation of data or diagnostic tasks where expert ground truth would be required. The "ground truth" here is objective measurement against specified criteria.

4. Adjudication Method for the Test Set:

Not Applicable. As no expert review or human interpretation for diagnosis is involved, there is no adjudication method in the traditional sense. The pass/fail criteria are defined by the testing standards and AQLs.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

No. An MRMC study is relevant for diagnostic devices that involve human interpretation (e.g., radiologists reading images). This submission is for a physical medical device (isolation gown) and does not involve human readers or diagnostic cases.

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

Not Applicable. This is not an AI/algorithm-based device. It is a physical product. The performance reported is that of the gown itself, as tested in a lab environment.

7. The Type of Ground Truth Used:

The "ground truth" for this device's performance is based on established industry and regulatory standards for protective apparel. This includes:
- ANSI/AAMI PB70:2012 Liquid Barrier Performance Classification of Protective Apparel and Surgical Drapes Intended for Use in Health Care Facilities (specifically Level 3).
- Various ASTM, AATCC, ISO, and CFR standards for material properties and flammability.
- ISO 10993 for biocompatibility.
The tests generate objective, measurable data that is compared directly to the numerical acceptance criteria defined in these standards.

8. The Sample Size for the Training Set:

Not Applicable. This device does not use machine learning or AI, and therefore does not have a "training set." The performance is inherent to its physical design and materials, verified through non-clinical testing.

9. How the Ground Truth for the Training Set was Established:

Not Applicable. As there is no training set, this question is not relevant.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

November 30, 2022

Paneffort, LLC % Shilpa Gampa Delivery Manager and US Agent Freyr Solutions 150 College Rd W #102 Princeton, New Jersey 08540

Re: K212717

Trade/Device Name: Paneffort AAMI Level 3 Isolation Gown Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FYC Dated: October 19, 2022 Received: October 20, 2022

Dear Shilpa Gampa:

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.

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

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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 medical devices and radiation-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,

Bifeng Qian -S

Bifeng Qian, M.D., 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 Ouality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K212717

Device Name Paneffort AAMI Level 3 Isolation Gown

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
-------------------------------------------------	--

Prescription Use (Part 21 CFR 801 Subpart D)

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

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510(k) Summary – K212717 Paneffort AAMI Level 3 Isolation Gown

1. Submitter Information:

Application Correspondent:Phone:E-mail:	Shilpa GampaDelivery Manager and US AgentFreyr Inc.150 College Rd W #102, Princeton, NJ 08540+1 908-483-7958 Ext 1780+1 760-583-4401usagent@freyrsolutions.com
Manufacturer:	Paneffort (Cambodia) Garment Co. Ltd.,National Road No.2, Kleang Sambatt,Pot Sar Ward, Bati District,Takeo 21309, Cambodia
Specification Developer& Product Owner	Paneffort, LLC700 Elmridge Center DriveRochester, NY 14626
Phone:	+855 12284810
Contact Person:	Harry Xu
E-mail:	Phil@paneffort.com
Date Prepared:	28-Nov-2022
2. Device Identification:
Device Trade Name:	Paneffort AAMI Level 3 Isolation Gown
Device Common Name:	Gowns, Isolation, Surgical
Classification Name:	Surgical Isolation Gown/Surgical Apparels
Device Class:	Class II
Regulation Number:	21 CFR 878.4040
Product Code:	EVC

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Predicate Device:

Device Name	510(k) Number
PRIMAGARD Isolation Gown(AAMI PB70 Level 3)	K160361

Table 1 List of Predicate Devices

3. Device Description

4. Intended Use/Indications for Use

The Paneffort AAMI Level 3 Isolation Gowns are intended to be worn by healthcare personnel in isolation applications to provide moderate barrier protection for health care personnel and patients from the transfer of microorganisms, body fluids, and particulate material. Paneffort AAMI Level 3 Isolation Gowns meet the requirements of level 3 Liquid Barrier Performance as per AAMI PB70:2012 and are provided non-sterile and are single use only.

5. Device and Predicate Device Technical Characteristics

The fundamental scientific technology, materials of construction and mechanism of operation are identical between the subject Paneffort AAMI Level 3 Isolation Gown and the predicate device. Table 2 summarizes the comparison of technological characteristics between the subject and predicate devices.

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S.No.	Parameters	PRIMAGARD Isolation Gown(AAMI PB70 Level 3)(Predicate Device)	Paneffort AAMI Level 3 IsolationGown(Subject Device)	Remarks
1.	Manufacturer	Primed Medical Products Inc.	Paneffort (Cambodia) Garment Co. Ltd.	N/A
2.	Product Classand Code	Class II, FYC	Class II, FYC	Same
3.	510(k) Number	K160361	K212717	N/A
4.	Regulation Number	21CFR 878.4040	21CFR 878.4040	Same
5.	Intended use/Indications for use	PRIMAGARD Level 3 IsolationGowns are intended to be worn byhealthcare personnel in isolationapplications to provide moderatebarrier protection for health carepersonnel and patients from thetransfer of microorganisms, bodyfluids, and particulate material.The PRIMAGARD IsolationGowns of this 510(k) meet therequirements of level 3 LiquidBarrier Performance as per AAMIPB70:2012 and are provided non-sterile and are single use only.	The Paneffort AAMI Level 3 IsolationGowns are intended to be worn byhealthcare personnel in isolationapplications to provide moderate barrierprotection for health care personnel andpatients from the transfer ofmicroorganisms, body fluids, andparticulate material. Paneffort AAMILevel 3 Isolation Gowns meet therequirements of level 3 Liquid BarrierPerformance as per AAMI PB70:2012 andare provided non-sterile and are single useonly.	Same
6.	Level of barrierprotection AAMI PB70	Level 3	Level 3	Same
7.	Material composition	Non-woven Polypropylene(SMS)	SMS non-woven (polypropylene)	Same
8.	Design	5 Models:Apron Neck Closure,Tape Tab Neck Closure,Hook and Loop Closure	Tie neck,Full back,Elastic cuffs,Blue belt tie	Similar1
S.No.	Parameters	PRIMAGARD Isolation Gown(AAMI PB70 Level 3)(Predicate Device)	Paneffort AAMI Level 3 IsolationGown(Subject Device)	Remarks
		Apron Neck Closure,Tie Neck Closure	taped seams.
9.	Color	Blue, Yellow	Blue	Similar²
10.	Sterility	Non-Sterile	Non-Sterile	Same
11.	Use	Single Use	Single Use; Disposable	Same
12.	Basis weight ASTMD3776	$39.97 ± 1.61 g/m²$$(1.17 oz/yd² ± 0.05)$	Tested to ASTM D3766. Met theacceptance criteria.	Similar³
13.	LBP: HydrostaticPressure AATCC 127	≥ 50 cm H₂ O	Pass, Met the standard's requirement(≥ 50 cm H₂ O)	Same
14.	LBP: Impact PenetrationAATCC 42	≤ 1 g	Pass, Met the standard's requirement(≤ 1.0 g)	Same
15.	Flammability: 16 CFRPart 1610.7	Class I	Class I	Same
16.	Breaking strength (MD)ASTM D5034	Tested to ASTM D5034.Met acceptance criteria	Tested to ASTM D5034. Metacceptance criteria	Similar⁴
17.	Breaking strength (CD)ASTM D5034			Similar⁵
18.	Tearing strength (MD)ASTM D5587-08	Tested to ASTM D5587.Met acceptance criteria	Tested to ASTM D5587. Met acceptancecriteria	Similar⁶
19.	Tearing strength (CD)ASTM D5587			Similar⁷
20.	Linting (ISO 9073-10)	Tested to NWSP 160.1 R0	Met acceptance criteria.	Similar⁸
S.No.	Parameters	PRIMAGARD Isolation Gown(AAMI PB70 Level 3)(Predicate Device)	Paneffort AAMI Level 3 IsolationGown(Subject Device)	Remarks
21.	Seam Strength	Tested to ASTM D5035.Met acceptance criteria.	Tested to ASTM D5035. Metacceptance criteria.	Similar9
22.	Thermal andEvaporative ResistanceASTM F1868	Tested to ASTM F1868PART C.Met acceptance criteria	Tested to ASTM F1868 PARTC.Met acceptance criteria	Similar10
23.	Air PermeabilityASTM D737	Tested to ASTM D737.Met acceptance criteria.	Tested to ASTM D737. Met acceptancecriteria.	Similar11
24.	Irritation	Under the conditions of the study,not an irritant.	Under the conditions of the study, not anirritant.	Same
25.	Sensitization	Under the conditions of the study,not a sensitizer.	Under the conditions of the study, not asensitizer.	Same
26.	Cytotoxicity	Under the conditions of the studythe device is non-cytotoxic.	Under the conditions of the study thedevice is non-cytotoxic.	Same

Table 2 Technological Characteristics Comparison of Proposed device and Predicate device

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Note:

N/A –refers that the section is Not applicable/ available.

Similar': The subject device design is sinilar to the additional features. The additional features do not raise related the safety and effectiveness of the device. Performance testing includion has been performed on the final finished device which includes all construction materials and color additives.

Similar': The subject device is offered only in single color while the predicate is offered in both Blue and Yellow colors. Peformance testing including biocompatibility evaluation has been the final finished device which includes all construction materials and color additives. Therefore, the difference does not raise any questions on the safety and effectiveness of the device.

Sinitar': The gowns were tested using the ASTM D3776 standard test method. As there linits for this test, we compared the test values obtained with a similar FDA approved (K203415) device. The test values for predicate and subject were less than the when evel

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Traditional 510(k) Paneffort AAMI Level 3 Isolation Gown

device, so we considered the difference in basis as acceptable. Therefore, the difference does not raise any gressions related to the safety and effectiveness of the device.

Similar' and Similar': The subject devices were tested for Breaking Strength using the ASTM F2407 recommended ASTM DS134 test nethod. The breaking strength of subject device differed from the recommended range of the ASTM P2407 Standard Specification for Sugical Gowns Intended for Use in Healthcare Facilities. The difference does not raise any questions on the safety and effectiveness of the device.

Similar and Similar : The subject devices were tested for Breaking Strength using the ASTM F2407 recommended ASTM D5887 test nethod. The tearing strength of the subject than the predicates, but it is within the recommended range of the ASTM F2407 for Surgical Gowns Intended for Use in Healthere, the difference does not raise any questions related to the safety and efectiveres of the device. Similar: Both the subject device and Predicate device were to the Gown using different test nethods of ASTM D1683/D1683M-11 a and ASTM D5035, respectively. Here, the Subject device to test method jielded the values within the recommended range of the ASTM F240 Standard Specification for Surgical Gowns Intented for Use in Healther. While the Predicate device was tested according to ASTM D505, which specifically utilizes cut strip test proce and elong force and elongation of most textile fabrics within the recommended range of the ASTM F2407 Standard Specification. As both the performed to indicate the durability of the fabric within the acceptable ranges, the difference does not raise any questions on the safety and effectiveness of the device.

Similar": Both the subject device were tested for Lint generation using the ISO 9073-10 standard recommended test nethod. As per the annicable ISO testing standard, there is no acception to Linting, However, the standard states that devending on the choice of particle counter, the size ranges can fall within of 0.3 um or 0.5 um. As test values obtained were within this particle size limit, the difference does not raise any questions related to the safety and effectiveness of the device.

Similar": Both the subject device and Predicted for Thermal and Euporative Resistance using the ASTM F1868-17 test nethod. As per the ASTM F1868 standard, the acceptance criteria are was evaporative resistance neasured for the speciment (that includes the test specinen (fabriches in test plate covered with a ligated. There are no acceptance criteria for the Reserver, as bath the gowns vere tested as per the applicable standard mot raise any questions related to the safety and effectiveness of the device.

Similar": Both the subject device and Predicty were tested for Air Permeability using the ASTM D737 est method. There is no minimum performance expectation for the air permeability parameter and Ashation gowns. Therefore, the difference does not ruise any questions related to the safety and effectiveness of the device.

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6. Non-Clinical Testing

Non-clinical tests were conducted to verify that the proposed device met all design specifications. The test results demonstrated that the proposed device complies with the following standards:

1. ASTM F2407-20 Standard Specification for Surgical Gowns Intended for Use in Healthcare Facilities
1. AAMI ANSI PB70:2012 Liquid Barrier Performance Classification of Protective Apparel and Drapes Intended for Use in Health Care Facilities
1. ASTM D3776/D3776/D3776M-2020 Test Methods for Mass Per Unit Area (Weight) of Woven Fabric
1. ASTM D5034-09(2013)- Standard Test Method for Breaking Strength and Elongation of Textile Fabrics (Grab Test)
ASTM D5587-08- Standard Test Method for Tearing Strength of Fabrics by ર. Trapezoid
1. AATCC 127-2017 Water Resistance: Hydrostatic Pressure Test
1. AATCC 42:2018 -Water Resistance: Impact Penetration Test
ISO 9073 Part 10: 2003 (for non-woven fabric) Lint and other particles generation 8. in the dry state (Lint Generation test)
1. ASTM D737-18 Standard Test Method for Air Permeability of Textile Fabrics
1. ASTM D1683/D1683M-11a Standard Test Method for Failure in Sewn Seams of Woven Apparel Fabrics
1. ASTM F1868-17 Standard Test Method for Thermal and Evaporative Resistance of Clothing Materials Using a Sweating Hot Plate
1. 16 CFR Part 1610-2008 Standard for the Flammability of Clothing
1. ISO 13938-2:2019 Pneumatic method for determination of bursting strength and bursting distension

The test summary table mentioned below includes the brief information for all the ASTM F2407-20 - Standard Specification for Surgical Gowns Intended for Use in Healthcare Facilities recommended tests that demonstrates the performance of Level 3 Isolation gowns.

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S.No	Test Performed	Device Description/ SampleSize	Test Methods/ Standards applicable	Acceptancecriteria	Unexpectedresults/Significantdeviations	Conclusion
1.	BurstingStrength	Paneffort AAMI Level 3Isolation Gown,32 samples each from 3different lots	ASTM D3786 Standard Test Method for BurstingStrength of Textile Fabrics	≥ 40 kPa (≥5.80 psi)	None	The test meets theAcceptanceCriteria
2.	Basis Weight	Paneffort AAMI Level 3Isolation Gown32 samples each from 3different lots	ASTM D3776 / D3776M - 20 :Standard Test Methods for Mass Per Unit Area(Weight) of Fabric; Method C	≥35 g/m2	None	The test meets theAcceptanceCriteria
3.	Linting Test	Paneffort AAMI Level 3Isolation Gown32 samples each from 3different lots	ISO 9073-10:2003:Test methods for nonwovens - Part 10: Lint andother particles generation in the dry state	Co-coefficient ofLinting ≤4.2	None	The test meets theAcceptanceCriteria
4.	AirPermeability	Paneffort AAMI Level 3Isolation Gown32 samples each from 3different lots	ASTM D737-18:Standard Test Method for Air Permeability ofTextile Fabrics	≥15 ft3/min/ft2	None	The test meets theAcceptanceCriteria
5.	WaterResistance:HydrostaticPressure	Paneffort AAMI Level 3Isolation Gown,3 lotsLot 1: 74 pieces;Lot 2: 72 pieces;Lot 3: 72 pieces.	AATCC 127-2018:Test Method for Water Resistance: HydrostaticPressure	≥ 50cm H2 O (Ас:3, Re: 4);AQL: 4% (Level 3ANSI/AAMI PB70:2012)	In Lot 1, threesamples (outof 32) failed thetest.In Lot 2, threesamples (outof 32) failed thetest. In Lot 3, twosamples (out of 32samples) failedthe test.	The test meets theAcceptanceCriteria
6.	WaterResistance:ImpactPenetration	Paneffort AAMI Level 3Isolation Gown,3 lotsLot 1: 74 pieces;Lot 2: 72 pieces:Lot 3: 72 pieces	AATCC 42-2017Test Method for Water Resistance: ImpactPenetration	≤1.0g (Ac: 3, Re:4);AQL: 4% (Level 3ANSI/AAMI PB70:2012)	None	The test meets theAcceptanceCriteria
7.	TensileStrength/BreakingStrength	Paneffort AAMI Level 3Isolation Gown,32 samples each from 3different lots	ASTM D5034-09 (2013):Standard Test Method for Breaking Strength andElongation of Textile Fabrics (Grab Test)	≥30N (≥7 lbf).	None	The test meets theAcceptanceCriteria
8.	TearingStrength	Paneffort AAMI Level 3Isolation Gown,32 samples each from 3different lots	ASTM D5587-08,Option 1: Standard Test Method for TearingStrength of Fabrics by Trapezoid Procedure	≥10N (≥2.3 lbf).	None	The test meets theAcceptanceCriteria
9.	Seam Strength	Paneffort AAMI Level 3Isolation Gown,32 samples each from 3different lots	ASTM D1683/ D1683M-11a:Standard Test Method for Failure in Sewn Seamsof Woven Fabrics	≥30N (≥7 lbf).	None	The test meets theAcceptanceCriteria
10.	Flammability	Paneffort AAMI Level 3Isolation Gown32 samples each from 3different lots	16 CFR Part 1610-2008: Standard for the Flammability ofClothing Textiles	Class I. Textileexhibiting normalflammability.	None	The test meets theAcceptanceCriteria
11.	Water Vapourresistance	Paneffort AAMI Level 3Isolation Gown32 samples each from 3different lots	ASTM F1868-17,Procedure Part B: Standard TestMethod for Thermal and EvaporativeResistance of Clothing Materials Using aSweating Hot Plate	0,0-1,0 kPa.m2 / W	None	The test meets theAcceptanceCriteria

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Traditional 510(k) Paneffort AAMI Level 3 Isolation Gown

7. Biocompatibility Testing

Biocompatibility tests were performed as per the ISO 10993-1:2018 Biological Evaluation of Medical Devices- Part 1: Evaluation and testing within a risk management process. The In-Vitro cytotoxicity, Skin irritation and Skin sensitization parameters were tested as per the below standards:

1. ISO 10993-5:2009 Biological Evaluation of Medical Device, Part 5-Tests for In Vitro cytotoxicity
1. ISO 10993-10:2010 Biological Evaluation of Medical Device, Part 10-Test for irritation and skin sensitization

The Paneffort AAMI Level 3 Isolation gowns passed biocompatibility studies per ISO-10993

8. Clinical Testing

No clinical study is included in this submission.

9. Conclusion

The conclusions drawn from the nonclinical tests demonstrate that the device, the Paneffort AAMI Level 3 Isolation gown, is as safe, as effective, and performs as well as or better than the legally marketed predicate device (K160361).

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.