The AZAC Protect X Level 3, Single Use, Non-Sterile, Protective Gown is intended to protect health care personnel and patients from the transfer of microorganisms, body fluids and particulate material. Not intended for use in the operating room.

The AZAC Protect X Level 3, Single Use, Non-Sterile, Protective Gown gown meets the barrier protection requirements of AAMI Level 3 per ANSI/AAMI PB70:2012 – Liquid Barrier Performance and Classification of Protective Apparel and Drapes Intended for Use in Health Care Facilities.

The AZAC Protect X Level 3, Single Use, Non-Sterile, Protective Gown is a single use, disposable medical device and is provided non-sterile.

Device Description

The AZAC Protect X Level 3, Single Use, Non-Sterile, Protective Gown is used in moderate risk situations such as venous blood draws, inserting IVs, and emergency room use. The gown is not sterile; is not an isolation gown and is not indicated for use in the Operating Room. The AZAC Protect X Level 3, Single Use, Non-Sterile, Protective Gown is made of one-piece chlorinated polyethylene elastomer non-woven tri-laminate. The Level 3 gown meets the ANSI/ AAMI PB70 Level 3 standards. The gown is a single use, disposable device.

AI/ML Overview

The provided document is a 510(k) premarket notification for a medical device: an AZAC Protect X Level 3, Single Use, Non-Sterile, Protective Gown. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than proving clinical effectiveness through new clinical trials as would be required for a premarket approval (PMA) application for a novel, high-risk device.

Therefore, the information typically requested about AI/algorithm performance studies (e.g., sample sizes for test and training sets, expert ground truth establishment, MRMC studies, effect sizes of AI assistance, standalone performance) is not applicable to this document. This document describes the testing of a physical medical device (a protective gown), not an AI/algorithm-based diagnostic or assistive system.

The acceptance criteria and performance data provided relate to the physical properties and barrier performance of the gown, not to an algorithm's accuracy or clinical utility.

Here's the information extracted from the document that is relevant to the acceptance criteria and the non-clinical study proving the device meets them:

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

Test Method (Acceptance Criteria)	Purpose	Criteria (Acceptance Criteria)	Result (Reported Device Performance)
AAMI PB70:2012	Overall barrier performance	Meet requirements for classification as AAMI PB70 Level 3 gown	Pass
Hydrostatic Pressure Test (AATCC 127:2018)	Resistance to static liquid	NLT 50.0 cm H2O	Pass
Impact Penetration (AATCC 42-2017)	Resistance to liquid stream	No penetration	Pass
ASTM D 3776 - Mass/unit area	Basis weight of material	26 g/m²	Pass
ASTM D5034 Breaking Strength - Grab Test	Durability: Grab test	Length – 27 N, Width – 31.5 N	Pass
ASTM D5587 Tear Strength - Trapezoid Test	Durability: Trapezoid	Length – 10.5 N, Width 14.0 N	Pass
16 CFR 1610 - Flammability	Flammability	Class 1	Pass
ISO 10993-5 Cytotoxicity	Biocompatibility: Cytotoxicity potential	Under the conditions of the study, non-cytotoxic	Pass
10993-10 Sensitization/Irritation	Biocompatibility: Sensitization and irritation	Under the conditions of the study, not a sensitizer; Under the conditions of the study, non-irritating	Pass

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

Sample Size: The document does not specify the exact sample sizes (number of gowns or material samples) used for each non-clinical test. It states that "Results confirm that the design inputs and performance specifications are met."
Data Provenance: The tests were conducted internally by AZAC Group or by labs on their behalf, based on "internal requirements and applicable standards." The country of origin and whether the data is retrospective or prospective are not detailed. These are standard laboratory tests for physical properties.

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

Not applicable. For physical and material property testing, "ground truth" is established by adhering to published ASTM, AATCC, AAMI, and ISO standard test methods and their specified procedures, rather than by human expert consensus or interpretation of complex data. The results are objective measurements or categorical determinations (e.g., pass/fail).

4. Adjudication method for the test set:

Not applicable. Adjudication methods like 2+1 or 3+1 are typically used for expert review of medical images or clinical cases to establish ground truth in diagnostic studies. For these non-clinical material tests, the results are determined by the specified test protocols and criteria.

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 document is for a physical protective gown, not an AI-assisted diagnostic tool.

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

Not applicable. This document is for a physical protective gown, not an algorithm.

7. The type of ground truth used:

For the non-clinical performance data, the "ground truth" is defined by the objective pass/fail criteria established by recognized industry standards (e.g., AAMI PB70:2012, AATCC 127:2018, ASTM D 3776, ISO 10993-5). These standards specify the test methodology and the performance thresholds required for a "Pass" result.

8. The sample size for the training set:

Not applicable. There is no "training set" as this is not an AI/machine learning device.

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

Not applicable. There is no "training set."

Summary

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November 17, 2021

AZAC Group Robert Seiple President QPM Consulting, LLC 3817 Seville Rd Denton, Texas 76205

Re: K211538

Trade/Device Name: AZAC Protect X Level 3, Single Use, Non-Sterile, Protective Gown Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: OPC Dated: October 8, 2021 Received: October 13, 2021

Dear Robert Seiple:

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 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, PhD 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) K211538

Device Name

AZAC Protect X Level 3, Single Use, Non-Sterile, Protective Gown

Indications for Use (Describe)

The AZAC Protect X Level 3, Single Use, Non-Sterile, Protective Gown is a single use, disposable medical device and is provided non-sterile.

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)	X

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510(k) Summary K211538

AZAC Protect X Level 3, Single Use, Non-Sterile, Protective Gown

1. Submission Sponsor

AZAC Group 17870 Castleton St., Suite 121 City of Industry, CA, 91748 USA Contact: Yen Ping Shan Title: COO

2. Submission Correspondent

Robert Seiple, RAC President, QPM Consulting, LLC Email: Robert@QPMconsult.com Direct number: (940) 390-0961

3. Date Prepared

16 November 2021

4. Device Identification

Type of 510(k) Submission: Traditional

Device:	Gown, Non-Sterile, Non-Isolation, intended to Provide Moderate orHigh Barrier Protection
Regulation Description	Surgical Apparel
Regulation Number:	21 CFR 878.4040
Product Code:	QPC: Gown, Non-sterile, Non-Isolation, Intended to provideModerate or High Barrier Protection
Class:	Class 2
Panel:	General Hospital

Trade or Proprietary Name: AZAC Protect X Level 3, Single Use, Non-Sterile, Protective Gown

5. Legally Marketed Predicate Device(s)

Device name:	BAM Corporation - Safe Care open Care Protective Gowns andValueCare Open Back Protective Gowns
510(k) number:	K160337
Manufacturer:	BAM Corporation

6. Indication for Use Statement

The AZAC Protect X Level 3, Single Use, Non-Sterile, Protective Gown is intended to protect health care personnel and patients from the transfer of microorganisms, body fluids and

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particulate material. Not intended for use in the operating room

The AZAC Protect X Level 3, Single Use, Non-Sterile, Protective Gown meets the barrier protection requirements of AAMI Level 3 per ANSI/AAMI PB70:2012 - Liquid Barrier Performance and Classification of Protective Apparel and Drapes Intended for Use in Health Care Facilities.

The AZAC Protect X Level 3, Single Use, Non-Sterile, Protective Gown is a single use, disposable medical device and is provided non-sterile.

7. Device Description

8. Comparison of Technological Characteristics with the Predicate Device

The following table compares the AZAC Protect X Level 3, Single Use, Non-Sterile, Protective Gown to the BAM Corporation SafeCare Open Back Protective Gowns (K160337).

Attribute	AZAC Protect X Level 3,Single Use, Non-Sterile,Protective Gown	BAM CorporationSafeCare Open BackProtective Gowns	Comparison
510(k) Number	K211538	K160337	-
Product Code	QPC	QPC	Same
RegulationNumber	878.4040	878.4040	Same
Indications ForUse	The AZAC Protect X Level 3,Single Use, Non-Sterile,Protective Gown is intended toprotect health care personneland patients from the transferof microorganisms, body fluidsand particulate material. Notintended for use in theoperating roomThe AZAC Protect X Level 3,Single Use, Non-Sterile,Protective Gown meets thebarrier protection requirementsof AAMI Level 3 per ANSI/AAMIPB70:2012 — Liquid BarrierPerformance and Classificationof Protective Apparel andDrapes Intended for Use inHealth Care Facilities.The AZAC Protect X Level 3,	These gowns are intended toprotect both health carepatients and health carepersonnel from the transfer ofmicroorganisms, body fluidsand particulate material. Theback of the gown is open andnon-protective. They are notintended for use in theoperating room.	Similar

Table 1 – Comparison AZAC Level 3 Gown vs BAM Corp Gown

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	Single Use, Non-Sterile,Protective Gown is a single use,disposable medical device andis provided non-sterile.
MaterialComposition	Chlorinated polyethyleneelastomer (CPE)	Extruded from plastic film	Similar.
AAMI PB70BarrierProtection Level	Level 3	Level 3	Same
Design Features	Over-the-head slip onIntegrated Belt TiesThumbhook cuffs	Open back, thumb loops,perforated back.	Similar
Sterility	Non-Sterile	Non-Sterile	Same
Use	Single Use, Disposable	Single Use, Disposable	Same
Color	Blue and Yellow	Blue and Yellow	Same
Biocompatibility	Under the conditions of thestudy, non-cytotoxicUnder the conditions of thestudy, not a sensitizerUnder the conditions of thestudy, non-irritating	Under the conditions of thestudy, non-cytotoxicUnder the conditions of thestudy, not a sensitizerUnder the conditions of thestudy, non-irritating	Same

9. Non-Clinical Performance Data

To demonstrate the safety and effectiveness of AZAC Protect X Level 3, Single Use, Non-Sterile, Protective Gown and to show substantial equivalence to the predicate device, AZAC Group completed the following non-clinical tests listed in the following table. Results confirm that the design inputs and performance specifications are met. The AZAC Protect X Level 3, Single Use, Non-Sterile, Protective Gown passed the following tests in accordance with internal requirements and applicable standards as shown below:

Test Method	Purpose	Criteria	Result
AAMI PB70:2012	Overall barrier performance	Meet requirements forclassification as AAMIPB70 Level 3 gown	Pass
Hydrostatic PressureTest (AATCC127:2018)	Resistance to static liquid	NLT 50.0 cm H2O	Pass
Impact Penetration(AATCC 42-2017)	Resistance to liquid stream	No penetration	Pass
ASTM D 3776 -Mass/unit area	Basis weight of material	26 g/m²	Pass
ASTM D5034Breaking Strength -Grab Test	Durability: Grab test	Length – 27 NWidth – 31.5 N	Pass
ASTM D5587Tear Strength -Trapezoid Test	Durability: Trapezoid	Length – 10.5 NWidth 14.0 N	Pass
16 CFR 1610 -Flammability	Flammability	Class 1	Pass

Table 2 – Non-clinical performance testing

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ISO 10993-5Cytotoxicity	Biocompatibility:Cytotoxicity potential	Under the conditions ofthe study, non-cytotoxic	Pass
10993-10Sensitization/Irritation	Biocompatibility:Sensitization and irritation	Under the conditions ofthe study, not a sensitizerUnder the conditions ofthe study, non-irritating	Pass

10. Clinical Performance Data

Clinical performance data was not used in support of this evaluation.

11. Statement of Substantial Equivalence

The conclusions drawn from the non-clinical testing demonstrate that the AZAC Protect X Level 3, Single Use, Non-Sterile, Protective Gown is as safe, as effective, and performs as well as or better than the legally marketed predicate SafeCare Open Back Protective Gowns (K160337)

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.