The Disposable Medical Masks are intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. They are in infection control practices to reduce the potential exposure to blood and body fluids.

Device Description

The Disposable Medical Masks are single use, three-layer, flat-folded masks with ear loops and nose clamp. The Disposable Medical Masks are manufactured with three layers, the inner and outer layers are made of non-woven fabric, and the middle layer is made of melt blown Fabric. The ear loops are held in place over the users' mouth and nose by two ear loops welded to the face mask. The ear loops are made of Polyamide & Spandex. The nose clamp in the layers of face mask is to allow the user to fit the face mask around their nose, which is made of galvanized iron wire wrapped with PE material. The Disposable Medical Masks will be provided in white, blue, and purple which are sold non- sterile and are intended to be single use, disposable devices.

AI/ML Overview

This document describes the acceptance criteria and the results of a study demonstrating that the "Disposable Medical Masks" device, manufactured by Hantech Medical Device Co., Ltd., meets these criteria.

1. Table of Acceptance Criteria and Reported Device Performance

Test Methodology	Purpose	Acceptance Criteria: ASTM F2100 Level 3	Result
Fluid Resistance, Synthetic Blood Penetration ASTM F1862	Evaluate Resistance to penetration by synthetic blood (Minimum pressure in mmHg)	≥ 29 samples out of 32 pass (AQL 4%) at 160 mmHg for level 3	PASS (32 out of 32 passes at 160 mmHg for level 3)
Particulate Filtration Efficiency ASTM F2299	Evaluate Sub-micron particulate filtration efficiency at 0.1 micron (%) (PFE)	≥ 98% (29 out of 32 pass)	PASS
Bacterial Filtration Efficiency ASTM F2101	Evaluate Bacterial filtration efficiency (BFE) (%)	≥ 98% (29 out of 32 pass)	PASS
Differential Pressure (Delta P) EN 14683 Annex C	Evaluate Differential pressure (Delta-P)	< 6.0 mmH2O/cm² (29 out of 32 pass)	PASS
Flammability, 16 CFR 1610	Evaluate Flame spread	Class 1	PASS
Cytotoxicity, ISO 10993-5	Demonstrate biocompatibility safety of the subject device	Non-cytotoxic	PASS
Irritation, ISO 10993-10	Demonstrate biocompatibility safety of the subject device	Non-irritating	PASS
Sensitization, ISO 10993-10	Demonstrate biocompatibility safety of the subject device	Non-sensitizing	PASS

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

Sample Size: 3 nonconsecutive lots were used for testing, with 32 samples for each model of surgical mask for the non-clinical tests.
Data Provenance: The document does not explicitly state the country of origin or whether the data was retrospective or prospective. However, Hantech Medical Device Co., Ltd. is based in the PEOPLE'S REPUBLIC OF CHINA. It can be inferred that the testing was conducted for the purpose of this premarket notification, making it prospective in nature relative to the submission.

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

This document describes performance testing for medical masks against established standards. The nature of these tests (e.g., fluid resistance, filtration efficiency, flammability) does not typically involve human expert consensus for "ground truth" establishment in the same way an AI diagnostic algorithm would. The results are obtained through objective physical and biological tests conducted in laboratories. Therefore, information about "experts used to establish ground truth" with specific qualifications is not applicable in this context. The "ground truth" is defined by the technical specifications and criteria within the referenced standards (e.g., ASTM F2100, ISO 10993).

4. Adjudication Method for the Test Set

Given that the tests involve objective measurements against predefined criteria and standards, an adjudication method like "2+1" or "3+1" (typically used for resolving discrepancies in expert interpretations) is not applicable. The results are quantitative and pass/fail based on the physical properties of the masks.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done. This type of study is typically performed for diagnostic devices where human readers interpret medical images or data, and their performance with and without AI assistance is evaluated. This submission is for medical masks, which do not involve human diagnostic interpretation.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

No standalone (algorithm-only) performance study was done. The device is a physical medical mask, not an algorithm or AI software.

7. The Type of Ground Truth Used

The "ground truth" for the performance of these medical masks is defined by established international and national standards and their specific criteria. These include:

ASTM F2100 (Standard Specification for Performance of Materials Used in Medical Face Masks)
ASTM F1862 (Standard Test Method for Resistance of Medical Face Masks to Penetration by Synthetic Blood)
EN 14683 (Medical Face Masks - Requirements and Test Methods)
ASTM F2101 (Standard Test Method for Evaluating the Bacterial Filtration Efficiency)
ASTM F2299 (Standard test method for determining the initial efficiency of materials used in medical face masks to penetration by particulates)
16 CFR 1610 (Standard for the Flammability of clothing textiles)
ISO 10993-5 (Biological Evaluation of Medical Devices - Tests For In Vitro Cytotoxicity)
ISO 10993-10 (Biological Evaluation of Medical Devices - Tests for Irritation and Skin Sensitization)

8. The Sample Size for the Training Set

This submission pertains to a physical medical device (disposable medical masks). There is no "training set" in the context of machine learning or AI algorithms for this type of device. The production of such devices involves manufacturing processes that are validated, but not "trained" in the computational sense.

9. How the Ground Truth for the Training Set Was Established

As there is no training set for a physical medical device in the context of an AI/ML algorithm, this question is not applicable. The "ground truth" for manufacturing quality relies on process validation and quality control measures against established product specifications.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. Underneath the square are the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

September 1, 2022

Hantech Medical Device Co., Ltd. % Dave Yungvirt CEO Third Party Review Group, LLC 25 Independence Blvd Warren, New Jersey 07059

Re: K221038

Trade/Device Name: Disposable Medical Masks Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: August 25, 2022 Received: August 29, 2022

Dear Mr. Yungvirt:

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,

Brent Showalter, Ph.D. Assistant Director DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K221038

Device Name Disposable Medical Masks

Indications for Use (Describe)

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

| Prescription Use (Part 21 CFR 801 Subpart D)

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

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510(k) SUMMARY

I. SUBMITTER

Hantech Medical Device Co., Ltd. No 288, Sanheng Road Changhe Industridal Park, Cixi City, Ningbo City, Zhejiang Province, 315326, PEOPLE'S REPUBLIC OF CHINA Name: Arnold YANG Title: Regulatory Affairs Phone: +86 18917368988 Fax: +86 574 5899 5557 E-mail: arnoldyang@hantechmedical.com

II. Correspondent Contact Information

Bruce Cai (Contact Person) Humiss Inc. Tel: +86-13585598660 E-mail: cc401vip@126.com Summary Preparation Date: 2021.12.6

III. DEVICE

Name of Device	Disposable Medical Masks
Models	Neo101, Neo102
Common Name	SURGICAL MASK
Classification Name	Mask, Surgical
Classification	Class II
Regulation Number	21 CFR 878.4040
Regulation Number	FXX
Review Panel:	General Hospital

IV. PREDICATE DEVICE

Predicate Device 510k number: K211899 Predicate Device Manufacturer: Hubei YI-YA PROTECTIVE PRODUCTS CO., LTD

V. Device Description

V1. Indications for use of the device:

The Disposable Medical Masks are intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. They are intended for use in infection control practices to reduce the potential exposure to blood and body fluids.

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V2. Device Description:

Models	Subject Device	Predicate DeviceK211899	Comparison
Product name	Disposable MedicalMasks, Neo101,Neo102	SURGICAL FACEMASK, Ear loops	Similar
Product code	FXX	FXX	Same
Regulationnumber	21 CFR 878.4040	21 CFR 878.4040	Same
Class	II	II	Same
Indications foruse	The Disposable MedicalMasks are intended tobe worn to protect boththe patient andhealthcare personnelfrom transfer ofmicroorganisms, bodyfluids and particulatematerial. They areintended for use ininfection controlpractices to reduce thepotential exposure toblood and body fluids.	The Surgical Face Masksare intended to be worn toprotect both the patientand healthcare personnelfrom transfer ofmicroorganisms, bodyfluids and particulatematerial. They areintended for use ininfection control practicesto reduce the potentialexposure to blood andbody fluids. This is asingle use, disposabledevice(s), provided non-sterile.	Same
Design Features	Ear Loops, Flat-pleated,3 layers	Ear Loops, Flat-pleated, 3layers	Same
Materials
Outer layer	Non-woven fabric(polypropylene)	Spunbond Polypropylene	Differencesresolved bybiocompatibility

Inner layer	White non-woven fabric(polyethylene,polyester)	Spunbond Polypropylene	Differences resolved by biocompatibility testing
Filter layer	Melt-blown Polypropylene	Melt-blown Polypropylene	Same
Nose clip (Nose clamp)	Galvanized iron wire wrapped with PE material	iron bar coated with polyolefin	Differences resolved by biocompatibility testing
Ear loops	Polyamide & Spandex	Spandex	Differences resolved by biocompatibility testing
Other Design Features
Color	White, Blue, Purple	White	Differences resolved by biocompatibility testing
Dimension (Length* Width)	17.5 x 9.5cm	(16.0cm±0.5cm) x(11.0cm±0.5cm)	Differences resolved by performance testing
OTC use	Yes	Yes	Same
Sterility	Non-Sterile	Non-Sterile	Same
Single Use	Yes	Yes	Same
Sterile	No	No	Same
ASTM F2100 Level	Level 3	Level 2	Subject device demonstrates ed higher resistance to fluid penetration
Biocompatibility	Comply with ISO 10993-5, ISO 10993-10	Comply with ISO 10993-5, ISO 10993-10	Same

VI. Predicate Comparison

Table 6 1 Surgical Eac Mock Dradionto C

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VII. Summary of Non-Clinical Test

Non-clinical tests were conducted using 3 nonconsecutive lots with 32 samples for each model of surgical mask to verify that the proposed device met all design specifications as was same to the predicate device.

The test results demonstrated that the proposed device complies with the following standards and the requirements stated in the Guidance for Industry and FDA Staff: Surgical Masks -Premarket Notification [510(k)] Submissions (Document issued on: March 5, 2004 and a

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correction posted on July 14, 2004)

ISO 10993-5: 2009 Biological Evaluation of Medical Devices -- Part 5: Tests For In Vitro Cytotoxicity
. ISO 10993-10: 2010 Biological Evaluation of Medical Devices - Part 10: Tests for Irritation and Skin Sensitization
. ASTM F2100, Standard Specification for Performance of Materials Used in Medical Face Masks
. ASTM F1862, Standard Test Method for Resistance of Medical Face Masks to Penetration by Synthetic Blood (Horizontal Projection of Fixed Volume at A Known Velocity);
EN 14683, Medical Face Masks - Requirements and Test Methods;
. ASTM F2101, Standard Test Method for Evaluating the Bacterial Filtration Efficiency (BFE) Of Medical Face Mask Materials, Using A Biological Aerosol of Staphylococcus Aureus:
. ASTM F2299, Standard test method for determining the initial efficiency of materials used in medical face masks to penetration by particulates using latex spheres;
16 CFR 1610, Standard for the Flammability of clothing textiles;

Test Methodology	Purpose	Acceptance Criteria:ASTM F2100 Level 3	Result
Fluid Resistance,Synthetic BloodPenetration ASTMF1862	The purpose of the test is to evaluate the Resistance to penetration by synthetic blood, Minimum pressure in mmHg	≥29 samples out of 32 pass (AQL 4%) at 160 mmHg for level 3	PASS32 out of 32passes at160 mmHgfor level 3
Particulate FiltrationEfficiency ASTMF2299	The purpose of the test is to evaluate the Sub-micron particulate filtration efficiency at 0.1 micron, % (PFE)	≥ 98%29 out of 32 pass	PASS
Bacterial FiltrationEfficiency ASTMF2101	The purpose of the test is to evaluate the Bacterial filtration efficiency (BFE) (%)	≥ 98%29 out of 32 pass	PASS
Differential Pressure(Delta P) EN 14683Annex C	The purpose of the test is to evaluate the Different pressure (Delta-P)	< 6.0mmH2O/cm²29 out of 32 pass	PASS
Flammability, 16CFR 1610	The purpose of the test is to evaluate the Flame spread	Class 1	PASS
Cytotoxicity, ISO10993-5	The purpose of the testing is to demonstrate the biocompatibility safety of	Non-cytotoxic	PASS

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	the subject device.
Irritation, ISO10993-10	The purpose of the testingis to demonstrate thebiocompatibility safety ofthe subject device.	Non-irritating	PASS
Sensitization, ISO10993-10	The purpose of the testingis to demonstrate thebiocompatibility safety ofthe subject device.	Non-sensitizing	PASS

VIII. Summary of Clinical Test Conclusion

No clinical study is included in this submission.

IX Conclusion

The differences between the predicate and the subject device do not raise any new or different questions of safety or effectiveness. The subject devices are substantially equivalent to the predicate devices with respect to the indications for use, target populations, treatment method, and technological characteristics.

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.