The Disposable Medical Surgical Masks is intended to be worn to protect both the patient and healthcare personnel from the transfer of microorganisms, body fluids, and particulate material. The Single-Use Surgical Mask with Ear Loop intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This is a single-use, disposable device(s), provided non-sterile.

Device Description

The Disposable Medical Surgical Masks is intended to be worn to protect both the patient and healthcare personnel from the transfer of microorganisms, body fluids, and particulate material. The Disposable Medical Surgical Masks intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This is a single-use, disposable device(s), provided non-sterile.

The proposed device(s) are Blue color, and Flat Pleated type mask, utilizing Ear Loops' way for wearing, and they all have Nose Piece design for fitting the facemask around the nose.

The proposed device(s) are manufactured with three layers, the inner and outer layers are made of spun-bond non-woven, and the middle layer is made of Melt-blown non-woven fabric.

The Disposable Medical Surgical Masks is held in place over the user's mouth and nose by two elastic ear loops welded to the facemask. The elastic ear loops are not made with Polyurethane fiber and Nylon.

The nose piece contained in the proposed device(s) is in the layers of the facemask to allow the user to fit the facemask around their nose, which is made of PE and iron wire.

The proposed device(s) are sold non-sterile and are intended to be single-use, disposable devices.

The proposed device(s) are meet the Level 3 Barrier requirements per ASTM F2100-19.

AI/ML Overview

This document is a 510(k) Premarket Notification for a medical device (Disposable Medical Surgical Masks). It is a regulatory submission to the FDA demonstrating that a new device is substantially equivalent to a legally marketed predicate device. As such, it focuses on comparing the new device to the predicate device based on non-clinical performance and specifications.

Therefore, many of the typical acceptance criteria and study details relevant to AI/ML-based medical devices (like MRMC studies, expert adjudication, separate training/test sets for AI, human-in-the-loop performance, etc.) are not applicable to this document, as it describes a physical medical device (surgical masks) and its performance based on standardized material testing.

Here's an analysis based on the provided document:

Acceptance Criteria and Reported Device Performance

The acceptance criteria for this device are based on meeting established industry standards for surgical masks, primarily ASTM F2100-19 for medical face mask materials, and other related standards (ISO 10993 for biocompatibility, ASTM F1862 for fluid resistance, etc.). The reported device performance is presented in comparison to these standards and a predicate device.

Table of Acceptance Criteria and Reported Device Performance (Summary from Section 6 and 7):

Test Item / Performance Characteristic	Acceptance Criteria (from ASTM F2100 Level 3 Requirements or relevant standard)	Proposed Device Reported Performance	Status (Meets/Exceeds/N/A)
Fluid Resistance Performance (ASTM F1862)	160 mmHg	160 mmHg	Meets
Particulate Filtration Efficiency (ASTM F2299)	≥ 98%	98.02 - 98.80%	Meets/Exceeds
Bacterial Filtration Efficiency (BFE) (ASTM F2101)	≥ 98%	99.6 - 99.7%	Meets/Exceeds
Differential Pressure (MIL-M-36945C)	< 6.0 mmH2O/cm²	3.20 - 4.18 mmH2O/cm²	Meets/Exceeds
Flammability (16 CFR 1610)	Class 1	Class 1	Meets
Biocompatibility - Cytotoxicity (ISO 10993-5)	Not cytotoxic effect	Not cytotoxicity effect	Meets
Biocompatibility - Irritation (ISO 10993-10)	Not an irritant	Not an irritant	Meets
Biocompatibility - Sensitization (ISO 10993-10)	Not a sensitizer	Not a sensitizer	Meets
Dimensions (Bench Testing)	Meets design specification	Meets design specification	Meets

Study Details (for a physical product, not an AI/ML algorithm)

It's important to reiterate that this is a submission for a physical medical device (surgical mask), not an AI/ML algorithm. Therefore, many standard AI/ML study components do not apply.

Sample size used for the test set and the data provenance:
- Test Set: No explicit "test set" in the AI/ML sense is mentioned. Instead, samples of the manufactured masks were subjected to various standardized non-clinical tests. The document does not specify the number of masks or samples tested for each criterion (e.g., how many masks were tested for BFE, how many for fluid resistance).
- Data Provenance: The tests were conducted by the manufacturer/sponsor (Tianjin Teda Jinshan Easy Packing Manufacture Co., Ltd., China) as part of their verification process for the 510(k) submission. This would be considered "prospective" in the sense that the tests were performed specifically for this submission, on samples of the device.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. Ground truth in the context of a physical device like a surgical mask is established by validated laboratory testing methods and compliance with published standards (e.g., ASTM, ISO). There are no human "experts" establishing a subjective "ground truth" for each mask. The "ground truth" is the quantitative result from the standardized test.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- None. Adjudication methods are relevant for subjective interpretations, typically in image analysis or clinical assessments. For standardized physical material testing, the results are quantitative and objective measurements from the validated test methods.
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 physical device, not an AI-assisted diagnostic tool.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This is a physical device, not an AI algorithm. Its performance is inherent to its materials and construction.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Objective Laboratory Test Results against Established Standards: The "ground truth" for the performance of the Disposable Medical Surgical Masks is the objective measurement obtained through specific, validated laboratory test methods (e.g., ASTM F2101 for BFE, ASTM F1862 for fluid resistance) and comparison against the specified acceptance criteria within those standards (e.g., ASTM F2100 Level 3 requirements).
The sample size for the training set:
- Not Applicable. This is a manufactured physical device, not an AI/ML model that requires a training set. The manufacturing process is analogous to a "training" phase where the design and materials are refined to meet specifications.
How the ground truth for the training set was established:
- Not Applicable. As above, no training set for an AI algorithm. The manufacturing process of a physical device involves quality control and adherence to specifications to ensure the final product meets its intended performance, which is then verified through non-clinical testing.

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 and Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

February 2, 2021

Tianjin Teda Jinshan Easy Packing Manufacture Co., LTD % Ray Wang General Manager Beijing Believe-Med Technology Service Co., Ltd Rm.912, Building #15, XiYueHui, No.5, YiHe North Rd., FangShan District Beijing, Beijing 102401 China

Re: K202323

Trade/Device Name: Disposable Medical Surgical Masks Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: August 12, 2020 Received: August 17, 2020

Dear Ray Wang:

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 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,

For CAPT Elizabeth Claverie, M.S. 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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known)

K202323

Device Name Disposable Medical Surgical Masks

Indications for Use (Describe)

The Disposable Medical Surgical Masks is intended to be worn to protect and healthcare personnel from the transfer of microorganisms, body fluids, and particulate material. The Single-Use Surgical Mask with Ear Loop intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This is a singleuse, disposable device(s), provided non-sterile.

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

This 510(k) Summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of SMDA 1990 and Title 21, CFR Section 807.92.

The assigned 510(k) Number: K202323

1. Date of Preparation:2021/02/02
1. Sponsor Identification

Tianjin Teda Jinshan Easy Packing Manufacture Co., Ltd. No.3 Wuhai Road, Jinhai Economic Development Area, Tianjin, China 301600

Contact Person: Hui Liu Position: International Trading Manager Tel: +86-22-68228888 Fax: +86-22-68225555 Email: jinshan@tedajinshan-bag.com

1. Designated Submission Correspondent
  Mr. Ray Wang

Beijing Believe-Med Technology Service Co., Ltd.

Rm.912, Building #15, XiYueHui, No.5, YiHe North Rd., FangShan District, Beijing, 102401, China

Tel: +86-18910677558 Fax: +86-10-56335780 Email: Ray.Wang@believe-med.com

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4. Identification of Proposed Device

Trade Name: Disposable Medical Surgical Masks Common Name: Surgical Face Mask

Regulatory Information Classification Name: Surgical Face Mask Classification: II Product Code: FXX Regulation Number: 878.4040 Review Panel: Surgical Apparel

Indication for use Statement:

Device Description

The Disposable Medical Surgical Masks is intended to be worn to protect both the patient and healthcare personnel from the transfer of microorganisms, body fluids, and particulate material. The Disposable Medical Surgical Masks intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This is a single-use, disposable device(s), provided non-sterile.

The proposed device(s) are Blue color, and Flat Pleated type mask, utilizing Ear Loops' way for wearing, and they all have Nose Piece design for fitting the facemask around the nose.

The proposed device(s) are manufactured with three layers, the inner and outer layers are made of spun-bond non-woven, and the middle layer is made of Melt-blown non-woven fabric.

The nose piece contained in the proposed device(s) is in the layers of the facemask to allow the user to fit the facemask around their nose, which is made of PE and iron wire.

The proposed device(s) are sold non-sterile and are intended to be single-use, disposable devices.

The proposed device(s) are meet the Level 3 Barrier requirements per ASTM F2100-19.

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న్. Identification of Predicate Device(s)
Predicate Device K153496 Disposable Surgical Face Mask Xiantao Rayxin Medical Products Co., ltd.
1. Non-Clinical Test Conclusion
  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:
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 F2100-19, Standard Specification For Performance Of Materials Used In Medical Face Masks.
ASTM F1862-17, Standard Test Method For Resistance Of Medical Face Masks To Penetration By Synthetic Blood (Horizontal Projection Of Fixed Volume At A Known Velocity)
MIL-M-36945C, Method 1 Military Specifications: Surgical Mask disposable;
ASTM F2101-19, Standard Test Method For Evaluating The Bacterial Filtration Efficiency A (Bfe) Of Medical Face Mask Materials, Using A Biological Aerosol Of Staphylococcus Aureus;
ASTM F2299-03, Stand test method for determining the initial efficiency of materials used in medical face masks to penetration by particulates using latex spheres;
A 16 CFR 1610, Standard for the Flammability of clothing textiles;
A Bench Testing for the performance of Dimensions.
1. Clinical Test Conclusion

No clinical study is included in this submission.

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Summary of the Technological Characteristics of the Device 8.

ITEM	Proposed Device K202323	Predicate Device K153496	Remark
Intended Use	The Disposable Medical Surgical Masks isintended to be worn to protect both thepatient and healthcare personnel from thetransfer of microorganisms, body fluids,and particulate material. The Single-UseSurgical Mask with Ear Loop intended foruse in infection control practices to reducethe potential exposure to blood and bodyfluids. This is a single-use, disposabledevice(s), provided non-sterile.	The Disposable Surgical Face Masks areintended to be worn to protect both thepatient and healthcare personnel fromtransfer of microorganisms, body fluidsand particulate material. These face masksare intended for use in infection controlpractices to reduce the potential exposureto blood and body fluids. This is a singleuse, disposable device(s), providednon-sterile.	SAME
Basic Design	Ear Loops, Flat Pleated, 3 layers	Ear Loops, Tie-On, Flat Pleated, 3 layers	SAME
Materials	Outer Facing Layer	Spun-bond non-woven fabric	Spun-bond polypropylene	Analysis
	Middle Layer	Melt blown non-woven fabric	Melt blown polypropylene filter
	Inner Facing Layer	Spun-bond non-woven fabric	Spun-bond polypropylene
	Nose Piece	PE + iron wire	Malleable aluminum wire
	Ear Loops	Polyurethane fibre + Nylon	Polyester
Color	Blue	Blue	SAME
Dimension (Length)	$17.5 cm +/- 5%$	$17.5 cm +/- 1cm$	Similar
Dimension (Width)	$10 cm +/- 5%$	$9.5 cm +/- 1cm$
OTC use	Yes	Yes	SAME
Single Use	Yes	Yes	SAME
Sterile	No	No	SAME
ASTM F2100 Level	Level 3	Level 2	Analysis

Table 1 General Comparison

Table 2 Performance Characteristic Comparison

ITEM	ProposedK202323	PredicateK153496	ASTM F2100Requirements forLevel 3 Classification	Remark
Fluid ResistancePerformance ASTMF1862	160 mmHg	120 mmHg	160 mmHg	Analysis
Particulate FiltrationEfficiency ASTMF2299	98.02 - 98.80%	98.46%	≥ 98%
Bacterial FiltrationEfficiency ASTMF2101	99.6 - 99.7%	98.7%	≥ 98%
Differential Pressure	3.20 - 4.18 mmH2O/cm2	4.2 mmH2O/cm2	< 6.0 mmH2O/cm2

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(Delta P)
MIL-M-36954C
Flammability16 CFR 1610	Class 1	Class 1	Class 1	SAME

Table 3 Biocompatibility Comparison

ITEM	Proposed Device K202323	Predicate Device K153496	Remark
Cytotoxicity	Under the conditions of the study, notcytotoxicity effect	Comply with ISO 10993-5	SAME
Irritation	Under the conditions of the study, not anirritant	Comply with ISO 10993-10	SAME
Sensitization	Under conditions of the study, not asensitizer.		SAME

Analysis:

The proposed device has different materials with the predicate device, the different material a. may cause biocompatibility risk, so the proposed device has conducted the biocompatibility testing as ISO 10993-5 and ISO 10993-10 for cytotoxicity, irritation and sensitization, the test results shown that the materials used in the proposed device could not raise biocompatibility risk. This difference between the proposed and predicate device will not affect the effectiveness and safety of the proposed device.
The proposed device has different barrier level as ASTM F2100 with the predicate device, b. Level 3 vs. Level 2, so the proposed device has conducted the performance testing as ASTM F2100, the test results shown that the proposed device meet the requirements of Level 3. This difference between the proposed and predicate device will not affectiveness and safety of the proposed device.
The proposed device has different Dimension with the predicate device, Level 3 vs. Level 2, so C. the proposed device has conducted the dimension testing, the test results shown that the proposed device meet the design specification. This difference between the proposed and predicate device will not affect the effectiveness and safety of the proposed device.
The proposed device has different Performance Characteristic as ASTM F2100 with the d. predicate device, so the proposed device has conducted the performance testing as ASTM F2100, the test results shown that the proposed device meet the requirements of ASTM F2100. This difference between the proposed and predicate device will not affect the effectiveness and safety of the proposed device.
1. Conclusion

Based on the nonclinical tests performed, the subject device is as safe, as effective, and performs as well as the legally marketed predicate device, Disposable Surgical Face Mask cleared under K153496.

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.