The Face Masks are intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. These face masks are intended for use in infection control practices to reduce the potential exposure to blood and body fluids. The Face Masks are single use, disposable devices, provided non-sterile.

Device Description

Face Mask is composed of three layers and is flat-pleated. The mask materials consist of an outer layer (spun-bond polypropylene), a middle layer, between the outer layer and inner layers (melt-blown polypropylene), and an inner layer (spun-bond polypropylene). Each mask contains ear loops to secure the mask over the users' mouth and face and includes a malleable nose piece (Iron wire covered by polypropylene) to provide a firm fit over the nose.

There are two models for Face Mask with different colors and sizes.

For Type A model is in blue, barrier level 2 and size 145mm95mm, ear loop type. For Type B model is in blue, barrier level 2 and size 175mm95mm, ear loop type.

AI/ML Overview

The provided text describes the acceptance criteria and performance data for a medical device (Face Mask) in the context of an FDA 510(k) premarket notification. It focuses on demonstrating substantial equivalence to a predicate device, primarily through non-clinical performance testing.

Here's a breakdown of the requested information based on the provided document:

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

Test	Acceptance Criteria (Predicate/Reference Device Performance)	Reported Device Performance (Subject Device)	Remark
Fluid Resistance (ASTM F1862)	32 out of 32 pass at 120mmHg	32 out of 32 pass at 120mmHg	Same
Particulate Filtration Efficiency (PFE) (ASTM F2299)	Pass at 99.88% (Predicate), >99.8% (Reference)	Pass at 99.70%	Same (Meets general acceptance for high filtration)
Bacterial Filtration Efficiency (BFE) (ASTM F2101)	Pass at 99.6% (Predicate), $\ge$ 99.8% (Reference)	Pass at 99.95%	Same (Meets general acceptance for high filtration)
Differential Pressure (Delta P) (MIL-M-36954C)	Pass at 3.0 mmH$_2$O/cm$^2$ (Predicate), < 4.2mmH$_2$O/cm$^2$ (Reference)	Pass at 3.0 mmH$_2$O/cm$^2$	Same
Flammability (16 CFR PART 1610)	Class 1 Non-Flammable	Class 1 Non-Flammable	Same
Biocompatibility - Cytotoxicity	Non-cytotoxic	Non-cytotoxic	Same
Biocompatibility - Irritation	Non-irritating	Non-irritating	Same
Biocompatibility - Sensitization	Non-sensitizing	Non-sensitizing	Same

Note on Acceptance Criteria: For this 510(k) submission, the "acceptance criteria" are implicitly defined by the performance of the legally marketed predicate and reference devices, as well as by established ASTM and other relevant standards mentioned. The goal is to show that the subject device performs as well as or better than these.

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

Sample Size: The document does not explicitly state the total sample size for each test. For Fluid Resistance (ASTM F1862), it states "32 out of 32 pass," indicating a sample size of 32 for that specific test. For other tests (PFE, BFE, Differential Pressure, Flammability, Biocompatibility), the document states "Pass" or similar, without specifying the exact number of samples tested for each.
Data Provenance: Not explicitly stated, but given the submission is from Jinhua Jingdi Medical Supplies Co., Ltd. in China, and the submission correspondent is in Shanghai, China, it's highly likely the testing was conducted in China. The document does not specify whether the tests were retrospective or prospective, but performance tests for regulatory submissions are typically conducted prospectively.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

This section is not applicable to this document. The "ground truth" for the performance of a surgical face mask is established through objective, standardized laboratory tests (e.g., measuring filtration efficiency, fluid resistance) against predefined metrics, not through expert consensus or interpretation of complex medical imagery. Therefore, there's no mention of experts establishing ground truth in the way one would for an AI diagnostic device.

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

Not applicable. As noted in point 3, the evaluation of face masks relies on objective physical and biological performance tests, not human interpretation that would require adjudication.

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 device is a face mask, not an AI diagnostic tool. Therefore, MRMC studies and AI assistance are not relevant.

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

Not applicable. This device is a physical medical product, not an algorithm.

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

The "ground truth" for this device is the objective measurement of its physical and biological performance characteristics, defined by recognized standards (e.g., ASTM F2100, ASTM F1862, ASTM F2299, ASTM F2101, MIL-M-36954C, 16 CFR PART 1610, ISO 10993 series). This includes:

Fluid resistance (measured in mmHg)
Particulate filtration efficiency (measured as a percentage)
Bacterial filtration efficiency (measured as a percentage)
Differential pressure (measured in mmH$_2$O/cm$^2$)
Flammability classification
Biocompatibility (cytotoxicity, irritation, sensitization, assessed as non-cytotoxic/non-irritating/non-sensitizing)

8. The sample size for the training set

Not applicable. This is a physical medical device, not an AI/machine learning model, so there is no concept of a "training set."

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

Not applicable. See point 8.

Summary

{0}------------------------------------------------

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. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

April 23, 2021

Jinhua Jingdi Medical Supplies Co., Ltd % Julie Chen RA Manager Shanghai Mind-link Business Consulting Co., Ltd. Room A08, Floor 14th, No 699, Jiaozhou Road, Jingan District Shangha, 200040 China

Re: K210007

Trade/Device Name: Face Mask Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: March 4, 2021 Received: March 8, 2021

Dear Julie Chen:

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

{1}------------------------------------------------

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,

Ryan Ortega, PhD Acting 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

{2}------------------------------------------------

Indications for Use

510(k) Number (if known) K210007

Device Name Face Mask

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

PSC Publishing Services (301) 443-6740 EF

{3}------------------------------------------------

510(K) Summary - K210007

I. SUBMITTER:

Jinhua Jingdi Medical Supplies Co.,Ltd Building 2, Ditian Function, Xiaoshun Town, JindongZone, Jinhua City, Zhejiang, China Contact Person: Hu Xiaojiang Title: Quality Manager Tel: +86 13989428215 Email: xiaojianghu@jhjingdi.com

Submission Correspondent: Julie Chen Email: julie.chen(@mind-link.net Tel:+86 13918045781

Summary prepared: 12/04/2020

II. DEVICE

Name of Device: Face Mask Regulation Number: 21 CFR PART 878.4040 Common Name: Surgical Mask Classification Name: Surgical Mask Regulatory Class: II Product Code: FXX

III. PREDICATE DEVICE

Primary predicate device: Surgical Face Masks (K182514)

IV. REFERENCE DEVICE

Reference device: Disposable Surgical Face Mask (K202491, Model: EL-M02 and EL-L02 Level 2)

{4}------------------------------------------------

V. DEVICE DESCRIPTION

There are two models for Face Mask with different colors and sizes.

For Type A model is in blue, barrier level 2 and size 145mm95mm, ear loop type. For Type B model is in blue, barrier level 2 and size 175mm95mm, ear loop type.

VI. INDICATIONS FOR USE

COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH VII. THE PREDICATE DEVICE

The Face Masks are compared with the predicate device (Surgical Face Masks (K182514)). The results are shown below in the Technological Characteristics Comparison Table:

DEVICE	Subject Device FaceMask	Primary Predicate DeviceSurgical Face Mask(K182514)	Reference DeviceDisposable Surgical FaceMask(K202491, Level 2)	Remark
Intended Use	The Face Masks areintended to be worn toprotect both the patientand healthcare personnelfrom transfer ofmicroorganisms, bodyfluids and particulatematerial. These face masksare intended for use ininfection control practices	The surgical face masksare intended to be wornto protect both thepatient and healthcarepersonnel from transferof microorganisms,body fluids, andparticulate material.These face masks areintended for use in	The Disposable SurgicalFace Mask are intended tobe worn to protect both thepatient and healthcarepersonnel from transferof microorganisms, bodyfluids, and particulatematerial. These face masksare intended for use ininfection control practices	Same
	to reduce the potentialexposure to blood andbody fluids. The FaceMasks are single use,disposable device,provided non-sterile.	infection control practicesto reduce the potentialexposure to blood andbody fluids. This is asingle-use, disposabledevice, provided non-sterile.	to reduce the potentialexposure to blood andbody fluids. The DisposableSurgical Face Masks aresingle use, disposabledevices, provided non-sterile.
Classification	FXX	FXX	FXX	Same
Product Code
Ear LoopModel	Ear Loops	Ear Loops	Ear Loops	Same
		Materials
Outer FacingLayer	Spun-bond polypropylenenon-woven fabric	Spun-bond polypropylene	Spun-bond Polypropylenenon-woven fabric	SimilarNote 1
Middle Layer	Melt-blownpolypropylene	Melt blown polypropylenefilter	Melt blown polypropylene	SimilarNote 1
Inner FacingLayer	Spun-bond polypropylenenon-woven fabric	Spun-bond polypropylene	Spun-bond polypropylenenon-woven fabric	SimilarNote 1
Nose Piece	Iron wirecoveredpolypropylene	Malleable aluminum wire	Malleable iron wire withplastic covering	SimilarNote 1
Ear Loops	75%Polyamie25% Spandex	Polyester	Spandex Elastic cord	SimilarNote 1
		Design Features
Color	Blue	White	Blue	DifferentNote 1
Style	Flat - Pleated	Flat - Pleated	Flat - Pleated	Same
MultipleLayers	3 Layers	3 Layers	3 Layers	Same
Single Use	Single use	Single use	Single use	Same
		Sterility
Sterile	Non-sterile	Non-sterile	Non-sterile	Same
		Dimensions
Length ×Width	145×95mm(±5mm)175×95mm (±5mm)	175×95mm(±10mm)	145×95mm (±5mm)175×95mm (±5mm)	DifferentNote 2
Technological Characteristics Product Barrier Specifications Per ASTM F2100 - Meets Level 2
FluidResistanceASTM F1862	32 out of 32 pass at120mmHg	32 out of 32 pass at120mmHg	Pass at 120mmHg	Same
ParticulateFiltrationEfficiency(PFE)	Pass at 99.70%	Pass at 99.88%	Pass at >99.8%	Same
ASTM F2299
BacterialFiltrationEfficiency(BFE)ASTM F2101	Pass at 99.95%	Pass at 99.6%	Pass at $\ge$ 99.8%	Same
DifferentialPressure(Delta P)MIL-M-36954C	Pass at $3.0 mmH_2O/cm^2$	Pass at $3.0 mmH_2O/cm^2$	Pass at $<4.2mmH_2O/cm^2$	Same
Flammability16 CFR PART1610	Class 1 Non-Flammable	Class 1 Non-Flammable	Class 1 Non-Flammable	Same
Biocompatibility
Cytotoxicity	Under the conditions of thestudy, the subject deviceextract was determined tobe non-cytotoxic.	Under the conditions of thestudy, the subject deviceextract was determined to benon-cytotoxic.	Under the conditions of thestudy, the subject deviceextract was determined to benon-cytotoxic.	Same
Irritation	Under the conditions of thestudy, the subject devicenon-polar and polar extractswere determined to be non-irritating.	Under the conditions of thestudy, the subject device non-polar and polar extracts weredetermined to be non-irritating.	Under the conditions of thestudy, the subject device non-polar and polarextracts were determinedto be non-irritating.	Same
Sensitization	Under the conditions of thestudy, the subject devicenon-polar and polar extractswere determined to be non-sensitizing	Under the conditions of thestudy, the subject device non-polar and polar extracts weredetermined to be non-sensitizing.	Under the conditions of thestudy, the subject device non-polar and polarextracts were determinedto be non-sensitizing.	Same

{5}------------------------------------------------

{6}------------------------------------------------

Comparison in Detail(s): Note 1:

Although the material including outer facing layer, inner facing layer, nose piece and ear loops, as well as the color of the subject device and the color is different from the predicate device, it meets the requirement of essential performance standard ISO 10993. The differences between the predicate device and subject device will not affect the safety and effectiveness of the subject device.

Note2:

Although Type A of the subject device is smaller than the predicate device, Type A match the dimension with reference device (Model: EL-M02, Level 2), the barrier protection performance of the subject device is same with the barrier protection performance of predicate device and the reference device, which is the Level 2 barrier protection. Therefore, the dimensional differences between the predicate device and the subject device will not affect the safety and effectiveness of

{7}------------------------------------------------

the subject device.

VIII. PERFORMANCE DATA

Non-Clinical Performance Test Conclusion

Non-clinical tests were conducted to verify that the proposed device met all design specifications was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the Face Masks complies with the following standards:

ASTM F2100-19 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 14683:2019+AC2019(E) Annex C .
ASTM F2299 Standard Test Method for Determining the Initial Efficiency of . Materials Used in Medical Face Masks to Penetration by Particulates Using Latex Spheres
ASTM F2101 Standard Method for Evaluating the Bacterial Filtration . Efficiency (BFE) of Medical Face Mask Materials, Using a Biological Aerosol of Staphylococcus aureus
MIL-M- 36954C Military Specification, Mask, Surgical, Disposable ●
16 CFR Part 1610 Standard for the Flammability of Clothing ●
ISO10993-1 Biological evaluation of medical devices Part 1: Evaluation and . testing within a risk management process
. ISO10993-5 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity of medical devices
ISO10993-10 Biological Evaluation of Medical Devices Part 10: Tests for . Irritation and Skin Sensitization

Clinical Test Conclusion

No clinical study is included in this submission.

IX. CONCLUSION

The conclusion drawn from the nonclinical tests demonstrates that the Face Mask subject device of this submission, K210007, is as safe, as effective, and performs as well as or better than the legally marketed predicate device Surgical Face Masks (K182514).

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.