The Surgical 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. This is a single use, disposable device(s), provided sterile.

Device Description

The Surgical Face Masks are Flat Pleated type mask, utilizing Ear straps way for wearing, and they all have Nose clip design for fitting the face mask around the nose. The Surgical Face Masks are manufactured with three layers. The outer layer is made of polypropylene spun-bond non-woven fabric. The middle layer with filtration function is made of polypropylene melt-blown non-woven fabric. The inner layer contact with face is made of polypropylene spun-bond non-woven fabric. The nose clip is made of polyethylene strip with iron wire inside. The ear straps are made of spandex polyester fiber. The Surgical Masks are single use, disposable device, provided sterile.

AI/ML Overview

The provided text is a 510(k) Premarket Notification for a Surgical Face Mask. It details the device's characteristics, comparison to a predicate device, and non-clinical testing results. However, it does not contain information about an AI/ML-based device or a comparative effectiveness study involving human readers.

Therefore, I cannot fulfill your request for information regarding:

A table of acceptance criteria and reported device performance for an AI/ML device.
Sample size used for the test set and data provenance for an AI/ML device.
Number of experts and qualifications to establish ground truth for an AI/ML device.
Adjudication method for an AI/ML device.
Multi-reader multi-case (MRMC) comparative effectiveness study or effect size for an AI/ML device.
Standalone performance for an AI/ML algorithm.
Type of ground truth used for an AI/ML algorithm.
Sample size for the training set for an AI/ML algorithm.
How ground truth for the training set was established for an AI/ML algorithm.

The document focuses on the physical and performance characteristics of a surgical face mask, such as fluid resistance, particulate filtration, bacterial filtration, differential pressure, flammability, and biocompatibility.

Here's the information that is available in the document regarding the physical device (surgical face mask):

1. Table of Acceptance Criteria and Reported Device Performance (for a Surgical Face Mask):

Test Purpose	ISO/ASTM Standard	Acceptance Criteria	Reported Device Performance
Fluid Resistance	ASTM F2100-19	29 out of 32 pass at 160mmHg	Meet the requirement
Particulate Filtration Efficiency (PFE)	ASTM F2100-19 & ASTM F2299-03	≥98%	Meet the requirement
Bacterial Filtration Efficiency (BFE)	ASTM F2101-19	≥98%	Meet the requirement
Differential Pressure	EN 14683:2019	< 6.0 mmH2O/cm²	Meet the requirement
Flammability	16 CFR 1610	Class I Non-flammable	Meet the requirement
In Vitro Cytotoxicity	ISO 10993-5:2009	The test article extract did not show potential toxicity to L929 cells.	Meet the requirement
Skin Sensitization	ISO 10993-10:2010	The test article extracts shows no evidence of causing delayed dermal contact sensitization in the guinea pig.	Meet the requirement
Skin Irritation	ISO 10993-10:2010	There is no erythema and no edema observed on the skin of the animals treated with the test extracts.	Meet the requirement

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

For Fluid Resistance: 32 samples (implied from "29 out of 32 pass").
Other tests' specific sample sizes are not explicitly stated, but often these are conducted on a statistically significant number of samples as per the respective standards.
Data Provenance: The document does not specify the country of origin for the non-clinical test data (e.g., where the lab testing was performed), nor does it describe the "data" as retrospective or prospective in a clinical study sense, as these are lab-based performance tests for a physical product.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable, as this document refers to a physical device and laboratory performance testing, not AI/ML model evaluation requiring human expert ground truth.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
Not applicable for laboratory performance testing of a physical device.

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:
No MRMC study was done, as this is a physical medical device (surgical face mask), not an AI/ML diagnostic or assistive device. The document explicitly states: "No clinical study is included in this submission."

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable, as this is a physical surgical face mask, not an AI/ML algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
For the physical device, the "ground truth" for compliance is defined by the technical specifications and methodologies outlined in the listed ISO/ASTM/EN standards. This is laboratory-derived data, not clinical ground truth.

8. The sample size for the training set:
Not applicable, as this is a manufactured physical product, not an AI/ML model that requires a training set.

9. How the ground truth for the training set was established:
Not applicable, for the reason mentioned in point 8.

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). 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.

January 14, 2022

Jiangxi Ganlong Pharmaceutical Co.,Ltd. % Stuart Situ Director Landlink Healthcare Technology (Shanghai) Co., Ltd. Room 1308, Baohua International Plaza, West Guangzhong Road Shanghai, 200071 China

Re: K212913

Trade/Device Name: Surgical Face Mask Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: September 7, 2021 Received: September 13, 2021

Dear Stuart Situ:

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

Page 2

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 Clarence W. Murray, III, 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 Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K212913

Device Name Surgical 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)

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510(k) Summary (K212913)

l Submitter

Jiangxi Ganlong Pharmaceutical Co.,Ltd. No. 164 Xiangjiang Ave. Ganzhou Economic and Technology Development Zone, Ganzhou City, Jiangxi Province, China

Establishment Registration Number: Not yet registration

Contact Person: Niansheng Liao Position: Manager Tel.: +86-18907977486 E-mail: Daniel.Liao@glpharma.cn

Preparation date: Sep.07, 2021

II Proposed Device

Trade Name of Device:	Surgical Face Mask
Model:	SMSE01
Common name:	Surgical Mask
Regulation Number:	21 CFR 878.4040
Regulatory Class:	Class II
Product code:	FXX
Review Panel	General Hospital

III Predicate Devices

510(k) Number:	K202354
Trade name:	Surgical Mask
Common name:	Surgical Mask
Classification:	Class II
Product Code:	FXX
Manufacturer:	Hunan Heng Chang Pharmaceutical Co., Ltd

IV Device description

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of polypropylene spun-bond non-woven fabric. The middle layer with filtration function is made of polypropylene melt-blown non-woven fabric. The inner layer contact with face is made of polypropylene spun-bond non-woven fabric. The nose clip is made of polyethylene strip with iron wire inside. The ear straps are made of spandex polyester fiber.

The Surgical Masks are single use, disposable device, provided sterile.

V Indication for use

VI Comparison of technological characteristics with the predicate devicesItem	Proposed device	Predicate device(K202354)	Discussion
Product name	Surgical Face Mask	Surgical Mask	Same
Product Code	FXX	FXX	Same
Regulation No.	21 CFR 878.4040	21 CFR 878.4040	Same
Class	Class II	Class II	Same
Mask style	Flat-pleated, ear strap, 3layers	Flat-pleated, ear strap, 3layers	Same
Indication for use	The Surgical Face Masksare intended to be worn toprotect both the patient andhealthcare personnel fromtransfer of microorganisms,body fluids and particulatematerial. These face masksare intended for use ininfection control practicesto reduce the potentialexposure to blood andbody fluids. This is a singleuse, disposable device(s),	The Surgical Masks areintended to be worn toprotect both the patient andhealthcare personnel fromtransfer of microorganisms,body fluids and particulatematerial. These face masksare intended for use ininfection control practicesto reduce the potentialexposure to blood andbody fluids. This is a singleuse, disposable device(s),providednon-sterile/	Same
		provided sterile.	sterile.
Material	Innerlayer	Spun-bond polypropylene	Spun-bond polypropylene	Same
	Middlelayer	Melt blown polypropylenefilter	Melt blown polypropylenefilter	Same
	Outerlayer	Spun-bond polypropylene	Spun-bond polypropylene	Same
	Ear strap	spandex polyester fiber	Spandex + Polyester	Different1
	Nose clip	polyethylene strip with ironwire inside	malleable polyethylene	Different1
Color		Blue	Blue	Same
Length		17.5 cm±5%	17.5 cm±5%	Same
Width		9.5 cm±5%	9.5 cm±5%	Same
OTC use		Yes	Yes	Same
sterile		sterile	Non-sterile, sterile	Similar
Sterilizationmethod		EO	EO	Same
Single for use		Yes	Yes	Same
	ASTM F2100Level	Level 3	Level 1	Different2
	Biocompatibility	Confirm to therequirements of ISO 10993series standards	Confirm to therequirements of ISO 10993series standards	Same

VI Comparison of technological characteristics with the predicate devices

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1 The difference in the materials does not raise additional questions for safety and effectiveness of the device. The biocompatibility evaluation test of the subject devices have been performed on the final finished device which includes all construction materials and color additives. The test results shows pass the requirements.

² The different level of specification does not affect the indications of the products.

VII Non-Clinical Testing

Non clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test

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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 F1862M-17, 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, Medical Face Mask-Test-Requirements and Test Methods; ●
ASTM F2101-19, Standard Test Method For Evaluating The Bacterial Filtration ● Efficiency (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;

Test Purpose	ISO/ASTMstandard	Acceptance criteria	Results
Fluid ResistancePerformance	ASTM F2100-19	29 out of 32 pass at160mmHg	Meet therequirement
ParticulateFiltrationEfficiency		≥98%	Meet therequirement
Bacterial FiltrationEfficiency		≥98%	Meet therequirement
DifferentialPressure		< 6.0 mmH2O/cm²	Meet therequirement
Flammability		Class I Non- flammable	Meet therequirement
In VitroCytotoxicity	ISO 10993-5:2009	The test articleextract did not showpotential toxicity toL929 cells.	Meet therequirement
Skin Sensitization	ISO 10993-10:2010	The test articleextracts shows noevidence of causing	Meet therequirement

16 CFR 1610, Standard for the Flammability of clothing textiles; ●

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		delayed dermalcontact sensitizationin the guinea pig.
Skin irritation	ISO 10993-10:2010	There is no erythemaand no edemaobserved on the skinof the animals treatedwith the test extracts	Meet therequirement

VIII Clinical Testing

No clinical study is included in this submission.

IX Conclusion

The proposed device has the same indication for use and has similar design features and technological characteristic as the predicate device. Performance testing data demonstrates that the proposed device is safety and effectiveness as the predicate device. Accordingly, the proposed device is substantially equivalent to the predicate device.

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.