The surgical face mask is intended to be worn to protect both the patient and healthcare personnel from the transfer of microorganisms, body fluids and particulate material. The face mask is 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

Surgical Face Mask is composed of a mask body, a nose clip, and two ear ropes. The mask body of ear loop type has three layers in structure: the inner and outer layers are made of polypropylene non-woven fabrics, and the middle layer is made of polypropylene melt-blown cloth. The component ratio is 24.5% melt blown cloth and 71.5% PP non-woven. The nose clip contained in the proposed device is in the layers of face mask to allow the user to fit the face mask around their nose, which is made of PE. The ear ropes are made of nylon and spandex. This is a single use, disposable device(s), provided non-sterile.

AI/ML Overview

The provided text describes the non-clinical performance testing for a medical device, a Surgical Face Mask (K210015). It does not describe a study involving an algorithm, AI assistance, or human readers, which is implied by several of the questions in the prompt. Therefore, I can only address aspects of the prompt that directly relate to the provided text regarding the performance of the surgical face mask.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided document:

Device: Surgical Face Mask (K210015)

Study Type: Non-clinical Performance Testing (physical and biological properties of the mask)

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

Item	Standard	Acceptance Criteria	Reported Device Performance
Fluid Resistance Performance (mmHg)	ASTM F1862: Standard Test Method for Resistance of Medical Face Masks to Penetration by Synthetic Blood	At least 29 out of 32 specimens show passing results at 160 mmHg	Total 3 lots 96/96. All samples met the predetermined acceptance criteria.
Particulate Filtration Efficiency (%)	ASTM F2299 / F2299M - 03(2017) Standard Test Method for Determining the Initial Efficiency of Materials Used in Medical Face Masks to Penetration by Particulates Using Latex Spheres	≥ 98%	99.6% , total 3 lots 95 out of 96 samples met the predetermined acceptance criteria.
Bacterial Filtration Efficiency (%)	ASTM F2100-19: Standard Specification for Performance of Materials Used in Medical Face Masks	≥ 98%	>99.9%, total 3 lots 96/96 All samples met the predetermined acceptance criteria.
Differential Pressure (Delta-P) (mm H2O/cm2)	ASTM F2100-19: Standard Specification for Performance of Materials Used in Medical Face Masks	< 6.0 mm H2O/cm2	2.2- 3.3 mm H2O/cm2, total 3 lots 96/96. All samples met the predetermined acceptance criteria.
Flammability	21 CFR 1610	Class I	Total 3 lots 96/96 Did Not Ignite. All samples met the predetermined acceptance criteria.
Cytotoxicity	ISO 10993-5: Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity	Non-cytotoxic	All samples met the predetermined acceptance criteria.
Irritation	ISO 10993-10: Biological evaluation of medical devices -Part 10: Tests for irritation and skin sensitization	Non-irritating	All samples met the predetermined acceptance criteria.
Sensitization	ISO 10993-10: Biological evaluation of medical devices-Part 10: Tests for irritation and skin sensitization	Non-sensitizing	All samples met the predetermined acceptance criteria.

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: For most tests (Fluid Resistance, Particulate Filtration, Bacterial Filtration, Differential Pressure, Flammability), the tests were conducted on "total 3 lots," with results reported as "96/96" or "95 out of 96 samples." For Fluid Resistance, the specific acceptance criteria mention "at least 29 out of 32 specimens," implying a testing batch size of 32 for that particular aspect within each lot. For the biological tests (Cytotoxicity, Irritation, Sensitization), it simply states "All samples met the predetermined acceptance criteria," without specifying the exact number of samples tested, but implies they were sufficient for ISO standard compliance.
Data Provenance: The document does not explicitly state the country of origin of the data or whether the studies were retrospective or prospective. Given that it's a premarket notification (510(k)) for a new device, the testing would generally be prospective, conducted specifically for this submission. The manufacturer is "Sample King Manufacturing Ltd" located in Shenzhen, China, so it's likely the testing was performed there or by associated labs.

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 question is not applicable. The studies described are non-clinical laboratory performance tests (e.g., measuring filtration efficiency, fluid resistance, flammability, and biological compatibility), not studies requiring expert interpretation of medical images or patient outcomes. The "ground truth" is established by the results of standardized laboratory measurements and compliance with specified thresholds, not by expert consensus.

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

This question is not applicable. Adjudication methods like "2+1" or "3+1" are typically used in clinical studies, especially those involving human readers assessing data, to resolve discrepancies or establish a definitive ground truth. The tests performed here are laboratory-based, with quantitative results compared against predefined acceptance 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

This question is not applicable. The provided document details the non-clinical performance testing of a physical medical device (surgical face mask), not an AI algorithm or a diagnostic tool that would involve human readers.

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

This question is not applicable. The document describes the performance of a physical surgical face mask, not an algorithm.

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

The "ground truth" for the performance tests of the surgical face mask is defined by the measured values obtained from standardized test methods (e.g., ASTM, ISO, CFR) and their comparison against pre-defined quantitative and qualitative acceptance criteria. For example:

For Particulate Filtration Efficiency, the ground truth is the measured percentage of particles filtered, compared to the ≥ 98% acceptance criterion.
For Flammability, the ground truth is whether the material ignited or not, compared to the Class I requirement.
For Cytotoxicity, the ground truth is the biological response observed in the in-vitro test, compared to the "Non-cytotoxic" acceptance criterion.

8. The sample size for the training set

This question is not applicable. There is no mention of a training set as this study is not for an AI/machine learning device. The "lots" mentioned are production batches from which samples for testing were drawn.

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

This question is not applicable, as there is no training set for a non-AI device.

Summary

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

Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name on the right. The symbol on the left is a stylized image of a human figure, while the FDA name on the right is written in blue letters. The words "U.S. FOOD & DRUG ADMINISTRATION" are written in a clear, sans-serif font.

June 10, 2021

Sample King Manufacturing Ltd Forest Cao OC Manager Southwest side of the intersection of Mingzhu Boulevard and Shenyan Road, Yantian District Shenzhen, Guangdong 518083 China

Re: K210015

Trade/Device Name: Surgical Face Mask Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: April 30, 2021 Received: May 3, 2021

Dear Forest Cao:

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,

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

Enclosure

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K210015

Device Name Surgical Face Mask

Indications for Use (Describe)

The surgical face mask is intended to be worn to protect both the patient and healthcare personnel from the wansfer of microorganisms, body fluids and particulate material. The face mask is 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.

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

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.

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

510(K) Summary

This summary of 510(K) is being submitted in accordance with the requirements of 21 CFR $807.92.

The assigned 510(K) number is: K210015

1. Submitter Information:

Name: Sample King Manufacturing Ltd Address: 1001# 1st floor and 4011# 4th floor of HESC Building, southwest side of the intersection of Mingzhu Boulevard and Shenyan Road, Yantian District, 518083, Shenzhen, China

Contact Person: Ms. Forest Cao Position: Manager Tel : 0086-0755-33095566 Fax : 0086-0755-33095565 Email: forest.cao(@sampleking.com

Date of 510(k) Summary Prepared:2020-12-29

2. Device Information

Trade/Common Name: Surgical Face Mask Models: Ear loop type, 17.5cm×9.5cm Regulatory Class: Class II Regulatory Number: 21 CFR 878.4040 Review Panel: General Hospital Product Code: FXX (Mask, Surgical)

3. Predicative Device

Manufacturer: WUHAN DYMEX HEALTHCARE CO., LTD Device Name: Surgical Face Mask Model(s): Ear Loop 510(k) Number: K182515

4. Device Description:

Surgical Face Mask is composed of a mask body, a nose clip, and two ear ropes.

The mask body of ear loop type has three layers in structure: the inner and outer layers are made of polypropylene non-woven fabrics, and the middle layer is made of polypropylene melt-blown cloth. The component ratio is 24.5% melt blown cloth and 71.5% PP non-woven.

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

The nose clip contained in the proposed device is in the layers of face mask to allow the user to fit the face mask around their nose, which is made of PE.

The ear ropes are made of nylon and spandex.

This is a single use, disposable device(s), provided non-sterile.

5. Indication for Use

6. Technological Characteristic Comparison Table

Provided below is a comparison of the proposed device with predicate device.

Table 1 Comparison of Technological characteristics
Item	Proposed device	Predicate Device	Comparison
Manufacturer	Sample King Manufacturing Ltd	WUHAN DYMEX HEALTHCARE CO., LTD	/
510(k) Number	K210015	K182515	/
Product name	Surgical Face Mask	Surgical Face Mask	Same
Product Code	FXX	FXX	Same
Indication for Use	The surgical face mask is intended to be worn to protect both the patient and healthcare personnel from the transfer of microorganisms, body fluids and particulate material. The face mask is 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 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 non-sterile.	Same
Model	Ear Loops, Flat Pleated, 3 layers	Ear Loops, Flat Pleated, 3 layers	Same
Color	Blue and White	Yellow	Different
Materials Inner and Outer Layers	Blue PP non-woven (Outer Layers)White PP non-woven (Inner Layers)	Spun-bond polypropylene	Similar

Table 1 Comparison of Technological characteristics

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

	MiddleLayer
		Whitepolypropylene filter	meltblownfilter	Meltblownpolypropylene	Same
	Earropes	Nylon+spandex	Spandex		Similar
	Noseclip	Malleable polyethylene wire	Malleable polyethylene wire		Same
Sterile		Non-sterile	Non-sterile		Same
Dimensions		17.5cm×9.5cm	17.5cm×9.5cm		Same
Use		Single Use, Disposable	Single Use, Disposable		Same
ASTMLevel	F2100	Level 3	Level 2		Different

7. Summary of Non-clinical Performance Testing

Non-clinical tests were conducted and conformed to the following standards and the requirements stated in the Guidance for Industry and FDA Staff: Surgical Masks - Premarket Notification [510(k)] Submission issued on March 05, 2004.

Item	Standard	Acceptance Criteria	Results
Fluid ResistancePerformance ( mmHg )	ASTM F1862: Standard Test Method forResistance of Medical Face Masks to Penetrationby Synthetic Blood	At least 29 out of 32specimens show passingresults at 160 mmHg	Total 3 lots 96/96. Allsamples met thepredetermined acceptancecriteria.
Particulate FiltrationEfficiencyPerformance (%)	ASTM F2299 / F2299M -03(2017)Standard Test Method forDetermining the InitialEfficiency of MaterialsUsed in Medical FaceMasks to Penetration byParticulates Using LatexSpheres	≥ 98%	99.6% , total 3 lots 95out of 96 samples met thepredetermined acceptancecriteria.

BacterialEfficiencyPerformance (%)	Filtration ASTM F2100-19:Standard Specification forPerformance ofMaterials Used in MedicalFace Masks	≥ 98%	>99.9%, total 3 lots 96/96All samples met thepredetermined acceptancecriteria.
Differential(Delta-P)(mm H2O/cm2)	Pressure ASTM F2100-19:Standard Specification forPerformance ofMaterials Used in MedicalFace Masks	< 6.0 mm H2O/cm2	2.2- 3.3 mm H2O/cm2,total 3 lots 96/96. Allsamples met thepredetermined acceptancecriteria.
Flammability	21 CFR 1610	Class I	Total 3 lots 96/96 Did NotIgnite.All samples met thepredetermined acceptancecriteria.
Cytotoxicity	ISO 10993-5: Biologicalevaluation of medicaldevices - Part 5: Tests forin vitro cytotoxicity	Non-cytotoxic	All samples met thepredetermined acceptancecriteria.
Irritation	ISO 10993-10: Biologicalevaluation of medicaldevices -Part 10: Tests forirritation and skinsensitization	Non-irritating	All samples met thepredetermined acceptancecriteria.
Sensitization	ISO 10993-10: Biologicalevaluation of medicaldevices-Part 10: Tests forirritation and skinsensitization	Non-sensitizing	All samples met thepredeterminedacceptance criteria.

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

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

8. Clinical performance Data

No clinical study is included in this submission.

9. Conclusion:

The conclusions drawn from the nonclinical test demonstrate that the device is as safe, as effective, and performs as well as or better than the legally marketed 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.