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.

Device Description

The Surgical Face Mask is blue color, single use, three-layer, flat-folded masks with nose piece and ear loops. The blue colorant is polypropylene (PP) master batch.

The body of the face mask is composed of three layers: the inner and outer layers are made of spun-bond polypropylene, and the middle layer is made of melt blown polypropylene filter.

The two elastic ear loops are welded to the face mask, can held the face mask in place over the users' mouth and nose. The elastic ear loops are made of Spandex and polyester, is not made with natural rubber latex.

The nose piece is in the layers of the facemask to allow the user to fit the facemask around their nose, which is made of PP-Ferrum wire.

The surgical face masks are sold non-sterile and are intended to be single use, disposable devices.

AI/ML Overview

The document is a 510(k) premarket notification for a Surgical Face Mask. It primarily focuses on the device's substantial equivalence to a predicate device, supported by non-clinical performance testing and biocompatibility assessments. It explicitly states that no clinical studies were performed. As such, the information provided does not pertain to the "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of an AI/human-in-the-loop diagnostic device as implied by the detailed questions.

Therefore, many of the requested details, such as those related to AI performance, human reader improvement, ground truth establishment for training and test sets, expert consensus, and multi-reader multi-case studies, are not applicable to this document.

However, I can extract the acceptance criteria and the device performance for the non-clinical tests conducted for this surgical face mask.

Here's the information based on the provided document, addressing the extractable points and noting the non-applicability of others:

Device: Surgical Face Mask (Kingstar Medical (Xianning) Co., Ltd.)
Predicate Device: K210433 Surgical Face Mask (Wuhan Dymex Healthcare Co., Ltd.)

1. Table of Acceptance Criteria and Reported Device Performance (for Non-Clinical Tests)

Test Methodology	Purpose	Acceptance Criteria: ASTM F2100 Level 3	Reported Device Performance (Result)
Fluid Resistance (ASTM F1862)	To demonstrate the functionality of the subject device.	29 out of 32 pass at 160 mmHg for level 3	Pass (32 out of 32 pass at 160 mmHg, 3 lots)
Particulate Filtration Efficiency (ASTM F2299)	To demonstrate the functionality of the subject device.	≥ 98%	Pass (minimum 99.21%)
Bacterial Filtration Efficiency (ASTM F2101)	To demonstrate the functionality of the subject device.	≥ 98%	Pass (99.9%)
Differential Pressure (EN 14683 Annex C)	To demonstrate the functionality of the subject device.	< 6.0 mmH2O/cm²	Pass (Maximum 3.7 mmH2O/cm²)
Flammability (16 CFR 1610)	To demonstrate the functionality of the subject device.	Class 1	Pass, Class 1
Cytotoxicity (ISO 10993-5)	To demonstrate the safety of the subject device and biocompatibility.	Non-cytotoxic	Under the conditions of the study, the device is non-cytotoxic.
Irritation (ISO 10993-10, ISO 10993-23)	To demonstrate the safety of the subject device and biocompatibility.	Non-irritating	Under the conditions of the study, the device is non-irritating.
Sensitization (ISO 10993-10)	To demonstrate the safety of the subject device and biocompatibility.	Non-sensitizing	Under the conditions of the study, the device is non-sensitizing.

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

Sample Size for Test Set:
- Fluid Resistance: "32 out of 32 pass" indicates at least 32 samples were tested across 3 lots.
- For other functional tests (PFE, BFE, Differential Pressure, Flammability) and biocompatibility tests (Cytotoxicity, Irritation, Sensitization), the specific number of masks or test replicates is not explicitly stated, beyond the qualitative "Pass" or "minimum/maximum" values. However, the tests are done according to recognized standards (ASTM, EN, ISO) which would prescribe sample sizes.
Data Provenance: The tests were non-clinical, conducted to verify compliance with standards. The origin of the raw materials is China (Xianning City, Hubei Province), and the testing facilities are not explicitly named or their location revealed. It is a pre-market notification, implying this data was generated specifically for this submission.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Not Applicable. This document describes the performance of a physical medical device (surgical face mask) through non-clinical laboratory testing, not a diagnostic AI device requiring expert-established ground truth.

4. Adjudication Method for the Test Set

Not Applicable. No human adjudication of results is mentioned for these physical performance tests. The tests are conducted according to standardized laboratory procedures yielding objective measurements.

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

Not Applicable. No clinical studies, especially MRMC studies comparing human readers with and without AI assistance, were performed. The submission explicitly states: "No clinical study is included in this submission."

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

Not Applicable. This is a physical medical device, not an algorithm or AI.

7. Type of Ground Truth Used

Not Applicable. The "ground truth" for this device's performance is established by objective measurements against recognized industry standards (e.g., ASTM F2100 Level 3 requirements for fluid resistance, filtration efficiency, etc.) and biocompatibility standards (e.g., ISO 10993 series).

8. Sample Size for the Training Set

Not Applicable. This device did not involve machine learning or AI, hence no training set.

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

Not Applicable. No training set was used.

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: the Department of Health & Human Services logo on the left and the FDA text logo on the right. The text logo has the FDA acronym in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

October 2, 2023

Kingstar Medical (Xianning) Co., Ltd. % Ms. Ivy Wang Technical Manager Shanghai Sungo Management Consulting Co. Ltd. 14th Floor, 1500# Century Avenue Shanghai, Shanghai China

Re: K232359

Trade/Device Name: Surgical Face Mask Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical apparel Regulatory Class: Class II Product Code: FXX Dated: August 7, 2023 Received: August 7, 2023

Dear Ms. 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.

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

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.

Brent Showalter -S

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

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

Indications for Use

510(k) Number (if known) K232359

Device Name Surgical Face Mask

Indications for Use (Describe)

The Surgical Face Masks are intended to be worn to protect both the patient and healthcare persomel 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.

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

Transactional Use (Identify STEs which belong to a Single Transaction)
Data Store (Comprehensive Use of STE data for a variety of purposes)

| | 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."

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

510(K) Summary

This summary of 510(K) safety and effectiveness information is being submitted in accordance with the requirement of 21 CFR 807.92.

Prepared date: 2023-08-04 A. Applicant: Kingstar Medical (Xianning) Co., Ltd. Address: No.79 Yong'andong Road, Xian'an District, Xianning City, Hubei Province, China Contact Person: Mr. Fan Rong Tel: +86 15871408114 Email: fan.rong@kingstarmedical.cn

Submission Correspondent: Primary contact: Ms. Ivy Wang Shanghai SUNGO Management Consulting Co., Ltd. Room 1401, Dongfang Building, 1500# Century Ave., Shanghai 200122, China Tel: +86-21-58817802 Email: zxfda@sungoglobal.com Secondary contact: Mr. Raymond Luo Room 1401, Dongfang Building, 1500# Century Ave., Shanghai 200122, China Tel: +86-21-68828050 Email: fda.sungo@gmail.com

B. Device:

Trade Name: Surgical Face Mask Common Name: Surgical Mask Model: Ear loop

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

C. Predicate device: (Primarv)

K210433 Surgical Face Mask Wuhan Dymex Healthcare Co., Ltd.

D. Indications for use of the device:

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 intended

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

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.

E. Device Description:

The Surgical Face Mask is blue color, single use, three-layer, flat-folded masks with nose piece and ear loops. The blue colorant is polypropylene (PP) master batch.

The body of the face mask is composed of three layers: the inner and outer layers are made of spun-bond polypropylene, and the middle layer is made of melt blown polypropylene filter.

The nose piece is in the layers of the facemask to allow the user to fit the facemask around their nose, which is made of PP-Ferrum wire.

The surgical face masks are sold non-sterile and are intended to be single use, disposable devices.

Device Proposed Device Predicate Device Result 510K number K210433 --Model name Surgical Face Mask Surgical Face Mask Same Class II Device, FXX (21 Class II Device, FXX (21 Same Classification CFR878.4040) CFR878.4040) The Surgical Face Masks are The Surgical Face Masks are Same intended to be worn to protect intended to be worn to protect both the patient and healthcare both the patient and healthcare personnel from transfer of personnel from transfer of microorganisms, body fluids and microorganisms, body fluids particulate material. These face and particulate material. These Intended use masks are intended for use in face masks are intended for use infection control practices to in infection control practices to reduce the potential exposure to reduce the potential exposure blood and body fluids. This is a to blood and body fluids. This single use, disposable device(s), is a single use, disposable provided non-sterile. device(s), provided non-sterile. Ear Loops, Tie-on, Similar Model Ear loop, Flat pleated,3 layers Flat-pleated, 3 layers Outer Same Spun-bond polypropylene Spun-bond polypropylene layer Same Middle Material Melt blown polypropylene Melt-blown Polypropylene layer Inner Same Spun-bond polypropylene Spun-bond polypropylene layer

F. Comparison with predicate device

Table 1 General Comparison

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

Nose piece	PP-Ferrum wire	Malleable polyethylene wire	Different
Ear loops	Spandex, polyester	Spandex	Different
Color	Blue	Blue	Same
Dimension (Length)		17.5cm±0.2cm	17.5cm±0.2cm	Same
Dimension (Width)		9.5cm±0.1cm	9.5cm±0.2cm	Similar
OTC use		Yes	Yes	Same
Sterility		Non-Sterile	Non-Sterile	Same
Use		Single Use, Disposable	Single Use, Disposable	Same
ASTM F2100 level		Level 3	Level 3	Same
FluidF1862	ResistancePerformance ASTM	32 out of 32 pass at 160 mmHg	32 out of 32 pass at 160 mmHg	Same
EfficiencyF2299	Particulate FiltrationASTM	≥ 98%	≥ 98%	Same
BacterialFiltrationEfficiencyF2101	ASTM	≥ 98%	≥ 98%	Same
Differential Pressure(Delta P) EN 14683Annex C		< 6.0mmH2O/cm²	< 6.0mmH2O/cm²	Same
1610 16	Flammability 16 CFR	Class 1	Class 1	Same
Biocompatibility		ISO10993	ISO10993	Same

G. Non-Clinical Test Conclusion

Non-clinical tests were conducted to verify that the proposed device met all design specification for the standards and test methods. 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)] Submission issued on March 5, 2004:

A ISO 10993-5: 2009 Biological Evaluation of Medical Devices -- Part 5: Tests For In Vitro Cytotoxicity
A ISO 10993-10: 2010 Biological Evaluation of Medical Devices - Part 10: Tests for Irritation and Skin Sensitization
ISO 10993-23:2021 Biological evaluation of medical devices - Part 23: Tests for irritation
ASTM F2100, Standard Specification for Performance of Materials Used in Medical Face A 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;

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

A 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, stand 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	The purpose of the performance testing is to demonstrate the functionality of the subject device.	29 out of 32 pass at 160 mmHg for level 3	Pass32 out of 32 pass at 160 mmHg, 3 lots
Particulate Filtration Efficiency		≥ 98%	Passminimum 99.21%
Bacterial Filtration Efficiency		≥ 98%	Pass99.9%
Differential Pressure		< 6.0mmH2O/cm²	PassMaximum 3.7mmH2O/cm²
Flammability		Class 1	Pass, Class 1
Cytotoxicity	The purpose of the testing is to demonstrate the safety of the subject device.	Non-cytotoxic	Under the conditions of the study, the device is non-cytotoxic.
Irritation		Non-irritating	Under the conditions of the study, the device is non-irritating.
Sensitization		Non-sensitizing	Under the conditions of the study, the device is non-sensitizing

Table 2 - Performance Testing & Biocompatibility

H. Clinical Test Conclusion

No clinical study is included in this submission.

I. Conclusion

The conclusions drawn from the nonclinical tests demonstrate that the subject device is as safe, as effective, and performs as well as or better than the legally marketed predicate device K210433.

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.