The Disposable Surgical 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 Disposable Surgical Mask is composed of mask body, nose clip and ear loop. The body of the 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 non-woven fabric, the nose clip is made of plastic materials and iron wire, ear loop is made of spandex.

The size of the disposable surgical mask is 17.5*9.5cm with tolerance±5% cm, the length of the ear loop is 16cm, and the length of the nose clip should no less than 8.0cm.

The outer layer of disposable surgical mask will be provided in blue, the inner layer of the disposable surgical mask will be provided in white, and it will be provided with non-sterile and is intended to be single use, disposable devices.

AI/ML Overview

The provided document is a 510(k) summary for a Disposable Surgical Mask (K201893). This type of regulatory submission demonstrates substantial equivalence to a predicate device based on non-clinical performance data. It does not involve AI or complex medical imaging, and therefore, many of the requested criteria (like ground truth establishment by experts, MRMC studies, training set details, or sample size for test sets in an AI context) are not applicable to this document.

However, I can extract and present the relevant "acceptance criteria" and "device performance" in a structured way, based on the provided tables.

Acceptance Criteria and Reported Device Performance for Disposable Surgical Mask (K201893)

The study proves the device meets the acceptance criteria through a series of non-clinical performance tests designed to show equivalence to a predicate device (K182514).

1. Table of Acceptance Criteria and Reported Device Performance

Item	Acceptance Criteria (for Level 2 Surgical Mask)	Reported Device Performance (Subject Device)	Result
Fluid Resistance (ASTM F1862)	≥ 29 out of 32 pass at 120 mmHg	32 out of 32 pass at 120 mmHg	Pass
Particulate Filtration Efficiency (ASTM F2299)	≥ 98%	99.62%	Pass
Bacterial Filtration Efficiency (ASTM F2101)	≥ 98%	99.9%	Pass
Differential Pressure (Delta P) (EN 14683 Annex C)	< 6.0 mmH2O/cm²	5.2 mmH2O/cm²	Pass
Flammability (16 CFR 1610)	Class 1	Class 1	Pass
Biocompatibility: Cytotoxicity (ISO 10993-5)	Non-cytotoxic	Non-cytotoxic	Pass
Biocompatibility: Irritation (ISO 10993-10)	Non-irritating	Non-irritating	Pass
Biocompatibility: Sensitization (ISO 10993-10)	Non-sensitizing	Non-sensitizing	Pass

Explanation of Applicability for Other Requested Information:

The following points are not applicable to this 510(k) submission for a non-AI medical device (surgical mask):

2. Sample size used for the test set and the data provenance: For physical performance tests like fluid resistance, specific sample sizes are often defined by the testing standards (e.g., 32 samples for ASTM F1862). The tests are typically conducted in a laboratory setting, and the data provenance would be internal testing reports, not patient data from specific countries or retrospective/prospective studies.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This is for AI/imaging devices where human interpretation is the ground truth. Not applicable here.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable, as there's no human interpretation or ground truth adjudication in the context of physical performance testing of a surgical mask.
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. MRMC studies are for AI-assisted diagnostic devices.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This refers to AI algorithm performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): The "ground truth" here is the defined performance standard (e.g., "≥ 98% BFE"). It's based on established scientific and engineering principles for material performance, not clinical outcomes or expert consensus on medical images.
8. The sample size for the training set: There is no "training set" for physical performance testing of a disposable surgical mask. This concept applies to machine learning models.
9. How the ground truth for the training set was established: Not applicable, as there is no training set.

In summary, this document describes a traditional medical device submission where the acceptance criteria are based on established performance standards for the product type, and the study proves compliance through direct physical and material testing, not through AI model validation methodologies.

Summary

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Build Correspondence

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December 9, 2020

Xiamen Probtain Medical Techology Co., LTD % Ivy Wang Technical Manager Shanghai Sungo Management Consulting Company Limited 13th Floor, 1500# Central Avenue Shanghai, Shanghai 200122 China

Re: K201893

Trade/Device Name: Disposable Surgical Mask Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: October 26, 2020 Received: October 26, 2020

Dear Ivy Wang:

We have reviewed vour 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

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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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Indications for Use

510(k) Number (if known) K201893

Device Name Disposable Surgical 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

K201893 Summary prepared Date: 2020-08-13

A. Applicant:

XIAMEN PROBTAIN MEDICAL TECHNOLOGY CO., LTD Address: 4th Floor,No.1 Building,No.6 Ji'an Road,Tong'an District,Xiamen, Fujian,361100, China

Contact Person: Kang JianLi Tel: +86-592-7557106 Fax: +86-592-7199255

Submission Correspondent: Primary contact: Ms. Ivy Wang Shanghai SUNGO Management Consulting Co., Ltd. Room 1309, Dongfang Building, 1500# Century Ave., Shanghai 200122, China Tel: +86-21-58817802 Email: haiyu.wang@sungoglobal.com Secondary contact: Mr. Raymond Luo Room 1309, Dongfang Building, 1500# Century Ave., Shanghai 200122, China Tel: +86-21-68828050 Email: fda.sungo@gmail.com

B. Device:

Trade Name: Disposable Surgical Mask Common Name: Disposable Surgical Mask Model(s): MP9017

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

C. Predicate device: K182514 SURGICAL FACE MASK

D. Indications for use:

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E. Device Description:

The size of the disposable surgical mask is 17.5*9.5cm with tolerance±5% cm, the length of the ear loop is 16cm, and the length of the nose clip should no less than 8.0cm.

	Table 1 General Comparison
Device	Subject Device	Predicate Device	Result
Manufacturer	XIAMEN PROBTAINMEDICAL TECHNOLOGY CO.,LTD	Xiantao Zhibo Non-wovenProducts Co., Ltd	-
510K number	K201893	K182514	-
Product Name	Disposable Surgical Mask	SURGICAL FACE MASK	Similar
Model	MP9017
Classification	Class II Device, FXX (21 CFR878.4040)	Class II Device, FXX (21 CFR878.4040)	Same
Indicationsfor use	The Disposable Surgical Masksare intended to be worn to protectboth the patient and healthcarepersonnel from transfer ofmicroorganisms, body fluids andparticulate material. These facemasks are intended to use ininfection control practices toreduce the potential exposure toblood and body fluids. This is adisposable device(s), providednon-sterile.	The Surgical Face Masks areintended to be worn to protectboth the patient and healthcarepersonnel from transfer ofmicroorganisms, body fluids andparticulate material. These facemasks are intended for use ininfection control practices toreduce the potential exposure toblood and body fluids. This is asingle use, disposable device(s),provided non-sterile.	Same
Material	Outerlayer	Spun-bond polypropylene	Spun-bond polypropylene	Same
	Middlelayer	Melt blown non-woven fabric	Melt blown polypropylene filter	Same

F. Comparison with predicate device

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Innerlayer	Spun-bond polypropylene	Spun-bond polypropylene	Same
Nose clip	Plastic materials and iron wire	Malleable aluminum wire	Different
Earloops	Spandex	Polyester	Different
Color	Blue	white	Different
DesignFeature	Ear Loops, Flat Pleated, 3 layers	Ear Loops, Flat Pleated, 3 layers	Same
Dimension(Length)	$17.5\pm5%$ cm	$17.5cm\pm1cm$	Similar
Dimension(Width)	$9.5cm\pm5%cm$	$9.5cm\pm1cm$	Similar
OTC use	Yes	Yes	Same
Sterility	Non-Sterile	Non-Sterile	Same
Use	Single Use, Disposable	Single Use, Disposable	Same
ASTM F2100level	Level 2	Level 2	Same
Biocompatibility	Meet ISO10993	Meet ISO10993	Same

Table 2 – Comparison of Performance Testing

Item	Subject device	Predicate Device	AcceptanceCriteria (level 2)	Result
Fluid ResistancePerformanceASTM F1862	32 out of 32 passat 120 mmHg	32 out of 32 pass at120 mmHg	29 out of 32 pass at120 mmHg	Similar
ParticulateFiltrationEfficiencyASTM F2299	99.62%	99.88%	≥ 98%	Similar
BacterialFiltrationEfficiencyASTM F2101	99.9%	99.6%	≥ 98%	Similar
DifferentialPressure (DeltaP) EN 14683Annex C	5.2mmH2O/cm²	3.0mmH2O/cm²	< 6.0mmH2O/cm²	Similar
Flammability 16CFR 1610	Class 1	Class 1	Class 1	Similar

Table 3 Biocompatibility Comparison

Item	Subject device	Predicate Device	Result

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Cytotoxicity	Under the conditions of thestudy, the device is non-cytotoxic.	Under the conditions of thestudy, the subject device wasnon-cytotoxic.	Same
Irritation	Under the conditions of thestudy, the device is non-irritating.	Under the conditions of thestudy, the subject device wasnon-irritating.	Same
Sensitization	Under the conditions of thestudy, the device is non-sensitizing	Under the conditions of thestudy, the subject device wasnon-sensitizing.	Same

G. Summary of Technological Characteristic

Non-clinical tests were conducted to verify that the proposed device met all design specifications as same to the predicate device. 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
ISO 10993-10: 2010 Biological Evaluation of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization
ASTM F2100, 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);
A EN 14683, Medical Face Masks-Requirements and Test Methods;
ASTM F2101, Standard Test Method for Evaluating the Bacterial Filtration Efficiency (BFE) Of Medical Face Mask Materials, Using A Biological Aerosol of Staphylococcus Aureus;
A ASTM F2299, Standard 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;

H. Clinical Test Conclusion

No clinical study is included in this submission.

I. Conclusion

Based on the nonclinical tests performed, the subject device is as effective, and performs as well as the legally marketed predicate device, K182514 Xiantao Zhibo Non-woven Products Surgical Face Mask.

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.