The Disposable Surgical Face Mask is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. This 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 Disposable Surgical Face Mask is indicated as a protective nose and mouth covering for healthcare workers and patients involved in medical and surgical procedures. The masks are indicated in any procedure or situation where there is a risk of exposure to microorganisms and body fluids.

Device Description

The Disposable Surgical Face Mask is single use, three-layer, flat-pleated style with ear-loop and nose piece. The mask is manufactured with three layers, the inner and outer layers, and the ear-loop is made of spandex and polyester, and the middle layer is made of melt blown fabrics. During use, the ear-loop shall be tied over user ear. The nose piece in the layers of facemask is to allow the user to fit the facemask around their nose, which is made of malleable polyethylene wire. The Disposable Surgical Face Mask is provided in blue color. The mask is sold non-sterile and are intended to be single use, disposable devices.

AI/ML Overview

The document describes the acceptance criteria and performance of a "Disposable Surgical Face Mask" (K210643) compared to a predicate device (K203200).

Here's the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

Performance Test	Acceptance Criteria	Reported Device Performance	ASTM F2100 Level (if applicable)
Fluid Resistance (ASTM F1862M-17)	160 mmHg (Level 3)	95 of 96 samples passed at 160mmHg	Level 3
Particulate Filtration Efficiency (PFE) (ASTM F2299-03)	≥98%	96/96 samples passed at ≥98%	Level 3
Bacterial Filtration Efficiency (BFE) (ASTM F2101-19)	≥98%	94/96 samples passed at ≥98%	Level 3
Differential Pressure (EN 14683 Annex C)	<6.0 mmH2O/cm²	92/96 samples passed at <6 mmH2O/cm²	Level 3
Flammability (16 CFR Part 1610)	Class 1 (≥3 seconds burn time)	96/96 samples passed at ≥3 seconds burn time - Class 1	Class 1
Cytotoxicity (ISO 10993-5:2009)	Non-cytotoxic	Device was non-cytotoxic	N/A
Irritation (ISO 10993-10:2010)	Non-irritating	Device was non-irritating	N/A
Sensitization (ISO 10993-10:2010)	Non-sensitizing	Device was non-sensitizing	N/A

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

For the performance tests (Fluid Resistance, PFE, BFE, Differential Pressure, Flammability): 3 lots tested with a total of 96 samples for each test (e.g., 32 samples per lot).
Data Provenance: The document does not explicitly state the country of origin of the test data (e.g., whether the tests were conducted in China where the manufacturer is located or another country). It also does not specify if the studies were retrospective or prospective, though performance testing of physical products is generally prospective.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not applicable as the document describes performance testing of a physical medical device (surgical face mask) against established technical standards, not an AI/software device requiring expert interpretation for ground truth.

4. Adjudication Method for the Test Set

This information is not applicable for the type of testing described (physical product performance against quantitative standards). Pass/fail criteria are defined by the standards themselves.

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 information is not applicable as the document describes the performance testing of a physical medical device (surgical face mask), not an AI/software device or a comparative effectiveness study involving human readers.

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

This information is not applicable as the document pertains to a physical medical device.

7. The Type of Ground Truth Used

The "ground truth" for the device's performance is based on pre-defined technical standards (e.g., ASTM F2101-19, EN 14683, ASTM F1862M-17, 16 CFR Part 1610, ISO 10993) which specify quantitative measurements and thresholds for acceptable performance. Biocompatibility (cytotoxicity, irritation, sensitization) is also assessed against established biological standards.

8. The Sample Size for the Training Set

This information is not applicable as the document describes performance testing of a physical medical device, which does not involve a training set as used in machine learning or AI.

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

This information is not applicable as the document does not relate to machine learning or AI and therefore does not have a "training set" or corresponding ground truth establishment process.

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 and Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

August 4, 2021

Shandong Zhushi Pharmaceutical Group Co., Ltd % Boyle Wang General Manager Shanghai Truthful Information Technology Co., Ltd. Room 608, No. 738, Shangcheng Rd., Pudong Shanghai, Shanghai 200120 China

Re: K210643

Trade/Device Name: Disposable Surgical Face Mask Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: June 21, 2021 Received: June 28, 2021

Dear Boyle 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.

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 and Part 809 ); medical device reporting (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, 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

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

Indications for Use

510(k) Number (if known) K210643

Device Name Disposable Surgical Face Mask

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 201 Subpart D)	Over-The-Counter Use (21 CFR 201 Subpart C)

_ | Prescription Use (Part 21 CFR 801 Subpart D)

|_ | 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

510k number: K210643 Date: July 26, 2021 This summary of 510(k) is being submitted in accordance with requirements of 21 CFR 807.92.

1.0 Submitter's information

Name: Shandong Zhushi Pharmaceutical Group Co., Ltd Address: No.6 Shande Road, Shan County, Heze City, Shandong, China Contact: Mr. Junhui Zhu Phone Number: 86-530-7150111 Fax number: 86-530-7150111 Date of Preparation: Jul.26, 2021 Email: 2307426957@gq.com

Designated Submission Correspondent

Mr. Boyle Wang Shanghai Truthful Information Technology Co., Ltd. Room 608, No. 738 Shangcheng Rd., Pudong Shanghai, 200120 China Tel: +86-21-50313932 Email: Info@truthful.com.cn

2.0 Subject Device information

Type of 510(k): Traditional Trade name: Disposable Surgical Face Mask Common name: Surgical mask Classification name: Mask, Surgical Model(s): ZS-B, ear-loop.

3.0 Classification

Production code: FXX Regulation number: 21CFR 878.4040 Classification: Class II Panel: Surgical apparel

4.0 Predicate device information

Manufacturer: Guangdong Haiou Medical Apparatus Co., Ltd.

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

Device: Disposable Medical Surgical Face Mask 510(k) number: K203200 Classification name: Mask, Surgical Production code: FXX Regulation number: 21CFR 878.4040 Classification: Class II Panel: Surgical apparel

5.0 Device description

6.0 Indication for Use Statement

7.0 Technological Characteristic Comparison

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

Item	Proposed device	Predicated device	Remark
Product Code	FXX	FXX	Same
Regulation No.	21 CFR 878.4040	21 CFR 878.4040	Same
Class	II	II	Same
Product name	Disposable Surgical Face Mask	Disposable Medical Surgical Face Mask	Same
510(k) No.	K210643	K203200	Different
Models	ZS-B, ear-loop.	HO-KZ01	Different
Composite	Flat Pleated, 3 layers	Ear loop, flat pleated, 3 layers	Same
Specification	17.5cm×9.5cm17.5cm×9.0cm	17.5cm×9.5cm	Different

	Table 3 - General Comparison

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

		17.0cm×9.0cm
		14.5cm×9.5cm
	Intended Use	The Disposable SurgicalFace Mask is indicated as aprotective nose and mouthcovering for healthcareworkers and patients involvedin medical and surgicalprocedures. The masks areindicated in any procedure orsituation where there is a riskof exposure tomicroorganisms and bodyfluids.	Disposable Medical SurgicalFace Mask is indicated as aprotective nose and mouthcovering for healthcareworkers and patients involvedin medical and surgicalprocedures. The masks areindicated in any procedure orsituation where there is a riskof exposure tomicroorganisms and bodyfluids.	Same
		OTC use	Yes	Yes	Same
		Internal layer	Spun-bond polypropylene	Spun-bond polypropylene	Same
		Middle layer	Melt blown polypropylene	Melt blown polypropylene	Same
	Material	External layer	Spun-bond polypropylene	Spun-bond polypropylene	Same
		Nose piece	Malleable polyethylenewire	Malleable polyethylenewith aluminum wire	Same
	Ear-loop		spandex +polyester	polyester	Similar
Color		Blue	Blue	Same
		17.5cm×9.5cm, ±5%
		17.5cm×9.0cm, ±5%	W: 17.5cm	Different
	Dimension (W×L)	17.0cm×9.0cm, ±5%	L: 9.5cm
		14.5cm×9.5cm, ±5%
Sterility		Non-Sterile	Non-Sterile	Same
	Single Use	Yes	Yes	Same
	Sterile	No	No	Same
	Fluid ResistancePerformance	31/32 Passed at 160mmHgLevel 3 ASTM F1862-17	Level 3: 160 mmHg	Same
	Particulate FiltrationEfficiency	32/32 Passed ≥98%ASTMF2299-03	≥98%	Same
	Bacterial FiltrationEfficiency	32/32 Passed at ≥98%ASTM F2101-19	≥98%	Same
Differential Pressure		32/32 Passed at <6mmH2O/cm2EN 14683: 2019, Annex C	<6.0 mmH2O/cm2	Similar
Flammability		32/32 Passed ≥ Second'sburn Time-Class 1 16 CFRPart 1610	Class 1, Non-Flammable	Same
Cytotoxicity	Under the conditions of thestudy, the subject devicewas non-cytotoxic	Under the conditions of thestudy, the predicate devicewas non-cytotoxic	Same
Irritation	Under the conditions of thestudy, the subject device wasnon-irritating	Under the conditions of thestudy, the predicate devicewas non-irritating	Same
Sensitization	Under the conditions of thestudy, the subject device wasnon-sensitization	Under the conditions of thestudy, the predicate devicewas non-sensitization	Same

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

8. Summary of Non-Clinical Performance Testing

Performance Testing Summary

Test Method	Purpose	Pass Criteria	Results
ASTM F2101-19StandardTestMethod forEvaluating the BacterialFiltration	The purpose of the test is toevaluate the Bacterial filtrationefficiency (BFE) (%)	≥98%	3 lots tested withtotal 96 samples,94/96 Passed at≥98% /Pass
EN 14683: 2019, AnnexC Medical face masks -Requirements andtest methods according toASTM F2100:2019	The purpose of the test is toevaluate the Different pressure(Delta-P)	<6.0mmH2O/cm²	3 lots tested withtotal 96 samples,92/96 Passed<6 mmH2O/cm²/ Pass
ASTM F2299-03Standard Test Methodfor Determining the InitialEfficiency of MaterialsUsed in Medical FaceMasks to Penetration byParticulates Using LatexSpheres according toASTMF2100:2019	The purpose of the test is toevaluate the Sub-micronparticulate filtration efficiencyat 0.1 micron, % (PFE)	≥98%	3 lots tested withtotal 96 samples,96/96 Passed at≥98% / Pass
ASTM F1862M-17Standard Test Method forResistance of MedicalFace Masks toPenetration by SyntheticBlood (HorizontalProjection of FixedVolume at a KnownVelocity) according toASTMF2100:2019forpass result	The purpose of the test is toevaluate the Resistance topenetration by synthetic blood,Minimum pressure in mmHg	Fluidresistantclaimed at160 mm Hg	3 lots tested withtotal 96 samples,95 of 96 test articlespassed at 160mmHg/Pass

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

16 CFR Part 1610 Standardfor the Flammability ofClothing according to ASTMF2100:2019	The purpose of the test is toevaluate the Flame spread	Class 1	3 lots tested withtotal 96 samples,96/96 Passed ≥3seconds burn Time-Class 1 /Pass
--------------------------------------------------------------------------------------------------	------------------------------------------------------------	---------	-------------------------------------------------------------------------------------------------------

Biocompatibility Testing According to ISO 10993-1:2009, the nature of body contact ● for the subject device is Surface Device category, Skin Contact and duration of contact is A-Limited (≤24h). The following tests for the subject device were conducted to demonstrate that the subject device is biocompatible and safe for its intended use:

{8}------------------------------------------------

In vitro Cytotoxicity Test per ISO 10993-5:2009 Biological evaluation of medical devices- Part 5: Tests for in vitro cytotoxicity,
Skin Sensitization Tests per ISO 10993-10:2010 Biological evaluation of medical devices— Part 10: Tests for irritation and skin sensitization,
Skin Irritation Tests per ISO 10993-10:2010 Biological evaluation of medical devices— Part 10: Tests for irritation and skin sensitization.

9. Summary of Clinical Performance Test

No clinical study is included in this submission

10.0 Conclusion

The conclusion drawn from the nonclinical tests demonstrates that the subject device in 510(K) submission K210643, the Disposable Surgical Face Mask is as safe, as effective, and performs as well as or better than the legally marketed predicate device cleared under K203200.

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.