The Surgical Face Mask is intended for single use by operation room personnel and other general healthcare workers to protect both patients and healthcare workers against transfer of microorganisms, blood and body fluids, and particulate materials.

Device Description

The proposed device, Surgical Face Mask is a three-layer, single-use, flat-pleated mask. The mask body is made of 25g/m² PP non-woven cloth. The mask contains tie strings or ear loops to secure the mask over the users' mouth and face and includes a nosepiece to provide a firm fit over the nose. Ear loops are made of Nylon and Spandex, and tie strings are made of 25g/m² PP non-woven cloth. The nose clip which is made of high-density polyethylene and Galvanized wire. The device is provided in sterile.

AI/ML Overview

This document is a 510(k) Premarket Notification for a Surgical Face Mask. The request asks for details about acceptance criteria and a study proving the device meets those criteria, typically found in AI/ML medical device submissions. However, this document is for a physical medical device (a surgical face mask), not an AI/ML device. Therefore, many of the requested categories (like number of experts for ground truth, MRMC studies, training set details, etc.) are not applicable and are not present in the provided text.

This document focuses on the performance of the surgical face mask based on established ASTM and ISO standards for biocompatibility and barrier protection.

Here's a breakdown of the available information based on your request, with a clear indication of what is not applicable for this type of device submission:

1. Table of Acceptance Criteria and Reported Device Performance

The document provides two tables: "Table 1 Summary of Biocompatibility Test Results" and "Table 2 Summary of Performance Testing".

Table 1: Summary of Biocompatibility Test Results

Test/Purpose	Test Method/Standard	Acceptance Criteria	Result
In Vitro Cytotoxicity Test	ISO 10993-5: 2009	Reduction of cell viability shall be not more than 30%.	Passed: No Cytotoxicity Observed
Skin Sensitization Test	ISO 10993-10: 2010	The skin reactions grades shall be less than 1.	Passed: No Skin Sensitization Observed
Skin Irritation Test	ISO 10993-10: 2010	The irritation response category shall be slight or less.	Passed: No Skin Irritation Observed

Table 2: Summary of Performance Testing (for Level 2 Mask - as per ASTM F2100-19)

Performance Test/Purpose	Test Standard	Acceptance Criteria	Test Results (Lot #1)	Test Results (Lot #2)	Test Results (Lot #3)
Bacterial Filtration	ASTM F2101-2019	Level 2: >98%	MIN: 98.99% AVG: 99.53%	MIN: 98.46% AVG: 99.10%	MIN: 98.36% AVG: 99.2%
Differential Pressure	EN 14683 Annex C	Level 2: <6.0 mm H2O/cm²	MAX: 4.05 AVG: 3.79	MAX: 4.18 AVG: 3.83	MAX: 4.12 AVG: 3.75
Flammability	16 CFR Part 1610	Level 2: Class I	Class I	Class I	Class I
Particulate Filtration	ASTM F2299/F2299M-03 (2017)	Level 2: >98%	MIN: 98.99% AVG: 99.58%	MIN: 98.30% AVG: 99.25%	MIN: 98.45% AVG: 99.11%
Resistance to Penetration	ASTM F1862/F1862M-17	Level 2: 120 mmHg	Pass at 120 mmHg	Pass at 120 mmHg	Pass at 120 mmHg
Seal strength of immediate package	ASTM F88/F88M-15	Seal strength >= 2N/15mm	MIN: 2.2 AVG: 3.04	MIN: 3.2 AVG: 3.54	MIN: 2.2 AVG: 2.9
Seal leak of immediate package	ASTM F1929-15	No apparent solution channel through the whole seal edge in the whole seal area	No	No	No
EO ECH Residue	ISO 10993-7:2008	EO residue <= 4mg/device ECH residue <= 9mg/device	EO: 0.01 mg/device ECH: 0.0053 mg/device	EO: 0.0053 mg/device ECH: 0.0027 mg/device	EO: 0.006 mg/device ECH: 0.01 mg/device

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

Sample Size: The document refers to testing "Lot #1, Lot #2, Lot #3" for performance tests. The specific number of masks/samples within each lot that were tested for each criterion is not stated in the provided text. This information would typically be found in the full test reports, which are summarized here.
Data Provenance: The device manufacturer is "Shandong Haidike Medical Products Co., Ltd." located in Heze City, Shandong Province, China. The testing was performed according to international standards (ASTM, ISO, EN) and US regulations (CFR). This implies an origin from China, and the data is prospective as it's generated from physical testing of the manufactured product lots for the purpose of this submission.

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

Not Applicable. This is a physical device. "Ground truth" in this context refers to the measured performance against established physical standards rather than expert interpretation of medical images or data. The "ground truth" is defined by the test methods and the acceptance criteria established by the various ASTM, ISO, and EN standards.

4. Adjudication Method for the Test Set

Not Applicable. As this is a physical device, there's no "adjudication" in the sense of reconciling human expert opinions on a test set. Objective physical measurements are taken.

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. This is for a physical medical device (surgical mask), not an AI/ML device. There are no "human readers" or AI assistance involved in its function or evaluation.

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

Not Applicable. This is for a physical medical device. There is no algorithm.

7. The Type of Ground Truth Used

For this physical device, the "ground truth" is based on:

Standardized Test Methods and Acceptance Criteria: As defined by the listed ASTM, ISO, and EN standards (e.g., ISO 10993 for biocompatibility, ASTM F2101 for bacterial filtration, EN 14683 for differential pressure).
Objective Physical Measurements: The device's performance is measured against these established quantitative and qualitative criteria.

8. The Sample Size for the Training Set

Not Applicable. This is a physical product, not an AI/ML model that requires a "training set." The masks are manufactured and then tested to meet standards.

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

Not Applicable. See point 8.

Summary

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June 14, 2021

Shandong Haidike Medical Products Co., Ltd. % Diana Hong General Manager Mid-Link Consulting Co., Ltd. P.O. Box 120-119 Shanghai, 200120 China

Re: K210518

Trade/Device Name: Surgical Face Mask Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: May 10, 2021 Received: May 13, 2021

Dear Diana Hong:

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 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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K210518

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

This 510(k) Summary is being submitted in accordance with requirements of Title 21, CFR Section 807.92.

The assigned 510(k) Number: K210518

1. Date of Preparation: 05/10/2021
1. Sponsor Identification

Shandong haidike Medical Products Co.,Ltd.

Tianfu Road, Dongcheng District, Shan County, 274300 Heze City, Shandong Province, China.

Establishment Registration Number: 3016426842.

Contact Person: Lili Xu Position: Registration Manager Tel: +86-530-4660062 Fax: +86 530 4660055 Email: registration@suturescn.com

1. Designated Submission Correspondent
  Ms. Diana Hong (Primary Contact Person) Ms. Ying Xu (Alternative Contact Person)

Mid-Link Consulting Co., Ltd.

P.O. Box 120-119, Shanghai, 200120, China

Tel: +86-21-22815850, Fax: 360-925-3199 Email: info@mid-link.net

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Identification of Proposed Device 4. Trade Name: Surgical Face Mask Common Name: Surgical Face Mask Regulatory Information Classification Name: Mask, Surgical Classification: II; Product Code: FXX; Regulation Number: 21CFR 878.4040 Review Panel: General Hospital
- Indication for use

Device Description:

న. Identification of Predicate Device
510(k) Number: K202029

Product Name: Medical Surgical Mask

6. Non-Clinical Test Conclusion

Non clinical tests, including biological tests and performance tests, has been performed on the

proposed device according to the following standards:

A ASTM F88/F88M-15 Standard test method for seal strength of flexible barrier materials;
ISO 10993-7:2008 Biological Evaluation of Medical Device- Part 7: Ethylene Oxide Sterilization Residuals
ASTM F1929-15 Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration;
A ASTM F1862/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);

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ASTM F2299/F2299M-03 (2017) Standard Test Method for Determining the Initial Efficiency of A Material Used in medical Face Masks to Penetration by Particulates using Latex Spheres;
ASTM F2101-2019 Standard Test Method for Evaluating the Bacterial Filtration Efficiency (BFE) of Medical Face Mask Materials, Using a Biological Aerosol of Staphylococcus aureus;
ASTM F2100-19 Standard Specification for Performance of Materials Used in Medical Face Masks
16 CFR Part 1610 Standard for the Flammability of Clothing Textiles;
ISO 10993-5 Third edition 2009-06-01 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity
ISO 10993-10 Third Edition 2010-08-01 Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization
EN 14683:2019 Medical face mask- Requirements and test methods- Annex C Method for determination of breathability (differential pressure)

And all the test results of non-clinical tests are summarized in the following table:

Test/Purpose	Test Method/Standard	Acceptance Criteria	Result
In Vitro Cytotoxicity Test	ISO 10993-5: 2009	Reduction of cell viability shall be not more than 30%.	Passed: No Cytotoxicity Observed
Skin Sensitization Test	ISO 10993-10: 2010	The skin reactions grades shall be less than 1.	Passed: No Skin Sensitization Observed
Skin irritation Test	ISO 10993-10: 2010	The irritation response category shall be slight or less.	Passed: No Skin irritation Observed

Table 1 Summary of Biocompatibility Test Results

Table 2 Summary of Performance Testing

PerformanceTest/ Purpose	TestStandard	Acceptance Criteria	Test Results
			Lot #1	Lot #2	Lot #3
Bacterial	ASTM F2101-2019	Level 2: >98%	MIN:98.99%	MIN:98.46%	MIN:98.36%
Filtration			AVG:99.53%	AVG:99.10%	AVG:99.2%

DifferentialPressure	EN 14683 Annex C	Level 2: <6.0 mmH2O/cm2	MAX: 4.05AVG: 3.79	MAX: 4.18AVG: 3.83	MAX: 4.12AVG: 3.75
Flammability	16 CFR Part 1610	Level 2: Class I	Class I	Class I	Class I
Particulate	ASTM		MIN:	MIN:	MIN:

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Filtration
Filtration	F2299/F2299M-03(2017)	Level 2: >98%	98.99%AVG:99.58%	98.30%AVG:99.25%	98.45%AVG:99.11%
Resistance toPenetration	ASTMF1862/F1862M-17	Level 2: 120 mmHg	Pass at 120 mmHg	Pass at 120 mmHg	Pass at 120 mmHg
Seal strength ofimmediatepackage	ASTMF88/F88M-15	Seal strength $\ge$ 2N/15mm	MIN: 2.2AVG: 3.04	MIN: 3.2AVG: 3.54	MIN: 2.2AVG: 2.9
Seal leak ofimmediatepackage	ASTM F1929-15	No apparent solution channel through the whole seal edge in the whole seal area	No	No	No
EOECHResidue	ISO 10993-7:2008	EO residue $\le$ 4mg/deviceECH residue $\le$ 9mg/device	EO Residue:0.01mg/deviceECHResidue:0.0053mg/device	EO Residue:0.0053mg/deviceECHResidue:0.0027mg/device	EO Residue:0.006mg/deviceECHResidue:0.01mg/device

1. Clinical Test Conclusion
  No clinical study is included in this submission.
1. Summary of Technological characteristics

	Table 1 General Comparison

ITEM	Proposed Device	Predicate DeviceK202029	Remark
Product Code	FXX	FXX	Same
Regulation No.	21 CFR 878.4040	21 CFR 878.4040	Same
Class	II	II	Same
Indication for Use	The Surgical Face Mask isintended for single use byoperation room personnel andother general healthcare workersto protect both patients andhealthcare workers againsttransfer of microorganisms,	The medical surgical mask isintended for single use byoperating room personnel andother general healthcare workersto protect both patients andhealthcare workers againsttransfer of microorganisms,	Same
	blood and body fluids, andparticulate materials.	blood and body fluids, andparticulate materials.
Mask style	Flat pleated	Flat pleated	Same
Mask Color	Blue	Blue	Same
Design feature	Ear loops or tie-on	Ear loops or tie-on	Same
Dimensions (mm)	Mask body: 175mm*95mmEar loops: 180mmEar strings: 380mmNose clip: 101mmTolerance: ±5%	Mask body: 175mm×95mm(Tolerance: ±1mm)Ear loops: (2.5-3)mm×200mmEar strings: 90mm×9mmNose clip: 100mm×(2.5-3.5)mmMask body: 145mm×90mm(Tolerance: ±1mm)Ear loops: (2.5-3)mm×160mmEar strings: 80mm×9mmNose clip: 80mm×(2.5-3.5)mmMask body: 120mm×70mm(Tolerance: ±1mm)Ear loops: (2.5-3)mm×140mmEar strings: 70mm×9mmNose clip: 70mm×(2.5-3.5)mmTolerance: ±1mm	Similar 1
	ASTM F2100 Level	Level 2	Level 2	Same
	Performance
	Fluid resistance	Pass at 120mmHg	Pass at 120mmHg	Same
	Particulate efficiency level	Average 99.19%	Average 98.87%	Similar 2
Bacterial filtration level	Average 99.23%	Average 99.46%	Similar 3
Differential pressure	Average 3.81 mmH2O/cm²	Average 3.72mmH2O/cm²	Similar 4
Flammability	Class 1	Class 1	Same
Label/Labeling	Complied with 21 CFR part 801	Complied with 21 CFR part 801	Same
Patient Contacting Material
Ear Loops	Spandex, nylon	Nylon and PU	Similar 5
Nose clip	Polyethylene, galvanized wire	Iron strip covered bypolypropylene covering	Similar 6
Mask body	25g/m² PP non-woven cloth	25g/m² PP non-woven cloth	Same
Biocompatibility
Sensitization	No Sensitization	No Sensitization	Same
Irritation	No Irritation	No Irritation	Same
Sterilization
Method	EO sterilized	EO sterilized	Same
SAL	10-6	10-6	Same

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Similar 1-Dimensions

The dimensions of proposed device are different from the predicate device. However, the dimensions of the proposed device are similar with the largest specification of the predicate device, and performance test result of the propose device can meet the requirements of level 2 mask according to the ASTM F2100-19. This difference does not affect intended use and will not raise any safety issues. Thus, this difference does not affect substantially equivalence between the proposed device and predicate device.

Similar 2-Particulate efficiency level

The particulate efficiency level of the proposed device is different from predicate device. However, the test result of the propose device can meet the requirements of level 2 mask according to the ASTM F2100-19. Therefore, this difference does not affect substantially equivalence between the proposed device and predicate device.

Similar 3-Bacterial filtration level

The bacterial filtration level for the proposed device is different from predicate device. However the test result of the proposed device can meet the requirements of level 2 mask according to the ASTM F2100-19. Therefore, this difference does not affect substantially equivalence between the proposed device and predicate device.

Similar 4-Differential pressure

The differential pressure of the proposed device is different from predicate device. However, the test result for the proposed device can meet the requirements of level 2 mask according to the ASTM F2100-19. Therefore, this difference does not affect substantially equivalence between the proposed device and predicate device.

Similar 5-Ear loops

The material of ear loops for the proposed device is partly different from predicate device. However, the biocompatibility test has been conducted on the proposed device and the test result does not show any adverse effect. Therefore, this difference does not affect substantially equivalence between the proposed

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device and predicate device.

Similar 6- Nose clip

The material of the Nose clip for proposed device is different from the predicate device. However, the biocompatibility test has been conducted on the proposed device and the test result does not show any adverse effect. Therefore, this difference does not affect substantially equivalence between the proposed device and predicate device.

1. Conclusion
  The conclusions drawn from the nonclinical tests demonstrate that the proposed subject device is as safe, as effective, and performs as well as the legally marketed predicate device K202029.

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.