The device is 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, provided non-sterile.

Device Description

The proposed devices, Standard Procedure Mask and Standard Surgical Mask, are a three-layer, singleuse, flat-pleated mask. Both the two masks have the same indications for use. The Standard Procedure Mask is an ear-loop surgical mask, and the Standard Surgical Mask is a tie-on surgical mask. The color of the proposed devices is blue. They are provided in non-sterile.

AI/ML Overview

This document describes the performance testing of a medical device, specifically a Standard Procedure Mask and a Standard Surgical Mask, to demonstrate substantial equivalence to a predicate device (K153496) for FDA 510(k) clearance.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

Name of the Test Methodology / Standard	Purpose	Acceptance Criteria	Reported Device Performance
Resistance to Penetration by Synthetic Blood	To evaluate the effectiveness of the test sample from possible exposure to blood and other body fluids.	No penetration at 120 mmHg	Pass at 120mmHg
Bacterial Filtration Efficiency (BFE)	To determine the bacterial filtration efficiency (BFE) of the test article.	$\ge 98%$	Average 98.61%
Particulate Filtration Efficiency (PFE)	To determine the Particle Filtration Efficiency.	$\ge 98%$	Average 98.58%
Differential Pressure (Breathability)	To determine the differential pressure, indicating how easily one can breathe through the mask.	$< 6.0 \text{ mm H2O/cm}^2$	Average 4.41 mm H2O/cm²
Flammability	To evaluate the flammability of the test sample.	Class I	Class I
Cytotoxicity (ISO 10993-5)	To assess if the device extract is cytotoxic.	Non-cytotoxic	Non-cytotoxic
Sensitization (ISO 10993-10)	To assess if the device extract is sensitizing.	Non-sensitizing	Non-sensitizing
Irritation (ISO 10993-10)	To assess if the device extract is irritating.	Non-irritating	Non-irritating

2. Sample Sizes and Data Provenance

Sample Sizes: The document does not explicitly state the sample sizes used for each of the non-clinical tests (e.g., number of masks tested for BFE, PFE, etc.). It only provides the average results for some tests.
Data Provenance: The tests were conducted to support a submission from Jiangsu Medplus Non-woven Manufacturer Co., Ltd. located in China. The data is from non-clinical laboratory testing performed on the physical samples of the medical masks. Since these are performance tests of a physical product, they are by definition prospective with respect to the testing itself, i.e., new samples are manufactured and then tested.

3. Number of Experts and Qualifications

This document describes non-clinical performance testing of a physical device (medical mask). Therefore, it does not involve human expert consensus for establishing ground truth or evaluating diagnostic performance. The "ground truth" here is based on the standardized test methods and their defined outcomes.

4. Adjudication Method

Not applicable. This is not a study requiring adjudication of expert opinions for ground truth. The tests are objective measurements based on standards.

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

No MRMC study was done. This document explicitly states: "No clinical study is included in this submission." The testing is purely non-clinical, focusing on the physical and performance characteristics of the mask. An MRMC study would be relevant for diagnostic imaging AI, where human readers interact with AI.

6. Standalone Performance

The reported performance data (BFE, PFE, Differential Pressure, etc.) represents the standalone performance of the device itself, as measured by standardized laboratory methods. It's important to note that "standalone" in this context refers to the device's inherent physical properties, not an "algorithm only without human-in-the-loop performance" typical of AI devices.

7. Type of Ground Truth Used

The "ground truth" for this device's performance is established by international and national standard test methodologies (e.g., ASTM F1862/F1862M-17, ASTM F2101-2019, ASTM F2299/F2299M-03, EN 14683:2019, 16 CFR 1610, ISO 10993 series). These standards define the procedures and acceptance criteria for classifying the mask's performance.

8. Sample Size for the Training Set

Not applicable. This device is a physical medical mask, not an AI/ML algorithm. Therefore, there is no "training set" in the context of machine learning. The "training" for the manufacturing process would be ensuring the production consistently meets quality standards, which is demonstrated by the non-clinical tests on production samples.

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

Not applicable. As stated above, this is not an AI/ML device requiring a "training set" with established ground truth labels by experts. The performance is assessed against established engineering and safety standards.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

February 10, 2021

Jiangsu Medplus Non-woven Manufacturer Co., Ltd. % Diana Hong General Manager Mid-Link Consulting Co.,Ltd P.O. Box 120-119 Shanghai. 200120 China

Re: K202605

Trade/Device Name: Standard Procedure Mask, Standard Surgical Mask Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: October 20, 2020 Received: November 19, 2020

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.

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)

K202605

Device Name

Standard Procedure Mask; Standard 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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K202605

510(k) Summary

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

1. Date of Preparation: 01/29/2021
1. Sponsor Identification

Jiangsu Medplus Non-woven Manufacturer Co., Ltd.

No.217 East Wencheng Road, Economic Development Zone, Siyang, Jiangsu, 223700, China

Contact Person: Shuying An Position: Product Manager Tel: +86-527-80300123 Fax: +86-527-80300123 Email: zongzhu@medplusgroup.com

Designated Submission Correspondent

Ms. Diana Hong (Primary Contact Person) Ms. Jing Cheng (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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4. Identification of Proposed Devices

Trade Name: Standard Procedure Mask; Standard Surgical 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:

Identification of Predicate Device

510(k) Number: K153496 Product Name: Disposable Surgical Face Mask

Summary of Non-Clinical Testing

The following performance data has been provided to demonstrate that the subject device meet the acceptance criteria in the standard.

Name of the TestMethodology / Standard	Purpose	Acceptance Criteria	Results
Resistance to Penetrationby Synthetic bloodASTM F1862/F1862M-17Standard Test Method for	The test was performed in accordance with ASTM F1862-17 Standard Test Method for Resistance of	No penetration at 120 mmHg	Pass at 120mmHg
Resistance of Medical	Medical Face Masks to Penetration by Synthetic Blood (Horizontal Projection of Fixed Volume at a Known Velocity) to evaluate the effectiveness of the test sample from possible exposure to blood and other body fluids
Bacterial FiltrationEfficiencyASTM F2101-2019Standard Test Method forEvaluating the BacterialFiltration Efficiency (BFE)of Medical Face MaskMaterials, Using aBiological Aerosol ofStaphylococcus aureus	The test was performed in accordance with ASTMF2101-19 Standard TestMethod for Evaluating theBacterial FiltrationEfficiency (BFE) of MedicalFace Mask Materials, using aBiological Aerosol ofStaphylococcus aureus todetermine the bacterialfiltration efficiency (BFE) ofthe test article.	$\ge98%$	Average 98.61%
Particulate FiltrationEfficiencyASTM F2299/F2299M-03(2017) Standard TestMethod for Determiningthe Initial Efficiency ofMaterial Used in medicalFace Masks to Penetrationby Particulates using LatexSpheres	The test was performed in accordance with ASTMF2299-03 (Reapproved2017) Standard Test Methodfor Determining the InitialEfficiency of Materials Usedin Medical Face Masks toPenetration by ParticulatesUsing Latex Spheres, todetermine the ParticleFiltration Efficiency.	$\ge98%$	Average 98.58%
Differential PressureEN 14683:2019 Medicalface masks- Requirementsand test methods	The test was performed in accordance with EN14683:2019 Medical facemasks-Requirements and testmethods, to determine thedifferential pressure.	$<6.0 mm H2O/cm2$	Average 4.41 mmH2O/cm²
Flammability	The test was performed in	Class I	Class I
the Flammability of	1610 STANDARD FOR
Clothing Textiles	THE FLAMMABILITY OF
Corrections	CLOTHING TEXTILES to
	evaluate the flammability of
	the test sample.

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1. Clinical Test Conclusion
  No clinical study is included in this submission.
Substantially Equivalent (SE) Comparison 8.

	Proposed Devices	Predicate Device	Remark
ITEM	K202605	K153496
Product Code	FXX	FXX	Same
Regulation No.	21 CFR 878.4040	21 CFR 878.4040	Same
Class	II	II	Same
Indication for Use	The device is 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, provided non-sterile.	The Disposable 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
Mask style	Flat pleated	Flat pleated	Same
Mask color	Blue	Blue	Same
Design Feature	Ear-loop or tie-on	Ear-loop or tie-on	Same
Dimension (mm)	175×95	175×95	Same
Level	Level 2	Level 2	Same
Fluid resistance	Pass at 120mmHg	Pass at 120mmHg	Same
Particulate efficiency level	≥98%	≥98%	Same
Bacterial filtration level	≥98%	≥98%	Same
Differential pressure	<6.0 mm H2O/cm²	4.2 mmH20/cm²	Different 1

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Flammability	Class 1	Class 1	Same
Label/Labeling	Complied with 21 CFR part 801	Complied with 21 CFR part 801	Same
Single use	Single use	Single use	Same
Ear strap	Polyester and spandex andSpunbonded nonwoven	Polyester and Spun-bondpolypropylene	Different 2
Nose clip	Plastic	Malleable aluminum wire	Different 2
Mask body	Spunbonded nonwoven and Melt-blown nonwoven fabric	Spun-bond polypropylene andMelt blown polypropylene filter	Different 2
Cytotoxicity	ISO 10993-5;Under the conditions of the study,the proposed device extract wasdetermined to be non - cytotoxic.	ISO 10993-5;Under the conditions of the study, the proposed deviceextract was determined to benon - cytotoxic.	Same
Sensitization	ISO 10993-10;Under the conditions of the study,the proposed device extract wasdetermined to be non-sensitizing.	ISO 10993-10;Under the conditions of the study, the proposed deviceextract was determined to benon-sensitizing.	Same
Irritation	ISO 10993-10;Under the conditions of the study,the proposed device extract wasdetermined to be non-irritating.	ISO 10993-10;Under the conditions of the study, the proposed deviceextract was determined to benon-irritating.	Same
Sterility	Non-sterile	Non-sterile	Same

Different 1- Differential pressure

The test result for different pressure for the proposed device is different from predicate devices. The differential pressure test standard has been updated to EN14683:2019, Annex C in ASTM F2100:2019. The differential pressure test of the proposed device was conducted according to EN14683:2019, Annex C, and the test result demonstrate that the differential pressure of the proposed device meet the requirements of level 2 specified in ASTM F2100:2019. Thus, this difference does not affect substantially equivalence between the proposed device and predicate devices.

Different 2- Patient Contacting Material

The patient contact material for the propose device is different from predicate devices. However, biocompatibility tests have been conducted on the propose 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 devices.

1. Conclusion

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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 K153496.

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.