The medical surgical mask is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. It 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.

Device Description

The medical surgical mask is single use, three-layer, flat-pleated style with ear loops and nose piece. The mask is manufactured with three layers, the inner and outer layers are made of nonwoven fabrics, and the middle layer is made of melt blown fabrics. The ear loops are held in place over the users' mouth and nose by two elastic ear loops welded to the facemask. The elastic ear loops are not made with natural rubber latex. The nose piece in the layers of facemask is to allow the user to fit the facemask around their nose, which is made of galvanized iron wire. The disposable medical face mask will be provided in blue. The masks are sold non-sterile and are intended to be single use, disposable devices.

AI/ML Overview

The provided text describes the performance criteria and testing for a Medical Surgical Mask to demonstrate its substantial equivalence to a predicate device.

Here's the breakdown of the acceptance criteria and study details:

1. Table of Acceptance Criteria and Reported Device Performance:

Item	Acceptance Criteria	Reported Device Performance
Bacterial filtration efficiency (BFE) (%)	≥98%	32/32 Passed at ≥98%
Differential pressure (Delta-P)	<6.0 mmH₂O/cm²	32/32 Passed <6 mmH₂O/cm² / Pass
Sub-micron particulate filtration efficiency (PFE) at 0.1 micron, %	≥98%	32/32 Passed at ≥98% / Pass
Resistance to penetration by synthetic blood (Minimum pressure for pass result)	29 of 32 test articles passed at 120mmHg / 160mmHg (This implies meeting 120mmHg or 160mmHg dependent on requirement)	32 of 32 test articles passed at 120mmHg, 160mmHg
Flame spread	Class 1	32/32 Passed ≥3 seconds burn Time-Class 1 / Pass
Shelf life	2 years	Pass
Biocompatibility: In vitro Cytotoxicity	Pass (Implied by "were conducted to demonstrate that the subject device is biocompatible and safe")	Biocompatible and safe
Biocompatibility: Skin Sensitization Tests	Pass (Implied by "were conducted to demonstrate that the subject device is biocompatable and safe")	Biocompatible and safe
Biocompatibility: Skin Irritation Tests	Pass (Implied by "were conducted to demonstrate that the subject device is biocompatible and safe")	Biocompatible and safe

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

Sample Size: For performance tests, the number of samples varied by test:
- Bacterial filtration efficiency: 32 samples
- Differential pressure: 32 samples
- Sub-micron particulate filtration efficiency: 32 samples
- Resistance to penetration by synthetic blood: 32 samples
- Flame spread: 32 samples
Data Provenance: The document does not explicitly state the country of origin of the data or whether it was retrospective or prospective. It only refers to "Non-Clinical Test Conclusion."

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

Not Applicable: For this type of medical device (surgical mask), the "ground truth" is established through standardized laboratory testing against objective criteria, not through expert consensus or interpretation of medical images. The tests listed are objective physical and microbiological measurements.

4. Adjudication Method for the Test Set:

Not Applicable: As the "ground truth" is established by standardized test methods with objective pass/fail criteria, an adjudication method in the sense of multiple expert reviews is not relevant. The results are based on the direct output of the specified ASTM and EN standards.

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 device is a physical surgical mask and does not involve AI or human "readers" interpreting data. Therefore, an MRMC study is not relevant.

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

Not Applicable: This device is a physical surgical mask and does not involve an algorithm or AI.

7. The Type of Ground Truth Used:

The ground truth for the performance criteria is based on standardized laboratory test methods (e.g., ASTM F2101-19, EN 14683:2019, ASTM F2299-03, ASTM F1862M-17, 16 CFR Part 1610, ISO 10993-1/5/10). These methods define objective parameters and thresholds for acceptable performance.

8. The Sample Size for the Training Set:

Not Applicable: This device is a physical product, not an AI or machine learning model, so there is no "training set."

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

Not Applicable: As there is no training set for a physical device, this question is not applicable.

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 - USA 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.

November 26, 2021

Henan Huibo Medical Co.,Ltd. Boyle Wang Official Correspondent Shanghai Truthful Information Technology Co., Ltd. RM.608, No.738, Shangcheng Rd., Pudong Shanghai, Shanghai 200120 China

Re: K202842

Trade/Device Name: Medical surgical mask Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: October 15, 2021 Received: October 20, 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.

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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 mediation-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 Ouality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K202842

Device Name Medical surgical mask

Indications for Use (Describe)

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

510k number: K202842

Date: Oct.14, 2021

This summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of SMDA 1990 and 21 CFR 807.92.

1.0 Submitter's information

Name: Henan Huibo Medical Co.,Ltd. Address: Weishi Road Central, Nanyang New Energy Economic and Technological Development Zone, 473000 Nanyang City, Henan Province, China Phone Number: 86-400-600-0067 Fax number: 86-377-60180999 Contact: Ms. Hui Lu Date of Preparation: Sep.17, 2020

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 Device information

Trade name: Medical Surqical mask Common name: Surgical mask Classification name: Mask, Surgical Model(s): Ear loop, 17.5×9.5cm

3.0 Classification

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

4.0 Predicate device information

Manufacturer: Wuhan Dymex Healthcare Co., Ltd Device: Surqical Face Mask 510(k) number: K182515

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5.0 Indication for Use Statement

6.0 Device description

7.0 Non-Clinical Test Conclusion

The proposed device was tested and conformed to the related recognized 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.

Item	Test method	Pass Criteria	Results
Bacterial filtrationefficiency (BFE) (%)	ASTM F2101-19Standard TestMethod for Evaluating the BacterialFiltration	≥98%	32/32 Passed at≥98%
Different pressure(Delta-P)	EN 14683: 2019, Annex C Medicalface masks - Requirements andtest methods according toASTM F2100:2019	<6.0 mmH2O/cm²	32/32 Passed<6 mmH2O/cm²/ Pass
Sub-micronparticulate filtrationefficiency at 0.1micron, % (PFE)	ASTM F2299-03 Standard TestMethod for Determining the InitialEfficiency of Materials Used inMedical Face Masks to Penetrationby Particulates Using LatexSpheres according to ASTMF2100:2019	≥98%	32/32 Passed at≥98% / Pass
Resistance topenetration by	ASTM F1862M-17 Standard TestMethod for Resistance of Medical	29 of 32 testarticles passed at	32 of 32 testarticles passed

Table 1 - Performance Testing Summary

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synthetic blood,Minimum pressure inmmHg for pass result	Face Masks to Penetration bySynthetic Blood (HorizontalProjection of Fixed Volume at aKnown Velocity) according to ASTMF2100:2019	120mmHg/160mmHg	at 120mmHg,160mmHg
Flame spread	16 CFR Part 1610 Standard for theFlammability of Clothing accordingto ASTM F2100:2019	Class 1	32/32 Passed ≥3seconds burnTime-Class 1 /Pass
Shelf life	Method of accelerated aging under55°C for 80 days	2 years	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: 1) 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.

8.0 _Clinical Test Conclusion

No clinical study implemented for the Medical surgical mask.

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	Medical surgical mask	Surgical Face Mask	-
510(k) No.	K202842	K182515	-
Models	Ear loop, 17.5×9.5cm	Ear loop	same
Intended Use	The medical surgical mask isintended to be worn to protectboth the patient andhealthcare personnel fromtransfer of microorganisms,body fluids and particulatematerial. It is intended for usein infection control practices	The Surgical Face Masksare intended to be worn toprotect both the patient andhealthcare personnel fromtransfer of microorganisms,body fluids and particulatematerial. These face masksare intended for use in	same

9.0 Technological Characteristic Comparison Table

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		to reduce the potentialexposure to blood and bodyfluids. This is a single use,disposable device(s),provided non sterile.	infection control practices toreduce the potentialexposure to blood and bodyfluids. This is a single use,disposable device(s),provided non-sterile.
	OTC use	Yes	Yes	same
Composite		Flat Pleated, 3 layers	Flat Pleated, 3 layers	same
Material	Internal layer	Spun-bond polypropylene	Spun-bond polypropylene	same
	Middle layer	Melt blown polypropylene	Melt blown polypropylene	same
	External layer	Spun-bond polypropylene	Spun-bond polypropylene	same
	Nose piece	monofilament	Malleable polyethylenewire	* Different 1
	Ear loop	spandex	spandex	same
	Color	Blue	Yellow	* Different 2
Dimension (Length)		$17.5cm\pm5%cm$	$17.5cm\pm0.2cm$	* similar 3
Dimension (Width)		$9.5cm\pm5%cm$	$9.5cm\pm0.2cm$	* similar 4
Sterility		Non-Sterile	Non-Sterile	same
Single Use		Yes	Yes	same
Sterile		No	No	same
ASTM F2100 Level		Level 2 / Level 3	Level 2	* different 5
Shelf life		2 years	No identified	* different 6

Gap analysis:

Different 1-2: the two devices have some difference in material and product color, product materials safety is proved by its bio-compatibility, and the difference does not raise additional questions for safety and effectiveness of device.

Different 3-4: the two devices share same dimensions otherwise the tolerance is different, the little deviation in tolerance does not raise additional questions for safety and effectiveness of device.

Different 5: the proposed device comply to level 3 at the same time, has better performance than the predicated device, the performance of proposed device is supported by its performance test, the difference does not raise additional questions for safety and effectiveness of device.

Different 6: the proposed device define its 2 years shelf life and verified, the equivalence device did not its shelf life, compared with the equivalence, defined shelf life of the proposed device can have lower potential risks of over shelf life use.

10.0 Conclusion

The conclusion drawn from the nonclinical tests demonstrates that the subject device

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in 510(K) submission K202842, the Medical surgical mask is as safe, as effective, and performs as well as or better than the legally marketed predicate device cleared under K182515.

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.