The Kangbeier Child Surgical Mask is intended to be worn by the patient (ages 5-10) to cover the nose and mouth to provide a barrier for the respiratory tract for microorganisms and particulate materials. The Kangbeier Child Surgical Mask is a single use, disposable device, provided non-sterile. This Face Mask is recommended for use in a healthcare setting with appropriate adult supervision.

Device Description

The Kangbeier Child Surgical Mask is composed of three layers of materials and pleated to form the mask. The inner layer is composed of spun-bond nonwoven polypropylene, the middle layer is meltblown polypropylene filter material, and the outer layer is spunbond nonwoven polypropylenen. The color on the outer layer is consists of Phthalocyanine Blue and PE wax and PP. Masks are held in place on wearer with elastic spun-bond polypropylene earloop and contain a malleable aluminum nosepiece strip.

The Kangbeier Child Surgical Mask is appropriately sized to the smaller faces of children across a diverse population.

The Kangbeier Child Surgical Mask is a single use, disposable device, provided nonsterile with no shelf-life. Storage conditions will not affect device safety of effectiveness. All of the materials used in this device are typical materials commonly used in the construction of Surgical Masks and are being used in current legally marketed devices.

AI/ML Overview

The provided text is a 510(k) Summary for the Kangbeier Child Surgical Mask. It demonstrates the device's substantial equivalence to a predicate device, K160100, "Prestige Ameritech Pediatric/Child's Face Mask."

Here's the breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria (Standard)	Predicate Device Performance	Subject Device Performance	Comparison Summary
Particulate Filtration Efficiency at 0.1 microns	≥98%	≥98%	Same
Bacterial Filtration Efficiency (BFE)	96.32%	≥98%	Similar (Subject Device better)
Differential Pressure (Delta P, mm H2O/cm²)	<6.0	<6.0	Same
Flammability Class (16 CFR Part 1610)	Class I	Class I	Same
Resistance to penetration by synthetic blood (minimum pressure in mmHg for pass result)	≥ 160 mmHg	≥ 160 mmHg	Same
Biocompatibility (ISO 10993-1, ISO 10993-5, ISO 10993-10)	Conforming	Conforming	Same
Intended Use	Child (recommended ages 4-12) to provide protection for the respiratory tract. Single use, disposable, non-sterile. Healthcare setting with appropriate adult supervision.	Child (ages 5-10) to cover nose and mouth as a barrier for microorganisms and particulate materials. Single use, disposable, non-sterile. Healthcare setting with appropriate adult supervision.	Similar (Age range of Subject Device is smaller)
Suitable Population	Child (ages 4-12)	Child (ages 5-10)	Similar (Age range of Subject Device is smaller)
Intended Use Sites	Healthcare setting	Healthcare setting	Same
Product Code, Device Class, and Regulation	OXZ, Class II, 21 CFR 878.4040	OXZ, Class II, 21 CFR 878.4040	Same
Mask Construction and Technological Features	Ultrasonic bonding, three layers (nonwoven and meltblown polypropylene), decorative patterns, knitted polyester/spandex elastic earloop, malleable aluminum nosepiece.	Three layers (spun-bond nonwoven polypropylene, meltblown polypropylene, spun-bond nonwoven polypropylene), phthalocyanine blue, PE wax, PP color on outer layer, elastic spun-bond polypropylene earloop, malleable aluminum nosepiece.	Same (described materials are typical for surgical masks and similar in function)
Performance Standards Met	ASTM F2100, ASTM F1862, ASTM F2299, ASTM F2101, 16 CFR Part 1610, Mil M36954 C, CPSC-CH-E1002-08, CPSC-CH-E1001-09, EN71-3	ASTM F2100, ASTM F1862, ASTM F2299, ASTM F2101, 16 CFR Part 1610, EN 14683:2019, CPSC-CH-E1002-08, CPSC-CH-E1001-09, EN71-3	Same (with EN 14683:2019 being specific to the subject device and Mil M36954 C specific to the predicate, but overall performance standards are comparable)

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

The document does not explicitly state the sample sizes used for each performance test. It only mentions that the device "has been tested under the following standards." The provenance of the data (country of origin, retrospective or prospective) is also not specified.

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

This information is not provided in the document. The tests performed are primarily laboratory-based physical and biological performance tests, not human-reader-based assessments requiring expert ground truth establishment in the traditional sense.

4. Adjudication Method for the Test Set:

Not applicable. The tests are scientific measurements against established standards, not judgmental interpretations requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance:

Not applicable. This device is a physical surgical mask, not an AI-based diagnostic or assistive technology.

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.

7. The Type of Ground Truth Used:

For the performance metrics, the "ground truth" is defined by the objective measurement criteria within the listed ASTM, EN, and CFR standards. For example:

Particulate Filtration Efficiency: Measured electronically against documented particulate sizes.
Bacterial Filtration Efficiency: Measured using a biological aerosol of Staphylococcus aureus.
Differential Pressure: Measured as resistance to airflow.
Flammability: Measured according to defined burn rate criteria.
Resistance to Penetration by Synthetic Blood: Measured by resistance to a fluid challenge at specified pressure.
Biocompatibility: In vitro cytotoxicity and irritation/sensitization tests as per ISO 10993 standards.

These are all objective, laboratory-derived measurements rather than expert consensus, pathology, or outcomes data in a clinical context.

8. The Sample Size for the Training Set:

Not applicable. This document describes a physical medical device, not a machine learning model that requires a training set.

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

Not applicable.

Summary

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December 21, 2023

Image /page/0/Picture/1 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 seal on the left and the FDA acronym along with the full name of the agency on the right. The FDA acronym is in a blue square, and the full name "U.S. Food & Drug Administration" is in blue text.

Xinxiang Kangbeier Medical Technology Co., Ltd. Shaoju Tian East Mancun Industrial District Changyuan, Henan 453400 China

Re: K221753

Trade/Device Name: Kangbeier Child Surgical Mask Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: OXZ Dated: December 6, 2023 Received: December 6, 2023

Dear Shaoju Tian:

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 (the 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 available 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

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Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.70) and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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,

Katherine D. Kavlock -S

for

Brent Showalter, Ph.D. Assistant Director DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

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Indications for Use

510(k) Number (if known) K221753

Device Name Kangbeier Child Surgical Mask

Indications for Use (Describe)

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

Research Use (Part 21 CFR 361. Subject to Phase 1)	Same Tier Comparator (21 CFR 361. Subject to Phase 1)
------------------------------------------------------------------	---------------------------------------------------------------------

__ Prescription Use (Part 21 CFR 801 Subpart D)

|X | Over-The-Counter Use (21 CFR 801 Subpart C)

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Section 5: 510(k) Summary:

This summary of 510k safety and effectiveness information is being submitted In accordance with the requirements of 21CFR 807.92

5.1 Submitter & Foreign Manufacture Identification

Xinxiang Kangbeier Medical Technology Co., Ltd. East Mancun Industrial District, Changyuan, Henan 453400 , China Tel: 13341254319 Submitter's FDA Registration Number: N/A

5.2 Contact Person

Name: Shaoju Tian Company: Blue Land Michigan Inc. Address: 5830 E 2nd St Ste 8 Casper, WY 82609 USA Tel: 86 13341254319 Email: technology@med-bridges.com

5.3 Date of Summary: December 6, 2023

5.4		Device Name:
-----	--	--------------

Proprietary Name:	Kangbeier Child Surgical Mask
Common Name:	Child Surgical Mask
Classification Name:	Pediatric/Child Facemask
Device Classification:	II
Regulation Number:	21 CFR 878.4040
Panel:	General Hospital
Product Code:	OXZ

ર.5 Predicate Device Information:

K160100, "Prestige Ameritech Pediatric/Child's Face Mask", (1) manufactured by "Prestige Ameritech"

5.6 Device Description:

The Kangbeier Child Surgical Mask is appropriately sized to the smaller faces of

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children across a diverse population.

5.7 Indications for Use:

5.8 Testing Summary:

To prove the safety and effectiveness of the Kangbeier Child Surgical Mask , we tested the device according to corresponding standards. Those tests include performance tests and biocompatibility tests.

The Kangbeier Child Surgical Mask has been tested under the following standards:

ASTM F2100-20 Standard Specification for Performance of Materials Used in Medical Face Masks

ASTM F1862-17 Standard Test Method for Resistance of Surgical Mask to Penetration by Synthetic Blood

ASTM F2299(2017) Test Method for Determining the Initial Efficiency of Materials Used in Medical Face Masks to Penetration by Particulates Using Latex Spheres

ASTM F2101-19 Standard Test Method for Evaluating the Bacterial Filtration

Efficiency (BFE) of surgical masks using a Biological Aerosol of Staphylococcus aureus 16 CFR Part 1610 Standard for the flammability of clothing textiles

EN 14683:2019,Annex C Medical Fask Masks-Requirements and Test Methods CPSC-CH-E1002-08 Total Lead Content Analysis

CPSC-CH-E1001-09.4 Standart Operating Procedure for Determination of Phthalates EN71-3:2019 Safety of Toys-Migration of certain 19 elements

ISO 10993-1, Biological evaluation of medical devices -- Part 1: Evaluation and testing within a risk management process

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

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5.9 Comparison with Predicate Device

The following table shows similarities and differences between our device and the predicate devices.

Table 5.1: Comparison

Characteristic	Subject Device	K160100 (Predicate)	Comparison
Particulate FiltrationEfficiency at 0.1 microns	≥98%	≥98%	Same
Bacterial Filtration	≥98%	96.32%	Similar(SubjectDevice betterthan PredicateDevice )
Differential Pressure(Delta P, mmH2O/cm2)	<6.0	<6.0	Same
Flammability Class, 16 CFRPart 1610	Class I	Class I	Same
Resistance to penetration bysynthetic blood(minimum pressure in mmHg forpass result)	≥ 160mmHg	≥ 160mmHg	Same
Biocompatibility	ISO 10993-1ISO 10993-5ISO 10993-10	ISO 10993-1ISO 10993-5ISO 10993-10	Same
Intended Use	The Kangbeier Child SurgicalMask is a single use, disposabledevice, provided non-sterile. TheKangbeier Child Surgical Mask isintended to be worn by thepatient (ages 5-10) to cover thenose and mouth to provide abarrier for the respiratory tractfor microorganisms andparticulate materials. This FaceMask is recommended for use ina healthcare setting withappropriate adultsupervision.	The Prestige AmeritechPediatric/Child Face Mask isintended to be worn bythepatient/child(recommendedages 4-12) to provideprotection for the respiratorytract. The Pediatric/Child'sFace Mask is a single use,disposable device, providednon-sterile with no shelf- life.Storage conditions will notaffect device safety ofeffectiveness. This Face Maskis recommended for use in ahealthcare setting withappropriate adultsupervision.	Similar (Theage range ofSubject Deviceis smaller thanPredicateDevice)
Suitable population	Child(ages5-10)	Child(ages4-12)	Similar (Theage range ofSubject Deviceis smaller thanPredicateDevice)
Intended Use Sites	Healthcare setting	Healthcare setting	Same
Product Code, Device Class, andRegulation	OXZ, Class IIMask, surgical (21 CFR878.4040)	OXZ, Class IIMask, Surgical (21 CFR878.4040)	Same
Mask Construction andTechnological Features	The Kangbeier ChildSurgical Mask	The Prestige AmeritechPediatric/Childs Face Mask
	The Kangbeier ChildSurgical Mask is composedof three layers of materialsand pleated to form themask. The inner layer iscomposed of spun-bondnonwoven polypropylene,the middle layer ismeltblown polypropylenefilter material, and theouter layer is spun-bondnonwoven polypropylenen.The color on the outerlayer is consists ofPhthalocyanine Blue and PEwax and polypropylene.Masks are held in place onwearer with elastic spun-bond polypropyleneearloop and contain amalleable aluminumnosepiece strip.The Kangbeier ChildSurgical Mask isappropriately sized to thesmaller faces of childrenacross a diversepopulation.The Kangbeier Child SurgicalMask is a single use, disposabledevice, provided non-sterilewith no shelf-life. Storageconditions will not affectdevice safety of effectiveness.All of the materials used in thisdevice are typical materialscommonly used in theconstruction of Surgical Masksand are being used in currentlegally marketed devices	The Prestige AmeritechPediatric/Childs Face Maskis manufactured usingultrasonic bonding,composed of three layersof materials and pleated toform the mask. The deviceis composed of nonwovenand meltblownpolypropylene filtermaterial.Decorative patterns areprinted with colored inks.Masks are held in place onwearer with knittedpolyester/spandex elasticearloop and contain amalleable aluminumnosepiece strip. ThePediatric/Child's FaceMask is appropriately sizedto the smaller faces ofchildren across a diversepopulation. ThePediatric/Child's Face Mask isa single use, disposabledevice, provided non-sterilewith no shelf- life. Storageconditions will not affectdevice safety oreffectiveness. All of thematerials used in this deviceare typical materialscommonly used in theconstruction of SurgicalMasks and are being used incurrent legally marketeddevices. This product is notmade with natural rubberlatex.	Same
Performance Standards	ASTM F2100ASTM F1862ASTM F2299ASTM F210116 CFR Part 1610EN 14683:2019CPSC-CH-E1002-08CPSC-CH-E1001-09	ASTM F2100ASTM F1862ASTM F2299ASTM F210116 CFR Part 1610Mil M36954 CCPSC-CH-E1002-08CPSC-CH-E1001-09	Same

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	EN71-3	EN71-3
--	--------	--------	--

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The above table shows that the performance is same or very similar between the subject and predicate device. The subject device is as safe and effective, and its performance meets the requirements of its pre-defined acceptance criteria and intended use.

5.10 Substantial Equivalence Conclusion

Based on the comparison of intended use, design and performance, Kangbeier Child Surgical Mask manufactured by "Xinxiang Kangbeier Medical Technology Co., Ltd." Is substantial equivalent to its predicate devices.

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.