Kangbeier Child Surgical Mask

K221753 · Xinxiang Kangbeier Medical Technology Co., Ltd. · OXZ · Dec 21, 2023 · General, Plastic Surgery

Device Facts

• Record ID: K221753
• Device Name: Kangbeier Child Surgical Mask
• Applicant: Xinxiang Kangbeier Medical Technology Co., Ltd.
• Product Code: OXZ · General, Plastic Surgery
• Decision Date: Dec 21, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4040
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

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 Story

Single-use, disposable surgical mask; designed for children ages 5-10. Composed of three layers: inner spun-bond nonwoven polypropylene, middle meltblown polypropylene filter, outer spun-bond nonwoven polypropylene. Features elastic earloops and malleable aluminum nosepiece. Used in healthcare settings; worn by pediatric patients under adult supervision. Provides physical barrier against microorganisms and particulate matter. Performance verified via bench testing against ASTM and EN standards.

Clinical Evidence

Bench testing only. Performance evaluated per ASTM F2100-20, ASTM F1862-17 (synthetic blood penetration), ASTM F2299 (particulate filtration), ASTM F2101-19 (bacterial filtration), 16 CFR Part 1610 (flammability), and EN 14683:2019. Biocompatibility testing conducted per ISO 10993-1, -5, and -10. Results demonstrate compliance with performance requirements.

Technological Characteristics

Three-layer pleated mask: spun-bond nonwoven polypropylene (inner/outer), meltblown polypropylene (filter). Includes elastic spun-bond polypropylene earloops and aluminum nosepiece. Non-sterile, single-use. Tested to ASTM F2100-20, ASTM F1862-17, ASTM F2299, ASTM F2101-19, 16 CFR 1610, EN 14683:2019, CPSC-CH-E1002-08, CPSC-CH-E1001-09.4, EN71-3:2019, ISO 10993-1, -5, -10.

Indications for Use

Indicated for children ages 5-10 to cover nose and mouth as a respiratory barrier against microorganisms and particulates in healthcare settings under adult supervision.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Prestige Ameritech Pediatric/Child's Face Mask (K160100)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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)

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.

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

| <span></span> Research Use (Part 21 CFR 361. Subject to Phase 1) | <span></span> 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: [phone] 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: [phone] Email: [e-mail]

#### 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 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

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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..

#### 5.7 Indications for Use:

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.

#### 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 Filtration<br>Efficiency at 0.1 microns | ≥98% | ≥98% | Same |
| Bacterial Filtration | ≥98% | 96.32% | Similar<br>(Subject<br>Device better<br>than Predicate<br>Device ) |
| Differential Pressure(Delta P, mm<br>H2O/cm2) | <6.0 | <6.0 | Same |
| Flammability Class, 16 CFR<br>Part 1610 | Class I | Class I | Same |
| Resistance to penetration by<br>synthetic blood<br>(minimum pressure in mmHg for<br>pass result) | ≥ 160<br>mmHg | ≥ 160<br>mmHg | Same |
| Biocompatibility | ISO 10993-1<br>ISO 10993-5<br>ISO 10993-10 | ISO 10993-1<br>ISO 10993-5<br>ISO 10993-10 | Same |
| Intended Use | The Kangbeier Child Surgical<br>Mask is a single use, disposable<br>device, provided non-sterile. The<br>Kangbeier Child Surgical Mask is<br>intended to be worn by the<br>patient (ages 5-10) to cover the<br>nose and mouth to provide a<br>barrier for the respiratory tract<br>for microorganisms and<br>particulate materials. This Face<br>Mask is recommended for use in<br>a healthcare setting with<br>appropriate adult<br>supervision. | The Prestige Ameritech<br>Pediatric/Child Face Mask is<br>intended to be worn by<br>the<br>patient/child(recommended<br>ages 4-12) to provide<br>protection for the respiratory<br>tract. The Pediatric/Child's<br>Face Mask is a single use,<br>disposable device, provided<br>non-sterile with no shelf- life.<br>Storage conditions will not<br>affect device safety of<br>effectiveness. This Face Mask<br>is recommended for use in a<br>healthcare setting with<br>appropriate adult<br>supervision. | Similar (The<br>age range of<br>Subject Device<br>is smaller than<br>Predicate<br>Device) |
| Suitable population | Child(ages5-10) | Child(ages4-12) | Similar (The<br>age range of<br>Subject Device<br>is smaller than<br>Predicate<br>Device) |
| Intended Use Sites | Healthcare setting | Healthcare setting | Same |
| Product Code, Device Class, and<br>Regulation | OXZ, Class II<br>Mask, surgical (21 CFR<br>878.4040) | OXZ, Class II<br>Mask, Surgical (21 CFR<br>878.4040) | Same |
| Mask Construction and<br>Technological Features | The Kangbeier Child<br>Surgical Mask | The Prestige Ameritech<br>Pediatric/Childs Face Mask | |
| | The Kangbeier Child<br>Surgical Mask is composed<br>of three layers of materials<br>and pleated to form the<br>mask. The inner layer is<br>composed of spun-bond<br>nonwoven polypropylene,<br>the middle layer is<br>meltblown polypropylene<br>filter material, and the<br>outer layer is spun-bond<br>nonwoven polypropylenen.<br>The color on the outer<br>layer is consists of<br>Phthalocyanine Blue and PE<br>wax and polypropylene.<br>Masks are held in place on<br>wearer with elastic spun-<br>bond polypropylene<br>earloop and contain a<br>malleable aluminum<br>nosepiece strip.<br><br>The Kangbeier Child<br>Surgical Mask is<br>appropriately sized to the<br>smaller faces of children<br>across a diverse<br>population.<br><br>The Kangbeier Child Surgical<br>Mask is a single use, disposable<br>device, provided non-sterile<br>with no shelf-life. Storage<br>conditions will not affect<br>device safety of effectiveness.<br>All of the materials used in this<br>device are typical materials<br>commonly used in the<br>construction of Surgical Masks<br>and are being used in current<br>legally marketed devices | The Prestige Ameritech<br>Pediatric/Childs Face Mask<br>is manufactured using<br>ultrasonic bonding,<br>composed of three layers<br>of materials and pleated to<br>form the mask. The device<br>is composed of nonwoven<br>and meltblown<br>polypropylene filter<br>material.<br>Decorative patterns are<br>printed with colored inks.<br>Masks are held in place on<br>wearer with knitted<br>polyester/spandex elastic<br>earloop and contain a<br>malleable aluminum<br>nosepiece strip. The<br>Pediatric/Child's Face<br>Mask is appropriately sized<br>to the smaller faces of<br>children across a diverse<br>population. The<br>Pediatric/Child's Face Mask is<br>a single use, disposable<br>device, provided non-sterile<br>with no shelf- life. Storage<br>conditions will not affect<br>device safety or<br>effectiveness. All of the<br>materials used in this device<br>are typical materials<br>commonly used in the<br>construction of Surgical<br>Masks and are being used in<br>current legally marketed<br>devices. This product is not<br>made with natural rubber<br>latex. | Same |
| Performance Standards | ASTM F2100<br>ASTM F1862<br>ASTM F2299<br>ASTM F2101<br>16 CFR Part 1610<br>EN 14683:2019<br>CPSC-CH-E1002-08<br>CPSC-CH-E1001-09 | ASTM F2100<br>ASTM F1862<br>ASTM F2299<br>ASTM F2101<br>16 CFR Part 1610<br>Mil M36954 C<br>CPSC-CH-E1002-08<br>CPSC-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.