MIPLNI YK-244 Disposable Surgical Mask

K210487 · Hunan Yuankang Biological Technology Co., Ltd. · FXX · Mar 16, 2021 · General, Plastic Surgery

Device Facts

• Record ID: K210487
• Device Name: MIPLNI YK-244 Disposable Surgical Mask
• Applicant: Hunan Yuankang Biological Technology Co., Ltd.
• Product Code: FXX · General, Plastic Surgery
• Decision Date: Mar 16, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4040
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

Intended Use

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.

Device Story

Disposable surgical face mask; flat pleated design; blue color. Three-layer construction: inner/outer layers spunbond polypropylene; middle layer melt-blown polypropylene filter. Features metal-core plastic nose piece and elastic spandex ear loops. Used in clinical settings for infection control; worn by healthcare personnel and patients to provide barrier protection against blood, body fluids, and particulates. Single-use; non-sterile. Provides physical barrier; performance verified via ASTM F2100 Level 3 standards.

Clinical Evidence

No clinical data; bench testing only. Performance verified against ASTM F2100-19, ASTM F1862-13 (fluid resistance), ASTM F2299-03 (PFE), ASTM F2101-19 (BFE), EN 14683:2019 (breathability), 16 CFR 1610 (flammability), and ISO 10993-5/10 (biocompatibility).

Technological Characteristics

Three-layer construction: spunbond polypropylene (inner/outer), melt-blown polypropylene (middle). Metal-core plastic nose piece; spandex ear loops. Flat pleated form factor. Non-sterile. ASTM F2100 Level 3 compliant. Biocompatibility per ISO 10993-5 and ISO 10993-10.

Indications for Use

Indicated for use by patients and healthcare personnel to reduce exposure to microorganisms, body fluids, and particulate material during infection control practices.

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

• Disposable Surgical Face Mask (K153496)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image contains 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. Underneath the square are the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Hunan Yuankang Biological Technology Co., Ltd % Prithul Bom Most Responsible Person Regulatory Technology Services, LLC 1000 Westgate Drive, Suite 510k Saint Paul, Minnesota 55114

Re: K210487

Trade/Device Name: MIPLNI YK-244 Disposable Surgical Mask Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: February 16, 2021 Received: February 19, 2021

Dear Prithul Bom:

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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Ryan Ortega, Ph.D. Acting 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) K210487

Device Name MIPLNI YK-244 Disposable Surgical Mask

#### Indications for Use (Describe)

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.

| Type of Use (Select one or both, as applicable) | Own-Use Production of CFR 221 Subject Cigarettes Contract Production of CFR 221 Subject Cigarettes |
|-------------------------------------------------|----------------------------------------------------------------------------------------------------------------------|
|-------------------------------------------------|----------------------------------------------------------------------------------------------------------------------|

__ 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

## Administrative Information

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

Assigned 510(k) Number: K210487

Date of Preparation: 2021/3/8

The submitter's information is listed in the Table below:

| Submitter Information | |
|--------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Establishment | Hunan Yuankang Biological Technology Co., Ltd<br>Heping Team, Sanlian Community, Xidu Town<br>Hengyang, Hunan, CN 421000 |
| Registration Number | 3016752849 |
| Contact | Kylin Rui Chen<br>Director, Business Operations<br>Heping Team, Sanlian Community, Xidu Town<br>Hengyang, Hunan, CN 421000<br>Phone: [phone]<br>Fax: [phone]<br>Email: [e-mail] |
| Submission Correspondent | Kelvin Fei Chu<br>Regulatory Consultant<br>KMax Medtech Consulting<br>3109 Butte St,<br>Santa Clara, CA 95051<br>Phone: [phone]<br>Fax: [phone]<br>Email: [e-mail] |

Table Submitter information

The subject device's information is listed in the Table below:

| Subject Device Information | |
|----------------------------|----------------------------------------|
| Trade Name | MIPLNI YK-244 Disposable Surgical Mask |

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| Subject Device Information | |
|----------------------------|--------------------|
| Common Name | Surgical Face Mask |
| Product Code | FXX |
| Classification | Class II |
| Classification Name | Mask, Surgical |
| CFR Section # | 878.4040 |
| Review Panel | General Hospital |

Table Subject device information

The predicate device's information is listed in the Table below:

| Predicate Device Information | |
|------------------------------|------------------------------------------|
| Predicate 510(k) # | K153496 |
| Predicate Trade Name | Disposable Surgical Face Mask |
| Predicate Manufacturer | Xiantao Rayxin Medical Products Co., ltd |
| Predicate Product Code | FXX |

Table Predicate device information

#### Intended Use / Indications for Use

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.

#### Device Description

The subject device has been designed following the recommendations provided in Surgical Masks - Premarket Notification [510(k)] Submissions Guidance for Industry and FDA Staff (2004).

The subject device is a Blue color and Flat Pleated type mask, utilizing the Ear Loops for wearing, and has Nose Piece design for fitting the facemask around the nose.

The subject device is manufactured with three layers, the inner and outer layers are made of spunbond polypropylene, and the middle layer is made of melt blown polypropylene filters.

The subject device is 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.

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The nose piece contained in the subject device is in the layers of facemask to allow the user to fit the facemask around their nose, which is made of metal core plastic (aluminum metal core inside of polypropylene).

The subject device is sold non-sterile and is intended to be single use, disposable device.

### Summary of Non-Clinical Performance Testing

Non-clinical performance tests have been conducted to verify that the subject device meets all design requirements following standards and items recommended in Surgical Masks - Premarket Notification [510(k)] Submissions Guidance for Industry and FDA Staff (2004).

- . ASTM F2100-19, Standard Specification for Performance of Materials Used in Medical Face Masks
- ASTM F1862-13, Standard Test Method for Resistance of Medical Face Masks to ● Penetration by Synthetic Blood (Horizontal Projection of Fixed Volume at A Known Velocity).
- ASTM F2299-03, Stand 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 Medical Face Mask Materials, Using a Biological Aerosol of Staphylococcus aureus
- . EN 14683:2019+AC:2019 Medical face masks - Requirements and test methods Annex C Method for determination of breathability (differential pressure)
- 16 CFR 1610, Standard for The Flammability of Clothing Textiles. ●
- 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
- Bench Testing for the performance of Dimensions ●

The summary of non-clinical performance testing is listed below in Table.

| Test Item | Standards | Acceptance Criteria | Results |
|---------------------------------------------------|-------------------------------------|--------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Dimensions | - | Mask Layer:<br>Length: 17.5cm±0.5cm<br>Width: 9.5cm±0.5cm<br>Nose Piece:<br>3mm x 105 mm x | Pass |
| Test Item | Standards | Acceptance Criteria | Results |
| | | 0.5mm<br>Ear loop:<br>2.8mm in diameter,<br>195mm in length. | |
| ASTM F2100 Level | ASTM F2100-19 | Level 3 | Pass |
| Fluid Resistance<br>Performance | ASTM F1862 | 32 out of 32 pass<br>at 160 mmHg | Pass<br>LOT<br>#YKWK20201108:<br>32/32 at 160 mmHg<br>LOT<br>#YKWK20201111:<br>32/32 at 160 mmHg<br>LOT<br>#YKWK20201120:<br>32/32 at 160 mmHg |
| Particulate<br>Filtration Efficiency<br>(PFE) | ASTM F2299 | ≥ 98% | Pass<br>LOT<br>#YKWK20201108:<br>32/32 99.9% ±0.1%<br>LOT<br>#YKWK20201111:<br>32/32 99.9% ±0.1%<br>LOT<br>#YKWK20201120:<br>32/32 99.9% ±0.1% |
| Bacterial Filtration<br>Efficiency<br>(BFE) | ASTM F2101 | ≥ 98% | Pass<br>LOT<br>#YKWK20201108:<br>32/32 99.9%<br>LOT<br>#YKWK20201111:<br>32/32 99.9%<br>LOT<br>#YKWK20201120:<br>32/32 99.9% |
| Test Item | Standards | Acceptance Criteria | Results |
| Differential<br>Pressure<br>(Delta P) | EN<br>14683:2019+AC:2019<br>Annex C | < 5.0 mmH2O/cm² | Pass<br><br>LOT #YKWK20201108:<br>32/32 < 3.6 mm H2O /cm²<br>(20-22°C and 55-62% RH, Flow Rate: 8 L/min)<br><br>LOT #YKWK20201111:<br>32/32 < 4.0 mm H2O / cm²<br>(20-22°C and 55-62% RH, Flow Rate: 8 L/min)<br><br>LOT #YKWK20201120:<br>32/32 < 4.0 mm H2O /cm²<br>(20-22°C and 55-62% RH, Flow Rate: 8 L/min) |
| Flammability | 16 CFR 1610 | Class 1 | Pass<br><br>LOT #YKWK20201108:<br>32/32 IBE<br><br>LOT #YKWK20201111:<br>32/32 IBE<br><br>LOT #YKWK20201120:<br>32/32 IBE |
| In Vitro<br>Cytotoxicity | ISO 10993-5 | Non-cytotoxic | Pass |
| Skin Irritation | ISO 10993-10 | Non-irritating | Pass |
| Test Item | Standards | Acceptance Criteria | Results |
| Skin Sensitization | ISO 10993-10 | Non-sensitizing | Pass |
| Table Summary of non-clinical performance testing | | | |

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# Summary of Clinical Performance Test

No clinical study is included in this submission.

## Comparison of Technological Characteristics with Predicate Device

A summary of the technological characteristics of the subject device as compared to the predicate device is listed below in Table.

| Device | Subject Device | Predicate Device | Comparison |
|-----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| 510 (k) # | K210487 | K153496 | - |
| Manufacturer | Hunan Yuankang Biological<br>Technology Co., Ltd | Xiantao Rayxin Medical<br>Products Co., ltd. | - |
| Product Name | Disposable Surgical Face Mask | Disposable Surgical Face Mask | Same |
| Classification | Class II Device, FXX<br>(21 CFR878.4040) | Class II Device, FXX<br>(21 CFR878.4040) | Same |
| Intended use | The Disposable Surgical Face<br>Masks are intended to be worn<br>to protect both the patient and<br>healthcare personnel from<br>transfer of microorganisms,<br>body fluids and particulate<br>material. These face masks are<br>intended for use in infection<br>control practices to reduce the<br>potential exposure to blood and<br>body fluids. This is a single use,<br>disposable device(s), provided<br>non-sterile. | The Disposable Surgical Face<br>Masks are intended to be worn<br>to protect both the patient and<br>healthcare personnel from<br>transfer of microorganisms,<br>body fluids and particulate<br>material. These face masks are<br>intended for use in infection<br>control practices to reduce the<br>potential exposure to blood and<br>body fluids. This is a single<br>use, disposable device(s),<br>provided non-sterile. | Same |
| | Material & Design | | |
| Outer facing<br>layer | Spun-bond polypropylene | Spun-bond polypropylene | Same |

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| Device | Subject Device | Predicate Device | Comparison |
|------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| Middle layer | Melt blown polypropylene filter | Melt blown polypropylene filter | Same |
| Inner facing layer | Spun-bond polypropylene | Spun-bond polypropylene | Same |
| Nose piece | Metal core plastic<br>(aluminum metal core inside of polypropylene) | Malleable aluminum wire | Similar |
| Ear loops | Spandex | Polyester | Similar |
| Design features | Color: Blue<br>Ear loops | Color: Blue<br>Ear Loops or Tie-On | Similar |
| Mask Style | Flat Pleated | Flat Pleated | Same |
| Specification and<br>Dimension | Length: 17.5cm±0.5cm<br>Width: 9.5cm±0.5cm | Length: 17.5cm±1cm<br>Width: 9.5cm±1cm | Similar |
| Usage | | | |
| OTC use | Yes | Yes | Same |
| Sterility | Non-Sterile | Non-Sterile | Same |
| Use | Single Use, Disposable | Single Use, Disposable | Same |
| Performance Testing | | | |
| ASTM F2100<br>Level | Level 3 | Level 2 | Better |
| | 32 out of 32 pass<br>at 160 mmHg<br>(ASTM F1862) | 32 out of 32 pass<br>at 120 mmHg<br>(ASTM F1862) | Better |
| Fluid Resistance<br>Performance | LOT #YKWK20201108: 32/32<br>at 160 mmHg<br>LOT #YKWK20201111: 32/32<br>at 160 mmHg<br>LOT #YKWK20201120: 32/32<br>at 160 mmHg | | |
| Device | Subject Device | Predicate Device | Comparison |
| Particulate<br>Filtration<br>Efficiency (PFE) | ≥ 98%<br>(ASTM F2299) | ≥ 98%<br>(ASTM F2299) | Same |
| | LOT #YKWK20201108: 32/32<br>99.9% ±0.1% | | |
| | LOT #YKWK20201111: 32/32<br>99.9% ±0.1% | | |
| | LOT #YKWK20201120: 32/32<br>99.9% ±0.1% | | |
| | | | |
| Bacterial<br>Filtration<br>Efficiency<br>(BFE) | ≥ 98%<br>(ASTM F2101) | ≥ 98%<br>(ASTM F2101) | Same |
| | LOT #YKWK20201108: 32/32<br>99.9% | | |
| | LOT #YKWK20201111: 32/32<br>99.9% | | |
| | LOT #YKWK20201120: 32/32<br>99.9% | | |
| | | | |
| Differential<br>Pressure<br>(Delta P) | < 5.0 mmH2O/cm2<br>(EN 14683:2019+AC:2019<br>Annex C) | < 5.0 mmH2O/cm2<br>(MIL-M-36954C) | Same |
| | LOT #YKWK20201108: 32/32<br>< 3.6 mm H2O / cm2<br>(20-22°C and 55-62% RH, Flow<br>Rate: 8 L/min) | | |
| | LOT #YKWK20201111: 32/32<br>< 4.0 mm H2O / cm2<br>(20-22°C and 55-62% RH, Flow<br>Rate: 8 L/min) | | |
| | LOT #YKWK20201120: 32/32<br>< 4.0 mm H2O / cm2<br>(20-22°C and 55-62% RH, Flow<br>Rate: 8 L/min) | | |
| | | | |
| Device | Subject Device | Predicate Device | Comparison |
| Flammability | Class 1<br>(16 CFR 1610) | Class 1<br>(16 CFR 1610) | Same |
| | LOT #YKWK20201108: 32/32<br>IBE | | |
| | LOT #YKWK20201111: 32/32<br>IBE | | |
| | LOT #YKWK20201120: 32/32<br>IBE | | |
| | Biocompatibility Testing | | |
| In Vitro<br>Cytotoxicity | Under the conditions of the<br>study, the subject device extract<br>was determined to be non-<br>cytotoxic. (ISO 10993-5) | Under the conditions of the<br>study, the predicate device<br>extract was determined to be<br>non-cytotoxic. (ISO 10993-5) | Same |
| Skin Irritation | Under the conditions of the<br>study, the subject device non-<br>polar and polar extracts were<br>determined to be non-irritating.<br>(ISO 10993-10) | Under the conditions of the<br>study, the predicate device non-<br>polar and polar extracts were<br>determined to be non-irritating.<br>(ISO 10993-10) | Same |
| Skin Sensitization | Under the conditions of the<br>study, the subject device non-<br>polar and polar extracts were<br>determined to be non-<br>sensitizing. (ISO 10993-10) | Under the conditions of the<br>study, the predicate device non-<br>polar and polar extracts were<br>determined to be non-<br>sensitizing. (ISO 10993-10) | Same |

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Table Comparison of the subject device and the predicate device

## Substantially Equivalent (SE) 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.