Disposable Medical Face Mask

K220487 · Hubei Mediunion Medical Products Co., Ltd. · FXX · Apr 26, 2022 · General, Plastic Surgery

Device Facts

• Record ID: K220487
• Device Name: Disposable Medical Face Mask
• Applicant: Hubei Mediunion Medical Products Co., Ltd.
• Product Code: FXX · General, Plastic Surgery
• Decision Date: Apr 26, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4040
• Device Class: Class 2

Intended Use

The Disposable Medical Face Mask 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(s), provided non-sterile.

Device Story

Disposable medical face mask; three-layer construction (inner/outer spunbond polypropylene, middle meltblown polypropylene); includes nose clip (metal strip with PP covering) and ear loops (nylon/spandex) or tie-on straps. Single-use, non-sterile device. Used in clinical settings by healthcare personnel and patients to provide barrier protection against blood, body fluids, and particulates. Provides physical barrier; reduces potential for cross-contamination. No electronic or software components.

Clinical Evidence

No clinical data. Bench testing only. Performance verified against ASTM F1862 (synthetic blood penetration), ASTM F2101 (Bacterial Filtration Efficiency), ASTM F2100 (material performance), and 16 CFR Part 1610 (flammability). Biocompatibility confirmed via ISO 10993-5 (cytotoxicity) and ISO 10993-10 (irritation/sensitization).

Technological Characteristics

Three-layer non-woven polypropylene construction; ear loops (nylon/spandex) or tie-on straps; metal nose clip with PP covering. Dimensions: 175mm x 95mm. ASTM F2100 Level 2 performance. Non-sterile. No energy source, software, or connectivity.

Indications for Use

Indicated for use by healthcare personnel and patients 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 Medical Surgical Face Mask (K202211)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG ADMINISTRATION' in blue text.

April 26, 2022

Hubei Mediunion Medical Products Co., Ltd. Jason Sheen Vice President No.1 ChuangYe Road, Zhongling Industrial Zone, Pengchang Town Xiantao. Hubei 433000 China

Re: K220487

Trade/Device Name: Disposable Medical Face Mask Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: February 9, 2022 Received: February 22, 2022

Dear Jason Sheen:

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

{1}------------------------------------------------

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,

Brent L. 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

Enclosure

{2}------------------------------------------------

# Indications for Use

510(k) Number (if known) K220487

Device Name Disposable Medical Face Mask

#### Indications for Use (Describe)

The Disposable Medical Face Mask 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(s), provided non-sterile.

| 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)

#### CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

#### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

# Section 3-510(k) summary

# I Submitter

| Device submitter: Hubei Mediunion Medical Products Co., Ltd. |
|----------------------------------------------------------------|
| No.1 Chuang Ye Road, Zhongling Industrial Zone, Pengchang Town |
| Xiantao city, Hubei province, China |

- Contact person: Jason Sheen Vice President Phone: [phone] E-mail: [e-mail] Date Prepared: April 25, 2022
# II Proposed Device

| Trade/Device Name: | Disposable medical face mask |
|--------------------|------------------------------|
| Regulation Number: | 21 CFR 878.4040 |
| Regulation Name: | Surgical Apparel |
| Regulatory Class: | Class II |
| Product code: | FXX |

# III Predicate Devices

| 510(k) Number: | K202211 |
|--------------------|---------------------------------------|
| Trade/Device Name: | Disposable Medical Surgical Face Mask |
| Regulation Number: | 21 CFR 878.4040 |
| Regulation Name: | Surgical Apparel |
| Classification: | Class II |
| Product Code: | FXX |
| Manufacturer | Guangdong Kaidi Garments Co.,Ltd |

# IV Device description

The Disposable medical face mask is designed for single-use and should be disposed of properly after one wear.

The Disposable medical face mask is divided into three layers, the inner and outer layers of the mask are made of Spunbond polypropylene, and the middle layer is made of Meltblown polypropylene. The mask contains ear loops or ear straps to secure the mask over the users' mouth and face and includes a nose clip to provide a firm fit over the nose. Ear loops are made of Nylon and Spandex, and tie strings are made of PP non-woven cloth,the nose clip is made of Metal strip covered with PP covering.

{4}------------------------------------------------

This is a single use, disposable device(s), provided non-sterile.

# V Indication for use

The Disposable Medical Face Mask is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. The Disposable medical face mask 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.

# VI Non-Clinical Test Conclusion

Non-clinical tests were conducted to verify that the proposed device met all design specifications as was same/similar to the predicate devices. The test results demonstrated that the proposed device complies with the following standards:

- A 16 CFR Part 1610 Standard for the Flammability of Clothing Textiles;
- A ASTM F1862/F1862M-17 Standard Test Method for Resistance of Medical Face Masks to Penetration by Synthetic Blood (Horizontal Projection of Fixed Volume at a Known Velocity)
- A ASTM F2101: 2019 Standard Test Method for Evaluating the Bacterial Filtration Efficiency (BFE) of Medical Face Mask Materials, Using a Biological Aerosol of Staphylococcus aureus
- A ASTM F2100: 2019 Standard Specification for Performance of Materials Used in Medical Face Masks
- EN 14683: 2019. Annex C. Medical face masks- Requirements and test methods >
- A ISO 10993-5:2012 Biological evaluation of medical device- Part 12: Sample preparation and reference materials
- A ISO 10993-10:2010 Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization

# VII Clinical Test Conclusion

No clinical study is included in this submission.

# VIII Summary of Technological characteristics

Table 1 Comparison of Disposable Medical face Mask

| Item | Subject device | Predicate device | Discussion | |
|-----------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------|
| Product name | Disposable medical face<br>mask | Disposable Medical<br>Surgical Face Masks | NA | |
| 510K number | | K202211 | NA | |
| Product Code | FXX | FXX | identical | |
| Intended use | The Disposable Medical<br>Face Mask is intended to<br>be worn to protect both the | The disposable medical<br>surgical face masks are | identical | |
| | | | | |
| | patient and healthcare<br>personnel from transfer of<br>microorganisms, body<br>fluids and particulate<br>material. The Disposable<br>Medical Face Mask is<br>intended for use in<br>infection control practices<br>to reduce the potential<br>exposure to blood and<br>body fluids. This is a<br>single use, disposable<br>device(s), provided<br>non-sterile. | intended to be worn to<br>protect both the patient<br>and healthcare personnel<br>from transfer of<br>microorganisms,body<br>fluids and particulate<br>material.These face masks<br>are intended for use in<br>infection control practices<br>to reduce the potential<br>exposure to blood and<br>body fluids.This is a single<br>use,disposable<br>device(s),provide<br>non-sterile. | | |
| ASTM F2100Level | Level 2 | Level 2 | identical | |
| Design feature | ear loop or tie-on | ear loop | Similar | |
| Color | Blue | Blue | identical | |
| Dimension | 175mmx95mm | 175mmx95mm | identical | |
| Sterility | Non-Sterile | Non-Sterile | identical | |
| Use | Single Use, Disposable | Single Use, Disposable | identical | |
| Particulate<br>filtration<br>efficiency | 3 non-consecutive lots<br>tested, using a sample size<br>of 32/lot.<br>Lot 1: 99.926%<br>Lot 2: 99.93%<br>Lot 3: 99.936% | 3 non-consecutive lots<br>tested, using a sample size<br>of 32/lot.<br>Lot 1: 99.68%<br>Lot 2: 99.56%<br>Lot 3: 99.81% | Similar | |
| Bacterial filtration<br>efficiency | 3 non-consecutive lots<br>tested, using a sample size<br>of 32/lot.<br>Lot 1: ≥99%<br>Lot 2: ≥99%<br>Lot 3: ≥99% | 3 non-consecutive lots<br>tested, using a sample size<br>of 32/lot.<br>Lot 1: 99.9%<br>Lot 2: 99.9%<br>Lot 3: 99.9% | Similar | |
| Differential pressure | 3 non-consecutive lots<br>tested, using a sample size<br>of 32/lot. | 3 non-consecutive lots<br>tested, using a sample size<br>of 32/lot. | Similar | |
| | | | | |
| | | Lot 2: <5 mm H2O/cm 2<br>Lot 3: <5 mm H2O/cm 2 | Lot 2: 3.6 mm H2O/cm 2<br>Lot 3: 3.7 mm H2O/cm 2 | |
| Flammability | | Class1, 3 non-consecutive<br>lots tested, using a sample<br>size of 32/lot. | Class1, 3 non-consecutive<br>lots tested, using a sample<br>size of 32/lot. | identical |
| | | | | |
| | | | | |
| Fluid resistance | | pass at 120 mmHg | 32 out of 32 per lot pass at<br>120 mmHg, 3<br>non-consecutive lots tested | Similar |
| | | | | |
| | | | | |
| Label/Labeling | | Complied with 21 CFR<br>part 801 | Complied with 21 CFR<br>part 801 | identical |
| | | | | |
| Patient Contacting Material | Inner and<br>Outer layers | Spunbond polypropylene | Spun-bond nonwoven<br>fabric | Different |
| | Middle layer | Meltblown polypropylene | Melt blown non-woven<br>fabric | Different |
| | Nose clip | Iron wire covered with PP<br>covering or aluminum<br>wire covered with PP<br>covering | PE and iron wire | Different |
| | Ear loops | Urethane elastic fiber or<br>spunbond polypropylene | Nylon and Spandex | Different |
| | Biocompatibility | ISO 10993-5 and<br>ISO10993-10;<br>Under the conditions of<br>thestudy, the proposed<br>deviceextract was<br>determined to<br>benon-cytotoxic,<br>non-sensitizing,and<br>non-irritating | ISO 10993-5 and<br>ISO10993-10;<br>Under the conditions of<br>thestudy, the proposed<br>deviceextract was<br>determined to<br>benon-cytotoxic,<br>non-sensitizing,and<br>non-irritating. | identical |
| | | | | |
| | | | | |
| | | | | |
| | | | | |

{5}------------------------------------------------

{6}------------------------------------------------

Different - Patient Contacting Material

The patient contacting material for the proposed device is different from the two predicate devices. However, biocompatibility test has been performed on the proposed device and the results does not show any adverse effect. Thus, this difference will not affect the safety and effectiveness between the proposed device and the two predicate devices.

# IX Conclusion

The proposed device has the same the intended use as the predicate device. It presents similar technological characteristics as the predicate device including the performance

{7}------------------------------------------------

parameters and biocompatibility. The non-clinical testing demonstrates that the device is as safe, as effective and performs as well as the legally marketed device.