Disposable Medical Mask

K214085 · Hubei Wanli Protective Products Co., Ltd. · FXX · Apr 6, 2022 · General, Plastic Surgery

Device Facts

• Record ID: K214085
• Device Name: Disposable Medical Mask
• Applicant: Hubei Wanli Protective Products Co., Ltd.
• Product Code: FXX · General, Plastic Surgery
• Decision Date: Apr 6, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4040
• Device Class: Class 2

Intended Use

The Disposable Medical 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, three-layer, flat-folded medical mask; features ear loops and nose clip. Outer/inner layers: non-woven spun-bond polypropylene; middle layer: melt-blown polypropylene filter. Nose clip: aluminum strip. Ear loops: spandex elastic. Device worn over mouth and nose to provide physical barrier against microorganisms, body fluids, and particulates. Used in clinical settings or general infection control. Single-use, non-sterile. Protects both patient and healthcare personnel; reduces exposure risk to blood and body fluids.

Clinical Evidence

No clinical data. Bench testing only. Compliance verified against ISO 10993-5 (cytotoxicity), ISO 10993-10 (irritation/sensitization), ASTM F2100, ASTM F1862 (fluid resistance), ASTM F2101 (BFE), ASTM F2299 (PFE), and 16 CFR 1610 (flammability). Results: BFE 99.9%, PFE >98%, Delta P <4.0 mmH2O/cm², fluid resistance pass at 120 mmHg.

Technological Characteristics

Three-layer non-woven polypropylene construction; melt-blown filter layer; aluminum nose clip; spandex ear loops. Dimensions: 175mm x 95mm. Non-sterile. ASTM F2100 Level 1. Biocompatible per ISO 10993-5/10.

Indications for Use

Indicated for use by patients and healthcare personnel to protect against transfer of microorganisms, body fluids, and particulate material; intended for infection control to reduce exposure to blood and body fluids.

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 Mask (K210150)

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). 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. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

April 6, 2022

Hubei Wanli Protective Products Co. Ltd % Ivy Wang Technical Manager Shanghai SUNGO Management Consulting Company Limited. Room 1401, Dongfang Building, 1500# Century Avenue Shanghai 200122 China

Re: K214085

Trade/Device Name: Disposable Medical Mask Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: February 28, 2022 Received: March 1, 2022

Dear Ivy 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.

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 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}------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

# Indications for Use

510(k) Number (if known)

K214085

Device Name Disposable Medical Mask

#### Indications for Use (Describe)

The Disposable Medical 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.

] 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 [e-mail]

"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}------------------------------------------------

# 510(K) Summary

<This summary of 510(K) safety and effectiveness information is being submitted in accordance with the requirement of 21 CFR 807.92 >

Date of summary prepared: 2021-11-30 A. Applicant: Name: Hubei Wanli Protective Products Co., Itd. Address: Yuanshi, Ganhe, Xiantao, Hubei, China Contact: Andy Wen Title: System Specialist Tel: [phone] Email: [e-mail]

Submission Correspondent: Primary contact: Ms. Ivy Wang Shanghai SUNGO Management Consulting Co., Ltd. Room 1401, Dongfang Building, 1500# Century Ave., Shanghai 200122, China Tel: [phone] Email: [e-mail] Secondary contact: Mr. Raymond Luo Room 1401, Dongfang Building, 1500# Century Ave., Shanghai 200122, China Tel: [phone] Email: [e-mail]

## B. Device:

Trade Name: Disposable Medical Mask Common Name: SURGICAL MASK Model: ear loops

Regulatory Information Classification Name: Surgical Face Mask Classification: Class II Product code: FXX Regulation Number: 878.4040 Review Panel: Surgical Apparel

## C. Predicate device:

K210150 Disposable Medical Mask Hubei Wanli Protective Products Co., Itd.

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

## D. Indications for use of the device:

The Disposable Medical 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.

# E. Device Description:

The Disposable Medical Masks are single use, three-layer, flat -folded masks with ear loops and nose clip. The Disposable Medical Masks are manufactured with three layers, the inner and outer layers are made of non-woven Spun-bond polypropylene, and the middle layer is made of melt blown polypropylene filter.

The ear loops are held in place over the users' mouth and nose by two strings welded to the facemask. The ear loops are made of 17cm spandex elastic strings(performance of the spandex elastic: Tensile strength> 100N; Elasticity≥2.8times; Breaking tension≥100N)

The nose clip in the layers of facemask is to allow the user to fit the facemask around their nose, which is not touch with the users' skin directly.

The Disposable Medical Masks will be provided in blue. The Disposable Medical Masks are sold non-sterile and are intended to be single use, disposable devices.

# F. Technological Characteristics Comparison Table

The proposed device is totally the same with the predicate device, only differ in the claim of ASTM LEVEL. Provided below is a comparison of the proposed device with the predicate device

| Device | Proposed Device | Predicate Device | Result |
|-----------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------|
| 510K # | | K210150 | - |
| Manufacturer | Hubei Wanli Protective Products Co., ltd. | Hubei Wanli Protective Products Co., ltd. | - |
| Model Name | Disposable Medical Mask | Disposable Medical Mask | Same |
| Classification | Class II Device, FXX (21 CFR878.4040) | Class II Device, FXX (21 CFR878.4040) | Same |
| Intend use | The Disposable Medical 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. | The Disposable Medical 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. | Same |
| Design Features | Ear Loops, Flat-pleated, 3 layers | Ear Loops, Flat-pleated, 3 layers | Same |

Table 1 General Comparison

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

| Materials | | Outer<br>layer<br>facing | Non-woven Spun-bond<br>Polypropylene | Non-woven Spun-bond<br>Polypropylene | Same |
|--------------------------------------------------------|--|--------------------------|----------------------------------------------------------------------------|----------------------------------------------------------------------------|--------------------------|
| | | Inner<br>layer<br>facing | Non-woven Spun-bond<br>Polypropylene | Non-woven Spun-bond<br>Polypropylene | Same |
| | | Filter layer | | Melt-blown Polypropylene | Melt-blown Polypropylene |
| | | Nose wire | | aluminum strip | aluminum strip |
| | | Ear loops | Spandex elastic | Spandex elastic | Same |
| Color | | | Blue | Blue | Same |
| Dimension (length) | | | 175mm±5mm | 175mm±5mm | Same |
| Dimension (width) | | | 95 mm±5mm | 95 mm±5mm | Same |
| OTC use | | | Yes | Yes | Same |
| Sterility | | | Non-Sterile | Non-Sterile | Same |
| Use | | | Single Use, Disposable | Single Use, Disposable | Same |
| ASTM F2100 Level | | | Level 1 | Level 2 | Different |
| Biocompatibility<br>(ISO10993) | | | Non-Cytotoxic, Non-Sensitizing,<br>Non-Irritating | Non-Cytotoxic, Non-Sensitizing,<br>Non-Irritating | Same |
| Fluid Resistance<br>Performance<br>ASTM F1862 | | | 32 out of 32 per lot pass at 120<br>mmHg, 3 non-consecutive lots<br>tested | 32 out of 32 per lot pass at 120<br>mmHg, 3 non-consecutive lots<br>tested | Same |
| Particulate<br>Filtration<br>Efficiency<br>ASTM F2299 | | | > 98% | > 98% | Same |
| Bacterial Filtration<br>Efficiency<br>ASTM F2101 | | | 99.9% | 99.9% | Same |
| Differential<br>Pressure (Delta P)<br>EN 14683 Annex C | | | < 4.0mmH2O/cm² | < 4.0mmH2O/cm² | Same |
| Flammability 16<br>CER 1610 | | | Class 1 | Class 1 | Same |

#### Different Analysis:

The proposed device has different ASTM LEVEL claim to the predicate device, but the performance testing was conducted and the test results showed that the proposed device can meet the requirements of ASTM F2100-19. Therefore, the difference do not affect the safety and effectiveness of the proposed device.

## G. Non-Clinical Test Conclusion

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

> ISO 10993-5: 2009 Biological Evaluation of Medical Devices -- Part 5: Tests For In Vitro Cytotoxicity

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

- > ISO 10993-10: 2010 Biological Evaluation of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization
- > ASTM F2100, Standard Specification for Performance of Materials Used In Medical Face Masks
- > ASTM F1862, Standard Test Method for Resistance of Medical Face Masks To Penetration by Synthetic Blood (Horizontal Projection of Fixed Volume At A Known Velocity);
- > EN 14683, Medical Face Masks-Requirements and Test Methods;
- A ASTM F2101, Standard Test Method for Evaluating the Bacterial Filtration Efficiency (BFE) Of Medical Face Mask Materials, Using A Biological Aerosol of Staphylococcus Aureus;
- A ASTM F2299, Standard test method for determining the initial efficiency of materials used in medical face masks to penetration by particulates using latex spheres;
- > 16 CFR 1610, Standard for the Flammability of clothing textiles;

| Test Methodology | Purpose | Acceptance Criteria:<br>ASTM F2100 Level 1 | Result |
|--------------------------------------|---------------------------------------------------------------------------------------------------------------|--------------------------------------------|------------------------------------------------------------------------|
| Fluid Resistance | | 29 out of 32 per lot pass<br>at 80 mmHg | Pass<br>32 out of 32 pass at 120 mmHg, 3 lots |
| Particulate<br>Filtration Efficiency | The purpose of the<br>performance testing is to<br>demonstrate the<br>functionality of the subject<br>device. | $\ge 95%$ | Pass<br>>98% |
| Bacterial Filtration<br>Efficiency | | $\ge 95%$ | Pass<br>99.9% |
| Differential<br>Pressure | | $<5.0mmH2O/cm²$ | Pass<br>$<4.0mmH2O/cm²$ |
| Flammability | | Class 1 | Pass<br>Class 1 |
| Cytotoxicity | The purpose of the testing<br>is to demonstrate the<br>safety of the subject<br>device. | Non-cytotoxic | Under the conditions of the<br>study, the device is<br>non-cytotoxic. |
| Irritation | | Non-irritating | Under the conditions of the<br>study, the device is<br>non-irritating. |
| Sensitization | | Non-sensitizing | Under the conditions of the<br>study, the device is<br>non-sensitizing |

## H. Clinical Test Conclusion

No clinical study is included in this submission.

#### l. Conclusion

The conclusions drawn from the nonclinical tests demonstrate that the subject device is as safe, as effective, and performs as well as or better than the legally marketed predicate device K210150.