Single-Use Surgical Mask

K201924 · Qiqihar Hengxin Medical Supplies, Ltd. · FXX · Mar 15, 2021 · General, Plastic Surgery

Device Facts

• Record ID: K201924
• Device Name: Single-Use Surgical Mask
• Applicant: Qiqihar Hengxin Medical Supplies, Ltd.
• Product Code: FXX · General, Plastic Surgery
• Decision Date: Mar 15, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4040
• Device Class: Class 2

Intended Use

The Single-Use Surgical Mask is intended to be worn to protect both the patient and healthcare personnel from the transfer of microorganisms, body fluids, and particulate material. The Single-Use Surgical Mask 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. Model: M and L, blue color, and Level 3 barrier level as ASTM F2100.

Device Story

Single-use, non-sterile, flat-pleated surgical mask; three-layer construction (inner/outer PP spun-bond non-woven, middle melt-blown non-woven); includes malleable aluminum nose piece for fit; secured via elastic ear loops. Intended for use in clinical settings by healthcare personnel and patients to provide a physical barrier against blood, body fluids, and particulates. Meets ASTM F2100 Level 3 barrier requirements. Device provides protection by filtering air and blocking fluid splashes; user adjusts nose piece for seal. No electronic components or software.

Clinical Evidence

No clinical data. Bench testing only: ASTM F1862 (synthetic blood penetration), ASTM F2299 (particulate filtration), ASTM F2101 (bacterial filtration), MIL-M-36954C (differential pressure), 16 CFR 1610 (flammability), and ISO 10993-5/10 (biocompatibility: cytotoxicity, irritation, sensitization).

Technological Characteristics

Three-layer non-woven construction: PP spun-bond (inner/outer), melt-blown (middle). Malleable aluminum nose piece. Elastic ear loops. ASTM F2100 Level 3 compliant. Non-sterile. No energy source or software.

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

• 3M High Fluid-Resistant Procedure Mask (K191355)

Submission Summary (Full Text)

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March 15, 2021

Qiqihar Hengxin Medical Supplies, Ltd. % Ray Wang General Manager Beijing Believe-Med Technology Service Co., Ltd. Rm.912, Building #15, XiYueHui, No.5, YiHe North Rd., FangShan District Beijing, Beijing 102401 China

Re: K201924

Trade/Device Name: Single-Use Surgical Mask Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: February 23, 2021 Received: February 26, 2021

Dear Ray 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.

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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 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 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.

For CAPT Elizabeth Claverie, M.S. 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) K201924

Device Name Single-Use Surgical Mask

Indications for Use (Describe)

The Single-Use Surgical Mask is intended to be worn to protect both the patient and healthcare personnel from the transfer of microorganisms, body fluids, and particulate material. The Single-Use Surgical Mask 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.

Model: M and L, blue color, and Level 3 barrier level as ASTM F2100

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

| <span></span> ☐ Prescription Use (Part 21 CFR 801 Subpart D) | <span></span> ☑ Over-The-Counter Use (21 CFR 801 Subpart C) |
|--------------------------------------------------------------|-------------------------------------------------------------|
|--------------------------------------------------------------|-------------------------------------------------------------|

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# 510(k) Summary

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.

The 510(k) Number: K201924

- 1. Date of Preparation:2021/03/13
- 2. Sponsor Identification

## Oigihar Hengxin Medical Supplies, Ltd.

10th Beijiang Road in Tiefeng Industrial Park, North Shuguang Ave. Tiefeng District, Qiqihar, Heilongjiang Province, China, 161000

Contact Person: Sihui Xiong Position: Commercial Manager Tel: [phone] Email: [e-mail]

- 3. Designated Submission Correspondent
Mr. Ray Wang

## Beijing Believe-Med Technology Service Co., Ltd.

Rm.912, Building #15, XiYueHui, No.5, YiHe North Rd., FangShan District, Beijing, 102401, China

Tel: [phone] Fax: [phone] Email: Ray.Wang(@believe-med.com

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#### 4. Identification of Proposed Device

Trade Name: Single-Use Surgical Mask Common Name: Surgical Face Mask Model(s): M, L

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

#### Indication for use Statement:

The Single-Use Surgical Mask is intended to be worn to protect both the patient and healthcare personnel from the transfer of microorganisms, body fluids, and particulate material. The Single-Use Surgical Mask 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. Model: M and L, blue color, and Level 3 barrier level as ASTM F2100.

## Device Description

The proposed device(s) are Blue color, and Flat Pleated type mask, utilizing Ear Loops' way for wearing, and they all have Nose Piece design for fitting the facemask around the nose.

The proposed device(s) are meet Level 3 requirements per ASTM F2100.

The proposed device(s) are manufactured with three layers, the inner and outer layers are made of PP spun-bond non-woven fabric, and the middle layer is made of Melt-blown non-woven fabric. The blue colorant is blue masterbatch.

The Single-Use Surgical Mask is held in place over the user's mouth and nose by two elastic ear loops welded to the facemask. The elastic ear loops are not made with Polypropylene fiber.

The nose piece contained in the proposed device(s) is in the layers of the facemask to allow the user to fit the facemask around their nose, which is made of malleable aluminum wire.

The proposed device(s) are sold non-sterile and are intended to be single-use, disposable devices.

There are two models included, Model M and L. The two models share the same indication for use, instruction for use, material used, and structure. The dimension, the model L is bigger than model M.

#### 5. Identification of Predicate Device(s)

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Predicate Device K191355 3M High Fluid-Resistant Procedure Mask 3M Health Care

- Summary of Non-Clinical Testing 6.
The following performance data has been provided to demonstrate that the subject device meet the acceptance criteria in the standard.

| Name of the Test<br>Methodology/standard | Purpose | Acceptance Criteria | Results |
|------------------------------------------|------------------------------------------------------------------|----------------------------|-----------------------------------------------------------------|
| ASTM F1862 | Resistance to penetration<br>by synthetic blood | 160 mm Hg | 160 mm Hg |
| ASTM F2299 | Sub-micron particulate<br>filtration efficiency at 0.1<br>micron | $\geq 98%$ | $\geq99.03%$ |
| ASTM F2101 | Bacterial Filtration<br>Efficiency | $\geq 98%$ | $\geq99.50%$ |
| MIL-M-36954C | Differential Pressure | $< 6.0 mm H_2O/cm^2$ | $\leq 5.1 mm H_2O/cm^2$ |
| 16 CFR 1610 | Flammability | Class 1 | Class 1 |
| ISO 10993-5 | Irritation | No irritation effect | Under the conditions<br>of the study, no<br>irritation effect |
| | Sensitization | No sensitization<br>effect | Under conditions of<br>the study, no<br>sensitization effect |
| ISO 10993-10 | Cytotoxicity | No cytotoxicity effect | Under the conditions<br>of the study, no<br>cytotoxicity effect |

- 7. Clinical Test Conclusion
No clinical study is included in this submission.

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#### Substantially Equivalent (SE) Comparison 8.

| ITEM | Proposed Device K201924 | Predicate Device K191355 | Remark | |
|--------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------|---------|
| Intended Use | The Single-Use Surgical Mask is intended to be worn to protect both the patient and healthcare personnel from the transfer of microorganisms, body fluids, and particulate material. The Single-Use Surgical Mask 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.<br>Model: M and L, blue color, and Level 3 barrier level as ASTM F2100. | The 3M High Fluid-Resistant Procedure 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 potential exposure to blood and body fluids. The face mask is single use, disposable device, provide non-sterile. | SAME | |
| Basic Design | Ear Loops, Flat Pleated, 3 layers | Ear Loops, Tie-On, Flat Pleated, 4 layers | Different | |
| Materials | Outer Facing Layer | Spun-bond non-woven fabric | Polypropylene Spunbond | Similar |
| | Insertion | Not Applicable | Polypropylene Spunbond | |
| | Middle Layer | Melt blown non-woven fabric | Polypropylene Melt blown | |
| | Inner Facing Layer | Spun-bond non-woven fabric | Polypropylene Thermal-bonded | |
| | Nose Piece | Malleable aluminum wire | Polyethylene Coated Steel | |
| | Ear Loops | Polyester | Spandex elastic cord (Polyurethane core with polyethylene terephthalate/nylon cover) | |
| Color | Blue | Green | Different | |
| Dimension (Length) | Model M: 14 cm ±1cm<br>Model L: 18 cm ±1cm | 6.9"±0.2" (17.5 cm±0.5cm) | Different | |
| Dimension (Width) | 9 cm +/- 1cm | 3.5"±0.3" (8.9 cm±0.8cm) | | |
| OTC use | Yes | Yes | SAME | |
| Single Use | Yes | Yes | SAME | |
| Sterile | No | No | SAME | |
| ASTM F2100 Level | Level 3 | Level 3 | SAME | |

Table 1 General Comparison

Table 2 Performance Characteristic Comparison

| ITEM | Proposed<br>Device<br>K201924 | Predicate<br>Device<br>K191355 | ASTM F2100<br>Requirements for<br>Level 3 Classification | Remark |
|-----------------------------------------------|-------------------------------|--------------------------------|----------------------------------------------------------|--------|
| Fluid Resistance<br>Performance ASTM<br>F1862 | 160 mmHg | 160 mmHg | 160 mmHg | SAME |
| Particulate Filtration | $\ge$ 99.03% | $\ge$ 98% | $\ge$ 98% | |

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| Efficiency<br>ASTM<br>F2299 | | | | |
|-----------------------------------------------------|-----------------|-----------------|-----------------|------|
| Bacterial Filtration<br>Efficiency ASTM<br>F2101 | ≥99.50% | ≥98% | ≥ 98% | |
| Differential Pressure<br>(Delta P) MIL-M-<br>36954C | ≤ 5.1 mmH2O/cm² | < 5.0 mmH2O/cm² | < 6.0 mmH2O/cm² | |
| Flammability<br>16 CFR 1610 | Class 1 | Class 1 | Class 1 | SAME |

#### Table 3 Biocompatibility Comparison

| ITEM | Proposed Device K201924 | Predicate Device K191355 | Remark |
|---------------|------------------------------------------------------------------------------|------------------------------------------------|--------|
| Cytotoxicity | Under the conditions of the study, not<br>cytotoxicity effect as ISO 10993-5 | Non-cytotoxic, Non-sensitizing, Non-irritating | SAME |
| Irritation | Under the conditions of the study, not an<br>irritant as ISO 10993-10 | | SAME |
| Sensitization | Under conditions of the study, not a<br>sensitizer as ISO 10993-10 | | SAME |

## Difference Analysis

The Single-Use Surgical Mask has the different with the predicate device (3M High Fluid-Resistant Procedure Mask) in Basic Design, Materials, Color and Dimension. But those differences are not critical to the intended use of the device and are not expected to affect the safety and effectiveness of the device when used as labeled based on the nonclinical tests performed.

#### 9. 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.