Single-use medical face mask

K210391 · Zhuhai Herald Datanetics Limited. · FXX · Jul 22, 2021 · General, Plastic Surgery

Device Facts

• Record ID: K210391
• Device Name: Single-use medical face mask
• Applicant: Zhuhai Herald Datanetics Limited.
• Product Code: FXX · General, Plastic Surgery
• Decision Date: Jul 22, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4040
• Device Class: Class 2

Intended Use

The Single-use 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, provided non-sterile.

Device Story

Single-use, non-sterile, flat-pleated medical face mask; three-layer construction (spunbonded non-woven outer/inner layers, melt-blown non-woven middle filter layer); features nose clip (PE-coated tin-plate wire) and elastic ear loops (spandex, latex-free). Used in clinical or general settings to provide barrier protection against blood, body fluids, and particulates. User secures mask over nose and mouth via ear loops and adjusts nose clip for fit. Device acts as physical barrier; performance verified against ASTM F2100 Level 3 standards. Benefits include reduced risk of cross-contamination between patients and healthcare personnel.

Clinical Evidence

No clinical data. Bench testing only. Performance verified via ASTM F1862 (Fluid Resistance: 160 mmHg), ASTM F2299 (Particulate Filtration Efficiency: 98.79%), ASTM F2101 (Bacterial Filtration Efficiency: 99.87%), MIL-M-36954C (Differential Pressure: 4.7 mmH2O/cm²), and 16 CFR 1610 (Flammability: Class 1). Biocompatibility confirmed via ISO 10993-1 testing (Cytotoxicity, Irritation, Sensitization).

Technological Characteristics

Three-layer non-woven construction (spunbonded/melt-blown/spunbonded); PE-coated tin-plate wire nose clip; spandex ear loops. Dimensions: 175mm x 95mm. Non-sterile, single-use. Meets ASTM F2100 Level 3, ASTM F2101, and ISO 10993 standards.

Indications for Use

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

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

• DemeMASK Surgical Mask (K201479)

Submission Summary (Full Text)

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July 22, 2021

Zhuhai Herald Datanetics Limited. % Cassie Lee Manager Share Info (Guangzhou) Medical Consultant Ltd. No. 1919-1920, Building D3, Minjie Plaza, Shuixi Road Huangpu District Guangzhou, Guangdong 510700 China

Re: K210391

Trade/Device Name: Single-use medical face mask Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: June 11, 2021 Received: June 17, 2021

Dear Cassie Lee:

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.

Clarence W. Murray, III, PhD 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) K210391

Device Name

Single-use medical face mask (Model: HD0969)

Indications for Use (Describe)

The Single-use medical face mask is intended to be worn to protect 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, provided nonsterile.

| 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)

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## 510(k) Summary

# 510(k) Summary

This summary of 510(K)is being submitted in accordance with the requirement of 21 CFR 807.92.

Subject Device: Single-use medical face mask (Model: HD0969) 510(k) Number: K210391

#### 1. Date of the summary prepared: July 22, 2021

#### 2. Submitter's Information

510(k) Owner's Name: Zhuhai Herald Datanetics Limited. Establishment Registration Number: Applying Address: Building#2, No.1 Pingxi Road 6, Nanping Science and Technology Industrial Park, Zhuhai, Guangdong, China Contact Person: Jackson Leung Email: [e-mail]

#### Application Correspondent:

Contact Person: Ms. Cassie Lee Share Info (Guangzhou) Medical Consultant Ltd. Address: No. 1919-1920, Building D3, Minjie Plaza, Shuixi Road, Huangpu District, Guangzhou, China Tel: [phone] Email: [e-mail]

## 3. Subject Device Information

Type of 510(k): Traditional Classification Name: Surgical Face Mask Trade Name: Single-use medical face mask Model Name: HD0969 Review Panel: Surqical Apparel Product Code: FXX Requlation Number: 878.4040 Requlatory Class: 2

## 4. Predicate Device Information

Sponsor: DemeTECH Corporation Trade Name: DemeMASK Surgical Mask Classification Name: Surgical Face Mask 510(K) Number: K201479 Review Panel: Surgical Apparel Product Code: FXX Regulation Number: 878.4040 Regulation Class: 2

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## 5. Indications for Use

The Single-use 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, provided non-sterile,

## 6. Device Description

The Single-use medical face mask is flat pleated style mask, utilizing ear loops way for wearing, and they all has nose clip design for fitting the face mask around the nose.

The proposed device(s) are manufactured with three layers, the inner and outer facing layers are made of spunbonded non-woven, and the middle layer is made of melt-blown non-woven the model of proposed device, ear loops, is held in place over the users' mouth and nose by two elastic ear loops welded to the face mask. The elastic ear loops are not made with natural rubber latex.

The nose clip contained in the proposed device(s) is in the layers of face mask to allow the user to fit the mask around their nose, which is made of PE coated Tin-plate wire.

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

| Elements of<br>Comparison | Subject Device | Predicate Device | Result | |
|---------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------|-------------------|
| Company | Zhuhai Herald Datanetics Limited. | DemeTECH Corporation | -- | |
| 510 (k) Number | K210391 | K201479 | -- | |
| Trade Name | Single-use medical face mask | DemeMASK Surgical Mask | -- | |
| Classification<br>Name | Surgical Face Mask | Surgical Face Mask | Same | |
| Classification | Class II Device, FXX (21<br>CFR 878.4040) | Class II Device, FXX (21<br>CFR 878.4040) | Same | |
| Indication for<br>use | The Single-use medical face mask is<br>intended to be worn to protect both<br>the patient and healthcare personnel<br>from transfer of microorganisms,<br>body fluids, and particulate material.<br>These face masks are intended for<br>use in infection control practices to<br>reduce the potential exposure to<br>blood and body fluids. This is a<br>single-use, disposable device,<br>provided non-sterile. | The Disposable Surgical Face<br>Masks are intended to be worn to<br>protect both the patient and<br>healthcare personnel from transfer of<br>microorganisms, body fluids and<br>particulate material. These face<br>masks are intended for use in<br>infection control practices to reduce<br>the potential exposure to blood and<br>body fluids. This is a single use,<br>disposable device provided<br>nonsterile. | Same | |
| Material | Outer<br>facing<br>layer | Spun-bonded non-woven | Spun-bond polypropylene | Similar<br>Note 1 |
| | Middle<br>layer | Melt-Blown non-woven | Melt blown polypropylene filter | Similar<br>Note 1 |
| | Inner<br>facing | Spun-bonded non-woven | Spun-bond polypropylene | Similar<br>Note 1 |

## 7. Summary of Technological Characteristics

Provided below is a comparison of the subject device and predicate device

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| Elements of<br>Comparison | | Subject Device | Predicate Device | Result |
|-----------------------------------------|--------------|-----------------------------|--------------------------------------------------------------|-------------------|
| | layer | | | |
| | Nose<br>clip | PE coated Tin-plate wire | Galvanized wire coated with<br>polyethylene | Similar<br>Note 1 |
| | Ear<br>loops | Spandex | Spandex and Nylon - Not<br>made from natural rubber<br>latex | Similar<br>Note 1 |
| Color | | white + blue | Not Applicable | Similar<br>Note 1 |
| Dimensions | | 175mm×95mm | Length: 17.5 cm±1 cm<br>Width: 9.5 cm±1 cm | Similar<br>Note 1 |
| OTC use | | Yes | Yes | Same |
| Sterility | | Non-Sterile | Non-Sterile | Same |
| Use | | Single Use, Disposable | Single Use, Disposable | Same |
| ASTM F2100<br>Level | | Level 3 | Level 3 | Same |
| Fluid Resistance<br>Performance | | Pass at 160 mmHg | Pass at 160 mmHg | Same |
| Particulate<br>Filtration<br>Efficiency | | ≥ 98% | Pass at ≥99% | Similar<br>Note 2 |
| Bacterial<br>Filtration<br>Efficiency | | ≥ 98% | Pass at ≥99% | Similar<br>Note 2 |
| Differential<br>Pressure | | On average of 4.7 mmH2O/cm2 | Average 3.6 mmH2O/cm2 | Similar<br>Note 2 |
| Flammability | | Class 1 | Class 1 | Same |

#### Comparison in Detail(s): Note 1:

Although the "Material" "Color" and "Dimensions" of subject device are slightly difference with predicate device, it meets the requirement standard ASTM F2100, ASTM F2101, and ISO 10993. Note 2:

Although the "Particulate Filtration Efficiency", "Bacterial Filtration Efficiency" and "Differential Pressure" of subject device is a little different from the predicate device, and they all meet the requirements of essential performance standard ASTM F2100.

Summary of Non-Clinical Performance Testing Performance Testing summary

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| Test Methodology | Purpose | Acceptance Criteria<br>for Level 3 | Test Results |
|--------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------|------------------------------------|---------------------------------------------------------|
| Fluid Resistance Performance<br>(mmHg)<br>ASTM F1862 | In order to verify whether the subject<br>equipment meets the performance<br>requirements of ASTM F2100 level 3. | Pass at 160mmHg | PASS<br>Average of 3<br>batch numbers:<br>160mmHg |
| Particulate Filtration Efficiency<br>Performance (%)<br>ASTM F2299 | In order to verify whether the subject<br>equipment meets the performance<br>requirements of ASTM F2100 level 3. | ≥ 98% | PASS<br>Average of 3<br>batch numbers:<br>98.79% |
| Bacterial Filtration Efficiency<br>Performance (%)<br>ASTM F2101 | In order to verify whether the subject<br>equipment meets the performance<br>requirements of ASTM F2100 level 3. | ≥ 98% | PASS<br>Average of 3<br>batch numbers:<br>99.87% |
| Differential Pressure (Delta-P)<br>(mmH2O/cm²)<br>MIL-M-36954C | In order to verify whether the subject<br>equipment meets the performance<br>requirements of ASTM F2100 level 3. | <6.0 mmH2O/cm² | PASS<br>Average of 3<br>batch numbers:<br>4.7 mmH2O/cm² |
| Flammability Class<br>16 CFR 1610 | In order to verify whether the subject<br>equipment meets the performance<br>requirements of ASTM F2100 level 3. | Class 1 | PASS<br>Class 1 |

# Biocompatibility Testing Summary:

According to ISO 10993-1: 2018, the nature of body contact for the subject device is the Surface Device category, Skin Contact, and duration of the contact is A-Limited (<24 h). The following tests for the subject device were conducted to demonstrate that the subject device is biocompatible and safe for its intended use:

| Test Item | Proposed device | Result |
|---------------|------------------------------------------------------------------------------------------------------------------------------|--------|
| Cytotoxicity | Under the conditions of the study, the subject device extract was determined to<br>be non-cytotoxic. | PASS |
| Irritation | Under the conditions of the study, the subject device non-polar and polar extracts<br>were determined to be non-irritating. | PASS |
| Sensitization | Under the conditions of the study, the subject device non-polar and polar extracts<br>were determined to be non-sensitizing. | PASS |

## 8. Summary of Clinical Performance Test

No clinical study is included in this submission.

## 9. Final Conclusion

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