Disposable Medical Surgical Mask

K210348 · Weihai Dishang Medical Technology Co., Ltd. · FXX · Oct 24, 2021 · General, Plastic Surgery

Device Facts

• Record ID: K210348
• Device Name: Disposable Medical Surgical Mask
• Applicant: Weihai Dishang Medical Technology Co., Ltd.
• Product Code: FXX · General, Plastic Surgery
• Decision Date: Oct 24, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4040
• Device Class: Class 2

Intended Use

The "Disposable Medical 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 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.

Device Story

Disposable flat-pleated surgical mask; three-layer construction (spunbond polypropylene outer/inner layers, meltblown polypropylene filter layer); features ear loops (knitted nylon/spandex) and integrated nose clip (synthetic iron wire, PP, PE). Used in clinical settings/infection control; worn by healthcare personnel and patients. Provides physical barrier against microorganisms, body fluids, and particulates. Single-use, non-sterile; no face shield; no natural rubber latex.

Clinical Evidence

No clinical data. Bench testing only. Performance testing (n=3 lots, 32 samples/lot) confirmed compliance with ASTM F2100-19: BFE ≥98%, PFE ≥98%, differential pressure <6.0 mmH2O/cm², synthetic blood penetration resistance at 120 mmHg, and flammability Class 1. Biocompatibility testing per ISO 10993-5 (cytotoxicity), ISO 10993-10 (irritation/sensitization), and ISO 10993-11 (acute systemic toxicity) performed.

Technological Characteristics

Three-layer construction: spunbond polypropylene (outer/inner), meltblown polypropylene (filter). Ear loops: knitted nylon/spandex. Nose clip: synthetic iron wire, PP, PE. Dimensions: 175mm x 95mm. Standards: ASTM F2100-19, ASTM F2101, ASTM F2299, ASTM F1862M-17, EN 14683:2019, 16 CFR 1610. Biocompatibility: ISO 10993-5, -10, -11. Non-sterile, single-use.

Indications for Use

Indicated for use by adults in infection control practices to protect patients and healthcare personnel from transfer of microorganisms, body fluids, and particulate material; reduces potential exposure to blood and body fluids. Single-use, non-sterile.

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 Mask (K202463)

Submission Summary (Full Text)

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

Image /page/0/Picture/0 description: The image shows 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, with the letters "FDA" in a blue square. Next to that is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

October 24, 2021

Weihai Dishang Medical Technology Co., Ltd Ricky Xia Manager Room 406-409, Block C, No.213 Torch Road, Torch High-Tech Industrial Development Zone Weihai, Shandong 264209 China

#### Re: K210348

Trade/Device Name: Disposable Medical Surgical Mask Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: August 25, 2021 Received: September 3, 2021

#### Dear Ricky Xia:

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.

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

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 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.

For 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

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

### Indications for Use

510(k) Number (if known) K210348

Device Name Disposable Medical Surgical Mask

Indications for Use (Describe)

The "Disposable Medical Surgical Mask" is intended to be worn to protect both the patient on the from the transfer of microorganisms, body fluids and particulate material. The 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, provided nonsterile.

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

Prescription Use (Part 21 CFR 801 Subpart D)

> 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}------------------------------------------------

## 510(K) Summary

Prepared in accordance with the requirements of 21 CFR Part 807.92

#### Prepared Date: August 25, 2021

## 1. Submitter's Information

The submitter of this pre-market notification is:

| Name: | Weihai Dishang Medical Technology Co.,Ltd |
|-----------------|-------------------------------------------------------------------------------------------------------------|
| Address: | Room 406-409,Block C,No.213 Torch Road,Torch High-tech<br>Industrial Development Zone,Weihai,Shandong China |
| Contact person: | Ricky.xia |
| Title: | Manager |
| E-mail: | [e-mail] |
| Tel: | [phone] |

### 2. Device Identification

| 510(K) number: | K210348 |
|--------------------|----------------------------------|
| Trade/Device Name: | Disposable Medical Surgical Mask |
| Models: | DSAL2-WHITE, DSAL1-WHITE |
| Common name: | Mask, Surgical |
| Regulation Number: | 878.4040 |
| Regulation Name: | Surgical apparel |
| Regulation Class: | Class 2 |
| Panel: | General Hospital |
| Product Code: | FXX |

### 3. Predicate Device

| 510(K) number: | K202463 |
|--------------------|--------------------------|
| Device Name: | Disposable Surgical Mask |
| Manufacturer: | UNISOURCES GROUP LLC |
| Common name | Mask, Surgical |
| Regulation Number: | 878.4040 |
| Regulation Name: | Surgical apparel |
| Regulation Class: | Class 2 |
| Panel: | General Hospital |
| Product Code: | FXX |

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

### 4. Device Description

The "Disposable Medical Surgical Mask" is single use, without face shield, Flat Pleated type, utilizing ear loops for wearing, and it has a Nose clip design for fitting the facemask around the nose. The "Disposable Medical Surgical Mask" is manufactured with three layers. The inner and outer layers are made of Spunbond fabric (Polypropylene), and the middle filter layer is made of a meltblown fabric (Polypropylene). The subject device is held in place over the user's mouth and nose by two ear loops welded to the facemask. The ear loop is made of Knited nylon and spandex. The nose clip contained in masks is in the layers of the facemask to allow the user to fit the facemask around their nose, which is made of Synthetic iron wire, PP and PE. The "Disposable Medical Surgical Mask" is sold non-sterile and are intended to be single-use, disposable devices. This product contains no components made with natural rubber latex.

#### 5. Indication for use

The " Disposable Medical Surgical Mask " is intended to be worn to protect both the patient and healthcare personnel from the transfer of microorqanisms, body fluids and particulate material. The 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.

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

### 6. Technological Characteristic Comparison to Predicate Device

Comparison to the predicate devices summarized in the following table

| SE<br>Comparisons | Proposed Device<br>DSAL2-WHITE<br>K210348 | Proposed Device<br>DSAL1-WHITE<br>K210348 | Predicate Device<br>K202463 | Comparison |
|-----------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------|
| Name | Disposable Medical Surgical<br>Mask | Disposable Medical Surgical<br>Mask | Disposable Surgical Mask | / |
| Model | DSAL2-WHITE | DSAL1-WHITE | FILTECH M201 | / |
| Classification | Class 2 | Class 2 | Class 2 | Same |
| Intended use | The "Disposable Medical<br>Surgical Mask" is intended to<br>be worn to protect both the<br>patient and healthcare<br>personnel from the transfer of<br>microorganisms, body fluids<br>and particulate material. The<br>face mask is intended for use<br>in infection control practices to<br>reduce the potential exposure<br>to blood and body fluids. This<br>is a single use, disposable<br>device(s), provided non-sterile. | The "Disposable Medical<br>Surgical Mask" is intended to be<br>worn to protect both the patient<br>and healthcare personnel from<br>the transfer of microorganisms,<br>body fluids and particulate<br>material. The face mask is<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<br>Mask, FILTECH M201 is<br>intended to be worn to<br>protect both the patient and<br>health care personnel from<br>transfer of microorganisms,<br>body fluids and particulate<br>material. The Disposable<br>Surgical Mask is intended for<br>use in infection control<br>practices to reduce the<br>potential exposure to blood<br>and body fluids. This is a<br>single use, disposable<br>device(s), provided non-<br>sterile. | Same |
| ASTM F2100<br>Level | Level 2 | Level 1 | Level 2 | Different<br>Note 1 |
| Mask Styles | Flat Pleated | Flat Pleated | Flat Pleated | Same |
| Design features | Ear loop | Ear loop | Ear loop | Same |
| Layers | 3 | 3 | 3 | Same |
| Color | White | White | Blue outside; white inside | Similar<br>Note 2 |
| Target<br>population | Adults | Adults | Adults | Same |
| Dimension<br>(length) | $175 mm\pm 5 mm$ | $175 mm\pm 5 mm$ | $175 \pm 5 mm$ | Same |
| Dimension<br>(width) | $95 mm\pm 5 mm$ | $95 mm\pm 5 mm$ | $95 \pm 5 mm$ | Same |
| Sterile | Non-sterile | Non-sterile | Non-sterile | Same |
| Use | Single use, disposable | Single use, disposable | Single use, disposable | Same |
| Anatomical site | Nose and mouth | Nose and mouth | Nose and mouth | Same |
| Technology | Self-suction filter mask | Self-suction filter mask | Self-suction filter mask | Same |
| Environment of<br>use | OTC | OTC | OTC | Same |
| Material of<br>Outer layer | Spunbond fabric<br>(Polypropylene) | Spunbond fabric<br>(Polypropylene) | Spunbond polypropylene | Same |
| Material of<br>middle layer | Meltblown fabric<br>(Polypropylene) | Meltblown fabric (Polypropylene) | Melt blown polypropylene<br>filter | Same |
| Material of<br>inner layer | Spunbond fabric<br>(Polypropylene) | Spunbond fabric<br>(Polypropylene) | Spunbond polypropylene | Same |
| Material of<br>ear loops | Knitted nylon and spandex | Knitted nylon and spandex | Spandex | Similar<br>Note 3 |
| Material of<br>Nose clip | Synthetic iron wire,PP and PE | Synthetic iron wire,PP and PE | Malleable polyethylene wire | Similar<br>Note 3 |
| Colorants | / | / | Polypropylene (PP) master<br>batch | Similar<br>Note 2 |

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

| Performance | | | | | |
|-------------|---------------|-------------------------------------------|----------------------------------------------|--------------------------------|--------|
| Test item | Test standard | Proposed Device<br>DSAL2-WHITE<br>K210348 | Proposed<br>Device<br>DSAL1-WHITE<br>K210348 | Predicate<br>Device<br>K202463 | Remark |

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

| BFE | ASTM F2101-19 | ≥98% | ≥98% | ≥98% | Same |
|-------------------------------------------|--------------------------------------------|---------|---------|---------|------|
| PFE | ASTM F2299-03(2017) | ≥98% | ≥98% | ≥98% | Same |
| Differential Pressure | EN<br>14683 :2019+AC (2019)(E)<br>Annex C | <6.0 | <6.0 | <6.0 | Same |
| Synthetic Blood<br>Penetration Resistance | ASTM F1862M-17 | 120mmHg | 120mmHg | 120mmHg | Same |
| Flammability | 16 CFR Part 1610<br>(As Amendment In 2008) | Class 1 | Class 1 | Class 1 | Same |

| Biocompatibility | | | | | |
|-------------------------|-----------------------|-------------------------------------------|-------------------------------------------|-----------------------------|--------------------|
| Test item | Test standard | Proposed Device<br>DSAL2-WHITE<br>K210348 | Proposed Device<br>DSAL1-WHITE<br>K210348 | Predicate Device<br>K202463 | Remark |
| Cytotoxicity | ISO 10993-<br>5:2009 | toxicity | toxicity | No Cytotoxicity | Different - Note 4 |
| Acute systemic toxicity | ISO 10993-<br>11:2017 | No systemic toxicity | No systemic toxicity | / | |
| Skin sensitization | ISO 10993-<br>10:2010 | No Irritation | No Irritation | No Irritation | Same |
| Skin irritation | 10:2010 | No Sensitization | No Sensitization | No Sensitization | Same |

Note 1: In this submission, we propose two model products, one is level 2, both of these models are subjected ASTM F2100-2019 tests.

Note 2: There is a difference in color.

{8}------------------------------------------------

Note 3:

We introduce materials "Knited nylon and spandex" in ear loop and materials "Synthetic iron wire, PP and PE" in nose clip.

Note 4:

We evaluated the In vitro cytotoxicity of surgical mask in accordance with ISO 10993-5:2009, the results showed potential toxicity to L929 cells, additionally we evaluated acute systemic toxicity of surgical mask in accordance with ISO 10993-11:2017, result showed no evidence of systemic toxicity from the extract.

### 8. Performance Data

### Clinical test:

Clinical testing is not required.

### Non-clinical data

The proposed device Disposable Medical Surgical Mask conducted below testing:

Performance: (Testing was performed using 3 nonconsecutive lots of 32 samples per lot)

1. ASTM F2100-19 Standard Specification for Performance of Materials Used in Medical Face Masks

2. Bacterial Filtration Efficiency-Determine the bacterial filtration efficiency as directed in Test method F2101.

Differential Pressure -Determine breathing resistance or differential pressure as directed in 3.

### EN 14683:2019,Annex C.

4. Sub-Micron Particulate Filtration-Determine particulate filtration efficiency as directed in Test Method F2299

Resistance to Penetration by Synthetic Blood-Determine synthetic bloodpenetration 5. resistance as specified in Test Method F1862.

6. Flammability-Determine flammability as specified in 16 CFR Part 1610.

| Test item | Purpose | Acceptance Criteria | Results |
|---------------------------------------------------------------------|------------------------------------------------------------------------------------|---------------------|----------|
| BFE<br>ASTM F2101-19 | The purpose of the testing to demonstrate the BFE of the device. | ≥98% | Accepted |
| PFE<br>ASTM F2299-<br>03(2017) | The purpose of the testing to demonstrate the PFE of the device. | ≥98% | Accepted |
| Differential Pressure<br>EN<br>14683 :2019+AC<br>(2019)(E), Annex C | The purpose of the testing to demonstrate the Differential pressure of the device. | <6.0 | Accepted |

{9}------------------------------------------------

| Synthetic Blood<br>Penetration<br>Resistance ASTM<br>F1862M-17 | The purpose of the testing to<br>demonstrate the Synthetic Blood<br>Penetration<br>Resistance of the device | 120mmHg | Accepted |
|----------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------|
| Flammability<br>16 CFR Part 1610<br>(As Amendment In<br>2008) | The purpose of the testing to<br>demonstrate the Flammability of the<br>device | (A) There are no burn<br>times; or<br>(B) There is only one burn<br>time and it is equal to or<br>greater than 3.5 seconds;<br>or<br>(C) The average burn time<br>of two or more specimens<br>is equal to or greater than<br>3.5<br>seconds. | Class 1 |

{10}------------------------------------------------

Biocompatibility:

- 1. ISO 10993-5:2009 Biological evaluation of medical devices Part 5: Tests for in vitro
- 2. I SO 10993-10:2010 Biological evaluation of medical devices Part 10: Tests for irritation

and skin sensitization.

3. ISO 10993-11:2017 Biological evaluation of medical devices - Part 11: Tests for systemic

toxicity.

| Test Method | Purpose | Acceptance Criteria | Results |
|---------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------|
| ISO 10993<br>-5:<br>2009 In Vitro<br>Cytotoxicity | In this study, mammalian L-<br>929 cells were cultured in<br>vitro according to ISO 10993-<br>5:2009 to test the potential<br>cytotoxicity of the test article.<br>The test articles and the<br>control material were<br>separately placed in MEM<br>medium containing 10% fetal<br>bovine serum and extracted<br>in a 37°C incubator for 24<br>hours. After the end of the<br>extraction, the cell culture<br>medium in the 96-well plate<br>(104 cells/well) cultured for 24<br>hours was removed and<br>replaced with the<br>corresponding extract,<br>cultured in 37°C, 5%<br>CO2, >90% humidity for 24<br>hours. After the culture the<br>morphology and cell lysis of<br>the cells were observed<br>under the microscope, and<br>the cytotoxicity of the test | The 50% extract of the test<br>article should have at least<br>the same or a higher viability<br>than the 100% extract.<br>Otherwise, the test should be<br>repeated.<br>The lower the Viab. % value,<br>the higher the cytotoxic<br>potential of the test article is.<br>If viability is reduced to <70%<br>of the blank, it has a<br>cytotoxic potential.<br>The Viab.% of the 100%<br>extract of the test article is<br>the final result. | Under the condition of<br>the test, the test article<br>was found to be<br>cytotoxic |
| | samples was determined by<br>MTT assay. | | |
| Skin Sensitization<br>ISO 10993<br>-10:<br>2010 | we took guinea pigs to<br>observe the skin sensitization<br>of the test article according to<br>ISO 10993-10: 2010.<br>The test article were<br>extracted in Constant<br>Temperature Vibrator at<br>50°C, 60 rpm for 72 h by<br>0.9 % Sodium Chloride<br>Injection and Sesame Oil.<br>Mix 50:50 (by volume) stable<br>emulsion of Freund's<br>complete adjuvant with<br>selected solvent. Intradermal<br>induction and topical<br>induction were operated in<br>the clipped intrascapular<br>region of each animal. After<br>the topical induction phase<br>was completed on day 14, all<br>test and control animals were<br>challenged with the test<br>sample. The erythema and<br>edema of the challenge site<br>were observed to test the<br>sensitization response of the<br>test article. According to the<br>Magnusson and Kligman<br>scales, the response to<br>erythema and edema at each<br>application site of the skin<br>was described and scored 24<br>hours and 48 hours after the<br>challenge phase. | Magnusson and Kligman<br>grades of 1 or greater in the<br>test group generally indicate<br>sensitization, provided<br>grades of less than 1 are<br>seen in control animals.<br>If grades of 1 or greater are<br>noted in control animals, then<br>the reactions of test animals<br>which exceed the most<br>severe reaction in control<br>animals are presumed to be<br>due to sensitization.<br>If the response is equivocal,<br>rechallenge is recommended<br>to confirm the results from<br>the first challenge. The<br>outcome of the test is<br>presented as the frequency<br>of positive challenge results<br>in test and control animals. | Under the conditions of<br>the test, the test article<br>was found to be non-<br>sensitizing |
| Skin Irritation test<br>ISO 10993<br>-10:<br>2010 | we took New Zealand white<br>Rabbits to observe the skin<br>irritation of the test article<br>according to ISO10993-<br>10:2010.<br>The test article were<br>extracted in Constant<br>Temperature Vibrator at<br>50°C, 60 rpm for 72 h by<br>0.9 % Sodium Chloride<br>Injection and Sesame Oil.<br>Apply 0.5 ml extracts of test<br>article or control to<br>2.5 cm x 2.5 cm absorbent<br>gauze patches, and then<br>apply the patch soaked with | Use only (24±2) h, (48±2) h<br>and (72±2) h observations for<br>calculation.<br>After the 72 h grading, all<br>erythema grades plus<br>oedema grades (24±2) h,<br>(48±2) h and (72±2) h were<br>totaled separately for each<br>test article and blank for each<br>animal. The primary irritation<br>score for an animal was<br>calculated<br>by dividing the sum of all the<br>scores by 6 (two<br>test/observation sites, three<br>time points). | Under the conditions of<br>the test, the test article<br>was found to be non-<br>irritating |
| | | | |
| | the extract of test article or<br>control directly to the skin on<br>each side of each rabbit, and<br>then wrap the application<br>sites with a bandage for a<br>minimum of 4 h. At the end of<br>the contact time, remove the<br>dressing. The describe and<br>score the skin reaction for<br>erythema and oedema for<br>each application site at each<br>time interval. Record the<br>appearance of each<br>application site at (1±0.1) h,<br>(24±2) h, (48±2) h and<br>(72±2)h following removal of<br>the patches. | To obtain the primary<br>irritation index for the test<br>article, add all the primary<br>irritation scores of the<br>individual<br>animals and divide by the<br>number of animals.<br>When blank or negative<br>control was used, calculate<br>the primary irritation score for<br>the controls and subtract<br>that score from the score<br>using the test material to<br>obtain the primary irritation<br>score. | |
| Acute systemic<br>toxicity<br>ISO 10993<br>-11:<br>2017 | A single dose of test article<br>extract was injected into the<br>designated group of mice<br>intraperitoneally at the dose<br>level of 50 mL/kg bw. The<br>negative control liquid was<br>injected similarly into the<br>separate group of designated<br>control mice.<br>Mice were observed for any<br>adverse clinical reactions<br>immediately after injection,<br>and then the animals were<br>returned to their cages. The<br>animals were observed for<br>signs of systemic reactions<br>at4,24,48 and 72 hours after<br>injection and weighed daily<br>for three days after dosing.<br>Any animal found dead or<br>showed abnormal signs<br>were subjected to gross<br>necropsy. | (1) If during the observation<br>period of an acute systemic<br>toxicity test none of the mice<br>treated with the test article<br>extract exhibited a<br>significantly greater biological<br>reactivity than control mice,<br>the test article met the<br>requirements. If two or more<br>animals died, or if abnormal<br>behavior such as<br>convulsions or prostration<br>occurs in two or more<br>animals, or if body weight<br>loss greater than<br>10 % occurs in three or more<br>animals, the test article did<br>not meet the requirements.<br>(2)If any animals treated with<br>the sample exhibited only<br>slight signs of biological<br>reactivity, andno more than<br>one animal showed gross<br>symptoms of biological<br>reactivity or died, repeat the<br>testing using groups of ten<br>animals. On the repeat test,<br>if all ten animals treated with<br>the test article extract<br>exhibited no scientifically<br>meaningful biological<br>reactivity above the vehicle<br>control animals during the<br>observation period, the test<br>article met the requirements. | Under the condition of<br>the test, the test article<br>was found to be non-<br>systemic toxicity |

{11}------------------------------------------------

{12}------------------------------------------------

{13}------------------------------------------------

### 9. Conclusion

The conclusion drawn from the nonclinical tests demonstrates that the subject device in 510(K) submission K210348, the Disposable Medical Surgical Mask (model: DSAL2-WHITE, DSAL1-WHITE), are as safe, as effective, and performs as well as or better than the legally marketed predicate device cleared under K202463.