Disposable Surgical Mask (Model: YYKZ-01)

K210845 · Jiaxing Amazing Travel-Ware Co., Ltd. · FXX · Oct 12, 2021 · General, Plastic Surgery

Device Facts

• Record ID: K210845
• Device Name: Disposable Surgical Mask (Model: YYKZ-01)
• Applicant: Jiaxing Amazing Travel-Ware Co., Ltd.
• Product Code: FXX · General, Plastic Surgery
• Decision Date: Oct 12, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4040
• Device Class: Class 2

Intended Use

The DISPOSABLE SURGICAL MASK is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids, and particulate materials in infection control practices to reduce the potential exposure to blood and body fluids. It is for single-use and provided non-sterile.

Device Story

Disposable surgical mask (Model: YYKZ-01); flat-pleated design; three-layer construction (polypropylene non-woven outer/inner layers; melt-blown polypropylene filter layer); elastic ear loops (polyester/spandex); iron/polypropylene nose piece. Used in clinical or OTC settings to protect wearer and patient from microorganisms, body fluids, and particulates. Device acts as physical barrier; reduces exposure to blood/body fluids. Non-sterile; single-use.

Clinical Evidence

No clinical data. Bench testing only: BFE (99.9%), PFE (99.8%), differential pressure (2.7 mmH2O/cm²), synthetic blood penetration resistance (80 mmHg), and flammability (Class 1) per ASTM F2100-19. Biocompatibility confirmed via ISO 10993-5 (cytotoxicity) and ISO 10993-10 (irritation/sensitization).

Technological Characteristics

Three-layer flat-pleated mask; non-woven polypropylene outer/inner layers; melt-blown polypropylene filter; polyester/spandex ear loops; iron/polypropylene nose piece. ASTM F2100-19 Level 1 performance. Non-sterile. No software or electronic components.

Indications for Use

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

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

• Medical Face mask (K202061)

Submission Summary (Full Text)

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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 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.

October 12, 2021

Jiaxing Amazing Travel-Ware CO., LTD Jiang Tao Head of Firm No.2196 Honggao Road, Xiuzhou Industrial Park Jiaxing, Zhejiang 314015 China

Re: K210845

Trade/Device Name: Disposable Surgical Mask (Model: YYKZ-01) Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: September 6, 2021 Received: September 13, 2021

Dear Jiang Tao:

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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's

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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 (OS) 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 Clarence W. Murray III, Ph.D. 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) K210845

Device Name DISPOSABLE SURGICAL MASK(Model: YYKZ-01)

Indications for Use (Describe)

The DISPOSABLE SURGICAL MASK is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids, and particulate materials in infection control practices to reduce the potential exposure to blood and body fluids. It is for single- use and provided non-sterile.

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

Prescription Use (Part 21 CFR 801 Subpart D)

X Over-The-Counter Use (21 CFR 801 Subpart C)

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Image /page/3/Picture/1 description: The image shows the word "JEGUN" in a stylized font. The letters are white and have a unique, interconnected design. The background is a light blue color, providing a clean and contrasting backdrop for the text. The overall design is modern and eye-catching.

# 510(K) Summary

Prepared in accordance with the requirements of 21 CFR Part 807.92

#### Prepared Date: Sep. 23, 2021

# 1. Submitter's Information

The submitter of this pre-market notification is:

| Name: | JIAXING AMAZING TRAVEL-WARE CO.,LTD |
|-----------------|----------------------------------------------------------------------------------|
| Address: | No.2196 Honggao Road, Xiuzhou Industrial Park<br>Jiaxing, Zhejiang, China 314015 |
| Contact person: | Jiang Tao |
| Title: | Head of Firm |
| E-mail: | [e-mail] |
| Tel: | [phone] |

# 2. Device Identification

| 510(k) Number: | K210845 |
|--------------------|--------------------------|
| Trade/Device Name: | DISPOSABLE SURGICAL MASK |
| Models: | YYKZ-01 |
| Common name: | Mask, Surgical |
| Regulation Number: | 878.4040 |
| Regulation Name: | Surgical apparel |
| Regulation Class: | Class II |
| Panel: | General Hospital |
| Product Code: | FXX |

## 3. Predicate Device

| 510(K) number: | K202061 |
|--------------------|-------------------------------------------------------|
| Device Name: | Medical Face mask |
| Manufacturer: | Jiangsu Province Jianerkang Medical Dressing Co., Ltd |
| Common name | Mask, Surgical |
| Regulation Number: | 878.4040 |
| Regulation Name: | Surgical apparel |
| Regulation Class: | Class II |
| Panel: | General Hospital |
| Product Code: | FXX |

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Image /page/4/Picture/1 description: The image shows the word "JEGUN" in a stylized, sans-serif font. The letters are white against a light blue background. The "G" in "JEGUN" is particularly distinctive, with a unique, geometric design that sets it apart from the other letters.

## 4. Device Description

The "DISPOSABLE SURGICAL MASK" is single use, blue color, without face shield, Flat Pleated type, utilizing elastic ear loops for wearing, and it has a Nose Piece design for fitting the facemask around the nose. The "DISPOSABLE SURGICAL MASK" is manufactured with three layers. The inner and outer layers are made of Non-woven fabric (Polypropylene), and the middle filter layer is made of a melt blown 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 elastic ear loop is made of Polyester and Spandex. The nose piece 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 iron strip and polypropylene. The"DISPOSABLE 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 SURGICAL MASK is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids, and particulate materials in infection control practices to reduce the potential exposure to blood and body fluids. It is for single-use and provided non-sterile.

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Image /page/5/Picture/0 description: The image is a logo for JEGUN. The logo is white text on a blue background. The text is stylized and appears to be a custom font.

# 6. Comparison to Predicate Device

Comparison to the predicate devices, the subject device has same intended use, similar product design, same performance effectiveness, performance safety as the predicate device as summarized in the following table

| SE<br>Comparisons | Proposed Device<br>K210845 | Predicate Device<br>K202061 | Similarities/<br>Differences |
|----------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------|
| Name | DISPOSABLE SURGICAL<br>MASK | Single-use Surgical Mask | / |
| Model | YYKZ-01 | FE2311 | / |
| Classification | Class II | Class II | Same |
| Intended use/<br>Indications for<br>Use | The DISPOSABLE<br>SURGICAL MASK is<br>intended to be worn to<br>protect both the patient and<br>healthcare personnel from<br>transfer of microorganisms,<br>body fluids, and particulate<br>materials in infection control<br>practices to reduce the<br>potential exposure to blood<br>and body fluids. It is for<br>single-use and provided<br>non-sterile. | The medical face mask is<br>intended to be worn to<br>protect both the patient and<br>healthcare personnel from<br>transfer of microorganisms,<br>body fluids, and particulate<br>materials in infection control<br>practices to reduce the<br>potential exposure to blood<br>and body fluids. It is for<br>single-use and provided<br>non-sterile. | Same |
| ASTM F2100<br>Level | Level 1 | Level 1 | Same |
| Mask Styles | Flat Pleated | Flat Pleated | Same |
| Design features | Ear loop | Ear loop | Same |
| Layers | 3 | 3 | Same |
| Color | Blue | Blue | Same |
| Target<br>population | Adults | Adults | Same |
| Dimension<br>(length) | $175 \pm 5$ mm | 175 mm | Same |
| Dimension<br>(width) | $95 \pm 5$ mm | 95 mm | Same |
| Sterile | Non-sterile | Non-sterile | Same |
| Use | Single use, disposable | Single use, disposable | Same |
| Anatomical site | Nose and mouth | Nose and mouth | Same |
| Technology | Self-suction filter mask | Self-suction filter mask | Same |
| Environment of<br>use | OTC | OTC | Same |
| | | | |
| Material of<br>Outer layer | Non-woven fabric<br>(Polypropylene) | polypropylene | Same |
| Material of<br>middle layer | Melt blown fabric<br>(Polypropylene) | Melt blown polypropylene | Same |
| Material of<br>inner layer | Non-woven fabric<br>(Polypropylene) | polypropylene | Same |
| Material of<br>ear loops | Spandex and nylon | Spandex and nylon | Same |
| Material of<br>Nose piece | Iron strip and Polypropylene | Polypropylene coated steel<br>wire | Note 1 |
| Performance testing Data comparison | | | |
| BFE | Average 99.9% | Average 99.8% | Meet level 1 |
| PFE | Average 99.8% | Average 96.09% | Meet level 1 |
| Differential<br>Pressure | Average 2.7 | Average 3.9 | Meet level 1 |
| Synthetic Blood<br>Penetration<br>Resistance | 80 | 80 | Meet level 1 |
| Flammability | Class 1 | Class 1 | Meet level 1 |
| Biocompatibility comparison | | | |
| In Vitro<br>Cytotoxicity | Under the conditions of the<br>test, the test article was<br>found to be non- cytotoxic | Under the conditions of the<br>test, the test article was<br>found to be non- cytotoxic | Same |
| Skin<br>Sensitization | Under the conditions of the<br>test, the test article was<br>found to be non- sensitizing | Under the conditions of the<br>test, the test article was<br>found to be non- sensitizing | Same |
| Skin Irritation<br>test | Under the conditions of the<br>test, the test article was<br>found to be non- irritating | Under the conditions of the<br>test, the test article was<br>found to be non- irritating | Same |

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Note 1: The nose piece material of the subject device is iron with polypropylene covering. The predicate device uses polypropylene coated steel wire. The nose piece does not directly contact the user's skin. Biocompatibility testing was conducted on the final device, and the tests showed there was no biocompatibility risk. Performance testing was conducted according to ASTM F2100-19, and the test results show that the proposed device meets the level 1 requirements.

Otherwise, all of the specifications and materials of the subject device, DISPOSABLE SURGICAL MASK (model: YYKZ-01), are the same as the predicate device K202061 with no identified new risks.

### 7. Performance Data Clinical test:

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Image /page/7/Picture/1 description: The image shows the word "JEGUN" in a stylized font. The letters are white and the background is light blue. The letters are connected to each other, and the overall design is modern and sleek.

Clinical testing is not required.

#### Non-clinical data

The proposed device DISPOSABLE SURGICAL MASK:

Performance:

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.

- 3. Differential Pressure -Determine breathing resistance or differential pressure as directed in
#### EN 14683:2019,Annex C.

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

- 5. Resistance to Penetration by Synthetic Blood-Determine synthetic blood penetration resistance as specified in Test Method F1862.
- 6. Flammability-Determine flammability as specified in 16 CFR Part 1610.

| standa<br>rd | Test item | Test method | Criteria | Results |
|----------------------|-------------------------------------------------|--------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------|
| ASTM<br>F2100<br>-19 | BFE | ASTM F2101-19 | ≥95% | Accepted |
| | PFE | ASTM F2299-03(2017) | ≥95% | Accepted |
| | Differential<br>Pressure | EN<br>14683 :2019+AC (2019)(E),<br>Annex C | <5.0 | Accepted |
| | Synthetic<br>Blood<br>Penetration<br>Resistance | ASTM F1862M-17 | 80mmHg | Accepted |
| | Flammability | 16 CFR Part 1610<br>(As Amendment In 2008) | (A) There are no burn times;<br>or<br>(B) There is only one burn<br>time and it is equal to or<br>greater than 3.5 seconds; or<br>(C) The average burn time of<br>two or more specimens is<br>equal to or greater than 3.5<br>seconds | Class 1 |

Biocompatibility:

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

| Stand ard | Test item | Test method | Criteria | Results |
|-----------|-----------|-------------|----------|---------|
| AVI | | | | |

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| ISO<br>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<br>samples was determined by<br>MTT assay. | 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<br>conditions<br>of the<br>test, the<br>test article<br>was found<br>to be non-<br>cytotoxic |
|------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------|
| ISO<br>10993<br>-10:<br>2010 | Skin<br>Sensitization | 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 | 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<br>conditions<br>of the<br>test, the<br>test article<br>was found<br>to be non-<br>sensitizin<br>g |
| | | | | |
| | 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. | | | |
| Skin<br>Irritation test | 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<br>Oil.Apply 0.5 ml extracts of<br>test article or control to<br>2.5 cm x 2.5 cm absorbent<br>gauze patches, and then<br>apply the patch soaked with<br>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. | 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>totalled 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).<br>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. | Under the<br>conditions<br>of the<br>test, the<br>test article<br>was found<br>to be non-<br>irritating | |

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### 8. Conclusion

The conclusions drawn from the nonclinical tests demonstrates that the subject device in 510(k) submission K210845, the DISPOSABLE SURGICAL MASK is as safe, as effective, and performs as well as or better than the legally marketed device predicate cleared under K202061.