SURGICAL MASK, Model Name:C015
Device Facts
| Record ID | K210218 |
|---|---|
| Device Name | SURGICAL MASK, Model Name:C015 |
| Applicant | Qingdao Hainuo Biological Engineering Co., Ltd. |
| Product Code | FXX · General, Plastic Surgery |
| Decision Date | May 7, 2021 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 878.4040 |
| Device Class | Class 2 |
Indications for Use
The "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 "SURGICAL 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 non-sterile.
Device Story
Surgical mask (Model C015); flat-pleated, three-layer design; non-sterile, single-use, disposable. Input: physical barrier over user's nose and mouth. Operation: mechanical filtration via three-layer construction (outer/inner non-woven polypropylene; middle melt-blown polypropylene filter). Features: elastic ear loops (polyester/spandex) and integrated nose piece (iron strip/polypropylene) for fit. Used in clinical/healthcare settings for infection control; operated by healthcare personnel or patients. Output: physical protection against microorganisms, body fluids, and particulates. Benefit: reduces potential exposure to blood/body fluids; protects both wearer and patient.
Clinical Evidence
No clinical data. Bench testing only. Performance verified against ASTM F2100-19 standards: BFE (ASTM F2101-19), PFE (ASTM F2299-03), Differential Pressure (EN 14683:2019), Synthetic Blood Penetration (ASTM F1862M-17), and Flammability (16 CFR Part 1610). Biocompatibility testing conducted per ISO 10993-5 (cytotoxicity) and ISO 10993-10 (sensitization and irritation). All tests passed.
Technological Characteristics
Three-layer flat-pleated mask. Materials: non-woven polypropylene (outer/inner), melt-blown polypropylene (filter), polyester/spandex ear loops, iron/polypropylene nose piece. ASTM F2100 Level 3. Non-sterile. No natural rubber latex. Mechanical filtration principle.
Indications for Use
Indicated for use by adults as a single-use, disposable surgical mask to protect patients and healthcare personnel from transfer of microorganisms, body fluids, and particulate material in 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
- Single-use Surgical Mask (K200923)
Submission Summary (Full Text)
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May 7, 2021
Qingdao Hainuo Biological Engineering Co., Ltd. Raphael Wang Director Industrial Park, Jiangshan Town, Laixi City Qingdao, Shandong 266000 China
Re: K210218
Trade/Device Name: SURGICAL MASK, Model Name:C015 Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: March 26, 2021 Received: April 5, 2021
Dear Raphael Wang:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal 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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Clarence W. Murray, III, Ph.D. Acting 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) K210218
Device Name SURGICAL MASK, Model Name:C015
Indications for Use (Describe)
The "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 "SURGICAL 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 non-sterile.
| 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) | <div> <span> </span> </div> |
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# K210218 510(K) Summary
Prepared in accordance with the requirements of 21 CFR Part 807.92
# Prepared Date: 29 April 2021
# 1. Submitter's Information
The submitter of this pre-market notification is:
| Name: | Qingdao Hainuo Biological Engineering Co., Ltd |
|-----------------|--------------------------------------------------------------------------------|
| Address: | Industrial Park, Jiangshan Town, Laixi City<br>Qingdao, Shandong, 266000 China |
| Contact person: | Raphael Wang |
| Title: | Director |
| E-mail: | hynaut@outlook.com |
| Tel: | +86-15065420708 |
# 2. Device Identification
| Trade/Device Name: | SURGICAL MASK, Model Name: C015 |
|--------------------|---------------------------------|
| 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: | K200923 |
|--------------------|------------------------------------|
| Device Name: | Single-use Surgical Mask |
| Manufacturer: | BYD Precision Manufacturer 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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#### 4. Device Description
The "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 "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 "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 "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 "SURGICAL 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.
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# 6. Technological Characteristics Comparison
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 Devices | Predicate Device<br>K200923 | Similarities/<br>Differences |
|-----------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------|
| Name | Surgical Mask | Single-use Surgical Mask | / |
| Model | C015 | FE2311 | / |
| Classification | Class II | Class II | Same |
| Intended use | The Surgical Mask is<br>intended to be worn to<br>protect both the patient and<br>healthcare personnel from<br>the transfer of<br>microorganisms, body fluids<br>and particulate material. The<br>face mask is intended for use<br>in infection control practices<br>to reduce the potential<br>exposure to blood and body<br>fluids. This is a single use,<br>disposable device(s),<br>provided non-sterile. | The Single-use Surgical<br>Mask (Model:FE2311) 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 3 | Level 3 | 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 | $175 \pm 4$ mm | Similar |
| Dimension<br>(width) | $95 \pm 5$ mm | $95 \pm 4$ mm | Similar |
| 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 | OTC | OTC | Same |
| use | | | |
| Material of<br>Outer layer | Non-woven fabric<br>(Polypropylene) | Spun-bond polypropylene | Same |
| Material of<br>middle layer | Melt blown fabric<br>(Polypropylene) | Melt blown polypropylene<br>filter | Same |
| Material of<br>inner layer | Non-woven fabric<br>(Polypropylene) | Spun-bond polypropylene | Same |
| Material of<br>ear loops | Polyester and Spandex | Polyester | Similar |
| Material of<br>Nose piece | Iron strip and Polypropylene | Metal Core Plastic | Same |
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#### 8. Performance Data
#### Clinical test:
Clinical testing is not required.
#### Non-clinical data
The proposed device SURGICAL MASK:
Performance:
ASTM F2100-19 Standard Specification for Performance of Materials Used in Medical Face 1. Masks was conducted on 3 discontinuous lots.
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.
4. Sub-Micron Particulate Filtration-Determine particulate filtration efficiency as directed in Test Method F2299
5. Resistance to Penetration by Synthetic Blood-Determine synthetic bloodpenetration resistance as specified in Test Method F1862.
6. Flammability-Determine flammability as specified in 16 CFR Part 1610.
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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<br>ard | Test item | Test method | Criteria | Results |
|------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------|
| ASTM<br>F2100<br>-19 | BFE | ASTM F2101-19 | ≥98% | 32pass/<br>32tested<br>Accepted |
| | PFE | ASTM F2299-03(2017) | ≥98% | 32pass/<br>32tested<br>Accepted |
| | Differential<br>Pressure | EN<br>14683 :2019+AC (2019)(E),<br>Annex C | <6.0 | 32pass/<br>32tested<br>Accepted |
| | Synthetic<br>Blood<br>Penetration<br>Resistance | ASTM F1862M-17 | 160mmHg | 32pass/<br>32tested<br>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 |
| 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 | 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 test,<br>the test<br>article was<br>found to<br>be non-<br>cytotoxic |
| | | 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 | | |
| ISO<br>10993<br>-10:<br>2010 | Skin<br>Sensitization | MTT assay.<br>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<br>conditions<br>of the test,<br>the test<br>article was<br>found to<br>be non-<br>sensitizing |
| | 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 | 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 | Under the<br>conditions<br>of the test,<br>the test<br>article was<br>found to<br>be non-<br>irritating |
| | 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. | 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. | | |
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#### 9. 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.
