Surgical Mask
Device Facts
| Record ID | K211255 |
|---|---|
| Device Name | Surgical Mask |
| Applicant | Tianchang Kanghui Protective Products Co, Ltd. |
| Product Code | FXX · General, Plastic Surgery |
| Decision Date | Aug 28, 2021 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 878.4040 |
| Device Class | Class 2 |
Indications for Use
The Surgical Mask (model: KH8001& KH8002) is intended to be worn to protect both the patient and healtheare personnel from transfer of microorganisms, body fluids and particulate material. These face intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This a single use, disposable device(s), provided non-sterile.
Device Story
Surgical mask (models KH8001, KH8002); three-layer construction; inner/outer layers spun-bond polypropylene; middle layer melt-blown polypropylene filter; includes galvanized wire nose clip and polyester/spandex ear loops. Device worn over mouth and nose to provide physical barrier against microorganisms, body fluids, and particulates. Used in clinical settings for infection control. Single-use, disposable, non-sterile. Provides protection to both patient and healthcare personnel.
Clinical Evidence
No clinical data. Bench testing only. Performance verified per ASTM F2100-19, including bacterial filtration efficiency (>98%), particulate filtration efficiency (>98%), differential pressure (<6.0 mmH2O/cm2), and synthetic blood penetration resistance (120/160 mmHg). Biocompatibility confirmed per ISO 10993-5 and ISO 10993-10.
Technological Characteristics
Three-layer flat pleated mask. Materials: spun-bond polypropylene (inner/outer), melt-blown polypropylene (filter), galvanized wire/polypropylene (nose clip), polyester/spandex (ear loops). ASTM F2100-19 Level 2 and 3 compliant. Biocompatibility per ISO 10993-5/10. Non-sterile, single-use.
Indications for Use
Indicated for use by healthcare personnel and patients to reduce exposure to microorganisms, body fluids, and particulate material during infection control practices.
Regulatory Classification
Identification
Surgical apparel are devices that are intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material. Examples include surgical caps, hoods, masks, gowns, operating room shoes and shoe covers, and isolation masks and gowns. Surgical suits and dresses, commonly known as scrub suits, are excluded.
Special Controls
*Classification.* (1) Class II (special controls) for surgical gowns and surgical masks. A surgical N95 respirator or N95 filtering facepiece respirator is not exempt if it is intended to prevent specific diseases or infections, or it is labeled or otherwise represented as filtering surgical smoke or plumes, filtering specific amounts of viruses or bacteria, reducing the amount of and/or killing viruses, bacteria, or fungi, or affecting allergenicity, or it contains coating technologies unrelated to filtration (e.g., to reduce and or kill microorganisms). Surgical N95 respirators and N95 filtering facepiece respirators are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 878.9, and the following conditions for exemption:(i) The user contacting components of the device must be demonstrated to be biocompatible. (ii) Analysis and nonclinical testing must: (A) Characterize flammability and be demonstrated to be appropriate for the intended environment of use; and (B) Demonstrate the ability of the device to resist penetration by fluids, such as blood and body fluids, at a velocity consistent with the intended use of the device. (iii) NIOSH approved under its regulation. (2) Class I (general controls) for surgical apparel other than surgical gowns and surgical masks. The class I device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 878.9.
Predicate Devices
- Disposable Surgical Face Masks (K203685)
Submission Summary (Full Text)
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August 28, 2021
Tianchang Kanghui Protective Products CO LTD % Ivy Wang Consultant Shanghai Sungo Management Consulting Company Limited 14th Floor, 1500# Central Avenue Shanghai, Shanghai 200122 China
Re: K211255
Trade/Device Name: Surgical Mask (model: KH8001& KH8002) Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical apparel Regulatory Class: Class II Product Code: FXX Dated: August 18, 2021 Received: August 18, 2021
Dear Ivy 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
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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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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) K211255
Device Name Surgical Mask (model: KH8001& KH8002)
#### Indications for Use (Describe)
The Surgical Mask (model: KH8001& KH8002) is intended to be worn to protect both the patient and healtheare personnel from transfer of microorganisms, body fluids and particulate material. These face intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This a single use, disposable device(s), 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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## 510(K) Summary K211255
#### Document prepared date: 8/25/2021
#### A. Applicant
Name: TIANCHANG KANGHUI PROTECTIVE PRODUCTS CO., LTD. Address: NO.16 WAYECONOMIC DEVELOPMENT ZONE, TIANCHANG, ANHUI Contact Person: Mark Wong Tel: +86-015255006789 Mail: mark@kanghuimedical.com
Submission Correspondent: Primary contact: Ms. Ivy Wang Shanghai SUNGO Management Consulting Co., Ltd. Room 1401, Dongfang Building, 1500# Century Ave., Shanghai 200122, China Tel: +86-21-58817802 Email: haiyu.wang@sungoglobal.com Secondary contact: Mr. Raymond Luo Room 1401, Dongfang Building, 1500# Century Ave., Shanghai 200122, China Tel: +86-21-68828050 Email: fda.sungo@@gmail.com
#### B. Device:
Trade Name: Surgical Mask Common Name: Surgical Face Mask Model: KH8001,KH8002
Regulatory Information Classification Name: Surgical Face Mask Classification: Class II Product code: FXX Regulation Number: 878.4040 Review Panel: Surgical Apparel
#### C. Predicate device:
| 510K | Device name | ASTM F2100-19<br>Level | Manufacturer |
|---------|-----------------------------------|------------------------|----------------------------------------------------------|
| K203685 | Disposable Surgical Face<br>Masks | Level 3, Level 2 | Xiantao Zhongyi Safety & Protection<br>Products Co., Ltd |
#### D. Indications for use of the device:
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The Surgical Masks (model: KH8001& KH8002) are 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 a single use, disposable devices, provided non-sterile.
### E. Device Description:
The proposed devices (model: KH8001& KH8002) are White color, and Flat Pleated type mask, utilizing Ear Loops way for wearing, and they all has Nose clips design for fitting the face mask around the nose.
The proposed devices are manufactured with three layers, the inner and outer layers are made of spun-bond polypropylene, and the middle layer is made of melt blown polypropylene filter. 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 made of polyester fiber and spandex. The nose piece in the proposed devices is made of Galvanized wire with polypropylene and is contained within the layers of face mask to allow the user to fit the face mask around their nose. The proposed devices are sold non-sterile and are intended to be single use, disposable devices.
## F. Technical Characteristic Comparison
Table 1 Summary of Technological Characteristics
| Device | | Proposed Device | Predicted Device | Comparison |
|------------------------------------------------------|------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| Manufacturer | | TIANCHANG KANGHUI<br>PROTECTIVE<br>PRODUCTS CO.,LTD. | Xiantao Zhongyi Safety &<br>Protection Products Co., Ltd | - |
| 510K number | | K211255 | K203685 | - |
| Classification | | Class II Device, FXX (21<br>CFR878.4040) | Class II Device, FXX (21<br>CFR878.4040) | Same |
| Indications for use | | The Surgical Masks (model:<br>KH8001& KH8002) are<br>intended to be worn to protect<br>both the patient and healthcare<br>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<br>reduce the potential exposure to<br>blood and body fluids. This<br>a single use, disposable device(s),<br>provided non-sterile. | The Disposable Surgical Face<br>Masks (model: ZYD- 02 & ZYD-<br>03) are intended to be worn to<br>protect both the patient and<br>healthcare personnel from transfer<br>of microorganisms, body fluids and<br>particulate material.<br>These face masks are intended<br>for use in infection control<br>practices to reduce the<br>potential exposure to blood<br>and body fluids. This a single<br>use, disposable device(s),<br>provided non-sterile. | Similar |
| Outer | | spun-bond polypropylene | Spun-bond polypropylene | Same |
| NO.16 WAYECONOMIC DEVELOPMENT ZONE, TIANCHANG, ANHUI | | | | |
| | Middle | Melt blown polypropylene filter | Melt blown polypropylene filter | Same |
| Material | Inner | Spun-bond polypropylene | Spun-bond polypropylene | Same |
| | Nose<br>clip | Galvanized wire<br>with polypropylene | Polypropylene and Iron | Different |
| | Ear<br>loops | polyester fiber and spandex | Spandex | Different |
| Color | | White | Blue | Different |
| Dimension<br>(Length) | | $17.5+/-0.3cm$ | $17.5 cm +/- 0.5 cm$ | Similar |
| Dimension<br>(Width) | | $9.0+/-0.3cm$ | $9.5 cm +/- 0.5 cm$ | Similar |
| OTC use | | Yes | Yes | Same |
| Sterility | | Non-Sterile | Non-Sterile | Same |
| Use | | Single Use, Disposable | Single Use, Disposable | Same |
| ASTM F2100 level | | Level 2, Level 3 | Level 2, Level 3 | Same |
| Fluid Resistance<br>Performance | | 32 out of 32 pass<br>at 120mmHg;<br><br>32 out of 32 pass<br>at 160mmHg; | 32 out of 32 pass at<br>120mmHg;<br><br>32 out of 32 pass at<br>160mmHg; | Same |
| Efficiency | Particulate Filtration | ≥ 98% | ≥ 98% | Same |
| Bacterial Filtration<br>Efficiency | | ≥ 98% | ≥ 98% | Same |
| Differential<br>Pressure (Delta P) | | < $6.0mmH_2O/cm^2$ | < $6.0mmH_2O/cm^2$ | Same |
| Flammability 16 | | | | |
| CFR 1610 | | Class 1 | Class 1 | Same |
| Biocompatibility | | Meet ISO10993:<br>Non-<br>Cytotoxic;<br>Non-Irritating; | Meet ISO10993:<br>Non-Cytotoxic; Non-<br>Irritating; Non-<br>Sensitizing; | Same |
| NO.10 WATECONOMIC DEVELOPMENT ZONE, TIANCHANG, ANHUI | | | | |
| | Non-<br>Sensitizing; | | | |
| | | | | |
| | | | | |
| | | | | |
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# HANG KANGHUI PROTECTIVE PRODUCTS
From the comparison we found the material of the current nose clip and the ear loop, as well as the mask color and dimension were different from the predicate device. The biocompatibility tests were conducted to both components to ensure their compliance to the ISO10993-5 and ISO10993-10. For the Performance testing, the test results are not identical to each other, but they are similar and they both meet the requirement of Level 2&3 medical mask according to the ASTM F 2100-19, Standard Specification for Performance of Materials Used In Medical Face Masks.
## G. Performance Testing
Non-clinical tests were conducted to verify that the proposed device met all design specifications as was similar to the predicate device. Provided below in Table 2 is the summary of the non-clinical testing that was performed per specification of the standard and test methodology using 3 non-consecutive lots with 32 samples for each lot listed below. The results of the performance testing demonstrated the subject device met the acceptance criteria of the standard and the test methodologies summarized below. The test results demonstrated that the proposed device complies with the requirements stated in the Guidance for Industry and FDA Staff: Surgical Masks - Premarket Notification [510(k)] Submission issued on March 5, 2004:
| Test Methodology | Purpose | Acceptance Criteria | Results |
|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------|
| ASTM F2101-19, Differential<br>Pressure, mm H2O/cm2 | Measuring the pressure of<br>dropping across a medical<br>face mask material. | < 6.0mmH2O/cm² | Level 3: Passed at<br>3.1 mmH2O/cm²<br>Level 2: Passed at<br>3.3 mmH2O/cm² |
| ASTM F1862-17, Standard<br>Test Method for Resistance<br>of Medical Face Masks to<br>Penetration by Synthetic<br>Blood (Horizontal Projection<br>of Fixed Volume at a Known<br>Velocity) | Testing the efficiency of<br>resistance to penetration by<br>synthetic blood. | Level 3: 29 out of 32 pass at<br>160 mmHg;<br>Level 2: 29 out of 32 pass at<br>120 mmHg | Level 3: 32 out of 32 passed<br>at 160 mmHg;<br>Level 2: 32 out of 32<br>passed at 120 mmHg |
| ASTM F2101-19, Standard<br>Test Method for Evaluating<br>the Bacterial Filtration<br>Efficiency (BFE) Of<br>Medical Face Mask<br>Materials, Using A<br>Biological Aerosol of<br>Staphylococcus Aureus | Testing the effectiveness of<br>medical face mask material<br>in preventing the passage of<br>aerosolized bacteria. | >98% | Level 3: passed at 99.8%<br>Level 2: passed at<br>99.9% |
| ASTM F2299-17, Standard<br>test method for determining<br>the initial efficiency of<br>materials used in medical<br>face masks to penetration by | Testing the efficiency of the<br>filter material in capturing<br>aerosolized particles smaller<br>than one micron. | >98% | Level 3: passed at 99.5%<br>Level 2: passed at<br>99.6% |
Table 2: Summary of Non-Clinical Testing
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| NO.16 WAYECONOMIC DEVELOPMENT ZONE, TIANCHANG, ANHUI | | | |
|--------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------|
| particulates using latex | | | |
| spheres | | | |
| 16 CFR 1610, Standard for<br>the Flammability of clothing<br>textiles | Testing the characteristics of a<br>material that pertain to its<br>relative ease of ignition and<br>relative ability to sustain<br>combustion. | Class 1 | Met Class 1 |
| ISO 10993-5:2009,<br>Biological Evaluation of<br>Medical Devices, Part 5:<br>Tests for In-Vitro<br>Cytotoxicity | Assess the biological response<br>of mammalian cells in vitro in<br>contact with a device or<br>extracts of a device | Non-Cytotoxic under the<br>conditions of the study | Passed, Non-<br>Cytotoxic under<br>the conditions of<br>the study |
| ISO 10993-10:2010,<br>Biological Evaluation of<br>Medical Devices, Part 10:<br>Tests for Irritation and<br>Sensitization | Assess medical devices and<br>their constituent materials for<br>their potential to produce skin<br>irritation or sensitization in<br>animal models | Non-Irritating and<br>Non-Sensitizing<br>under the<br>conditions of the<br>study | Passed, Non-<br>Irritating and Non-<br>Sensitizing under<br>the conditions of<br>the study |
| ISO 10993-10:2010,<br>Biological Evaluation of<br>Medical Devices, Part 10:<br>Tests for Irritation and<br>Sensitization | Assess medical devices and<br>their constituent materials for<br>their potential to produce skin<br>irritation or sensitization in<br>animal models | Non-Irritating and<br>Non-Sensitizing<br>under the<br>conditions of the<br>study | Passed, Non-<br>Irritating and Non-<br>Sensitizing under<br>the conditions of<br>the study |
## H. Clinical Test Conclusion
No clinical study is included in this submission.
## I. Conclusion
The conclusion drawn from the nonclinical tests demonstrates that the subject device in 510(K) submission K211255, Surgical Mask, is as safe, as effective, and performs as well as or better than the legally marketed predicate device cleared under K203685.
