Surgical Face Mask (Tie on/ Ear loops)
Device Facts
| Record ID | K240916 |
|---|---|
| Device Name | Surgical Face Mask (Tie on/ Ear loops) |
| Applicant | Xiantao Daoqi Plastic Co., Ltd. |
| Product Code | FXX · General, Plastic Surgery |
| Decision Date | Oct 18, 2024 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 878.4040 |
| Device Class | Class 2 |
Indications for Use
Surgical Face Mask is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. It 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
Surgical face mask; single-use, disposable, non-sterile; three-layer flat-pleated design. Layers consist of nonwoven fabrics (inner/outer) and melt-blown polypropylene (middle). Available in tie-on or elastic ear-loop configurations; nose piece made of polypropylene with iron core. Used in clinical settings for infection control; worn by healthcare personnel and patients to provide barrier protection against blood, body fluids, and particulates. Device functions as a physical barrier; no active components or software.
Clinical Evidence
No clinical data. Bench testing only. Performance testing included Bacterial Filtration Efficiency (BFE) (99.7-99.9%), differential pressure (3.2-3.7 mmH2O/cm²), sub-micron particulate filtration efficiency (PFE) (97.16-99.52%), synthetic blood penetration resistance (160 mmHg), and flammability (Class 1). Biocompatibility testing confirmed compliance with ISO 10993-5 (cytotoxicity), ISO 10993-23 (irritation), and ISO 10993-10 (sensitization).
Technological Characteristics
Three-layer flat-pleated mask. Materials: Spun-bond polypropylene (inner/outer layers, ties), melt-blown polypropylene (middle layer), polypropylene/iron core (nose piece). Dimensions: 17.5cm x 9.5cm. Non-sterile, single-use. ASTM F2100-23 Level 3 performance. No software or electronic components.
Indications for Use
Indicated for use by patients and healthcare personnel to reduce exposure to microorganisms, body fluids, and particulate material in infection control settings.
Regulatory Classification
Identification
Surgical apparel are devices that are intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material. Examples include surgical caps, hoods, masks, gowns, operating room shoes and shoe covers, and isolation masks and gowns. Surgical suits and dresses, commonly known as scrub suits, are excluded.
Special Controls
*Classification.* (1) Class II (special controls) for surgical gowns and surgical masks. A surgical N95 respirator or N95 filtering facepiece respirator is not exempt if it is intended to prevent specific diseases or infections, or it is labeled or otherwise represented as filtering surgical smoke or plumes, filtering specific amounts of viruses or bacteria, reducing the amount of and/or killing viruses, bacteria, or fungi, or affecting allergenicity, or it contains coating technologies unrelated to filtration (e.g., to reduce and or kill microorganisms). Surgical N95 respirators and N95 filtering facepiece respirators are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 878.9, and the following conditions for exemption:(i) The user contacting components of the device must be demonstrated to be biocompatible. (ii) Analysis and nonclinical testing must: (A) Characterize flammability and be demonstrated to be appropriate for the intended environment of use; and (B) Demonstrate the ability of the device to resist penetration by fluids, such as blood and body fluids, at a velocity consistent with the intended use of the device. (iii) NIOSH approved under its regulation. (2) Class I (general controls) for surgical apparel other than surgical gowns and surgical masks. The class I device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 878.9.
Predicate Devices
- Surgical face mask (K220777)
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 the FDA logo, with the letters "FDA" in a blue square. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
October 18, 2024
Xiantao Daoqi Plastic Co., Ltd. Honghong Bie Quality Manager No.83, Wagou New District Pengchang Town Xiantao, Hubei 433018 China
Re: K240916
Trade/Device Name: Surgical Face Mask (Tie on/ Ear loops) Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: September 12, 2024 Received: September 12, 2024
Dear Honghong Bie:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
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(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rue"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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).
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Sincerely,
# Allan Guan -S
For Bifeng Qian, M.D., Ph.D. Assistant Director DHT4C: Division of Infection Control 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) K240916
Device Name Surgical Face Mask (Tie on/ Ear loops)
#### Indications for Use (Describe)
Surgical Face Mask is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. It 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.
| 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 (K240916)
This summary of 510(k) safety and effectiveness information is being submitted in accordance with 21 CFR 807.92.
#### 1.0 Submitter's information
Name: XIANTAO DAOQI PLASTIC CO., LTD. Address: No.83, Wagou New District, Pengchang Town, Xiantao City, Hubei Province, 433018, China Phone Number: +86-728 2620008 Contact: Ms. Bie Honghong Date of Preparation: 10/18/2024
#### Designated Submission Correspondent
Mr. Boyle Wang Shanghai Truthful Information Technology Co., Ltd. Room 608, No. 738 Shangcheng Rd., Pudong Shanghai, 200120 China Tel: +86-21-50313932 Email: Info@truthful.com.cn
### 2.0 Device information
| Trade name: | Surgical Face Mask |
|----------------------|--------------------------|
| Common name: | Surgical Mask |
| Classification name: | Mask, Surgical |
| Model(s): | Ear loops (17.5cm×9.5cm) |
| | Tie-on (17.5cm×9.5cm) |
#### 3.0 Classification
Production code: FXX Regulation number: 21CFR 878.4040 Classification: Class II Panel: Surgical apparel
#### 4.0 Predicate device information
Manufacturer: Hubei Qianjiang Kingphar Medical Material Co., Ltd Device: Surgical face mask 510(k) number: K220777
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#### 5.0 Indication for Use Statement
Surgical Face Mask is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. It 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.
#### 6.0 Device description
The Surgical face mask is single use, three-layer, flat-pleated style with ear loops/ties and nose piece. The mask is manufactured with three layers, the inner and outer layers, and the straps are made of nonwoven fabrics, the middle layer is made of melt blown fabrics.
The model of proposed device, tie-on, is held in place over the user's mouth and nose by four ties welded to the face mask. The tie is made of spun-bond polypropylene.
The model of proposed device, ear loops, is held in place over the user's mouth and nose by two elastic ear loops welded to the face mask. The elastic ear loops are not made with natural rubber latex.
The ties/ear loops are not made with natural rubber latex. The nose piece on the layers of face mask is to allow the user to fit the face mask around their nose, which is made of Polypropylene with iron core. The Surgical face mask will be provided in blue. The masks are sold non-sterile and are intended to be single use, disposable devices.
#### 7.0 Technological Characteristic Comparison Table
#### Table 1 - General Comparison
| Item | Proposed device | Predicate device | Comparison |
|--------------|-----------------|------------------|------------|
| Product Code | FXX | FXX | Same |
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| Regulation No. | 21 CFR 878.4040 | 21 CFR 878.4040 | Same | | |
|--------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------|--------------------------|------|
| Class | II | II | Same | | |
| Product name | Surgical Face Mask | Surgical Face Mask | Same | | |
| 510(k) No. | K240916 | K220777 | - | | |
| Mask styles | Ear loops/Tie on | Ear loops/Tie on | Same | | |
| Intended Use | The surgical Face Mask is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. It 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. | The Surgical Face Mask is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. It 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. | Same | | |
| | OTC use | Yes | Yes | Same | |
| | Design Features | Flat Pleated, 3 layers | Flat Pleated, 3 layers | Same | |
| | Materials | Internal layer | Spun-bond polypropylene | Spun-bond polypropylene | Same |
| | | Middle layer | Melt blown polypropylene | Melt blown polypropylene | Same |
| External layer | | Melt blown polypropylene | Spun-bond polypropylene | Same | |
| Nose piece | | Polypropylene+iron core | Polypropylene+Galvanize d-iron dual core | Similar | |
| Ear loops | | Polyester+spandex | Polyester, spandex | * Gap 1 | |
| | Ties | Spun-bond polypropylene | | | |
| Color | Blue | Blue | Same | | |
| Dimension (Length) | 17.5cm±0.5cm | 17.5cm±0.5cm | Same | | |
| Dimension (Width) | 9.5cm±0.5cm | 9.5cm±0.5cm | Same | | |
| Sterility | Non-Sterile | Non-Sterile | Same | | |
| Single Use | Yes | Yes | Same | | |
| Sterile | No | No | Same | | |
| ASTM F2100 Level | Level 3 | Level 3 | Similar | | |
| Shelf Life | 2 years | 5 years | Different | | |
* Gap analysis:
Gap 1: the two devices have some difference in materials, product materials safety is proved by its biocompatibility, and the difference does not raise additional questions for safety and effectiveness of device.
| Item | Proposed device | Predicate device | Remark |
|----------------------------------------------|-----------------------------------|-----------------------------|-----------------------------|
| Bacterial filtration<br>efficiency (BFE) (%) | ASTM F2100-23 Level 3, ≥98 | ASTM F2100-19 Level 3, ≥98 | Same |
| | Different pressure<br>(mmH2O/cm²) | ASTM F2100-23 Level 3, <6.0 | ASTM F2100-19 Level 3, <6.0 |
#### Table 2 Performance Comparison
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| Sub-micron particulate<br>filtration efficiency at<br>0.1 micron, % (PFE) | ASTM F2100-23 Level 3, ≥85 | ASTM F2100-19 Level 3, ≥98 | Similar |
|----------------------------------------------------------------------------------------------------|----------------------------|----------------------------|---------|
| Resistance to<br>penetration by synthetic<br>blood, Minimum<br>pressure in mmHg for<br>pass result | ASTM F2100-23 Level 3, 160 | ASTM F2100-19 Level 3, 160 | Same |
| Flame spread | Class 1 | Class 1 | Same |
#### Biocompatibility Comparison Table 3
| Item | Proposed Device | Predicate Device | Remark |
|---------------|--------------------------|--------------------------|--------|
| Cytotoxicity | Comply with ISO 10993-5 | Comply with ISO 10993-5 | Same |
| Irritation | Comply with ISO 10993-23 | Comply with ISO 10993-10 | Same |
| Sensitization | Comply with ISO 10993-10 | Comply with ISO 10993-10 | Same |
#### 8.0 Summary of Non-Clinical Testing
The proposed device was tested and conformed to the related recognized standards and the requirements stated in the Guidance for Industry and FDA Staff: Surgical Masks - Premarket Notification [510(k)] Submission issued on March 5, 2004 and following recognized standards:
#### Biocompatibility Testing
2-245 ISO 10993-5 Third edition 2009-06-01 Biological Evaluation of Medical Devices -Part 5: Tests For In Vitro Cytotoxicity
2-291 ISO 10993-23 First edition 2021-01 Biological evaluation of medical devices- Part 23: Tests for irritation
2-296 ISO 10993-10 Fourth edition 2021-11 Biological Evaluation of Medical Devices -Part 10: Tests for Skin Sensitization.
#### Performance Testing (Bench)
6-492 ASTM F2100-23 Standard Specification for Performance of Materials Used in Medical Face Masks 6-493 ASTM F2101-23 Standard Test Method of Evaluating the Bacterial Filtration Efficiency (BFE) of Medical Face Mask Materials, Using a Biological Aerosol of
Staphylococcus aureus
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6-406 ASTM F1862/F1862M-17 Standard Test Method for Resistance of Medical Face Masks to Penetration by Synthetic Blood (Horizontal Projection of Fixed Volume at a Known Velocity)
| Items | Purpose | Acceptance Criteria<br>Level 3<br>( ASTM F2100-23) | Result |
|----------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------|-----------------------------------|
| Bacterial filtration<br>efficiency (BFE) (%) | The purpose of the test is<br>to evaluate the Bacterial<br>filtration<br>efficiency (BFE) (%) | ≥98 | 99.7%-99.9%<br>Pass |
| Different pressure<br>(mmH2O/cm2) | The purpose of the test is<br>to evaluate the Different<br>pressure<br>(mmH2O/cm2) | <6.0 mmH2O/cm² | 3.2-3.7<br>mmH2O/cm²<br>Pass |
| Sub-micron particulate<br>filtration efficiency at<br>0.1 micron, % (PFE) | The purpose of the test is<br>to evaluate the<br>Sub-micron particulate<br>filtration efficiency at 0.1<br>micron, % (PFE) | ≥85 | 97.16-99.52%<br>Pass |
| Resistance to<br>penetration by<br>synthetic blood,<br>Minimum pressure in<br>mmHg for pass result | The purpose of the test is<br>to evaluate the<br>Resistance to penetration<br>by synthetic blood,<br>Minimum pressure in<br>mmHg for pass result | 29 of 32 test articles passed<br>at 160mmHg | 32 of 32 test<br>articles<br>Pass |
| Flame spread | The purpose of the test is<br>to evaluate the<br>Flammability | Class 1 | 32 of 32 test<br>articles<br>Pass |
#### Table 4 - Performance Testing
#### Table 5 - Biocompatibility Testing
| Items | Purposes | Acceptance Criteria | Result | Summary |
|---------------|---------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------|
| Cytotoxicity | To evaluate the<br>risk of the sample<br>to induce biological<br>response of L-929 | ISO 10993-5:2009<br>Viability < 70 %, it has<br>a cytotoxic potential. | Tie on:<br>the viability ratio of the<br>100% test article extract<br>was 91.0%, no potential | Pass |
| | | cells | toxicity of L-929 cells. | |
| | | | Ear loops:<br>the viability ratio of the<br>100% test article extract<br>was 70.5%, no potential<br>toxicity of L-929 cells. | |
| Irritation | To evaluate the<br>potential of skin<br>irritation of<br>samples under of<br>the test conditions | ISO 10993-23:2021 | Tie on:<br>The primary irritation<br>indexes of the polar and<br>non-polar test group were<br>both calculated to be 0.<br>The extract of the test<br>article did not induce skin<br>irritation.<br>Ear loops:<br>The primary irritation<br>indexes of the polar and<br>non-polar test group were<br>both calculated to be 0.<br>The extract of the test<br>article did not induce skin<br>irritation. | Pass |
| | | If the primary irritation<br>index is 0-0,4, the<br>response category is<br>Negligible.<br>0,5-1,9 means slight<br>2-4,9 means moderate<br>5-8 means severe<br>Primary<br>Irritation-Index≤ 2.0 | | |
| Sensitization | To evaluate the<br>potential of a test<br>article to cause<br>skin sensitization<br>using Guinea Pig<br>Maximization Test | ISO 10993-10:2021 | Tie on:<br>The skin sensitization rates<br>of polar and non-polar<br>extract group were both<br>determined with 0%.<br>Ear loops:<br>The skin sensitization rates<br>of polar and non-polar<br>extract group were both<br>determined with 0% | Pass |
| | | provided grades less<br>than 1, otherwise<br>sensitization. | | |
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### 9.0 Summary of Clinical Testing
No clinical study conducted for the Surgical Face Mask.
#### 10.0 Conclusion
The conclusions drawn from the nonclinical tests demonstrate that the proposed device is as safe, as effective, and performs as well as or better than the legally marketed predicate device.
