Disposable Ear-loop Medical Face Mask, Disposable Tie-On Medical Face Mask
Device Facts
| Record ID | K211462 |
|---|---|
| Device Name | Disposable Ear-loop Medical Face Mask, Disposable Tie-On Medical Face Mask |
| Applicant | Xiantao S&J Protective Products Co., Ltd. |
| Product Code | FXX · General, Plastic Surgery |
| Decision Date | Aug 19, 2021 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 878.4040 |
| Device Class | Class 2 |
Indications for Use
The Disposable Ear-loop Medical Face Mask/Disposable Tie-On Medical Face Mask is 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 is a single-use, disposable device, provided non-sterile.
Device Story
Three-layer, flat-pleated medical face mask; available in ear-loop or tie-on styles; constructed from PP non-woven cloth with aluminum nose clip; available in ASTM F2100-19 barrier levels 1, 2, and 3. Device functions as physical barrier to reduce exposure to blood, body fluids, and particulates. Used in clinical settings by healthcare personnel and patients. Single-use, disposable, non-sterile. Provides protection via filtration and fluid resistance; performance verified through bench testing against ASTM standards. No clinical data included.
Clinical Evidence
No clinical data. Bench testing only. Performance verified via ASTM F1862 (synthetic blood penetration), ASTM F2299 (particulate filtration), ASTM F2101 (bacterial filtration), EN 14683 (differential pressure), and 16 CFR Part 1610 (flammability). Biocompatibility assessed per ISO 10993-5 and ISO 10993-10.
Technological Characteristics
Three-layer PP non-woven cloth construction; aluminum wire nose clip; nylon/spandex ear loops or PP non-woven tie strings. Dimensions: 17.5 cm x 9.5 cm. ASTM F2100-19 performance levels 1-3. Non-sterile. No software or electronic components.
Indications for Use
Indicated for use by patients and healthcare personnel to protect against 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
- Surgical Face Masks (Ear loops and Tie-on) (K160269)
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.
August 19, 2021
Xiantao S&J Protective Products Co., Ltd. % Diana Hong General Manager Mid-Link Consulting Co., Ltd P.O. Box 120-119 Shanghai. 200120 China
Re: K211462
Trade/Device Name: Disposable Ear-loop Medical Face Mask, Disposable Tie-On Medical Face Mask Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: July 8, 2021 Received: July 15, 2021
Dear Diana Hong:
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 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,
For Clarence W. Murray, III, PhD Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
## Indications for Use
510(k) Number (if known)
K211462
Device Name Disposable Ear-loop Medical Face Mask Disposable Tie-On Medical Face Mask
### Indications for Use (Describe)
The Disposable Ear-loop Medical Face Mask/Disposable Tie-On Medical Face Mask is 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 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)
X Over-The-Counter Use (21 CFR 801 Subpart C)
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## 510(k) Summary – K211462
This 510(k) Summary is being submitted in accordance with requirements of Title 21, CFR Section 807.92.
The assigned 510(k) Number: K211462
- 1. Date of Preparation: 08/02/2021
- 2. Sponsor Identification
# Xiantao S&J Protective Products Co., Ltd.
103 Mianyang Road, Xiantao, Hubei, China.
Establishment Registration Number: 3011434305
Contact Person: Dove Wei Position: Marketing Director Tel: +86 18672857899 Fax: +86 728 8877866 Email: wei@sjdisposable.com
- 3. Designated Submission Correspondent
Ms. Diana Hong (Primary Contact Person) Ms. Jinlei Tang (Alternative Contact Person)
Mid-Link Consulting Co., Ltd. P.O. Box 120-119, Shanghai, 200120, China
Tel: +86-21-22815850, Fax: 360-925-3199 Email: info@mid-link.net
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#### 4. Identification of Proposed Device
Trade Name: Disposable Ear-loop Medical Face Mask Disposable Tie-On Medical Face Mask Common Name: Surgical Face Mask
Regulatory Information Classification Name: Mask, Surgical Classification: II; Product Code: FXX; Regulation Number: 21CFR 878.4040 Review Panel: General Hospital
## Indication for use
The Disposable Ear-loop Medical Face Mask/Disposable Tie-On Medical Face Mask is 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 is a single-use, disposable device, provided nonsterile.
Device Description:
The proposed device is a three-layers, flat-pleated mask. Its size is 17.5 cm x 9.5 cm, and it is available in two types, Ear-loop and Tie-On. Both the ear loop and tie-on masks are available in three barrier levels (Level 1, Level 3) based on ASTM F2100: 2019. The mask body is composed of three layers which is made of PP non-woven cloth. The difference between the three levels mask is the density of middle material. The ear loop or tie strings is used to secure the mask over the users' mouth and face. The nosepiece provides a firm fit over the nose. Ear loops are made of Nylon and spandex, and tie strings are made of PP non-woven cloth. The nose clip is made of Aluminum wire.
- Identification of Predicate Device રું.
510(k) Number: K160269 Product Name: Surgical Face Masks (Ear loops and Tie-on)
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#### Technological Characteristics Comparison 6.
| ITEM | Proposed Device | | | Predicate Device K160269 | | | Comparison |
|------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------|---------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------|-------------------------|------------|
| | Disposable Ear-loop Medical Face Mask/Disposable Tie-On<br>Medical Face Mask | | | Surgical Face Masks<br>(Ear loops and Tie-on) | | | |
| | Level 1 | Level 2 | Level 3 | Level 1 | Level 2 | Level 3 | |
| Product Code | FXX | | | FXX | | | Same |
| Regulation No. | 21 CFR 878.4040 | | | 21 CFR 878.4040 | | | Same |
| Class | II | | | II | | | Same |
| Indication for Use | The Disposable Ear-loop Medical Face Mask/Disposable Tie-On Medical Face Mask is 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 is a single-use, disposable device, provided non-sterile. | | | The surgical face masks 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 is a single-use, disposable device, provided non-sterile. | | | Same |
| | | | | Level 1 Face Mask Models: # EL 10000, EL 10010, TO<br>10000, TO 10010 | | | |
| | | | | Level 2 Face Mask Models: # EL 20000, EL 20010, TO<br>20000, TO 20010 | | | |
| | | | | Level 3 Face Mask Models: # EL 30000, EL 30010, TO<br>30000, TO 30010 | | | |
| Mask style | Flat pleated | | | Flat pleated | | | Same |
| Design feature | Ear-loop / Tie-on | | | Ear loop / Tie-on | | | Same |
| Dimension (mm) | Ear loops: Body: 175 mm×95 mm, nose clip: 125mm,<br>Ear-loop: 175mm<br>Tie-on: Body: 175 mm×95 mm, nose clip: 125mm,<br>Tie strings: 910mm | | | 175 mm×90 mm<br>180 mm×90 mm | | Analysis 1 | |
| ASTM F2100 Level | Level 1 | Level 2 | Level 3 | Level 1 | Level 2 | Level 3 | Same |
| Fluid resistance | Pass at 80mmHg | Pass at 120mmHg | Pass at 160mmHg | Pass at 80mmHg | Pass at 120mmHg | Pass at 160mmHg | Same |
| Particulate efficiency level | Pass at 98.2% | Pass at 99.3% | Pass at 99.6% | Pass at 99.6% | Pass at 99.6% | Pass at 99.7% | Analysis 2 |
| Bacterial filtration level | Pass at 98.9% | Pass at 99.4% | Pass at 99.6% | Pass at >98% | Pass at >98% | Pass at >99% | Analysis 3 |
| Differential pressure | Pass at 3.6 mmH2O/cm² | Pass at 4.0 mmH2O/cm² | Pass at 4.6 mmH2O/cm² | Passed at 2.0 mmH2O/cm² | Passed at 1.6 mmH2O/cm² | Passed at 2.5 mmH2O/cm² | Analysis 4 |
| Flammability | Class 1 | | | Class 1 | | | Same |
| Label/Labeling | Complied with 21 CFR part 801 | | | Complied with 21 CFR part 801 | | | Same |
| Materials | | | | | | | |
| Outer layer Material | 23g/m² PP non-woven cloth | | | Polypropylene | | | Analysis 5 |
| Inner layer Material | 20g/m² PP non-woven cloth | | | Polypropylene | | | |
| Middle layer Material | 22g/m² PP non-woven cloth | 25g/m² PP non-woven cloth | 33g/m² PP non-woven cloth | 1. Polypropylene spunbond<br>2. Polypropylene melt blown | | | |
| Nose Clip | Aluminum wire | | | Polyethylene coated steel wire | | | |
| Ear-Loop | Nylon and Spandex | | | Polyester, Polyurethane, Side tapes: Polyester spunbond<br>(ear loops mask only) | | | |
| Tie strings | 35 g/m² PP non-woven cloth | | | Polypropylene spunbond or Polyester spunbond | | | |
| Colors | Blue | | | Blue and white | | | Analysis 6 |
## Table 1 General Comparison
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| Biocompatibility | | | |
|------------------|--------------------------------------------------------------------------------|-------------------------------------------------------------------------------|------|
| Cytotoxicity | Under the conditions of the study, the proposed device was<br>non-cytotoxic. | Under the conditions of the study, the subject device was<br>non-cytotoxic. | Same |
| Sensitization | Under the conditions of the study, the proposed device was<br>non-sensitizing. | Under the conditions of the study, the subject device was<br>non-sensitizing. | Same |
| Irritation | Under the conditions of the study, the proposed device was<br>non-irritating. | Under the conditions of the study, the subject device was<br>non-irritating. | Same |
| Sterility | Non-Sterile | Non-Sterile | Same |
Analysis 1 - Dimension (mm)
The dimension for the proposed device is different from predicate device.
Analysis 2 - Particulate efficiency level
The test result of particulation efficiency for the proposed device. However, the test result of the proposed devices can meet the requirements of level 1/level 2/level 3 based on ASTM F2100-19.
Analysis 3 - Bacterial filtration level
The test result of bacteria filtration efficiency for the proposed device is different from predicate device.
Analysis 4 - Differential pressure
The test result and reference standard of different in the proposed device is different from predicate device can med the requirents of the standard ASTM F2100: 2019 which was recognized by FDA.
Analysis 5 - Materials
The material for the proposed device is different from producted to the been performed on the proosed device and the results does not show any adverse effect.
Analysis 6 - Color
The proposed device is blue, and the provided in two colors, the color of the proposed device can be covered by the predicate device.
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#### 7. Summary of Non-Clinical Test
Nonclinical tests were conducted to verify that the proposed device met all design specifications as was same/similar to the predicate device. The test results from three nonconsecutive lots of 32 samples per lots (total of 96 samples) for each level claimed below demonstrated that the proposed device complies with the following standards:
- > ASTM F1862/F1862M: 2017 Standard Test Method for Resistance of Medical Face Masks to Penetration by Synthetic Blood (Horizontal Projection of Fixed Volume at a Known Velocity);
- > ASTM F2299/F2299M-03 (2017) Standard Test Method for Determining the Initial Efficiency of Material Used in medical Face Masks to Penetration by Particulates using Latex Spheres;
- > ASTM F2101: 2019 Standard Test Method for Evaluating the Bacterial Filtration Efficiency (BFE) of Medical Face Mask Materials, Using a Biological Aerosol of Staphylococcus aureus;
- > ASTM F2100: 2019 Standard Specification for Performance of Materials Used in Medical Face Masks
- > EN 14683:2019+AC: 2019 Annex C Medical face masks - Requirements and test methods
- > 16 CFR Part 1610 Standard for the Flammability of Clothing Textiles;
- > ISO 10993-5 Third edition 2009-06-01 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity
- > ISO 10993-10 Third Edition 2010-08-01 Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization
| Test Methodology | Purpose | Acceptance Criteria | Result |
|-------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Resistance to Penetration<br>by Synthetic blood | The test was performed in<br>accordance with ASTM<br>F1862/F1862M: 2017<br>Standard Test Method for<br>Resistance of Medical<br>Face Masks to<br>Penetration by Synthetic<br>Blood (Horizontal<br>Projection of Fixed<br>Volume at a Known<br>Velocity) to evaluate the<br>effectiveness of the test<br>sample from possible<br>exposure to blood and<br>other body fluids. | Level 1: No penetration at<br>80 mmHg | Level 1: Pass at 80mmHg |
| | | Level 2: No penetration at<br>120 mmHg | Level 2: Pass at<br>120mmHg |
| | | Level 3: No penetration at<br>160 mmHg | Level 3: Pass at<br>160mmHg |
| Particulate Filtration<br>Efficiency | The test was performed in<br>accordance with ASTM<br>F2299/F2299M-03 (2017)<br>Standard Test Method for<br>Determining the Initial<br>Efficiency of Material<br>Used in medical Face<br>Masks to Penetration by<br>Particulates using Latex<br>Spheres to determine the<br>particle filtration<br>efficiency (PFE) of the<br>test article. | Level 1: ≥95% | Pass at 98.2% |
| | | Level 2: ≥98% | Pass at 99.3% |
| | | Level 3: ≥98% | Pass at 99.6% |
| | The test was performed in<br>accordance with ASTM<br>F2101: 2019 Standard<br>Test Method for<br>Evaluating the Bacterial<br>Filtration Efficiency<br>(BFE) of Medical Face<br>Mask Materials, Using a<br>Biological Aerosol of<br>Staphylococcus aureus to<br>determine the bacterial<br>filtration efficiency (BFE)<br>of the test article. | Level 1: ≥95% | Pass at 98.9% |
| Bacterial Filtration<br>Efficiency | | Level 2: ≥98% | Pass at 99.4% |
| | | Level 3: ≥98% | Pass at 99.6% |
| | | | |
| Differential Pressure | The test was performed in<br>accordance with EN<br>14683:2019+AC: 2019<br>Annex C Medical face<br>masks - Requirements<br>and test methods. | $<5.0 \text{ mmH}_2\text{O/cm}^2$ | Pass at $3.6 \text{ mmH}_2\text{O/cm}^2$ |
| | | $<6.0 \text{ mmH}_2\text{O/cm}^2$ | Pass at $4.0 \text{ mmH}_2\text{O/cm}^2$ |
| | | $<6.0 \text{ mmH}_2\text{O/cm}^2$ | Pass at $4.6 \text{ mmH}_2\text{O/cm}^2$ |
| Flammability | The test was performed in<br>accordance with 16 CFR<br>Part 1610 Standard for the<br>Flammability of Clothing<br>Textiles. | Class 1 | Class 1 |
| Cytotoxicity | The test was performed in<br>accordance with ISO<br>10993-5 Third edition<br>2009-06-01 Biological<br>evaluation of medical<br>devices - Part 5: Tests for<br>in vitro cytotoxicity to<br>evaluate the cytotoxicity<br>of the test sample. | The viability should be<br>≥70% of the blank. And<br>the 50% extract of the test<br>sample should have at<br>least the same or a higher<br>viability than the 100%<br>extract. | The viability was ≥70%<br>of the blank. And the 50%<br>extract of the test sample<br>had a higher viability than<br>the 100% extract.<br>Under the conditions of<br>the study, the proposed<br>device was non-cytotoxic. |
| Sensitization | The test was performed in<br>accordance with ISO<br>10993-10 Third Edition<br>2010-08-01 Biological<br>evaluation of medical<br>devices - Part 10: Tests<br>for irritation and skin<br>sensitization to evaluate<br>the sensitization of the<br>test sample. | Non-sensitizing | Under the conditions of<br>the study, the proposed<br>device was non-<br>sensitizing. |
| Irritation | The test was performed in<br>accordance with ISO<br>10993-10 Third Edition<br>2010-08-01 Biological<br>evaluation of medical<br>devices - Part 10: Tests<br>for irritation and skin<br>sensitization to evaluate<br>the irritation of the test<br>sample. | Non-irritating | Under the conditions of<br>the study, the proposed<br>device was non-irritating. |
Table 2 Summary of Non-clinical Testing
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- 8. Clinical Test Conclusion
No clinical study is included in this submission.
- 9. Conclusion
The conclusions drawn from the nonclinical tests demonstrate that the proposed device is as safe, as effective, and performs as well as the legally marketed predicate device K160269.
