Surgical Masks
Device Facts
| Record ID | K212120 |
|---|---|
| Device Name | Surgical Masks |
| Applicant | Hubei Xinxin Non-Woven Co., Ltd. |
| Product Code | FXX · General, Plastic Surgery |
| Decision Date | Jan 28, 2022 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 878.4040 |
| Device Class | Class 2 |
Indications for Use
The surgical masks are intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids, and particulate material. These masks are intended for use in infection control practices to reduce the potential exposure to bloody fluids. This is a single-use, disposable device, provided non-sterile.
Device Story
Surgical masks; single-use, flat-pleated, non-sterile. Protects patient and healthcare personnel from microorganisms, body fluids, and particulates. Configurations: ear loop or tie-on, with or without PET shield. Materials: spunbond polypropylene (outer/inner layers), meltblown polypropylene (filter), spandex (ear loops), iron wire/polypropylene (nose piece). Used in clinical settings for infection control. User adjusts nose piece to bridge of nose for fit. Benefits: barrier protection against fluid/particulate transfer.
Clinical Evidence
No clinical data. Bench testing only. Performance verified via ASTM F2100-19, ASTM F2299 (PFE), ASTM F2101 (BFE), ASTM F1862 (synthetic blood penetration), and EN 14683 (differential pressure). Biocompatibility confirmed via ISO 10993-5 (cytotoxicity) and ISO 10993-10 (irritation/sensitization).
Technological Characteristics
Flat-pleated surgical mask. Materials: Spunbond polypropylene (layers/ties), meltblown polypropylene (filter), spandex (ear loops), PET (shield), iron wire/polypropylene (nose piece). ASTM F2100-19 performance levels 1, 2, and 3. Non-sterile. No electronic components or software.
Indications for Use
Indicated for use by patients and healthcare personnel to reduce transfer of microorganisms, body fluids, and particulate material, and to reduce potential exposure to blood and body fluids 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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January 28, 2022
Hubei Xinxin Non-woven Co.,Ltd. % Diana Hong General Manager Mid-Link Consulting Co., Ltd P.O. Box 120-119 Shanghai. 200120 China
Re: K212120
Trade/Device Name: Surgical Masks Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: December 20, 2021 Received: December 27, 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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542 of the Act); 21 CFR 1000-1050.
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-
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 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) K212120
Device Name Surgical Masks
Indications for Use (Describe)
The surgical masks are intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids, and particulate material. These masks are intended for use in infection control practices to reduce the potential exposure to bloody fluids. This is a single-use, disposable device, provided non-sterile.
XX0009 Ear loop Level: Level 1, Level 2 and Level 3 XX0008 Tie-on Level: Level 1, Level 2 and Level 3 XX0006 Tie-on with shield Level: Level 1, Level 2 and Level 3 XX0005 Ear loop with shield Level: Level 1, Level 2 and Level 3
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
This 510(k) Summary is being submitted in accordance with requirements of Title 21, CFR Section 807.92.
The assigned 510(k) Number: _K212120_
- 1. Date of Preparation: 01/27/2022
- 2. Sponsor Identification
# Hubei Xinxin Non-woven Co., Ltd.
Taizihu Industrial Park, Pengchang Town, Xiantao, Hubei, 433018, China
Establishment Registration Number: 3011547453.
Contact Person: Nicole Jin Position: QA Manager Tel: +86-728-2618155 Email: nicole jin@xtxfsl.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: Surgical Masks 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 surgical masks are intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids, and particulate material. These 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.
XX0009 Ear loop Level: Level 1, Level 2 and Level 3 XX0008 Tie-on Level: Level 1, Level 2 and Level 3 XX0006 Tie-on with shield Level: Level 1, Level 2 and Level 3 XX0005 Ear loop with shield Level: Level 1, Level 2 and Level 3
### Device Description:
The surgical masks are single use, flat-pleated masks that are provided in blue. The outer and inner layers of the mask are made of spunbond polypropylene. The middle filter is made of one layer of meltblown polypropylene filter. The Surgical Masks are available in four types due to different configurations, including ear loop, tie-on, ear loop with shield and tie-on with shield. Detail configurations of them are presented in Table 1 Surgical Masks Description. The ties are made of spunbond polypropylene and the ear loops are made of spandex. The shield is made of PET. The nose piece is made of iron wire and polypropylene. Users can adjust the nose piece according to the shape of the bridge of the nose, and fix the mask on the bridge of the nose to prevent the mask from falling off. The proposed devices are provided in non-sterile. The proposed devices contain four (4) types of masks: XX0009, XX008, XX0006 and XX0005. Each of these types have three different levels, level 2, and level 3. Therefore, the proposed devices have 12 models in toto, and detailed model information is provided in Table 1.
| Product Model | Ear loop | Tie-on | Shield | ASTM F2100 Level |
|---------------|----------|--------|--------|------------------------------|
| XX0009 | √ | NA | NA | Level 1, Level 2 and Level 3 |
| XX0008 | NA | √ | NA | Level 1, Level 2 and Level 3 |
Table 1. Surgical Masks Description
Page 2 of 8
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| XX0006 | NA | √ | √ | Level 1, Level 2 and Level 3 |
|--------|----|----|---|------------------------------|
| XX0005 | √ | NA | √ | Level 1, Level 2 and Level 3 |
- ર. Identification of Predicate Device
510(k) Number: K160269 Product Name: Surgical Face Masks (Ear loops and Tie-on)
- Summary of Technological characteristics 6.
| ITEM | Proposed Device K212120 | Predicate Device K160269 | Remark |
|-----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------|
| Product Code | FXX | FXX | Same |
| Regulation<br>No. | 21 CFR 878.4040 | 21 CFR 878.4040 | Same |
| Class | II | II | Same |
| Indication for<br>Use | The surgical masks are intended to be worn<br>to protect both the patient and healthcare<br>personnel from transfer of microorganisms,<br>body fluids, and particulate material. These<br>masks are intended for use in infection<br>control practices to reduce the potential<br>exposure to blood and body fluids. This is a<br>single-use,<br>disposable<br>device, provided<br>non-sterile.<br>XX0009 Ear loop Level: Level 1, Level 2<br>and Level 3<br>XX0008 Tie-on Level: Level 1, Level 2 and<br>Level 3<br>XX0006 Tie-on with shield Level: Level 1,<br>Level 2 and Level 3<br>XX0005 Ear loop with shield Level: Level 1,<br>Level 2 and Level 3 | The surgical face masks are intended to be<br>worn to protect both the patient and<br>healthcare personnel from transfer of<br>microorganisms, body fluids, and<br>particulate material. These face masks are<br>intended for use in infection control<br>practices to reduce the potential exposure to<br>blood and body fluids. This is a single-use,<br>disposable device, provided non-sterile. | Same |
| Mask style | Flat-pleated | Flat-pleated | Same |
| Configurations | Ear loop;<br>Tie-on;<br>Ear loop with shield;<br>Tie-on with shield | Ear loop;<br>Tie-on;<br>Ear loop with visor;<br>Tie-on with visor | Same |
| Color | Blue | Blue, White | Different |
| Dimension | Mask: | Length: 90±3mm; | Different |
# Table 1. Comparison of Surgical Masks
Page 3 of 8
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| Length: 175±5mm; | | | Width: 175±5mm; | | | | |
|-----------------------------------------|--------------------------------|--------------------------|--------------------------|------------------------------------------------------------------|--------------------------|--------------------------|-----------|
| Width: 95±5mm; | | | Or | | | | |
| Nose piece: | | | Length:90±3mm; | | | | |
| Length:115mm±10mm; | | | Width: 180±5mm | | | | |
| Ear loop: | | | | | | | |
| | Natural length: 165±10mm; | | | | | | |
| | Stretched length: 420±10mm; | | | | | | |
| | Ties: | | | | | | |
| | Length: 400±10mm; | | | | | | |
| | Shield: | | | | | | |
| | Length: 295±5mm; | | | | | | |
| | Width: 122±5mm | | | | | | |
| Sterility | Non-Sterile | | | Non-Sterile | | Same | |
| Use | Single Use, Disposable | | | Single Use, Disposable | | Same | |
| ASTM F2100<br>Level | Level 1 | Level 2 | Level 3 | Level 1 | Level 2 | Level 3 | Same |
| Particulate<br>filtration<br>efficiency | Pass at<br>96.17% | Pass at<br>98.95% | Pass at<br>99.06% | Pass at<br>99.6% | Pass at<br>99.6% | Pass at<br>99.7% | Different |
| Bacterial<br>filtration<br>efficiency | Pass at<br>96.80% | Pass at<br>98.90% | Pass at<br>99.04% | Pass at >98% | Pass at >98% | Pass at >99% | Different |
| Differential<br>pressure | Pass at 4.0<br>mmH2O/cm² | Pass at 5.1<br>mmH2O/cm² | Pass at 5.2<br>mmH2O/cm² | Pass at 2.0<br>mmH2O/cm² | Pass at 1.6<br>mmH2O/cm² | Pass at 2.5<br>mmH2O/cm² | Different |
| Flammability | Class 1 | Class 1 | Class 1 | Class 1 | Class 1 | Class 1 | Same |
| Fluid<br>resistance | Pass at<br>80 mmHg | Pass at 120<br>mmHg | Pass at 160<br>mmHg | Pass at<br>80 mmHg | Pass at 120<br>mmHg | Pass at 160<br>mmHg | Same |
| Label/Labeling | Complied with 21 CFR part 801 | | | Complied with 21 CFR part 801 | | | Same |
| Patient Contacting Material | | | | | | | |
| Outer facing<br>layer | Spunbond Polypropylene | | | Polypropylene | | | |
| Middle layer | Meltblown Polypropylene Filter | | | Meltblown Polypropylene Filter;<br>Spunbond Polypropylene Filter | | | |
| Inner facing<br>layer | Spunbond Polypropylene | | | Polypropylene | | | Different |
| Nose piece | Iron wire and Polypropylene | | | Polyethylene coated steel wire | | | |
| Ear loop | Spandex | | | Polyester, Polyurethane<br>Side tapes: | | | |
| | | | | Polyester spunbond (ear loops mask only) | | | |
| Ties | Spunbond Polypropylene | | | Polypropylene<br>spunbond<br>or<br>polyester | | | |
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| | | spunbond | |
|------------------|-----------------------------------------------------------------------------|----------------------------------------------------------------------------|------|
| Shield | PET | Polyester | |
| Biocompatibility | | | |
| Cytotoxicity | Under the conditions of the study, the proposed device was non-cytotoxic. | Under the conditions of the study, the subject device was non-cytotoxic. | |
| Irritation | Under the conditions of the study, the proposed device was non-irritating. | Under the conditions of the study, the subject device was non-irritating. | Same |
| Sensitization | Under the conditions of the study, the proposed device was non-sensitizing. | Under the conditions of the study, the subject device was non-sensitizing. | |
### Different - Color
The proposed device is blue and the predicate device is provided in two colors, the proposed device can be covered by the predicate device.
### Different - Dimension
The dimension for the proposed device is different from the predicate device.
Different - Particulate filtration efficiency
The test result for particulate filtration efficiency for the proposed device is different from the predicate device.
Different - Bacterial filtration efficiency
The test result for bacterial filtration efficiency for the proposed device is different from the predicate device.
Different - Differential pressure
The test result and reference standard of differential pressure for the proposed device is different from predicate device.
Different - Patient Contacting Material
The patient contacting material for the proposed device is different from the predicate device.
- 7. Non-Clinical Test Conclusion
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Non clinical tests were conducted to verify that the proposed device met all design specifications as was same/similar to the predicate device. The test results demonstrated that the proposed device complies with the following standards:
- 16 CFR Part 1610 Standard for the Flammability of Clothing Textiles; >
- > 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)
- > 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, Annex C, Medical face masks- Requirements and test methods
- > ISO 10993-5:2009 Biological evaluation of medical device- Part 5: Tests for in vitro cytotoxicity
- > ISO 10993-10:2010 Biological evaluation of medical device- Part 10: Tests for irritaion and skin sensitization
- A ISO 10993-1:2018 Biological evaluation of medical devices - Part 1 Evaluation and testing within a risk management process.
| Test Methodology | Purpose | Acceptance Criteria | Result |
|----------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Particulate<br>Filtration Efficiency | The test was performed in accordance<br>with ASTM F2299/F2299M-03 (2017)<br>Standard Test Method for Determining<br>the Initial Efficiency of Material Used<br>in medical Face Masks to Penetration<br>by Particulates using Latex Spheres to<br>determine the particle filtration<br>efficiency (PFE) of the test article. | Level 1: ≥95% | Pass at 96.17% |
| | | Level 2: ≥98% | Pass at 98.95% |
| | | Level 3: ≥98% | Pass at 99.06% |
| Bacterial Filtration<br>Efficiency | The test was performed in accordance<br>with ASTM F2101: 2019 Standard Test<br>Method for Evaluating the Bacterial<br>Filtration Efficiency (BFE) of Medical<br>Face Mask Materials, Using a<br>Biological Aerosol of Staphylococcus<br>aureus to determine the bacterial<br>filtration efficiency (BFE) of the test<br>article. | Level 1: ≥95% | Pass at 96.80% |
| | | Level 2: ≥98% | Pass at 98.90% |
| | | Level 3: ≥98% | Pass at 99.04% |
| Differential<br>Pressure | The test was performed in accordance<br>with EN 14683:2019+AC: 2019 Annex | $<5.0{\text{ mmH}}_2{\text{O/cm}}^2$ | Pass at 4.0 mmH2O/cm² |
| | C Medical face masks - Requirements<br>and test methods. | | |
| | | <6.0 mmH2O/cm² | Pass at 5.1 mmH2O/cm² |
| | | <6.0 mmH2O/cm² | Pass at 5.2 mmH2O/cm² |
| Flammability | The test was performed in accordance<br>with 16 CFR Part 1610 Standard for<br>the Flammability of Clothing Textiles. | Class 1 | Class 1 |
| | The test was performed in accordance<br>with ASTM F1862/F1862M: 2017<br>Standard Test Method for Resistance | Level 1: No penetration at 80 mmHg | Level 1: Pass at 80 mmHg |
| Resistance<br>to<br>Penetration<br>by<br>Synthetic blood | of Medical Face Masks to Penetration<br>by Synthetic Blood (Horizontal<br>Projection of Fixed Volume at a<br>Known Velocity) to evaluate the | Level 2: No penetration at 120 mmHg | Level 2: Pass at 120 mmHg |
| | effectiveness of the test sample from<br>possible exposure to blood and other<br>body fluids. | Level 3: No penetration at 160 mmHg | Level 3: Pass at 160 mmHg |
| Cytotoxicity | The test was performed in accordance<br>with ISO 10993-5 Third edition<br>2009-06-01 Biological evaluation of<br>medical devices - Part 5: Tests for in<br>vitro cytotoxicity to evaluate the<br>cytotoxicity of the test sample. | The viability should be $≥$ 70%<br>of the blank. And the 50%<br>extract of the test sample<br>should have at least the same<br>or a higher viability than the<br>100% extract. | The viability was<br>$≥$ 70% of the blank.<br>And the 50% extract<br>of the test sample<br>had a higher viability<br>than the 100%<br>extract.<br>Under the conditions<br>of the study, the<br>proposed device was<br>non-cytotoxic. |
| Sensitization | The test was performed in accordance<br>with ISO 10993-10 Third Edition<br>2010-08-01 Biological evaluation of<br>medical devices - Part 10: Tests for<br>irritation and skin sensitization to<br>evaluate the sensitization of the test<br>sample. | Non-sensitizing | Under the conditions<br>of the study, the<br>proposed device was<br>non-sensitizing. |
| Irritation | The test was performed in accordance<br>with ISO 10993-10 Third Edition<br>2010-08-01 Biological evaluation of<br>medical devices - Part 10: Tests for<br>irritation and skin sensitization to | Non-irritating | Under the conditions<br>of the study, the<br>proposed device was<br>non-irritating. |
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| | evaluate the irritation of the test<br>sample. |
|--|------------------------------------------------|
|--|------------------------------------------------|
#### 8. Clinical Test Conclusion
No clinical study is included in this submission.
#### 9. Conclusion
The conclusion drawn from the non-clinical tests demonstrates that the surgical masks is as safe, as effective, and performs as well as or better than the legally marketed predicate device cleared under K160269.
