Surgical Masks
Device Facts
| Record ID | K212807 |
|---|---|
| Device Name | Surgical Masks |
| Applicant | Weihai Hongyu Nonwoven Fabric Products Co., Ltd. |
| Product Code | FXX · General, Plastic Surgery |
| Decision Date | Dec 3, 2021 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 878.4040 |
| Device Class | Class 2 |
Indications for Use
The Surgical Masks is intended to be worn to protect both the patient and healthcare personnel from the transfer of microorganisms, body fluids, and particulate material. The Surgical Masks 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 Model YH-EZ-004(White Color, Blue Color) is Level 2 barrier as ASTM F2100 requirements.
Device Story
Surgical mask (Model YH-EZ-004) designed as flat-pleated, three-layer barrier device; worn over mouth and nose using elastic ear loops; includes integrated polyethylene nose piece for fit. Outer/inner layers composed of spunbonded non-woven fabric; middle layer composed of melt-blown non-woven fabric. Intended for single-use, non-sterile, over-the-counter or clinical application. Provides ASTM F2100 Level 2 barrier protection against blood and body fluids. Healthcare providers use device to mitigate infection transmission risks during procedures or patient care. Benefits include reduced exposure to pathogens and particulates for both wearer and patient.
Clinical Evidence
No clinical data. Bench testing only. Performance verified against ASTM F2100-19, ASTM F1862-17 (synthetic blood penetration), ASTM F2299-03 (particulate filtration), ASTM F2101-19 (bacterial filtration), EN 14683:2019 (differential pressure), and 16 CFR 1610 (flammability). Biocompatibility confirmed via ISO 10993-5 and ISO 10993-10.
Technological Characteristics
Three-layer flat-pleated mask. Materials: spunbonded non-woven (outer/inner), melt-blown non-woven (middle), polyethylene (nose piece), terylene/spandex (ear loops). ASTM F2100 Level 2 barrier performance. Non-sterile, single-use. Dimensions: 17.5 cm x 9.5 cm (±5%).
Indications for Use
Indicated for use by healthcare personnel and patients 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
- Medical Surgical Masks-Non Sterile (K202594)
Submission Summary (Full Text)
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December 3, 2021
Weihai Hongyu Nonwoven Fabric Products Co., Ltd. Ray Wang General Manager Beijing Believe-Med Technology Service Co., Ltd Rm. 912, Building #15, XiYueHui, No.5, YiHe North RD., FangShan District Beijing, Beijing 102401 China
Re: K212807
Trade/Device Name: Surgical Masks Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical apparel Regulatory Class: Class II Product Code: FXX Dated: August 31, 2021 Received: September 3, 2021
## Dear Ray 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.
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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 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 Quality Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
# Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.
510(k) Number (if known)
K212807
Device Name Surgical Masks
Indications for Use (Describe)
The Surgical Masks is intended to be worn to protect both the patient and healthcare personnel from the transfer of microorganisms, body fluids, and particulate material. The Surgical Masks 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 Model YH-EZ-004(White Color, Blue Color) is Level 2 barrier as ASTM F2100 requirements.
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 of 510(k) safety and effectiveness information is being submitted in a ccordance with requirements of SMDA 1990 and Title 21, CFR Section 807.92.
- 1. Date of Preparation:2021/8/31
- 2. Sponsor Identification
#### WEIHAI HONGYU NONWOVEN FABRIC PRODUCTS CO., LTD.
No.567 Gushan Road , Area of Economy and Technique, Weihai City, Shandong Province, 264205, CHINA.
Contact Person:Bin Dong Position: Manager Tel: +86-15662383633 Fax: +86-0631-3636910 Email: dbfeel@163.com
- 3. Designated Submission Correspondent
Mr. Ray Wang
### Beijing Believe-Med Technology Service Co., Ltd.
Rm.912, Building #15, XiYueHui, No.5, YiHe North Rd., FangShan District, Beijing, 102401, China
Tel: +86-18910677558 Fax: +86-10-56335780 Email: information@believe-med.com
- 4. Identification of Proposed Device
Trade Name:Surgical Masks Common Name: Mask, Surgical
Regulatory Information Classification Name: Mask, Surgical Classification: II Product Code: FXX Regulation Number: 878.4040 Review Panel: General Hospital
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Indication For Use Statement:
The Surgical Masks is intended to be worn to protect both the patient and healthcare personnel from the transfer of microorganisms, body fluids, and particulate material. The Surgical Masks 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 Model YH-EZ-004(White Color, Blue Color) is Level 2 barrier as ASTM F2100 requirements.
Device Description:
The proposed device(s) includes 1 model, which is YH-EZ-004. This model has two colors,Blue color and White color.This model is Flat Pleated type mask, utilizing Ear Loops' way for wearing, and it has Nose Piece design for fitting the facemask around the nose.
All two colors of the model YH-EZ-004 of proposed device(s) share same materials and structure, they all are manufactured with three layers, the inner and outer layers are made of spunbonded non-woven fabric, and the middle layer is made of melt-blown non-woven fabric.
The nose piece contained in the proposed device(s) is in the layers of the facemask to allow the user to fit the facemask around their nose, which is made of polyethylene.
The proposed device(s) is held in place over the user's mouth and nose by two elastic ear loops welded to the facemask. The elastic ear loops are made with terylene and spandex.
The proposed device(s) are sold non-sterile and are intended to be single-use, disposable devices.
- 5. Identification of Predicate Device(s)
510(K) number:K202594 Device name:Medical Surgical Masks-Non Sterile Manufacturer:SHANDONG T&F NONWOVEN CO., LTD.
- 6. Technological Characteristics Comparison
| Table 1 General Comparison | |
|----------------------------|--|
| | |
| | |
| ITEM | Proposed Device | Predicate Device K202594 | Remark |
|--------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------|
| | ASTM F2100 Level 2 | ASTM F2100 Level 2 | |
| Intended Use | The Surgical Masks is intended to be worn to protect both the patient and healthcare personnel from the transfer of microorganisms, body fluids, and particulate material. The Surgical Masks is intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This is a | The Medical Surgical Masks-Non Sterile is intended to be worn to protect both the patient and healthcare personnel from the transfer of microorganisms, body fluids, and particulate material. The Medical Surgical Masks-Non Sterile is intended for use in infection control practices to reduce the potential exposure to blood and body | SAME |
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| | | single-use, disposable device(s), provided<br>non-sterile.<br>The Model YH-EZ-004(White Color, Blue<br>Color) is Level 2 barrier as ASTM F2100<br>requirements. | fluids. This is a single-use, disposable<br>device(s), provided non-sterile. | |
|------------------------------|--------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------|----------|
| | Basic Design | Ear Loops, Flat Pleated, 3 layers | Ear Loops, Flat-Pleated, 3 layers | SAME |
| Materials | Outer Facing Layer | spunbonded non-woven fabric | polypropylene non-woven fabric | Analysis |
| | Middle Layer | melt-blown non-woven fabric | polypropylene melt-blown fabric | |
| | Inner Facing Layer | spunbonded non-woven fabric | polypropylene non-woven fabric | |
| | Nose Piece | polyethylene | PP + iron wire | |
| | Ear Loops | terylene, spandex | polyamide and polyurethane | |
| | Color | Blue, White | White | Analysis |
| Dimension<br>(Length, Width) | | 17.5 cm ±5%cm<br>9.5 cm ±5%cm | 17.5 cm +/- 5mm<br>9.5 cm +/- 5mm | Similar |
| | OTC use | | Yes | Yes |
| Single Use | | Yes | Yes | SAME |
| Sterile | | Non-sterile | Non-sterile | SAME |
### Table 2 Performance Characteristic Comparison
| ITEM | Proposed Device | Predicate Device K202594 | ASTM F2100 Requirements | Remark | |
|-------------------------------------------------------------------------|-------------------------------|------------------------------|-------------------------|---------------------|------|
| ASTM F2100<br>Level | YH-EZ-004<br>White<br>Level 2 | YH-EZ-004<br>Blue<br>Level 2 | Level 2 | Level 2 | SAME |
| Fluid Resistance<br>Performance<br>ASTM F1862 | 120 mmHg | 120 mmHg | 120 mmHg | 120 mmHg | SAME |
| Particulate<br>Filtration<br>Efficiency ASTM<br>F2299 | ≥99.77% | ≥99.30% | ≥99% | ≥ 98% | |
| Bacterial<br>Filtration<br>Efficiency ASTM<br>F2101 | ≥99.04% | ≥98.54% | ≥99% | ≥ 98% | |
| Differential<br>Pressure (Delta P)<br>EN 14683:2019+<br>AC:2019 Annex C | < 5.0 mmH2O<br>/cm² | < 5.4mmH2O<br>/cm² | < 4.8 mmH2O/cm² | < 6.0 mmH2O<br>/cm² | |
| Flammability<br>16 CFR 1610 | Class 1 | Class 1 | Class 1 | Class 1 | SAME |
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#### Table 3 Biocompatibility Comparison
| ITEM | Proposed Device | Predicate Device K202594 | Remark |
|---------------|-----------------|--------------------------|--------|
| Cytotoxicity | Non-cytotoxic | Non-cytotoxic | SAME |
| Irritation | Non-irritating | Non-irritating | SAME |
| Sensitization | Non-sensitizing | Non-sensitizing | SAME |
#### Analysis:
The proposed device is different with the predicate device in materials used and color, which may raise the risk about biocompatibility, for this risk we have conducted the testing according to the ISO10993-1, cytotoxicity, irritation and sensitization. The test results shown that no biocompatibility risk would be raised.
So, we consider that the proposed device has same biocompatibility performance with the predicate device.
Based on the nonclinical tests performed, the subject device is as safe, as effective, and performs as well as the legally marketed predicate device, Medical Surgical Masks-Non Sterile cleared under K202594.
#### 7. Non-Clinical Test Conclusion
Non clinical tests were conducted to verify that the proposed device met all design specifications. The test results demonstrated that the proposed device complies with the following standards:
- A ISO 10993-5: 2009 Biological Evaluation Of Medical Devices -- Part 5: Tests For In Vitro Cytotoxicity
- > ISO 10993-10: 2010 Biological Evaluation Of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization.
- > ASTM F2100-19, Standard Specification For Performance Of Materials Used In Medical Face Masks.
- > ASTM F1862-17, Standard Test Method For Resistance Of Medical Face Masks To Penetration By Synthetic Blood (Horizontal Projection Of Fixed Volume At A Known Velocity)
- EN 14683-2019+AC:2019 Annex C, Medical face masks Requirements and test methods; A
- A ASTM F2101-19, Standard Test Method For Evaluating The Bacterial Filtration Efficiency (Bfe) Of Medical Face Mask Materials, Using A Biological Aerosol Of Staphylococcus Aureus;
- > ASTM F2299-03, Stand test method for determining the initial efficiency of materials used in
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medical face masks to penetration by particulates using latex spheres;
- > 16 CFR 1610, Standard for the Flammability of clothing textiles;
- > Bench Testing for the performance of Dimensions.
| Test Method | Purpose | Acceptance<br>Criteria | Results(Blue<br>Color) | Results(White Color) |
|---------------------|---------------------------------------------------------------------|----------------------------|--------------------------------------------------------------------|-----------------------------------------------------------------|
| ASTM F1862 | Resistance to<br>penetration by<br>synthetic blood | 120 mm Hg | 120 mm Hg | 120 mm Hg |
| ASTM F2299 | Sub-micron<br>particulate filtration<br>efficiency at 0.1<br>micron | ≥ 98% | ≥ 99.30% | ≥ 99.77% |
| ASTM F2101 | Bacterial Filtration<br>Efficiency | ≥ 98% | ≥ 98.54% | ≥ 99.04% |
| EN 14683<br>Annex C | Differential<br>Pressure | < 6.0 mm<br>H2O/cm² | < 5.4mm H2O/cm² | < 5.0mm H2O/cm² |
| 16 CFR 1610 | Flammability | Class 1 | Class 1 | Class 1 |
| ISO 10993-10 | Irritation | No irritation<br>effect | Under the<br>conditions of the<br>study, no irritation<br>effect | Under the conditions<br>of the study, no<br>irritation effect |
| | Sensitization | No sensitization<br>effect | Under conditions<br>of the study, no<br>sensitization<br>effect | Under conditions of<br>the study, no<br>sensitization effect |
| ISO 10993-5 | Cytotoxicity | No cytotoxicity<br>effect | Under the<br>conditions of the<br>study, no<br>cytotoxicity effect | Under the conditions<br>of the study, no<br>cytotoxicity effect |
#### 8. Clinical Test Conclusion
No clinical study is included in this submission.
#### 9. Conclusion
The conclusions drawn from the nonclinical tests demonstrate that the device is as safe, as effective, and performs as well as or better than the legally marketed device K202594.
