WYZ Surgical Mask
Device Facts
| Record ID | K211576 |
|---|---|
| Device Name | WYZ Surgical Mask |
| Applicant | Wyz Medical Supplies, LLC |
| 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 WYZ Surgical 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 a single use, disposable device(s), provided non-sterile.
Device Story
WYZ Surgical Mask (model WYZ201) is a flat-pleated, three-layer disposable face mask; worn by healthcare personnel and patients to provide a barrier against microorganisms, body fluids, and particulates. Device features include two elastic ear loops for securement and an integrated nose clip for facial fit. Outer and inner layers consist of polypropylene (PP) spun-bond; middle layer consists of PP melt-blown filter material. Nose clip is galvanized iron wire with PP+PE coating; ear loops are styrene block copolymer (SBC) film with polyolefin outer layer. Device is provided non-sterile for single use. Healthcare providers use the mask in clinical settings to mitigate infection transmission risks during procedures or patient care. Benefits include reduced potential exposure to blood and body fluids.
Clinical Evidence
No clinical data. Bench testing only. Performance verified against ASTM F2100, F1862 (fluid resistance), F2299 (particulate filtration), F2101 (bacterial filtration), EN 14683 (differential pressure), and 16 CFR 1610 (flammability). Biocompatibility confirmed via ISO 10993-5 (cytotoxicity) and ISO 10993-10 (irritation/sensitization).
Technological Characteristics
Three-layer construction: PP spun-bond outer/inner layers, PP melt-blown middle layer. Nose clip: galvanized iron wire with PP+PE coating. Ear loops: SBC film with polyolefin outer layer. ASTM F2100 Level 2 compliant. Non-sterile, single-use, disposable. Biocompatibility per ISO 10993.
Indications for Use
Indicated for use by healthcare personnel and patients to reduce exposure to microorganisms, body fluids, and particulate material during infection control practices.
Regulatory Classification
Identification
Surgical apparel are devices that are intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material. Examples include surgical caps, hoods, masks, gowns, operating room shoes and shoe covers, and isolation masks and gowns. Surgical suits and dresses, commonly known as scrub suits, are excluded.
Special Controls
*Classification.* (1) Class II (special controls) for surgical gowns and surgical masks. A surgical N95 respirator or N95 filtering facepiece respirator is not exempt if it is intended to prevent specific diseases or infections, or it is labeled or otherwise represented as filtering surgical smoke or plumes, filtering specific amounts of viruses or bacteria, reducing the amount of and/or killing viruses, bacteria, or fungi, or affecting allergenicity, or it contains coating technologies unrelated to filtration (e.g., to reduce and or kill microorganisms). Surgical N95 respirators and N95 filtering facepiece respirators are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 878.9, and the following conditions for exemption:(i) The user contacting components of the device must be demonstrated to be biocompatible. (ii) Analysis and nonclinical testing must: (A) Characterize flammability and be demonstrated to be appropriate for the intended environment of use; and (B) Demonstrate the ability of the device to resist penetration by fluids, such as blood and body fluids, at a velocity consistent with the intended use of the device. (iii) NIOSH approved under its regulation. (2) Class I (general controls) for surgical apparel other than surgical gowns and surgical masks. The class I device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 878.9.
Predicate Devices
- Disposable Surgical Face Masks (K153496)
Submission Summary (Full Text)
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August 19, 2021
WYZ Medical Supplies LLC % Ivy Wang Consultant Shanghai Sungo Management Consulting Company Limited 13th Floor, 1500# Central Avenue Shanghai, Shanghai 200122 China
Re: K211576
Trade/Device Name: WYZ Surgical Mask Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: May 21, 2021 Received: May 21, 2021
Dear Ivy Wang:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies.combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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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 medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Clarence W. Murray, III, PhD Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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# Indications for Use
510(k) Number (if known) K211576
Device Name WYZ Surgical Mask
#### Indications for Use (Describe)
The WYZ Surgical 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 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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WYZ Medical Supplies LLC 5913 Imperial Loop, College Station, TX 77845, U.S.A.
# 510(K) Summary
# K211576
#### Document prepared date: 7/30/2021
A. Applicant:
Name: WYZ Medical Supplies LLC Address: 5913 Imperial Loop, College Station, TX 77845, U.S.A. Contact Person: Daniel Chen Tel: +1 512-942-7893 Mail: daniel@wyzmedical.com
Submission Correspondent: Primary contact: Ivy Wang Shanghai SUNGO Management Consulting Co., Ltd. Room 1409, Dongfang Building, 1500# Century Ave., Shanghai 200122, China Tel: +86-21-58817802 Email: haiyu.wang@sungoglobal.com Secondary contact: Mr. Raymond Luo 1500# Century Ave., Shanghai 200122, China Tel: +86-21-68828050 Email: fda.sungo@gmail.com
### B. Device:
Trade Name: WYZ Surgical Mask Common Name: Surgical Face Mask Model(s): WYZ201
Regulatory Information Classification Name: Surgical Face Mask Classification: Class II Product code: FXX Regulation Number: 878.4040 Review Panel: Surgical Apparel
## C. Predicate device:
| 510K | Device name | Manufacturer |
|---------|--------------------------------|-------------------------------------------|
| K153496 | Disposable Surgical Face Masks | Xiantao Rayxin Medical Products Co., Ltd. |
## D. Indications for use of the device:
The WYZ Surgical Masks (model: WYZ201) 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
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## WYZ Medical Supplies LLC 5913 Imperial Loop, College Station, TX 77845, U.S.A.
body fluids. This a single use, disposable device(s), provided non-sterile.
# E. Device Description:
The proposed device (model: WYZ201) is blue color, and Flat Pleated type mask, utilizing Ear Loops way for wearing, and it has Nose clips design for fitting the face mask around the nose.
The proposed devices are manufactured with three layers, the inner and outer layers are made of Polypropylene (PP) spun-bond, and the middle layer is made of Polypropylene (PP) melt-blown. The WYZ201 model of proposed device, ear loops, is held in place over the users' mouth and nose by two elastic ear loops welded to the face mask. The elastic ear loops are made of Elastic film based on styrene block copolymer (SBC) with polyolefin (PO) outer layer. Hotmelt based on styrene-isoprene block copolymers (SIS) Nonwoven on both sides based on polypropylene (PP) spun-bond. The nose piece contained in the proposed device(s) is in the layers of face mask to allow the user to fit the face mask around their nose, which is made of Galvanized iron wire with PP+PE coating.
The proposed devices are sold non-sterile and are intended to be single use, disposable device.
# F. Comparison with predicate device/
| Device | Proposed Device | Predicate Device 1 | Comparison |
|---------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| Manufacturer | WYZ Medical Supplies LLC | Xiantao Rayxin Medical<br>Products Co., Ltd. | - |
| 510K number | - | K153496 | - |
| Classification | Class II Device, FXX (21<br>CFR878.4040) | Class II Device, FXX (21<br>CFR878.4040) | Same |
| Indications for use | The WYZ Surgical Mask (model:<br>WYZ201) are intended to be worn to<br>protect both the patient and healthcare<br>personnel from transfer of<br>microorganisms, body fluids and<br>particulate material. These face masks<br>are intended for use in infection control<br>practices to reduce the potential<br>exposure to blood and body fluids. This<br>a single use, disposable device(s),<br>provided non-sterile. | The Disposable Surgical<br>Face Masks are intended to<br>be worn to protect both the<br>patient and healthcare<br>personnel from transfer of<br>microorganisms, body fluids<br>and particulate material.<br>These face masks are<br>intended<br>for use in infection control<br>practices to reduce the<br>potential exposure to blood<br>and body fluids.<br>This is a single use,<br>disposable<br>device(s), provided<br>non-sterile. | Similar |
# Table 1 General Comparison
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WYZ Medical Supplies LLC 5913 Imperial Loop, College Station, TX 77845, U.S.A.
| Style | Ear Loops, Flat Pleated, 3 layers | Ear Loops, Flat Pleated, 3 layers | Same | |
|--------------------|-----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------|----------|
| | | | | |
| Material | Outer layer | Polypropylene (PP) spun-bond | Spun-bond polypropylene | Same |
| | Middle layer | Polypropylene (PP) melt-blown | Melt blown polypropylene filter | Same |
| | Inner layer | Polypropylene (PP) spun-bond | Spun-bond polypropylene | Same |
| | Nose clip | Galvanized iron wire with PP+PE coating | Malleable aluminum wire | Analysis |
| | Ear loops | Elastic film based on styrene block copolymer (SBC) with polyolefin (PO) outer layer. Hotmelt based on styrene-isoprene block copolymers (SIS) Nonwoven on both sides based on polypropylene (PP) spun-bond | Polyester | Analysis |
| Color | | Blue | Blue | Same |
| Dimension (Length) | | 17.5 cm +/- 1 cm | 17.5 cm +/- 0.1 cm | Same |
| Dimension (Width) | | 10 cm +/- 1 cm | 9.5 cm +/- 0.1 cm | Analysis |
| OTC use | | Yes | Yes | Same |
| Sterility | | Non-Sterile | Non-Sterile | Same |
| Use | | Single Use, Disposable | Single Use, Disposable | Same |
| ASTM F2100 level | | Level 2 | Level 2 | Same |
| Biocompatibility | | ISO10993 | ISO10993 | Same |
## G. Non-Clinical Test Conclusion
Non-clinical tests were conducted to verify that the proposed device met all design specifications as was similar to the predicate device. The test results demonstrated that the proposed device complies with the following 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:
- 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
- A ASTM F2100, Standard Specification for Performance of Materials Used In Medical Face Masks
- > ASTM F1862, Standard Test Method for Resistance of Medical Face Masks To Penetration by
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## WYZ Medical Supplies LLC 5913 Imperial Loop, College Station, TX 77845, U.S.A.
Synthetic Blood (Horizontal Projection of Fixed Volume At A Known Velocity);
- > EN 14683, Medical Face Masks-Requirements and Test Methods;
- > ASTM F2101, Standard Test Method for Evaluating the Bacterial Filtration Efficiency (BFE) Of Medical Face Mask Materials, Using A Biological Aerosol of Staphylococcus Aureus;
- > ASTM F2299, Stand test method for determining the initial efficiency of materials used in medical face masks to penetration by particulates using latex spheres;
- > 16 CFR 1610, Standard for the Flammability of clothing textiles;
| Test Item | Purpose | Acceptance Criteria<br>(level 2) | Result |
|--------------------------------------------------------|---------------------------------------------------------------------------------------------------------------|----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|
| Fluid Resistance<br>Performance ASTM<br>F1862 | The purpose of the<br>performance testing<br>is to demonstrate the<br>functionality of the<br>subject device. | 29 out of 32 pass at 120<br>mmHg | PASS<br>3 non-consecutive lots tested, using a<br>sample size of 32/lot.<br>32 out of 32 pass at 120 mmHg |
| Particulate Filtration<br>Efficiency ASTM<br>F2299 | | ≥ 98% | PASS<br>3 non-consecutive lots tested, using a<br>sample size of 32/lot.<br>Lot1: 99.82%<br>Lot2: 99.78%<br>Lot3: 99.72% |
| Bacterial Filtration<br>Efficiency ASTM<br>F2101 | | ≥ 98% | PASS<br>3 non-consecutive lots tested, using a<br>sample size of 32/lot.<br>Lot1: 99.92%<br>Lot2: 99.84%<br>Lot3: 99.86% |
| Differential Pressure<br>(Delta P) EN 14683<br>Annex C | | < 6.0mmH2O/cm² | PASS<br>3 non-consecutive lots tested, using a<br>sample size of 32/lot.<br>Lot1: 3.79 mmH2O/cm²<br>Lot2: 4.03 mmH2O/cm²<br>Lot3: 4.05 mmH2O/cm² |
| Flammability 16<br>CFR 1610 | Class 1 | | PASS<br>3 non-consecutive lots tested, using a<br>sample size of 32/lot.<br>Class 1 |
Table 2 - Performance Testing
Table 3 Biocompatibility Comparison
| Item | Purpose | Acceptance Criteria | Result |
|--------------|----------------------------------------------------------------------------|---------------------|-------------------------------------------------------------------------|
| Cytotoxicity | The purpose of the performance testing is to demonstrate the functionality | Non-Cytotoxic | PASS<br>Under the conditions of the study, the device is non-cytotoxic. |
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WYZ Medical Supplies LLC 5913 Imperial Loop, College Station, TX 77845, U.S.A.
| | of the subject device. | | |
|---------------|------------------------|-----------------|-----------------------------------------------------------------------------|
| Irritation | | Non-Irritating | PASS<br>Under the conditions of the study,<br>the device is non-irritating. |
| Sensitization | | Non-Sensitizing | PASS<br>Under the conditions of the study,<br>the device is non-sensitizing |
# H. Clinical Test Conclusion
No clinical study is included in this submission.
#### I. Conclusion
Based on the nonclinical tests performed, the subject device (Model: WYZ201) is as safe, as effective, and performs as well as the legally marketed predicate device, K153496, Xiantao Rayxin Medical Products Co., Ltd, Single-use Surgical Masks.
