(307 days)
Not Found
No
The 510(k) summary describes a standard surgical face mask and its performance characteristics based on material properties and filtration efficiency. There is no mention of AI, ML, image processing, or any computational analysis of data.
No.
The device description and intended use clearly state that the surgical face mask is for protection against microorganisms, body fluids, and particulate material, not for treating a disease or condition.
No
Explanation: The device is a surgical face mask whose intended use is to protect from the transfer of microorganisms, body fluids, and particulate material. It is not designed to diagnose any condition.
No
The device description clearly outlines a physical product made of nonwoven polypropylene materials with ear loops or tie tapes and a nose clip. The performance studies focus on physical properties like fluid resistance, filtration efficiency, and flammability, which are characteristic of hardware devices, not software.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use clearly states the mask is for protecting against the transfer of microorganisms, body fluids, and particulate material. This is a physical barrier function, not a diagnostic test performed on samples taken from the body.
- Device Description: The description details the physical construction and materials of the mask. There is no mention of reagents, test strips, or any components used for analyzing biological samples.
- Performance Studies: The performance studies focus on the mask's barrier properties (fluid resistance, filtration efficiency), breathability (differential pressure), flammability, and biocompatibility (cytotoxicity, irritation, sensitization). These are all relevant to a physical barrier device, not an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information about a patient's health status.
In summary, the device functions as a physical barrier for protection, which is not the purpose of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Surgical Face Mask is intended to be worn to protect both the patient and healthcare persomel 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.
Product codes
FXX
Device Description
The Surgical Face Mask is 3-layer, and it is two model is HSD-TYP2R (Ear loops) and HSD-TYP2RT (Tie-On). Flat-folded masks constructed of nonwoven polypropylene materials. The mask is provided with ear loops (spandex and polyester) or tie tapes (spun-bond polypropylene). A malleable nose clip is placed in the layers of facemask for comfort and individualized fit. The surgical face mask color is blue. Product is Level 3 based on ASTM F2100-19. The surgical face mask is single-use, disposable devices, provided non-sterile.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Healthcare personnel
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Non-clinical tests were conducted to verify that the proposed device met all design specifications.
- Fluid Resistance Performance: The purpose of the performance testing is to demonstrate the functionality of the subject device. Acceptance Criteria: 29 out of 32 pass at 160 mmHg. Result: Pass.
- Particulate Filtration Efficiency: Acceptance Criteria: greater than or equal to 98%. Result: Pass.
- Bacterial Filtration Efficiency: Acceptance Criteria: greater than or equal to 98%. Result: Pass.
- Differential Pressure: Acceptance Criteria: less than 6.0 mmH2O/cm squared. Result: Pass.
- Flammability: Acceptance Criteria: Class 1. Result: Pass.
- Biocompatibility - Cytotoxicity: Purpose: The purpose of the testing is to demonstrate safety of the subject device. Acceptance Criteria: Non-Cytotoxic. Result: Under the conditions of the study, the device is non-cytotoxic.
- Biocompatibility - Irritation: Acceptance Criteria: Non-Irritating. Result: Under the conditions of the study, the device is non-irritating.
- Biocompatibility - Sensitization: Acceptance Criteria: Non-Sensitizing. Result: Under the conditions of the study, the device is non-sensitizing.
No clinical study is included in this submission.
Key Metrics
- Fluid Resistance: 29 out of 32 pass at 160 mmHg
- Particulate Filtration Efficiency: >= 98%
- Bacterial Filtration Efficiency: >= 98%
- Differential Pressure:
§ 878.4040 Surgical apparel.
(a)
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.(b)
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.
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March 13, 2023
Wuhan Huashida Protective Products Co., Ltd. Mei Chen Manager No. 511 Weihu Rd, Shamao St, Hannan District Wuhan, Hubei 430090 China
Re: K221352
Trade/Device Name: Surgical Face Mask Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: February 27, 2023 Received: February 27, 2023
Dear Mei Chen:
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
1
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,
Katherine D. Kavlock -S
for
Brent Showalter, Ph.D. Assistant Director DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic 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
510(k) Number (if known) K221352
Device Name Surgical Face Mask
Indications for Use (Describe)
The Surgical Face Mask is intended to be worn to protect both the patient and healthcare persomel 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)
× Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) summary
I Submitter
| Device submitter: | Wuhan Huashida Protective Products Co., Ltd. |
|---|---|
| No.511 Weihu Rd, Shamao St, Hannan district, Wuhan, Hubei, China | |
| Contact person: | Chen Mei |
| Manager | |
| Phone: +86-18971272798 | |
| E-mail: Happy@huashida168.cn |
II Proposed Device
| Trade/Device Name: | Surgical Face Mask |
|---|---|
| Regulation Number: | 21 CFR 878.4040 |
| Regulation Name: | Surgical Apparel |
| Regulatory Class: | Class II |
| Product code: | FXX |
| Review Panel: | General Hospital |
III Predicate Devices
| 510(k) Number: | K202903 |
|---|---|
| Trade/Device Name: | Surgical Face Mask |
| Regulation Number: | 21 CFR 878.4040 |
| Regulation Name: | Surgical Apparel |
| Classification: | Class II |
| Product Code: | FXX |
| Manufacturer | Rizhao Sanqi Medical & Health Articles Co., Ltd |
IV Indication for use
The Surgical Face Mask is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids, and particulate material. 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.
V Device Description
The Surgical Face Mask is 3-layer, and it is two model is HSD-TYP2R (Ear loops) and HSD-TYP2RT (Tie-On). Flat-folded masks constructed of nonwoven polypropylene materials.
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The mask is provided with ear loops (spandex and polyester) or tie tapes (spun-bond polypropylene). A malleable nose clip is placed in the layers of facemask for comfort and individualized fit. The surgical face mask color is blue. Product is Level 3 based on ASTM F2100-19. The surgical face mask is single-use, disposable devices, provided non-sterile.
| Item | Subject device | Predicate device (K202903) | Discussion | ||
|---|---|---|---|---|---|
| Product name | Surgical Face Mask | Surgical Face Mask | NA | ||
| Product model | HSD-TYP2R, HSD-TYP2RT | Level 3 Surgical Face Mask models: SQ-3001, SQ-3001H | NA | ||
| Classification | Class II Device, FXX (21 CFR878.4040) | Class II Device, FXX (21 CFR878.4040) | Identical | ||
| Intended use | The Surgical Face Mask is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids, and particulate material. 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 Mask is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids, and particulate material. When worn properly, 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. This is a single use, disposable device(s), provided non-sterile | Identical | ||
| Component and Materials | Structure | Materials | Structure | Materials | Different |
| Outer layer | Spun-bond polypropylene | Outer layer | Polypropylene | ||
| Inner layer | polypropylene | Inner layer | Polypropylene | ||
| Filter layer | melt-blown polypropylene | Filter layer | 3 Flat leated: Melt-blown Polypropylene | ||
| Nose clip | malleable aluminum wire | Nose clip | Steel coated by polypropylene | ||
| Ear loops | spandex and polyester | Ear loops | Spandex | ||
| Tie Tapes | spun-bond polypropylene | Tie Tapes | Spunbond Polypropylene |
VI Summary of Technological characteristics
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| Item | Subject device | Predicate device
(K202903) | Discussion |
|-----------------------------------------|---------------------------------------------------|---------------------------------------------------|------------|
| Mask style | Flat-pleated | Flat-pleated | Identical |
| Design
Features | Ear Loops, Tie-on | Ear Loops, Tie-on | Identical |
| Mask style | 3 Flat Pleated | 3 Flat Pleated
4 Flat Pleated | Similar |
| Color | Blue | Blue, white, pink, green, yellow | Similar |
| Dimension
(Length) | 175±10mm | 175±5mm | Similar |
| Dimension
(Width) | 90±10mm | 95±5mm | Similar |
| ASTM F2100
Level | Level 3 | Level 3 | Identical |
| OTC use | Yes | Yes | Identical |
| Sterility | Non-Sterile | Non-Sterile | Identical |
| Use | Single Use, Disposable | Single Use, Disposable | Identical |
| Particulate
filtration
efficiency | Meet ASTM F2299-17 | Meet ASTM F2299-17 | Identical |
| Bacterial
filtration
efficiency | Meet ASTM F2101-19 | Meet ASTM F2101-19 | Identical |
| Differential
pressure | Meet EN 14683: 2019, Annex C | Meet EN 14683: 2019, Annex C | Identical |
| Flammability | Meet 16 CFR 1610 | Meet 16 CFR 1610 | Identical |
| Fluid
resistance | Meet ASTM F1862-17 | Meet ASTM F1862-17 | Identical |
| Biocompatibil
ity | Non-cytotoxic, Non-sensitizing,
non-irritating | Non-cytotoxic, Non-sensitizing,
non-irritating | Identical |
Section 3-510(k) Summary
Different - Patient Contacting Material
The patient contacting material for the proposed device is different from the predicate devices. However, biocompatibility test has been performed on the proposed device and the results does not show any adverse effect. Thus, this difference will not affect the safety and effectiveness between the proposed device and the two predicate devices.
VII Non-Clinical Test Conclusion
Non-clinical tests were conducted to verify that the proposed device met all design specifications as was same to the predicate device. The test results demonstrated that the proposed device complies with the following standards and the requirements stated in the
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Guidance for Industry and FDA Staff: Surgical Masks - Premarket Notification [510(k)] Submission issued on March 5, 2004:
- A 16 CFR Part 1610 Standard for the Flammability of Clothing Textiles;
- A ASTM F1862 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 Standard Test Method for Determining the Initial Efficiency of Material Used in medical Face Masks to Penetration by Particulates using Latex Spheres
- A 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 F2100 Standard Specification for Performance of Materials Used in Medical Face Masks
-
EN 14683 Medical face masks- Requirements and test methods
- A ISO 10993-5:2009 Biological evaluation of medical device- Part 5: Tests for in vitro cytotoxicity
- A ISO 10993-10:2010 Biological evaluation of medical device- Part 10: Tests for irritaion and skin sensitization
| Items | Purpose | Acceptance Criteria | Result |
|---|---|---|---|
| Fluid Resistance | |||
| Performance | The purpose of the | ||
| performance testing | |||
| is to demonstrate | |||
| The functionality of | |||
| the subject device | 29 out of 32 | ||
| pass at 160 mmHg | Pass | ||
| Particulate Filtration | |||
| Efficiency | $\geq$ 98% | Pass | |
| Bacterial Filtration | |||
| Efficiency | $\geq$ 98% | Pass | |
| Differential Pressure |