(307 days)
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.
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.
This document is a 510(k) Premarket Notification from Wuhan Huashida Protective Products Co., Ltd. for their Surgical Face Mask. It is a submission to the FDA demonstrating that their device is substantially equivalent to a legally marketed predicate device.
The premise of a 510(k) submission is to demonstrate "substantial equivalence' to a legally marketed device, not necessarily to prove the device's independent safety and effectiveness through extensive clinical trials as would be required for a PMA (Premarket Approval) application. For a device like a surgical face mask, the FDA generally relies on performance testing against recognized standards rather than clinical studies, especially if the device is similar in design and materials to existing cleared devices.
Therefore, the information provided below is based on the provided document and tailored to how a 510(k) submission addresses "acceptance criteria" through non-clinical testing.
Here's an analysis of the provided text in relation to your request about acceptance criteria and the study proving the device meets them:
1. A table of acceptance criteria and the reported device performance
The document provides a table of acceptance criteria and results from non-clinical performance and biocompatibility testing.
| Items | Purpose | Acceptance Criteria | Result |
|---|---|---|---|
| For Surgical Face Mask Performance | |||
| 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 | (Implied: To demonstrate the mask's ability to filter particulate material) | $\geq$ 98% | Pass |
| Bacterial Filtration Efficiency | (Implied: To demonstrate the mask's ability to filter microorganisms) | $\geq$ 98% | Pass |
| Differential Pressure | (Implied: To measure the breathability of the mask) | <6.0 mmH2O/cm² | Pass |
| Flammability | (Implied: To assess the flammability risk of the mask material) | Class 1 | Pass |
| For Surgical Face Mask Biocompatibility | |||
| Cytotoxicity | The purpose of the testing is to demonstrate safety of the subject device | Non-Cytotoxic | Under the conditions of the study, the device is non-cytotoxic. |
| Irritation | (Implied: To assess potential skin irritation from mask materials) | Non-Irritating | Under the conditions of the study, the device is non-irritating. |
| Sensitization | (Implied: To assess potential allergic reactions or sensitization from mask materials) | Non-Sensitizing | Under the conditions of the study, the device is non-sensitizing. |
2. Sample sized used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Sample Size:
- For "Fluid Resistance Performance," the sample size is explicitly stated as 32 (29 out of 32 pass).
- For other performance and biocompatibility tests, specific sample sizes are not explicitly stated in this summary document. They would typically be defined within the testing protocols for each standard (e.g., ASTM F2299, ASTM F2101, ISO 10993-5, etc.).
- Data Provenance: The tests were conducted by the manufacturer, Wuhan Huashida Protective Products Co., Ltd., in China. The data would be considered prospective as it involves new testing performed specifically for this submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This type of information is not applicable to this submission. This document addresses a physical medical device (surgical face mask) evaluated through non-clinical performance testing against recognized standards. The "ground truth" for such devices is established by the specifications in the standards themselves (e.g., a BFE of >=98% is the target). There are no human "experts" establishing a subjective ground truth like in a diagnostic AI study. The results are quantitative measurements.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This is not applicable for non-clinical performance and biocompatibility testing. Adjudication methods like 2+1 or 3+1 are used in studies where human readers (e.g., radiologists) are involved in interpreting medical images or data, and their disagreements need to be resolved to establish a "ground truth" or reference standard. This document pertains to physical device testing.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This is not applicable. An MRMC study is relevant for evaluating the performance of AI-assisted diagnostic tools where human interpretation plays a role. This submission pertains to a surgical face mask, which is a physical barrier device, not an AI diagnostic tool. The document explicitly states: "No clinical study is included in this submission."
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. This question refers to the performance of an AI algorithm in isolation. The product is a surgical face mask, not an algorithm. The testing performed is standalone in the sense that it's the mask's performance being measured directly against established standards.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" in this context is based on pre-defined, quantitative performance specifications established by relevant industry standards and regulatory guidance. For example:
- Fluid Resistance: Resistance to penetration by synthetic blood at a specified pressure (ASTM F1862).
- Filtration Efficiency (Particulate & Bacterial): Percentage of particles/bacteria filtered out (ASTM F2299, ASTM F2101).
- Differential Pressure: How easily air can pass through (EN 14683).
- Flammability: A classification based on burn rate (16 CFR 1610).
- Biocompatibility: Absence of cytotoxic, irritating, or sensitizing effects as per ISO 10993 standards.
These standards define the 'truth' or expected performance for a surgical mask of a certain level.
8. The sample size for the training set
This is not applicable. This device is a manufactured medical product, not an AI algorithm that requires a "training set."
9. How the ground truth for the training set was established
This is not applicable, as there is no "training set" for this type of device submission.
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is a seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" arranged in a circular pattern. To the right of the seal, there is the FDA logo in blue, with the words "U.S. FOOD & DRUG" on top and "ADMINISTRATION" below. The logo is simple and professional, reflecting the FDA's role in regulating food and drugs.
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
{2}------------------------------------------------
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number.
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.
{3}------------------------------------------------
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.
{4}------------------------------------------------
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
{5}------------------------------------------------
| Item | Subject device | Predicate device(K202903) | Discussion |
|---|---|---|---|
| Mask style | Flat-pleated | Flat-pleated | Identical |
| DesignFeatures | Ear Loops, Tie-on | Ear Loops, Tie-on | Identical |
| Mask style | 3 Flat Pleated | 3 Flat Pleated4 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 F2100Level | Level 3 | Level 3 | Identical |
| OTC use | Yes | Yes | Identical |
| Sterility | Non-Sterile | Non-Sterile | Identical |
| Use | Single Use, Disposable | Single Use, Disposable | Identical |
| Particulatefiltrationefficiency | Meet ASTM F2299-17 | Meet ASTM F2299-17 | Identical |
| Bacterialfiltrationefficiency | Meet ASTM F2101-19 | Meet ASTM F2101-19 | Identical |
| Differentialpressure | Meet EN 14683: 2019, Annex C | Meet EN 14683: 2019, Annex C | Identical |
| Flammability | Meet 16 CFR 1610 | Meet 16 CFR 1610 | Identical |
| Fluidresistance | Meet ASTM F1862-17 | Meet ASTM F1862-17 | Identical |
| Biocompatibility | 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
{6}------------------------------------------------
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 ResistancePerformance | The purpose of theperformance testingis to demonstrateThe functionality ofthe subject device | 29 out of 32pass at 160 mmHg | Pass |
| Particulate FiltrationEfficiency | $\geq$ 98% | Pass | |
| Bacterial FiltrationEfficiency | $\geq$ 98% | Pass | |
| Differential Pressure | <6.0 mmH2O/cm² | Pass | |
| Flammability | Class 1 | Pass |
For Surgical Face Mask Performance
For Surgical Face Mask Biocompatibility
| Items | Purpose | AcceptanceCriteria | Result |
|---|---|---|---|
| Cytotoxicity | The purpose ofthe testing is todemonstratesafety of thesubject device | Non-Cytotoxic | Under the conditions of the study, thedevice is non-cytotoxic. |
| Irritation | Non-Irritating | Under the conditions of the study, thedevice is non-irritating. | |
| Sensitization | Non-Sensitizing | Under the conditions of the study, thedevice is non-sensitizing. |
{7}------------------------------------------------
VIII Clinical Test Conclusion
No clinical study is included in this submission.
IX Conclusion
The conclusions drawn from the nonclinical tests demonstrate that the subject device is as safe, as effective, and performs as well as or better than the legally marketed predicate device K202903.
§ 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.