(82 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. They are in infection control practices to reduce the potential exposure to blood and body fluids. This a single use, disposable device(s), provided non-sterile.
The proposed device(s) are blue color, and flat pleated type mask, utilizing ear loops way for wearing, and they all have nose clips design for fitting the face mask around the nose. The proposed device(s) are manufactured with three layers, the inner and outer layers are made of spunbond polypropylene, and the middle layer is made of melt blown polypropylene filter. The 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 Spandex and polyester fiber. 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 polypropylene (PP) and iron wire. The proposed device(s) are sold non-sterile and are intended to be single use, disposable device.
The provided document is a 510(k) summary for a Medical Face Mask, indicating it's a submission for clearance rather than a detailed study report. Therefore, information related to AI or clinical studies (such as MRMC, direct human-in-the-loop improvements, independent algorithm performance, expert ground truth establishment for AI, or training set details) will not be present.
The acceptance criteria and device performance are based on non-clinical tests required for establishing substantial equivalence for medical face masks.
Here's a summary of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
Device: Surgical Face Mask (HuBei Kangning Protective Products Co., Ltd.)
Predicate Device: Surgical Face Mask (Non-sterile) (K203426) by Nantong Taiweishi Medical Technology Co., Ltd.
ASTM F2100 Level: Level 2
| Test Methodology | Acceptance Criteria (Level 2) | Reported Device Performance (mean or range from 3 lots) |
|---|---|---|
| Fluid Resistance (ASTM F1862) | 29 out of 32 Pass at 120 mmHg | Lot1: 31 out of 32 Pass at 120 mmHgLot2: 29 out of 32 Pass at 120 mmHgLot3: 31 out of 32 Pass at 120 mmHg |
| Particulate Filtration Efficiency (ASTM F2299) | ≥ 98% | Lot1: 99.79%Lot2: 99.83%Lot3: 99.82% |
| Bacterial Filtration Efficiency (ASTM F2101) | ≥ 98% | Lot1: 99.9%Lot2: 99.9%Lot3: 99.9% |
| Differential Pressure (Delta P) (EN 14683 Annex C) | < 6.0 mmH2O/cm² | Lot1: 4.4 mmH2O/cm²Lot2: 4.3 mmH2O/cm²Lot3: 4.3 mmH2O/cm² |
| Flammability (16 CFR 1610) | Class 1 | Lot1: Class ILot2: Class ILot3: Class I |
| Cytotoxicity (ISO 10993-5) | Non-Cytotoxic | Under the conditions of the study, the device is non-cytotoxic. |
| Irritation (ISO 10993-10) | Non-Irritating | Under the conditions of the study, the device is non-irritating. |
| Sensitization (ISO 10993-10) | Non-Sensitizing | Under the conditions of the study, the device is non-sensitizing. |
2. Sample Size Used for the Test Set and Data Provenance
The document indicates testing was performed on three different lots of the device. For specific tests like Fluid Resistance, the sample size per lot was 32 units. For other tests, such as filtration efficiencies, differential pressure, and flammability, while not explicitly stated per test, the results are reported for each of the three lots, implying samples were drawn from each lot as per the respective standard's requirements.
The data provenance is from HuBei Kangning Protective Products Co., Ltd., China, as per the applicant information. These are non-clinical (laboratory) tests, not patient-derived data, and thus are inherently "retrospective" in the sense that they were conducted on already manufactured product lots.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This section is not applicable as the document describes non-clinical performance and biocompatibility testing for a physical device (surgical face mask), not a diagnostic or AI-driven device requiring expert-established ground truth. The "ground truth" for these tests is defined by the objective measurement procedures detailed in the referenced ASTM, EN, and ISO standards.
4. Adjudication Method for the Test Set
Not applicable. This pertains to expert review of data, which is not relevant for the objective laboratory tests conducted for a medical face mask.
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
Not applicable. This document is for the clearance of a physical medical device (surgical face mask) and does not involve AI software or human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This document is for the clearance of a physical medical device (surgical face mask) and does not involve AI software or algorithms.
7. The Type of Ground Truth Used
The "ground truth" for the performance and biocompatibility tests is based on the objective measurements and pass/fail criteria defined by internationally recognized standards (e.g., ASTM F1862, ASTM F2299, ASTM F2101, EN 14683, 16 CFR 1610, ISO 10993-5, ISO 10993-10). These standards specify the methodology and acceptable limits for each characteristic.
8. The Sample Size for the Training Set
Not applicable. There is no "training set" as this is not an AI/machine learning device. The tests are laboratory validations of a physical product against established safety and performance standards.
9. How the Ground Truth for the Training Set was Established
Not applicable. As there is no training set or AI component, this information is not relevant to the content of the provided document.
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, featuring a stylized human figure. To the right is the FDA logo, with the acronym "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in a larger, bolder font, and "ADMINISTRATION" in a smaller font below.
July 24, 2021
HuBei Kangning Protective Products Co., Ltd. % Ivy Wang Consultant Shanghai Sungo Management Consulting Company Limited 14th Floor, 1500# Central Avenue Shanghai, Shanghai 200122 China
Re: K211363
Trade/Device Name: Medical Face Mask Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: May 3, 2021 Received: May 3, 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.
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 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
{2}------------------------------------------------
Indications for Use
510(k) Number (if known) K211363
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. They are 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)
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."
{3}------------------------------------------------
510(k) Summary
{4}------------------------------------------------
510(K) Summary K211363
A. Applicant:
Name: HuBei Kangning Protective Products Co., Ltd. Address:Special No1, Xuefu Road, Xiantao City, Hubei , China Person: Zhao Yuxuan Tel: +86-13907227068
Submission Correspondent: Primary contact: Ms. Ivy Wang Shanghai SUNGO Management Consulting Co., Ltd. Room 1401, Dongfang Building, 1500# Century Ave., Shanghai 200122, China Tel: +86-21-58817802 Email: haiyu.wang@sungoglobal.com Secondary contact: Mr. Raymond Luo Room 1401, Dongfang Building, 1500# Century Ave., Shanghai 200122, China Tel: +86-21-68828050 Email: fda.sungo@@gmail.com
B. Device:
Trade Name: Surgical Face Mask Common Name: Surgical Face Mask Model: Ear loops; Non-sterile
Regulatory Information Classification Name: Surgical Face Mask Classification: Class II Product code: FXX Regulation Number: 878.4040 Review Panel: Surgical Apparel
C. Predicate device:
K203426 Surgical Face Mask(Non-sterile)
D. Indications 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. They 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(s), provided non-sterile.
{5}------------------------------------------------
E. Device Description:
The proposed device(s) are blue color, and flat pleated type mask, utilizing ear loops way for wearing, and they all have nose clips design for fitting the face mask around the nose.
The proposed device(s) are manufactured with three layers, the inner and outer layers are made of spunbond polypropylene, and the middle layer is made of melt blown polypropylene filter. The 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 Spandex and polyester fiber. 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 polypropylene (PP) and iron wire. The proposed device(s) are sold non-sterile and are intended to be single use, disposable device.
| Table 1 General Comparison | ||||
|---|---|---|---|---|
| Device | Proposed Device | Predicate Device | Result | |
| Manufacturer | HuBei Kangning Protective Products Co., Ltd. | Nantong Taiweishi Medical Technology Co., Ltd. | - | |
| 510K number | K211363 | K203426 | - | |
| Model name | Surgical Face Mask | Surgical Face Mask(Non-sterile) | - | |
| Classification | Class II Device, FXX (21 CFR878.4040) | Class II Device, FXX (21 CFR878.4040) | Same | |
| 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. They 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(s), provided non-sterile. | The Surgical Face Mask (non-sterile) 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. | Same | |
| Model | Ear loop, Flat pleated,3 layers | Ear loop, Flat pleated,3 layers | Same | |
| Material | Outer layer | Spun-bond polypropylene | Spun-bond polypropylene | Same |
| Middle layer | Melt blown polypropylene filter | Melt blown polypropylene filter | Same | |
| Inner layer | Spun-bond polypropylene | Spun-bond polypropylene | Same | |
| Nose clip | polypropylene (PP) and iron wire | Polyethylene | Different |
F. Comparison with predicate device
{6}------------------------------------------------
| Earloops | Spandex and polyester fiber | Nylon and Spandex | Different | |
|---|---|---|---|---|
| Color | Blue | Blue | Same | |
| Dimension | 180mm+/-10mm | 175mm+/-5% | Similar | |
| Dimension (Width) | 95mm+/-10mm | 95mm+/-5% | Similar | |
| 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 |
HuBei Kangning Protective Products Co., Ltd. Special No1. Xuefu Road. Xiantao City. Hubei . China
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
- A 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 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 A 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;
- A 16 CFR 1610, Standard for the Flammability of clothing textiles;
Table 2 - Performance Testing
| Test Methodology | Propose | Acceptance Criteria(level 2) | Result |
|---|---|---|---|
| Fluid ResistancePerformance ASTM F1862 | The purpose of theperformance testing is todemonstrate the | 29 out of 32 Pass at120 mmHg | Lot1: 31 out of 32 Pass at120 mmHg;Lot2: 29 out of 32 Pass at120 mmHg;Lot3: 31 out of 32 Pass at120 mmHg; |
{7}------------------------------------------------
HuBei Kangning Protective Products Co., Ltd. Special No1, Xuefu Road, Xiantao City, Hubei , China
| Special No1, Xuelu Road, Xiantao City, Hubei, China | |||
|---|---|---|---|
| Particulate FiltrationEfficiency ASTM F2299 | functionality of the subjectdevice. | ≥ 98% | Lot1: 99.79%Lot2: 99.83%Lot3: 99.82% |
| Bacterial FiltrationEfficiency ASTM F2101 | ≥ 98% | Lot1: 99.9%Lot2: 99.9%Lot3: 99.9% | |
| Differential Pressure (DeltaP) EN 14683 Annex C | < 6.0mmH2O/cm2 | Lot1: 4.4mmH2O/cm2Lot2: 4.3mmH2O/cm2Lot3: 4.3mmH2O/cm2 | |
| Flammability 16 CFR 1610 | Class 1 | Lot1: Class ILot2: Class ILot3: Class I |
Table 3 Biocompatibility Comparison
| Test Methodology | Purpose | Acceptance Criteria | Result |
|---|---|---|---|
| CytotoxicityISO 10993-5 | The purpose of thetesting is to demonstratethe safety of the subjectdevice. | Non-Cytotoxic | Under the conditions of the study, thedevice is non-cytotoxic. |
| IrritationISO 10993-10 | Non-Irritating | Under the conditions of the study, thedevice is non-irritating. | |
| SensitizationISO 10993-10 | Non-Sensitizing | Under the conditions of the study, thedevice 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 is as safe, as effective, and performs as well as the legally marketed predicate device, K203426 Nantong Taiweishi Medical Technology Co., Ltd. Surgical Face Mask(Non-sterile).
§ 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.