(71 days)
The Medical Face Mask is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. The face mask 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 Medical Face Mask is blue color, single use, three-layer, flat-folded masks with nose piece and ear loops. The blue colorant is polypropylene (PP) master batch.
The Medical Face Mask is 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 ear loops are held in place over the users' mouth and nose by two elastic ear loops welded to the facemask. The elastic ear loops are not made with natural rubber latex.
The nose piece in the layers of facemask is to allow the user to fit the facemask around their nose, which is made of Malleable polyethylene wire.
The medical face masks are available in five sizes, 17.59.5cm, 15.59.5cm, 14.59.5cm, 149.5cm.
The medical face masks are sold non-sterile and are intended to be single use, disposable devices.
The provided text is related to the FDA 510(k) clearance for a Medical Face Mask. It details the non-clinical tests performed to demonstrate substantial equivalence to a predicate device, rather than focusing on AI/ML-driven device performance. Therefore, many of the requested elements for describing an AI-powered device's acceptance criteria and study cannot be directly extracted from this document, as they are not applicable to the type of device (medical face mask) being discussed.
However, I can extract the acceptance criteria and performance data relevant to this medical face mask:
1. Table of Acceptance Criteria and Reported Device Performance
| Test Methodology | Purpose | Acceptance Criteria (ASTM F2100 Level 1) | Reported Device Performance |
|---|---|---|---|
| Fluid Resistance (ASTM F1862) | Demonstrate functionality | 29 out of 32 per lot pass at 80 mmHg | Pass (32 out of 32 pass at 80 mmHg, 3 lots) |
| Particulate Filtration Efficiency (ASTM F2299) | Demonstrate functionality | $\ge$ 95% | Pass (> 95%) |
| Bacterial Filtration Efficiency (ASTM F2101) | Demonstrate functionality | $\ge$ 95% | Pass (> 99%) |
| Differential Pressure (Delta P) (EN 14683 Annex C) | Demonstrate functionality | < 5.0 mmH₂O/cm² | Pass (< 4.0 mmH₂O/cm²) |
| Flammability (16 CFR 1610) | Demonstrate functionality | Class 1 | Pass (Class 1) |
| Cytotoxicity (ISO 10993-5) | Demonstrate safety | Non-cytotoxic | Non-cytotoxic |
| Irritation (ISO 10993-10) | Demonstrate safety | Non-irritating | Non-irritating |
| Sensitization (ISO 10993-10) | Demonstrate safety | Non-sensitizing | Non-sensitizing |
Since this is a submission for a medical face mask and not an AI/ML device, the following points are not applicable or cannot be answered from the provided text:
- Sample size used for the test set and the data provenance: The document mentions "3 non-consecutive lots" for fluid resistance testing but doesn't specify an overall sample size for the various performance tests. Data provenance in terms of country of origin or retrospective/prospective is not specified as these are material performance tests, not clinical data sets.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a physical product like a face mask is established by validated laboratory testing against standards, not by expert consensus.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. This is for expert review of complex data, not physical product testing.
- 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 is a medical device (face mask), not an AI-assisted diagnostic tool.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. No algorithm is involved.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The ground truth for this device is established through adherence to recognized international and national standards for medical face masks, such as ASTM F2100, ASTM F1862, ASTM F2101, EN 14683, 16 CFR 1610, and ISO 10993 for biocompatibility.
- The sample size for the training set: Not applicable. This is not an AI/ML device, so there is no training set.
- How the ground truth for the training set was established: Not applicable.
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March 8, 2022
Hubei Medlink Healthcare Co., Ltd Ivy Wang Technical Manager Shanghai Sungo Management Consulting Company Limited 14th Floor, 1500# Central Avenue Shanghai, Shanghai 200122 China
Re: K214087
Trade/Device Name: Medical Face Mask Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: November 30, 2021 Received: December 27, 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.
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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Indications for Use
510(k) Number (if known) K214087
Device Name Medical Face Mask
Indications for Use (Describe)
The Medical Face Mask is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. The face mask 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.
| Description | Size specification | Model No. | Color | Barrier Level |
|---|---|---|---|---|
| Ear loop mask | 17.5*9.5 | MFS11 | Blue | Level 1 |
| Ear loop mask | 16*9.5 | MFS12 | Blue | Level 1 |
| Ear loop mask | 15.5*9.5 | MFS13 | Blue | Level 1 |
| Ear loop mask | 14.5*9.5 | MFS14 | Blue | Level 1 |
| Ear loop mask | 14*9.5 | MFS15 | Blue | Level 1 |
| 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 summary of 510(K) safety and effectiveness information is being submitted in accordance with the requirement of 21 CFR 807.92.>
Date of summary prepared: 2022-03-01 A. Applicant: Name: HUBEI MEDLINK HEALTHCARE CO., LTD Address: 36F, Tower1, New World International Trade Tower, 568 Jianshe Avenue, Wuhan, China Contact: Sophie Liu Title: Sales Manager Tel: +86-27-8462 1898 Fax: +86-27-8464 4151 Email: sophie.l@dymexhealthcare.com
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: Medical Face Mask Common Name: SURGICAL MASK Model:
| Description | Size specification | Model No. | Color | Barrier Level |
|---|---|---|---|---|
| Ear loop mask | 17.5*9.5 | MFS11 | Blue | Level 1 |
| Ear loop mask | 16*9.5 | MFS12 | Blue | Level 1 |
| Ear loop mask | 15.5*9.5 | MFS13 | Blue | Level 1 |
| Ear loop mask | 14.5*9.5 | MFS14 | Blue | Level 1 |
| Ear loop mask | 14*9.5 | MFS15 | Blue | Level 1 |
Regulatory Information Classification Name: Surgical Face Mask Classification: Class II Product code: FXX
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Regulation Number: 878.4040 Review Panel: Surgical Apparel
C. Predicate device:
K201729 MEDICAL MASK Zhende Medical Co., Ltd.
D. Indications for use of the device:
The Medical Face Mask is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. The face mask 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.
E. Device Description:
The Medical Face Mask is blue color, single use, three-layer, flat-folded masks with nose piece and ear loops. The blue colorant is polypropylene (PP) master batch.
The Medical Face Mask is 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 ear loops are held in place over the users' mouth and nose by two elastic ear loops welded to the facemask. The elastic ear loops are not made with natural rubber latex.
The nose piece in the layers of facemask is to allow the user to fit the facemask around their nose, which is made of Malleable polyethylene wire.
The medical face masks are available in five sizes, 17.59.5cm, 15.59.5cm, 14.59.5cm, 149.5cm.
The medical face masks are sold non-sterile and are intended to be single use, disposable devices.
F. Technological Characteristics Comparison Table
Provided below is a comparison of the subject device with the predicate device Table 1 General Comparison
| Device | Proposed Device | Predicate Device | Result | |
|---|---|---|---|---|
| 510K # | K201729 | - | ||
| Manufacturer | HUBEI MEDLINK HEALTHCARE CO., LTD | Zhende Medical Co., Ltd. | - | |
| Model Name | MEDICAL FACE MASKEar loops | MEDICAL MASKEar loops | Similar | |
| Classification | Class II Device, FXX (21 CFR878.4040) | Class II Device, FXX (21 CFR878.4040) | Same | |
| Intend use | The Medical Face Mask is intendedto be worn to protect both thepatient and healthcare personnelfrom transfer of microorganisms,body fluids and particulate | The Medical Masks are intended tobe worn to protect both the patientand healthcare personnel fromtransfer of microorganisms, bodyfluids and particulate material. These | Same | |
| material. The face mask is intendedfor use in infection controlpractices to reduce the potentialexposure to blood and body fluids.This is a single use, disposabledevice(s), provided non-sterile. | face masks are intended for use ininfection control practices to reducethe potential exposure of the wearerto blood and body fluids. This is asingle use, disposable device(s),provided non-sterile. | |||
| Design Features | Ear Loops, Flat-pleated, 3 layers | Ear Loops, Flat-pleated, 3 layers | Same | |
| Outer layer | Spunbond Polypropylene | Spunbond Polypropylene | Same | |
| Inner layer | Spunbond Polypropylene | Spunbond Polypropylene | Same | |
| Filter layer | Melt-blown Polypropylene | Melt-blown Polypropylene | Same | |
| Material | Nose wire | Malleable polyethylene wire | Malleable polypropylene withiron wire | Different |
| Ear loops | Spandex | Polyester, Spandex | Different | |
| Color | Blue | Blue | Same | |
| Dimension(maskbody) | 17.59.5cm169.5cm15.59.5cm14.59.5cm14*9.5cm | 18cm*9.5cm | Different | |
| Dimension (ear loop) | 16cm16cm16cm15.5cm15.5cm | 17cm | Different | |
| Dimension(nosewire) | 10.5cm10cm10cm9.5cm9.5cm | Not known | Different | |
| OTC use | Yes | Yes | Same | |
| Sterility | Non-Sterile | Non-Sterile | Same | |
| Use | Single Use, Disposable | Single Use, Disposable | Same | |
| ASTM F2100 Level | Level 1 | Level 1 | Same | |
| Biocompatibility(ISO10993) | Non-Cytotoxic, Non-Sensitizing,Non-Irritating | Non-Cytotoxic, Non-Sensitizing,Non-Irritating | Same | |
| Fluid ResistancePerformanceASTM F1862 | 32 out of 32 per lot pass at 80mmHg, 3 non-consecutive lotstested | 32 out of 32 per lot pass at 80mmHg, 3 non-consecutive lotstested | Same | |
| ParticulateFiltrationEfficiencyASTM F2299 | ≥ 95% | ≥ 95% | Same | |
| Bacterial FiltrationEfficiencyASTM F2101 | $\ge$ 95% | $\ge$ 95% | Same | |
| DifferentialPressure (Delta P)EN 14683 Annex C | < 5.0mmH2O/cm² | < 5.0mmH2O/cm² | Same | |
| Flammability 16CFR 1610 | Class 1 | Class 1 | Same |
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Different Analysis:
The proposed device has different material of nose clamp and ear loop to the predicate device, but the material has been tested and the test results shown that the material differences do not affect the safety of the proposed device.
The proposed device has different dimension (mask body, ear loop and nose clip dimension) to the predicate device. Smaller masks are suitable for user with smaller face. This difference does not affect intended use and will not raise any safety issues. The difference will not affect the safety and effectiveness of the proposed device.
G. 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 Guidance for Industry and FDA Staff: Surgicol 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 Synthetic Blood (Horizontal Projection of Fixed Volume At A Known Velocity);
-
EN 14683, Medical Face Masks—Requirements and Test Methods;
- 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 F2299, Standard 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 Methodology | Purpose | Acceptance Criteria:ASTM F2100 Level 1 | Result |
|---|---|---|---|
| Fluid Resistance | The purpose of the performance testing is to demonstrate the functionality of the subject device. | 29 out of 32 per lot pass at 80 mmHg | Pass32 out of 32 pass at 80 mmHg, 3 lots |
| Particulate Filtration Efficiency | $\geq$ 95% | Pass>95% | |
| Bacterial Filtration | $\geq$ 95% | Pass |
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| Efficiency | >99% | ||
|---|---|---|---|
| DifferentialPressure | < $5.0mmH_2O/cm^2$ | Pass< $4.0mmH_2O/cm^2$ | |
| Flammability | Class 1 | PassClass 1 | |
| Cytotoxicity | The purpose of the testingis to demonstrate thesafety of the subjectdevice. | Non-cytotoxic | Under the conditions of thestudy, the device isnon-cytotoxic. |
| Irritation | Non-irritating | Under the conditions of thestudy, the device isnon-irritating. | |
| Sensitization | Non-sensitizing | Under the conditions of thestudy, the device isnon-sensitizing |
H. Clinical Test Conclusion
No clinical study is included in this submission.
l. 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 K201729.
§ 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.