(96 days)
The Disposable Medical 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. It is intended for adults only (greater than 21 years of age).
The Disposable Medical Mask is a blue, flat pleated type mask, which utilizes an Earloop to Wear. It has a nose piece design to fit the facemask around the nose. The Disposable Medical Masks are manufactured with three layers and the inner and outer layers are made of spun-bond polypropylene, and the middle laver is made of melt-blown polypropylene filter. The model of the proposed device, earloop, is held in place over the user's 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 mask is in the facemask layers to allow the user to fit the facemask around their nose, made of malleable aluminum wire. The Disposable Medical Masks are sold non-sterile and are intended to be a single-use, disposable device.
The provided document is a 510(k) summary for a disposable medical mask. It details the device's technical characteristics and performance testing against established standards, primarily for determining substantial equivalence to a predicate device.
Here's the information requested based on the document:
1. Table of Acceptance Criteria and Reported Device Performance
The device is seeking to meet Level 2 classification according to ASTM F2100-19.
| Test | Standards | Acceptance Criteria for Level 2 Mask | Reported Device Performance |
|---|---|---|---|
| Bacterial Filtration Efficiency (BFE, %) | ASTM F2101 | ≥ 98 | Average 99.54% (Pass) |
| Particulate Filtration Efficiency (PFE, at 0.1 µm, %) | ASTM F2299 | ≥ 98 | Average 99.37% (Pass) |
| Differential Pressure (Delta P, mm H2O/cm²) | ASTM F2100-19 EN 14683:2019, Annex C | < 6.0 | 4.00 mm H2O/cm² (Pass) |
| Resistance to penetration by synthetic blood (minimum pressure in mmHg for pass result) | ASTM F1862/F1862M-17 | ≥ 120 mmHg | 32 out of 32 pass at 120mmHg (Pass) |
| Flame Spread | 16 CFR 1610 | Class 1 Non-Flammable | Class 1 Non-Flammable (Pass) |
| In Vitro Cytotoxicity | ISO10993-5: 2009 | Non-cytotoxic | Non-cytotoxic (Pass) |
| Skin Sensitization | ISO10993-10: 2010 | Non-sensitizing | Non-sensitizing (Pass) |
| Skin Irritation | ISO10993-10 | Non-irritating | Non-irritating (Pass) |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
The document does not explicitly state the sample sizes for each specific performance test (e.g., the number of masks tested for BFE or PFE). For the Fluid Resistance test, it is stated that "32 out of 32 pass at 120mmHg," implying a sample size of 32 for that specific test.
The document does not specify the country of origin of the data or whether the studies were retrospective or prospective. It only mentions that the device manufacturer is in China: "TUOSHENG PROTECTIVE PRODUCTS (NINGBO) CO.,LTD... Zhejiang Province, CHINA".
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable. The evaluations are based on objective, standardized laboratory tests (e.g., ASTM, ISO standards) for material performance and biocompatibility, not on expert interpretation of medical images or clinical data. There is no concept of "ground truth" established by experts in this context.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This information is not applicable as the evaluation is based on objective laboratory testing against pre-defined numerical and qualitative criteria, not on subjective assessments requiring adjudication.
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
No such study was performed or is relevant to this device. This document describes the testing of a medical mask, not an AI-powered diagnostic or assistive tool for human readers.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
This information is not applicable. The device is a physical medical mask, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" in this context is defined by the objective, quantitative performance specifications outlined in the referenced international consensus standards (ASTM, EN, ISO, 16 CFR). For example, a BFE of ≥98% is the objective standard (ground truth) for a Level 2 mask in that particular test.
8. The sample size for the training set
This information is not applicable. The device is a physical medical mask. There is no "training set" as it is not a machine learning model.
9. How the ground truth for the training set was established
This information is not applicable for the reasons stated in point 8.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
June 7, 2021
Tuosheng Protective Products (Ningbo) Co., Ltd % Charles Mack Principal Engineer Irc 2950 E Lindrick Drive Chandler, Arizona 85249
Re: K210641
Trade/Device Name: Disposable Medical Mask Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: April 30, 2021 Received: May 5, 2021
Dear Charles Mack:
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 Clarence W. Murray III, Ph.D. Acting 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)
Device Name Disposable Medical Mask
Indications for Use (Describe)
The Disposable Medical 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. It is intended for adults only (greater than 21 years of age).
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
| Registration Under Part 375, ECL Subject to Cleanup Plan |
|---|
| Brownfield Cleanup Program Under Article 27, Title 14, ECL |
| | Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
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K210641 510(k) SUMMARY
| Preparation Date: | June 3, 2021 |
|---|---|
| Manufacturer's Name and Address: | TUOSHENG PROTECTIVEPRODUCTS (NINGBO) CO.,LTDNo 1728 Xiaolin Ave, North IndustrialZone, Xiaolin Town, Cixi City, ZhejiangProvince, CHINA315321Mr. Nanping YuanGeneral ManagerTel: 86-574-63795109Fax: 86-574-63795109Email: yuan@tuoshengprotective.comFDA Establishment Registration No.:3016844771 |
| Designated Submission Correspondentand US Agent: | IRC USA2950 E Lindrick Dr., Chandler, Arizona85249, USAMr. Charles MackPRINCIPAL ENGINEERTel: 931-6254938Email: charliemack@irc-us.com |
| Telephone Number: | 931-625-4938 |
| Email Address: | charliemack@irc-us.com |
| Trade Name: | Disposable Medical Mask |
| Common Name(s): | Disposable Medical Mask |
| Regulation Name(s): | mask, surgical |
| Regulation Number(s): | 21CFR878.4040 |
| Product Code: | FXX |
| Device Class: | Class II |
| Predicate Device: | Xiantao Rayxin Medical Products Co.,Ltd.Disposable Surgical Face MaskK153496 |
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Device Description:
The Disposable Medical Mask is a blue, flat pleated type mask, which utilizes an Earloop to Wear. It has a nose piece design to fit the facemask around the nose. The Disposable Medical Masks are manufactured with three layers and the inner and outer layers are made of spun-bond polypropylene, and the middle laver is made of melt-blown polypropylene filter. The model of the proposed device, earloop, is held in place over the user's 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 mask is in the facemask layers to allow the user to fit the facemask around their nose, made of malleable aluminum wire. The Disposable Medical Masks are sold non-sterile and are intended to be a single-use, disposable device.
This product contains no components made from natural rubber latex.
Intended Use / Indications for Use
The Disposable Medical 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. It is intended for adults only (greater than 21 years of age).
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| Features | Subject Device | Predicate Device | Comparison |
|---|---|---|---|
| Device | Disposable Medical Mask | Disposable Surgical Face Mask | N/A |
| Model | Ear Loop | Ear Loop and Tie-On | N/A |
| Manufacturer | Tuosheng Protective Products (Ningbo) Co., Ltd. | Xiantao Rayxin Medical Products Co., ltd. | N/A |
| 510(k) | K210641 | K153496 | N/A |
| Indication for Use | The Disposable Medical 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. It is intended for adults only (greater than 21 years of age). | The Disposable Surgical Face Masks 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 body fluids. This is a single-use, disposable device(s) provided non-sterile. | Similar |
| OTC or Prescription | OTC | OTC | Identical |
| Product Code | FXX | FXX | Identical |
| Classification | Class 2, CFR878.4040 | Class 2, CFR878.4040 | Identical |
| Material: | |||
| Outer facing layer | Spun-bond polypropylene | Spun-bond polypropylene | Identical |
| Middle layer | Melt blown polypropylene filter | Melt blown polypropylene filter | Identical |
| Inner facing layer | Spun-bond polypropylene | Spun-bond polypropylene | Identical |
| Nose piece | Malleable aluminum wire | Malleable aluminum wire | Identical |
| Earloop | Polyurethane + Polyester | Polyester | Different |
| Colorant | Polypropylene (PP) master batch | Polypropylene (PP) master batch | Identical |
| Design features | Color: BlueEar Loop | Color: BlueEar Loop | Identical |
| Mask Style | Flat Pleated | Flat Pleated | Identical |
| Specification andDimension | Length: 17.5 cm ± 0.85 cmWidth: 9.5 cm ± 0.45 cm | Length: 17.5cm±1cmWidth: 9.5cm±1cm | Identical |
| Features | Subject Device | Predicate Device | Comparison |
| Sterility | Non-sterile | Non-sterile | Identical |
| Usage | Disposable, Single Use | Disposable, Single Use | Identical |
| Performance: | |||
| PerformanceTesting (ASTMF2100-19) | Level 2 | Level 2 | Identical |
| Fluid ResistancePerformance ASTMF1862 | 32 out of 32 pass at 120mmHg | 32 out of 32 pass at 120mmHg | Meets the ASTM F2100-19 Requirementsfor Level 2 Classification |
| Particulate FiltrationEfficiency ASTMF2299 | Average 99.37% | Average 98.46% | Meets the ASTM F2100-19 Requirementsfor Level 2 Classification |
| Bacterial FiltrationEfficiency ASTMF2101 | Average 99.54% | Average 98.70% | Meets the ASTM F2100-19 Requirementsfor Level 2 Classification |
| Differential Pressure(Delta P)EN 14683:2019,Annex C | 4.00 mm H2O/cm² | 4.2 mm H2O/cm² | Meets the ASTM F2100-19 Requirementsfor Level 2 Classification |
| Flammability 16 CFR1610 | Class 1Non-Flammable | Class 1Non-Flammable | Identical |
| Biocompatibility | |||
| Cytotoxicity (ISO10993-5) | Under the conditions of the study, notcytotoxic. Complies with ISO-10993-5. | Under the conditions of the study, notcytotoxicity effect | Identical |
| Sensitization (ISO10993-10) | Under conditions of the study, not asensitizer. Complies with ISO-10993-10. | Under conditions of the study, not asensitizer. | Identical |
| Irritation (ISO 10993-10) | Under the conditions of the study, not anirritant. Complies with ISO-10993-10. | Under the conditions of the study, not anirritant | Identical |
Comparison of Technological Characteristics with the Predicate Device
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Discussion:
Although the materials used in the ear loops of the subject and predicate masks are not the final subject masks are tested for biocompatibility and specification performance. Therefore, this difference does not raise any new questions about safety and effectiveness.
Although there is a slight difference in performance test results between the subject device, they comply with the same performance standards, for ASTM F2100 Level 2. The minor differences in the technological characteristics do not raise issues on the safety and effectiveness of the subject device.
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Performance Testing
Performance testing was provided to validate and verify that the Disposable Medical Mask, non- sterile, earloop met all requirements of related international standards, including biocompatibility and product specifications. These tests' results demonstrate compliance with the requirements of the consensus standards noted below.
Non-clinical Testing
| Standards | Scope |
|---|---|
| ASTM F2100-19Standard Specification for Performance of Materials Used in MedicalFace Masks | Performance |
| ASTM F1862/F1862M-17Standard Test Method for Resistance of Medical Face Masks toPenetration by Synthetic Blood (Horizontal Projection of Fixed Volume ata Known Velocity | Performance:Fluid ResistancePerformance |
| ASTM F2101-19Standard Test Method for Evaluating the Bacterial Filtration Efficiency(BFE) of Medical Face Mask Materials, Using a Biological Aerosol ofStaphylococcus aureus | Performance:Bacterial FiltrationEfficiency (BFE) |
| ASTM F2299-2003Standard Test Method for Determining the Initial Efficiency of MaterialsUsed in Medical Face Masks to Penetration by Particulates Using LatexSpheres | Performance:Particulate FiltrationEfficiency (PFE) |
| ASTM F2100-19EN14683: 2019 Annex C | Performance:Differential Pressure(Delta P) |
| 16 CFR 1610 | Performance:Flammability |
| ISO10993-1:2009Biological evaluation of medical devices--Part 1: Evaluation and testing | Biocompatibility |
| ISO10993-5:2009Biological Evaluation of Medical Devices - Part 5 Tests for In VitroCytotoxicity. | Biocompatibility |
| ISO10993-10:2002/Amd. 1:2006(E)Biological Evaluation of Medical Devices - Part 10: Tests for Irritationand Delayed-Type Hypersensitivity | Biocompatibility |
| FDA Guidance: Surgical Masks - Premarket Notification [510(k)]Submissions; Guidance for Industry and FDA | Guidance |
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| Test | Standards | Acceptance Criteriafor Level 2 Mask | Test Result |
|---|---|---|---|
| Bacterial Filtration Efficiency(BFE, %) | ASTM F2101 | ≥ 98 | Pass |
| Particulate FiltrationEfficiency (PFE, at 0 1 µm, %) | ASTM F2299 | ≥ 98 | Pass |
| Differential Pressure(Delta P, mm H2O/cm2) | ASTM F2100-19EN 14683:2019,Annex C | < 6.0 | Pass |
| Resistance to penetration bysynthetic blood (minimumpressure in mmHg for passresult) | ASTMF1862/F1862M-17 | ≥ 120 mmHg | Pass |
| Flame Spread | 16 CFR 1610 | Class 1 Non-Flammable | Pass |
Biocompatibility
The subject device is classified as a surface device and contact intact skin for limited contact duration.
We conducted the applicable tests noted below:
- In Vitro Cytotoxicity (ISO10993-5) -
- Skin Sensitization (ISO10993-10) -
- Skin Irritation (ISO10993-10) -
| Standard | Device Tests | Test Results |
|---|---|---|
| In Vitro Cytotoxicity(ISO10993-5: 2009) | Following the standard's defined conditions, the device is non-cytotoxic. | Pass |
| Skin Sensitization(ISO10993-10: 2010) | Following the standard's defined conditions, the device is non-sensitizing. | Pass |
| Skin Irritation (ISO10993-10) | Following the standard's defined conditions, the device is non-irritating. | Pass |
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All of the pre-determined acceptance criteria were met.
Clinical Test:
No clinical study is included in this submission.
Conclusions:
The conclusion drawn from the nonclinical tests demonstrates that the subject device in this 510(k) submission, K210641, Disposable Medical Mask, is as safe, as effective, and performs as well as or better than the legally marketed predicate device cleared under K153496.
END
§ 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.