(162 days)
The Medical 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 of the wearer to blood and body fluids. This is a single use, disposable device(s), provided non-sterile.
The Medical Masks are single use, three-layer, flat –folded masks with ear loops and nose clamp. The Medical Masks are manufactured with three layers, the inner and outer layers are made of spun-bond 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 clamp 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 Masks will be provided in blue. The medical masks are sold non-sterile and are intended to be single use, disposable devices.
The provided text describes the acceptance criteria and the study conducted for the Medical Mask (Model L1171801) by Zhende Medical Co., Ltd. Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance:
| Item | Acceptance Criteria (Level 1) | Reported Device Performance | Result |
|---|---|---|---|
| Fluid Resistance Performance (ASTM F1862) | 29 out of 32 pass at 80 mmHg | 32 out of 32 per lot pass at 80 mmHg, 3 non-consecutive lots tested | PASS |
| Particulate Filtration Efficiency (ASTM F2299) | $\ge$ 95% | $\ge$ 95% | PASS |
| Bacterial Filtration Efficiency (ASTM F2101) | $\ge$ 95% | $\ge$ 95% | PASS |
| Differential Pressure (Delta P) (EN 14683 Annex C) | < 5.0 mmH2O/cm² | < 5.0 mmH2O/cm² | PASS |
| Flammability (16 CFR 1610) | Class 1 | Class 1 | PASS |
| Cytotoxicity (ISO 10993-5) | Non-Cytotoxic | Under the conditions of the study, the device is non-cytotoxic. | PASS |
| Irritation (ISO 10993-10) | Non-Irritating | Under the conditions of the study, the device is non-irritating. | PASS |
| Sensitization (ISO 10993-10) | Non-Sensitizing | Under the conditions of the study, the device is non-sensitizing | PASS |
2. Sample size used for the test set and the data provenance:
- Fluid Resistance Performance (ASTM F1862): 3 non-consecutive lots were tested. For each lot, 32 samples were tested. Thus, the total sample size for fluid resistance testing was $3 \times 32 = 96$ masks.
- Other performance tests (Particulate Filtration Efficiency, Bacterial Filtration Efficiency, Differential Pressure, Flammability) and Biocompatibility tests (Cytotoxicity, Irritation, Sensitization): The specific sample sizes for these tests are not explicitly stated in the provided text, beyond the acceptance criteria for fluid resistance.
- Data Provenance: Not explicitly stated whether the data is from the country of origin (China) or elsewhere. The study appears to be a manufacturer-conducted non-clinical study to demonstrate compliance with international standards. The study is retrospective in the sense that it's a pre-market submission, testing the final manufactured device according to established protocols.
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 as the study is a non-clinical performance evaluation of a physical medical device (Medical Mask) rather than an AI/software device requiring expert interpretation of results. The "ground truth" for the test set is defined by the objective measurement standards outlined in the industrial specifications (e.g., ASTM F1862, ASTM F2299, ASTM F2101, EN 14683, ISO 10993).
4. Adjudication method for the test set:
This is not applicable since the study involves objective physical and biological performance tests, not human interpretation or adjudication of complex data. The acceptance criteria define the pass/fail for each test.
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 as the device is a Medical Mask, not an AI/software device that would involve human readers or AI assistance for medical image interpretation or diagnosis.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This is not applicable as the device is a Medical Mask.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The "ground truth" for this device's performance evaluation is based on objective, standardized test methods and their defined limits (e.g., minimum filtration efficiency, maximum pressure differential, pass/fail for cytotoxicity). These standards are well-established in the medical device industry for surgical masks.
8. The sample size for the training set:
This is not applicable as the Medical Mask is a physical device, not an AI/machine learning model that requires a training set. The manufacturing process is designed and validated, not "trained" in the AI sense.
9. How the ground truth for the training set was established:
This is not applicable for the reasons stated above.
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December 3, 2020
Zhende Medical Co., Ltd % Ivy Wang Technical Manager Shanghai Sungo Management Consulting Company Limited 13th Floor, 1500# Central Avenue Shanghai, Shanghai 200122 China
Re: K201729
Trade/Device Name: Medical Mask Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: November 20, 2020 Received: November 27, 2020
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
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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 CAPT Elizabeth Claverie, M.S. Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K201729
Device Name Medical Mask
Indications for Use (Describe)
The Medical 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 of the wearer to blood and body fluids. This is a single use, disposable device(s), provided non-sterile.
| Description | Model No. | Color | Barrier Level |
|---|---|---|---|
| Ear loop mask | L1171801 | 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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Zhende Medical Co., Ltd. Gaobu Town, 312035, Shaoxing, Zhejiang, P.R. China
510(K) Summary
K201729
Date of Summary prepared: 12/01/2020
A. Applicant:
Zhende Medical Co., Ltd. Address: Gaobu Town, 312035, Shaoxing, Zhejiang, P.R. China Contact Person: Chen Ming Tel: +86-575-88770363 Fax: +86-575-88084736
Submission Correspondent: Primary contact: Ms. Ivy Wang Shanghai SUNGO Management Consulting Co., Ltd. Room 1309, Dongfang Building, 1500# Century Ave., Shanghai 200122, China Tel: +86-21-58817802 Email: haiyu.wang@sungoglobal.com Secondary contact: Mr. Raymond Luo Room 1309, Dongfang Building, 1500# Century Ave., Shanghai 200122, China Tel: +86-21-68828050 Email: fda.sungo@gmail.com
B. Device:
Trade Name: MEDICAL MASK Common Name: MEDICAL FACE MASK Model(s): L1171801 (Ear Loop with blue color, Barrier 1)
Regulatory Information Classification Name: Surgical Face Mask Classification: Class II Product code: FXX Regulation Number: 878.4040 Review Panel: Surgical Apparel
C. Predicate device:
K110455 Kimberly-Clark KC100 Mask Kimberly-Clark
D. Intended use of the device:
The Medical Masks are intended to be worn to protect both the patient and healthcare personnel from
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transfer of microorganisms, body fluids and particulate material. These face masks are intended for use in infection control practices to reduce the potential exposure of the wearer to blood and body fluids. This is a single use, disposable device(s), provided non-sterile.
E. Device Description:
The Medical Masks are single use, three-layer, flat –folded masks with ear loops and nose clamp.
The Medical Masks are manufactured with three layers, the inner and outer layers are made of spun-bond 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 clamp 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 Masks will be provided in blue. The medical masks are sold non-sterile and are intended to be single use, disposable devices.
F. Comparison with predicate device
| Device | Proposed Device | Predicate Device | Result | |
|---|---|---|---|---|
| Manufacturer | Zhende Medical Co., Ltd. | Kimberly-Clark | - | |
| 510K number | K201729 | K110455 | - | |
| Model Name | MEDICAL MASK | Kimberly-Clark KC100 Mask | Similar | |
| Model No. | L1171801 | KC100 | - | |
| Classification | Class II Device, FXX (21 CFR878.4040) | Class II Device, FXX (21 CFR878.4040) | Same | |
| Intend use | The Medical 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 of the wearer to blood and body fluids. This is a single use, disposable device(s), provided non-sterile. | The Kimberly-Clark KC100 Procedure Mask(s) 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 of the wearer to blood and body fluids. The Kimberly-Clark KC100 Procedure Mask(s) is a single use, disposable devices, provided non-sterile. | Same | |
| Model | Ear Loops, Flat Pleated, 3 layers | Ear Loops, Tie-On, Flat Pleated, 3 layers | Similar | |
| Material | Outer facing layer | Spun-bond polypropylene | Spun-bond polypropylene | Same |
| Middle layer | Melt blown polypropylene filter | Melt blown polypropylene filter | Same |
Table 1 General Comparison
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Zhende Medical Co., Ltd. Gaobu Town, 312035, Shaoxing, Zhejiang, P.R. China
| Innerfacinglayer | Spun-bond polypropylene | Spun-bond polypropylene | Same | |
|---|---|---|---|---|
| Noseclamp | Malleable polypropylene with ironwire | NA | Different* | |
| Earloops | Polyester, Spandex | Polyester/lycra knitted | Different* | |
| Color | Blue | Variety (include blue) | Similar | |
| Dimension(Length) | $180 \pm 10mm$ | $165 \pm 19mm$ | Similar | |
| Dimension(Width) | $95 \pm 10mm$ | $102 \pm 19mm$ | Similar | |
| 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 |
Different*:
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.
G. Non-Clinical Test Conclusion
Non-clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) 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
-
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);
- A EN 14683, Medical Face Masks-Requirements and Test Methods;
-
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;
- A 16 CFR 1610, Standard for the Flammability of clothing textiles;
Table 2 - Performance Testing
| Item | Proposed device | Acceptance Criteria (level 1) | Result |
|---|---|---|---|
| ------ | ----------------- | ------------------------------- | -------- |
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Zhende Medical Co., Ltd. Gaobu Town, 312035, Shaoxing, Zhejiang, P.R. China
| Fluid Resistance PerformanceASTM F1862 | 32 out of 32 per lot pass at 80 mmHg, 3 non-consecutive lots tested | 29 out of 32 pass at 80 mmHg | PASS |
|---|---|---|---|
| Particulate Filtration EfficiencyASTM F2299 | $\ge$ 95% | $\ge$ 95% | PASS |
| Bacterial Filtration EfficiencyASTM F2101 | $\ge$ 95% | $\ge$ 95% | PASS |
| Differential Pressure (Delta P)EN 14683 Annex C | < 5.0mmH2O/cm² | < 5.0mmH2O/cm² | PASS |
| Flammability 16 CFR 1610 | Class 1 | Class 1 | PASS |
Table 3 Biocompatibility Comparison
| Item | Proposed device | Acceptance Criteria | Result |
|---|---|---|---|
| Cytotoxicity | Under the conditions of the study, the device is non-cytotoxic. | Non-Cytotoxic | PASS |
| Irritation | Under the conditions of the study, the device is non-irritating. | Non-Irritating | PASS |
| Sensitization | Under the conditions of the study, the device is non-sensitizing | Non-Sensitizing | PASS |
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, MEDICAL MASK, is as safe, as effective, and performs as well as or better than the legally marketed predicate device, Kimberly-Clark KC100 Mask (K110455).
§ 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.