(60 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. 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 has 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 spun-bond 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 Nylon and polyester. 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 polyethylene coated galvanized wire. The proposed device(s) are sold non-sterile and are intended to be single use, disposable device.
This document pertains to the 510(k) premarket notification for a Medical Face Mask, and as such, it describes performance testing for a physical medical device, not software or an AI-powered diagnostic tool. Therefore, many of the requested criteria related to AI/algorithm performance, ground truth establishment, expert adjudication, and MRMC studies are not applicable.
However, I can extract the relevant information regarding the device's acceptance criteria and the studies performed to demonstrate it meets those criteria.
Acceptance Criteria and Device Performance for Ammex-Weida (Hubei) Health and Safety Products Co., Ltd's Medical Face Mask
The device under review is a Medical Face Mask, a physical device, not an AI/algorithm-based one. The acceptance criteria are based on established performance standards for medical face masks.
1. Table of Acceptance Criteria and Reported Device Performance
Device: Medical Face Mask (Proposed Device, K211062)
Classification: Class II, ASTM F2100 Level 3 (meets Level 3 requirements)
| Performance Characteristic | Acceptance Criteria (ASTM F2100 Level 3) | Reported Device Performance (Proposed Device) | Result |
|---|---|---|---|
| Fluid Resistance (ASTM F1862) | 29 out of 32 Pass at 160 mmHg | 32 out of 32 Pass at 160 mmHg | PASS |
| Particulate Filtration Efficiency (ASTM F2299) | ≥ 98% | 98.98% | PASS |
| Bacterial Filtration Efficiency (ASTM F2101) | ≥ 98% | 99.9% | PASS |
| Differential Pressure (Delta P) (EN 14683 Annex C) | < 6.0 mmH₂O/cm² | 5.54 mmH₂O/cm² | PASS |
| Flammability (16 CFR 1610) | Class 1 | Class 1 | PASS |
Biocompatibility Testing (ISO 10993)
| Biocompatibility Test | Acceptance Criteria | Reported Device Performance (Proposed Device) | Result |
|---|---|---|---|
| Cytotoxicity | Non-Cytotoxic | Under the conditions of the study, the device is non-cytotoxic. | PASS |
| Irritation | Non-Irritating | Under the conditions of the study, the device is non-irritating. | PASS |
| Sensitization | Non-Sensitizing | Under the conditions of the study, the device is non-sensitizing. | PASS |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Sizes: The document specifies sample sizes for some tests:
- Fluid Resistance (ASTM F1862): 32 samples were tested ("32 out of 32 Pass").
- For other tests like Particulate Filtration Efficiency, Bacterial Filtration Efficiency, Differential Pressure, Flammability, and Biocompatibility, specific sample sizes are not explicitly stated in this summary, but these are standardized tests that follow defined sample size protocols for regulatory compliance.
- Data Provenance: The tests were non-clinical and conducted to verify design specifications and similarity to the predicate device. The tests were performed according to specified standards (e.g., ASTM, EN, ISO, CFR). The country of origin for the manufacturing company is China (Hubei, China), and the submission correspondent is based in Shanghai, China. The document does not specify whether the data collection for these performance tests was retrospective or prospective, though performance testing for device clearance is typically prospective by nature.
3. Number of Experts Used to Establish Ground Truth and Qualifications
- Not Applicable. This is a physical device, not an AI/algorithm requiring expert-established ground truth for diagnostic accuracy. Performance is measured against physical and biological properties.
4. Adjudication Method for the Test Set
- Not Applicable. As this is a physical device, there is no "ground truth" established by human experts that requires adjudication in the context of diagnostic accuracy. The testing involves standardized laboratory methods with objective measurements.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- Not Applicable. This type of study is relevant for diagnostic imaging or AI algorithms where human interpretation is involved. This device is a medical face mask, and its effectiveness is determined by objective physical and biological barrier tests, not human interpretation.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance)
- Not Applicable. This is a physical device, not an algorithm.
7. Type of Ground Truth Used
- Objective Measurement against Standards: The "ground truth" for this device's performance is established by objective laboratory measurements against predefined international and national standards (ASTM, EN, ISO, CFR). For example:
- Fluid Resistance: Measured by the device's ability to resist penetration by synthetic blood at a certain pressure.
- Filtration Efficiency: Measured by the percentage of particles or bacteria filtered out.
- Differential Pressure: Measured by the breathability of the material.
- Flammability: Measured by how easily the material ignites and burns.
- Biocompatibility: Measured by the material's non-toxicity, non-irritating, and non-sensitizing properties in biological tests.
8. Sample Size for the Training Set
- Not Applicable. This device does not involve a "training set" in the context of machine learning. The manufacturing process and material selection are based on established engineering and materials science principles and validated through the non-clinical tests described.
9. How the Ground Truth for the Training Set was Established
- Not Applicable. As there is no training set for an AI/algorithm, there is no corresponding "ground truth establishment."
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June 8, 2021
Ammex-Weida (Hubei) Health and Safety Products Co., Ltd % Cynthia Xiang Consultant Shanghai Sungo Management Consulting Company Limited 14th Floor, 1500# Central Avenue Shanghai, Shanghai 200122 China
Re: K211062
Trade/Device Name: Medical Face Mask Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: April 6, 2021 Received: April 9, 2021
Dear Cynthia Xiang:
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 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,
Ryan Ortega, PhD 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 Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K211062
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. 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)
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K211062
510(K) Summary
A. Applicant:
Name: Ammex-Weida (Hubei) Health and Safety Products Co., Ltd Address: Southern Industrial Zone (Xinlirenkou), Xiantao, Hubei, China 433011 Contact Person: Cai Mingqing Tel: +86-27-85577096/85577097/85577099/85577233
Submission Correspondent: Primary contact: Ms. Cynthia Xiang Shanghai SUNGO Management Consulting Co., Ltd. Room 1401, Dongfang Building, 1500# Century Ave., Shanghai 200122, China Tel: +86-21-58817802 Email: shouqiu.xiang@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: Disposable Medical Face Mask Model: Ear loop; 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 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. 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.
E. Device Description:
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The proposed device(s) are blue color, and flat pleated type mask, utilizing ear loops way for wearing, and they all has 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 spun-bond 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 Nylon and polyester. 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 polyethylene coated galvanized wire. The proposed device(s) are sold non-sterile and are intended to be single use, disposable device.
F. Comparison with predicate device
Table 1 General Comparison
| Device | Proposed Device | Predicate Device | Result | |
|---|---|---|---|---|
| Manufacturer | Ammex-Weida (Hubei) Health andSafety Products Co., Ltd | Nantong Taiweishi MedicalTechnology Co., Ltd. | - | |
| 510K number | K211062 | K203426 | - | |
| Model name | Medical Face Mask | Surgical Face Mask(Non-sterile) | Same | |
| Classification | Class II Device, FXX (21CFR878.4040) | Class II Device, FXX (21CFR878.4040) | Same | |
| Intended use | The Medial Face Mask is intended tobe worn to protect both the patientand healthcare personnel fromtransfer of microorganisms, bodyfluids and particulate material. Theyare intended for use in infectioncontrol practices to reduce thepotential exposure to blood and bodyfluids. This is a single use, disposabledevice(s), provided non-sterile. | The Surgical Face Mask(non-sterile) is intended to be worn toprotect both the patient and healthcarepersonnel from transfer ofmicroorganisms, body fluids andparticulate material. These face masksare intended for use in infection controlpractices to reduce the potentialexposure to blood and body fluids. Thisa single use, disposable device(s),provided non-sterile. | Same | |
| Model | Ear loop, Flat pleates,3 layers | Ear loop, Tie-on, Flat pleated,3 layers | Similar | |
| Material | Outerlayer | Spun-bond polypropylene | Spun-bond polypropylene | Same |
| Middlelayer | Melt blown polypropylene filter | Melt blown polypropylene filter | Same | |
| Innerlayer | Spun-bond polypropylene | Spun-bond polypropylene | Same | |
| Noseclip | polyethylene coated galvanized wire. | Polyethylene | Different | |
| Earloops | Nylon and polyester | Nylon and Spandex | Different |
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Ammex-Weida (Hubei) Health and Safety Products Co., Ltd Southern Industrial Zone (Xinlirenkou), Xiantao, Hubei, China 433011
| Color | Blue | Blue | Same |
|---|---|---|---|
| Dimension | 175mm+/-10mm | 175mm+/-5% | Similar |
| Dimension (Width) | 95mm+/-5mm | 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 3 | Level 2 | Similar |
| Biocompatibility | ISO10993 | ISO10993 | Same |
| FluidResistancePerformanceASTM F1862 | 32 out of 32 pass at 160 mmHg; | 32 out of 32 pass at 120 mmHg | Similar |
| ParticulateFiltrationEfficiencyASTMF2299 | 98.98% | 99.16% | Similar |
| Bacterial FiltrationEfficiencyASTMF2101 | 99.9% | 99.74% | Similar |
| DifferentialPressure (Delta P)EN 14683 Annex C | 5.54mmH2O/cm² | 3.7mm H2O/cm² | Similar |
| Flammability 16CFR 1610 | Class 1 | Class 1 | Same |
From the comparison we found the material of the current nose clip and the ear loop were different from the predicate device. The biocompatibility tests were conducted to both components to ensure their compliance to the ISO10993-5 and ISO10993-10. There is no new risk generated from the difference of the material.
For the Performance testing, the test results are not identical to each other, but they are similar. The predicate device meet the requirement of Level 2 medical mask according to the ASTM F 2100,the proposed device meet the requirement of Level 3 medical mask according to the ASTM F 2100.
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:
- ISO 10993-5: 2009 Biological Evaluation of Medical Devices -- Part 5: Tests For In Vitro A Cytotoxicity
- ISO 10993-10: 2010 Biological Evaluation of Medical Devices Part 10: Tests for Irritation and A
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Skin Sensitization
-
ASTM F2100, Standard Specification for Performance of Materials Used in Medical Face Masks
- 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);
- A 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;
- A 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;
| Item | Proposed device | Predicate device | Acceptance Criteria(level 3) | Result |
|---|---|---|---|---|
| Fluid ResistancePerformance ASTM F1862 | 32 out of 32 Pass at160 mmHg | 32 out of 32 Pass at120 mmHg | 29 out of 32 Pass at160 mmHg | PASS |
| Particulate FiltrationEfficiency ASTM F2299 | 98.98% | 99.16% | ≥ 98% | PASS |
| Bacterial FiltrationEfficiency ASTM F2101 | 99.9% | 99.74% | ≥ 98% | PASS |
| Differential Pressure (DeltaP) EN 14683 Annex C | 5.54mmH2O/cm2 | 3.7mm H2O/cm2 | < 6.0mmH2O/cm2 | PASS |
| Flammability 16 CFR 1610 | Class 1 | Class 1 | Class 1 | PASS |
Table 2 - Performance Testing
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.
I. Conclusion
Based on the nonclinical tests performed, the subject device is 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.