(100 days)
The Disposable 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 to blood and body fluids. This is a single use, disposable device(s), provided non-sterile.
The Disposable Medical Masks are single use, three-layer, flat -folded masks with ear loops and nose clip. The Disposable Medical Masks are manufactured with three layers, the inner and outer layers are made of non-woven 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 strings welded to the facemask. The ear loops are made of 17cm spandex elastic strings(performance of the spandex elastic: Tensile strength> 100N; Elasticity>=2.8times; Breaking tension>=100N) The nose clip in the layers of facemask is to allow the user to fit the facemask around their nose, which is not touch with the users' skin directly. The Disposable Medical Masks will be provided in blue. The Disposable Medical Masks are sold non-sterile and are intended to be single use, disposable devices.
This document is a 510(k) premarket notification for a Disposable Medical Mask. It is for a physical medical device (mask), not an AI/ML powered device. Therefore, many of the requested categories related to AI/ML device studies (such as multi-reader multi-case studies, expert adjudication, training set ground truth, etc.) are not applicable here.
However, I can extract information related to the acceptance criteria and non-clinical testing performed for this medical mask.
1. Table of Acceptance Criteria and Reported Device Performance
| Test Methodology | Purpose | Acceptance Criteria (ASTM F2100 Level 1) | Reported Device Performance (Result) |
|---|---|---|---|
| Fluid Resistance (ASTM F1862) | Performance testing to demonstrate functionality | 29 out of 32 per lot pass at 80 mmHg | Pass: 32 out of 32 pass at 120 mmHg, 3 lots |
| Particulate Filtration Efficiency (ASTM F2299) | Performance testing to demonstrate functionality | $\ge 95%$ | Pass: $>98%$ |
| Bacterial Filtration Efficiency (ASTM F2101) | Performance testing to demonstrate functionality | $\ge 95%$ | Pass: $99.9%$ |
| Differential Pressure (EN 14683 Annex C) | Performance testing to demonstrate functionality | $<5.0mmH2O/cm²$ | Pass: $<4.0mmH2O/cm²$ |
| Flammability (16 CFR 1610) | Performance testing to demonstrate functionality | Class 1 | Pass: Class 1 |
| Cytotoxicity (ISO 10993-5) | Safety testing to demonstrate safety of the subject device | Non-cytotoxic | Pass: Device is non-cytotoxic |
| Irritation (ISO 10993-10) | Safety testing to demonstrate safety of the subject device | Non-irritating | Pass: Device is non-irritating |
| Sensitization (ISO 10993-10) | Safety testing to demonstrate safety of the subject device | Non-sensitizing | Pass: Device is non-sensitizing |
2. Sample Size Used for the Test Set and Data Provenance
- Fluid Resistance: 32 samples per lot, tested across 3 non-consecutive lots.
- Other Performance and Biocompatibility Tests: Specific sample sizes are not explicitly stated for individual tests other than Fluid Resistance, but are implied to be sufficient for standard test protocols outlined by the referenced ASTM and ISO standards.
- Data Provenance: The tests were conducted to verify that the proposed device met design specifications and complied with listed standards. The data provenance is internal testing performed by the manufacturer (Hubei Wanli Protective Products Co., Ltd.) or contracted laboratories adhering to international standards. The document does not specify country of origin for the test data as it pertains to clinical data, but rather product manufacturing. The testing conducted is non-clinical performance and biocompatibility testing. The data is most likely prospective testing for this device.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts
This is not applicable as the device is a physical medical mask, and the "ground truth" for its performance is established through standardized laboratory testing against objective criteria (e.g., filtration efficiency percentages, pressure differentials, biocompatibility assays), not expert interpretation of diagnostic images or clinical scenarios.
4. Adjudication Method for the Test Set
Not applicable. As above, this is laboratory performance and biocompatibility testing, not human review requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. This is a physical medical mask, not an AI-powered diagnostic device. No human reader studies (with or without AI assistance) were conducted.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
Not applicable. This is a physical medical mask. The concept of an "algorithm" or "human-in-the-loop performance" does not apply.
7. Type of Ground Truth Used
The "ground truth" for the device's performance is established by objective, quantitative measurements obtained through standardized laboratory test methods (e.g., ASTM F1862 for fluid resistance, ASTM F2101 for BFE, ISO 10993 for biocompatibility). The results are compared against predefined numerical acceptance criteria.
8. Sample Size for the Training Set
Not applicable. This is a physical medical device, not an AI/ML algorithm requiring a "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable. There is no training set for this type of device.
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Image /page/0/Picture/0 description: The image contains 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.
April 6, 2022
Hubei Wanli Protective Products Co. Ltd % Ivy Wang Technical Manager Shanghai SUNGO Management Consulting Company Limited. Room 1401, Dongfang Building, 1500# Century Avenue Shanghai 200122 China
Re: K214085
Trade/Device Name: Disposable Medical Mask Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: February 28, 2022 Received: March 1, 2022
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,
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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
Device Name Disposable Medical Mask
Indications for Use (Describe)
The Disposable 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 to blood and body fluids. This is a single use, disposable device(s), provided non-sterile.
] 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: 2021-11-30 A. Applicant: Name: Hubei Wanli Protective Products Co., Itd. Address: Yuanshi, Ganhe, Xiantao, Hubei, China Contact: Andy Wen Title: System Specialist Tel: 0086-728-3227299 Email: sale01@hbwanli.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: Disposable Medical Mask Common Name: SURGICAL MASK Model: ear loops
Regulatory Information Classification Name: Surgical Face Mask Classification: Class II Product code: FXX Regulation Number: 878.4040 Review Panel: Surgical Apparel
C. Predicate device:
K210150 Disposable Medical Mask Hubei Wanli Protective Products Co., Itd.
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D. Indications for use of the device:
The Disposable 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 to blood and body fluids. This is a single use, disposable device(s), provided non-sterile.
E. Device Description:
The Disposable Medical Masks are single use, three-layer, flat -folded masks with ear loops and nose clip. The Disposable Medical Masks are manufactured with three layers, the inner and outer layers are made of non-woven 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 strings welded to the facemask. The ear loops are made of 17cm spandex elastic strings(performance of the spandex elastic: Tensile strength> 100N; Elasticity≥2.8times; Breaking tension≥100N)
The nose clip in the layers of facemask is to allow the user to fit the facemask around their nose, which is not touch with the users' skin directly.
The Disposable Medical Masks will be provided in blue. The Disposable Medical Masks are sold non-sterile and are intended to be single use, disposable devices.
F. Technological Characteristics Comparison Table
The proposed device is totally the same with the predicate device, only differ in the claim of ASTM LEVEL. Provided below is a comparison of the proposed device with the predicate device
| Device | Proposed Device | Predicate Device | Result |
|---|---|---|---|
| 510K # | K210150 | - | |
| Manufacturer | Hubei Wanli Protective Products Co., ltd. | Hubei Wanli Protective Products Co., ltd. | - |
| Model Name | Disposable Medical Mask | Disposable Medical Mask | Same |
| Classification | Class II Device, FXX (21 CFR878.4040) | Class II Device, FXX (21 CFR878.4040) | Same |
| Intend use | The Disposable 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 to blood and body fluids. This is a single use, disposable device(s), provided non-sterile. | The Disposable 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 to blood and body fluids. This is a single use, disposable device(s), provided non-sterile. | Same |
| Design Features | Ear Loops, Flat-pleated, 3 layers | Ear Loops, Flat-pleated, 3 layers | Same |
Table 1 General Comparison
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| Materials | Outerlayerfacing | Non-woven Spun-bondPolypropylene | Non-woven Spun-bondPolypropylene | Same | |
|---|---|---|---|---|---|
| Innerlayerfacing | Non-woven Spun-bondPolypropylene | Non-woven Spun-bondPolypropylene | Same | ||
| Filter layer | Melt-blown Polypropylene | Melt-blown Polypropylene | |||
| Nose wire | aluminum strip | aluminum strip | |||
| Ear loops | Spandex elastic | Spandex elastic | Same | ||
| Color | Blue | Blue | Same | ||
| Dimension (length) | 175mm±5mm | 175mm±5mm | Same | ||
| Dimension (width) | 95 mm±5mm | 95 mm±5mm | Same | ||
| 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 2 | Different | ||
| 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 120mmHg, 3 non-consecutive lotstested | 32 out of 32 per lot pass at 120mmHg, 3 non-consecutive lotstested | Same | ||
| ParticulateFiltrationEfficiencyASTM F2299 | > 98% | > 98% | Same | ||
| Bacterial FiltrationEfficiencyASTM F2101 | 99.9% | 99.9% | Same | ||
| DifferentialPressure (Delta P)EN 14683 Annex C | < 4.0mmH2O/cm² | < 4.0mmH2O/cm² | Same | ||
| Flammability 16CER 1610 | Class 1 | Class 1 | Same |
Different Analysis:
The proposed device has different ASTM LEVEL claim to the predicate device, but the performance testing was conducted and the test results showed that the proposed device can meet the requirements of ASTM F2100-19. Therefore, the difference do 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: 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 Cytotoxicity
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-
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);
-
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, 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 | 29 out of 32 per lot passat 80 mmHg | Pass32 out of 32 pass at 120 mmHg, 3 lots | |
| ParticulateFiltration Efficiency | The purpose of theperformance testing is todemonstrate thefunctionality of the subjectdevice. | $\ge 95%$ | Pass>98% |
| Bacterial FiltrationEfficiency | $\ge 95%$ | Pass99.9% | |
| DifferentialPressure | $<5.0mmH2O/cm²$ | Pass$<4.0mmH2O/cm²$ | |
| 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 K210150.
§ 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.