(86 days)
The Disposable Surgical Face Masks are intended to be worn to protect both the patient and healthcare personnel from transferring of microorganisms, body fluids and particulate material. These surgical 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 subject Disposable Surgical Face Masks have two model: FM-34EE, Level 2 and Model: FM-44EE, Level 3.
The Disposable Surgical Face Masks (Model: FM-34EE, Level 2) are three-layer, flat-pleaded masks with nose piece and ear loops, which are composed of inner layer and outer layer. The colorant is polypropylene (PP) master batch.
The inner layer and outer layer of FM-34EE mask are made of spun-bond polypropylene, the middle layer is made of melt-blown polypropylene.
The Disposable Surgical Face Masks (Model: FM-44EE, Level 3) are four-layer, flat-pleaded masks with nose piece and ear loops, which are composed of inner layer, filtration layer and outer layer. The colorant is polypropylene (PP) master batch.
The inner layer and outer layer of FM-44EE are made of spun-bonded polypropylene, the second layer is made of PE film, the filtration layer is made of melt-blown polypropylene.
The ear loops of both models are held in place over the users' mouth and nose by two ear loops welded to the face mask. The ear loops are made with nylon and spandex. The nose piece in the layers of face mask is to allow the user to fit the mask around their nose, which is made of aluminum.
The Disposable Surgical Face Masks of both models are sold non-sterile and are intended to be single use, disposable devices.
The masks are designed and manufactured in accordance with ASTM F2100-19 Standard Specification for Performance of Materials Used in Medical Face Masks.
The acceptance criteria and study proving the device meets them are detailed below, based on the provided text.
The device in question is the "Disposable Surgical Face Masks (FM-34EE, FM-44EE)".
1. Table of Acceptance Criteria and Reported Device Performance
The device includes two models: FM-34EE (Level 2) and FM-44EE (Level 3). The acceptance criteria and performance are outlined for both levels where applicable.
| Performance Testing | Test Methodology | Acceptance Criteria for Level 2 Barrier | Acceptance Criteria for Level 3 Barrier | Reported Performance (Result for both Levels) |
|---|---|---|---|---|
| Bacterial Filtration Efficiency | ASTM F2101 | $\geq$ 98% | $\geq$ 98% | Passed (Level 2: average 99.9%, Level 3: average 99.9%) |
| Differential Pressure (mmH2O/cm²) | EN 14683:2019 Annex C | $<$ 6.0 mmH2O/cm² | $<$ 6.0 mmH2O/cm² | Passed (Level 2: average 3.45 mmH2O/cm², Level 3: average 3.65 mmH2O/cm²) |
| Sub-micron Particulate Filtration Efficiency | ASTM F2299-17 | $\geq$ 98% | $\geq$ 98% | Passed (Level 2: average 98.43%, Level 3: average 98.56%) |
| Resistance to Penetration by Synthetic Blood | ASTM F1862-17 | 120 mmHg | 160 mmHg | Passed (Level 2: Pass at 120mmHg, Level 3: Pass at 160mmHg) |
| Flammability | 16 CFR Part 1610-2008 | Class I | Class I | Passed (Class 1) |
| Biocompatibility: Cytotoxicity | ISO 10993-5 | Non-cytotoxic | Non-cytotoxic | Passed (Non-cytotoxic) |
| Biocompatibility: Sensitization | ISO 10993-10 | Non-sensitizing | Non-sensitizing | Passed (Non-sensitizing) |
| Biocompatibility: Irritation | ISO 10993-10 | Negligibly irritating | Negligibly irritating | Passed (Negligibly irritating) |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the specific sample sizes for each test set (e.g., number of masks tested for BFE, differential pressure, etc.). It only indicates that "The Disposable Surgical Face Mask was tested in accordance with the tests recommended in the FDA guidance document...".
The data provenance is not specified regarding country of origin or whether it was retrospective or prospective. It is implied that the testing was conducted by the manufacturer or a contracted testing facility to support the 510(k) submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable. The device is a surgical face mask, and "ground truth" as typically used in AI/image analysis studies (e.g., expert consensus on medical images) is not relevant here. The performance evaluation relies on standardized laboratory test methods for physical and biological properties.
4. Adjudication Method for the Test Set
Adjudication methods (e.g., 2+1, 3+1) are typically used in clinical studies involving human interpretation or subjective assessments. For the laboratory-based performance testing of the surgical face mask, no such adjudication method is mentioned or expected. The tests follow established scientific protocols with measurable outcomes.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. Surgical masks are evaluated based on their physical and biological barrier properties, not on human reader performance. Therefore, an effect size of human readers improving with AI vs. without AI assistance is not applicable to this device.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
No, this pertains to an AI/algorithm-based device, which this surgical face mask is not. The performance is the inherent protective capability of the physical mask itself, evaluated through laboratory testing.
7. The Type of Ground Truth Used
The "ground truth" for the device's performance is established by objective, standardized laboratory test methods outlined by organizations like ASTM and ISO, and FDA guidance. These methods provide quantifiable measurements of bacterial filtration efficiency, particulate filtration efficiency, differential pressure, fluid resistance, flammability, and biocompatibility. There is no expert consensus, pathology, or outcomes data used as ground truth in the context of device performance assessment for this type of product.
8. The Sample Size for the Training Set
This information is not applicable. The device is a physical product (surgical face mask), not an algorithm or AI model that requires a training set.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable, as there is no training set for a physical device like a surgical face mask.
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May 26, 2022
Qingdao Bestex Rubber & Plastic Products Co.,Ltd. % Ivy Wang Technical Manager Shanghai Sungo Management Consulting Company Limited 14th Floor, 1500# Century Avenue Shanghai, 200122 China
Re: K220597
Trade/Device Name: Disposable Surgical Face Mask (FM-34EE, FM-44EE) Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: March 1, 2022 Received: March 1, 2022
Dear Ms. 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
Submission Number (if known)
Device Name
Disposable Surgical Face Mask (FM-34EE, FM-44EE)
Indications for Use (Describe)
The Disposable Surgical Face Masks are intended to be worn to protect both the patient and healthcare personnel from transferring of microorganisms, body fluids and particulate material. These surgical 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.
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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K220597
510(K) Summary
Date prepared: 22nd, February, 2022
A. Applicant:
Name: Qingdao Bestex Rubber & Plastic Products Co., Ltd. Address: No.8-5 Guangzhou Road, Pingdu, Qingdao, China ,266701 Contact: Lucy Wang Title: Sales Manager Tel: +86- 18562823807 Email: lucy@bestex-china.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 Surgical Face Mask (FM-34EE, FM-44EE) Common Name: Surgical Mask
Regulatory Information Classification Name: Surgical Face Mask Classification: Class II Product code: FXX Regulation Number: 21 CFR 878.4040 Review Panel: Surgical Apparel
C. Predicate device:
K210030 Medical surgical mask Tianjin Aoshang Outdoor Equipment Co., Ltd.
D. Indications for use of the device:
The Disposable Surgical Face Masks are intended to be worn to protect both the patient and healthcare
K220597 510(k) Summary 1 / 6
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personnel from transfer of microorganisms, body fluids and particulate material. These surgical masks are intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This a single use, disposable device(s), provided non-sterile.
E. Device Description:
The subject Disposable Surgical Face Masks have two model: FM-34EE, Level 2 and Model: FM-44EE, Level 3.
The Disposable Surgical Face Masks (Model: FM-34EE, Level 2) are three-layer, flat-pleaded masks with nose piece and ear loops, which are composed of inner layer and outer layer. The colorant is polypropylene (PP) master batch.
The inner layer and outer layer of FM-34EE mask are made of spun-bond polypropylene, the middle layer is made of melt-blown polypropylene.
The Disposable Surgical Face Masks (Model: FM-44EE, Level 3) are four-layer, flat-pleaded masks with nose piece and ear loops, which are composed of inner layer, filtration layer and outer layer. The colorant is polypropylene (PP) master batch.
The inner layer and outer layer of FM-44EE are made of spun-bonded polypropylene, the second layer is made of PE film, the filtration layer is made of melt-blown polypropylene.
The ear loops of both models are held in place over the users' mouth and nose by two ear loops welded to the face mask. The ear loops are made with nylon and spandex. The nose piece in the layers of face mask is to allow the user to fit the mask around their nose, which is made of aluminum.
The Disposable Surgical Face Masks of both models are sold non-sterile and are intended to be single use, disposable devices.
The masks are designed and manufactured in accordance with ASTM F2100-19 Standard Specification for Performance of Materials Used in Medical Face Masks.
F. Non-clinical Test Conclusion
The Disposable Surgical Face Mask was tested in accordance with the tests recommended in the FDA guidance document, Guidance for Industry and FDA Staff Surgical Masks – Premarket Notification [510(k)] Submission issued March of 2004. Based upon the guidance document the following testing has been performed.
| Performance Testing | ||||
|---|---|---|---|---|
| Test Methodology | Purpose | Acceptance Criteria for Level 2 Barrier | Acceptance Criteria for Level 3 Barrier | Result |
| Bacterial Filtration Efficiency | Measure bacterial filtration efficiency | $\geq$ 98% | $\geq$ 98% | Passed |
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| ASTM F2101 | ||||
|---|---|---|---|---|
| DifferentialPressure(mmH2O/cm²)EN 14683:2019Annex C | Determinebreathability of themask | <6.0 mmH2O/cm² | <6.0 mmH2O/cm² | Passed |
| Sub-micronParticulateFiltrationEfficiency ASTMF2299-17 | Measure initialparticle filtrationefficiency | ≥98% | ≥98% | Passed |
| Resistance toPenetration bySynthetic BloodASTM F1862-17 | Evaluate theresistance topenetration byimpact of smallvolume of syntheticblood | 120 mmHg | 160 mmHg | Passed |
| Flammability16 CFR Part1610-2008 | Response ofmaterials to heatand flame | Class I | Class I | Passed |
Biocompatibility Testing
The biocompatibility evaluation for the Disposable Surgical Face Mask was conducted in accordance with ISO 10993-1:2018 Biological Evaluation of Medical Devices-Part 1: Evaluation and Testing within a Risk Management Process, as recognized by FDA. The Medical Surgical Mask is classified as a surface contacting device. Specific biocompatibility tests were selected under the guidance of ISO 10993-1:2018 Annex A.
| Biological Effect | Standard | Result | ||
|---|---|---|---|---|
| 1 | Cytotoxicity | ISO 10993-5 | Non-cytotoxic | Passed |
| 2 | Sensitization | ISO 10993-10 | Non-sensitizing | Passed |
| 3 | Irritation | ISO 10993-10 | Negligibly irritating | Passed |
G. Summary of Technological Characteristics
Table 1 Comparison of Proposed and Predicate Devices
| Device | Proposed Device | Predicate Device | Result |
|---|---|---|---|
| 510K # | - | K210030 | - |
| Manufacturer | Qingdao Bestex Rubber & Plastic Products Co., Ltd. | Tianjin Aoshang Outdoor Equipment Co., Ltd. | - |
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| Product Name | Disposable Surgical Face Mask | Medical surgical mask | Similar |
|---|---|---|---|
| Level | Level 2 and Level 3 | Level 2 and Level 3 | Same |
| Product Code | FXX | FXX | Same |
| RegulationNumber | 21 CFR 878.4040 | 21 CFR 878.4040 | Same |
| Indications foruse | The Disposable Surgical Face Masks areintended to be worn to protect both thepatient and healthcare personnel fromtransfer of microorganisms, body fluids andparticulate material. These surgical masksare intended for use in infection controlpractices to reduce the potential exposure toblood and body fluids. This a single use,disposable device(s), provided non-sterile. | The Disposable Surgical Face Masksare intended to be worn to protect boththe patient and healthcare personnelfrom transfer of microorganisms, bodyfluids and particulate material. Thesesurgical masks are intended for use ininfection control practices to reducethe potential exposure to blood andbody fluids. This a single use,disposable device(s), providednon-sterile. | Same |
| Design Feature | Level 2: Ear loopLevel 3: Ear loop | Level 2: Ear loopLevel 3: Ear loop and tie-on | Similar |
| Color | Blue | Blue | Same |
| Dimension | $17.5cm \times 9.5cm$ | $17.5cm \times 9.5cm$ | Same |
| Sterility | Non-sterile | Non-sterile | Same |
| Use | Single Use, Disposable | Single Use, Disposable | Same |
| Particulatefiltrationefficiency | Level 2: average 98.43%Level 3: average 98.56% | Level 2: average 99.71%Level 3: average 99.93% | Different |
| Bacterialfiltrationefficiency | Level 2: average 99.9%Level 3: average 99.9% | Level 2: average 99.7%Level 3: average 99.9% | Different |
| Differentialpressure | Level 2: average $3.45 mmH_2O/cm^2$Level 3: average $3.65 mmH_2O/cm^2$ | Level 2: average $2.8 mmH_2O/cm^2$Level 3: average $4.0 mmH_2O/cm^2$ | Different |
| Flammability | Class 1 | Class 1 | Same |
| Fluidresistance | Level 2: Pass at 120mmHgLevel 3: Pass at 160mmHg | Level 2: Pass at 120mmHgLevel 3: Pass at 160mmHg | Same |
| Label/Labeling | Complied with 21 CFR part 801 | Complied with 21 CFR part 801 | Same |
| Material | |||
| Outer layer | Spun-bond polypropylene | Spunbond Polypropylene | Same |
| Middle layer | Level 2: Meltblown Polypropylene FilterLevel 3: | Meltblown Polypropylene Filter | Different |
| Second layer: PE film | |||
| Filter layer: Meltblown Polypropylene Filter | |||
| Inner layer | Spun-bond polypropylene | Spunbond Polypropylene | Same |
| Nose wire | Aluminum | PE+iron | Different |
| Ear loops | Nylon and spandex | Spandex | Different |
| Biocompatibility Testing | |||
| Cytotoxicity | Non-cytotoxic | Non-cytotoxic | Same |
| Skin Irritation | Non-irritating | Non-irritating | Same |
| SkinSensitization | Non-sensitizing | Non-sensitizing | Same |
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Difference Analysis:
-
The test results for particulate filtration efficiency, bacterial filtration efficiency and differential pressure for the proposed device are different from the predicate device. However, the test result for the proposed device can meet the requirements of level 2 mask and Level 3 mask. Thus, these differences will not affect the safety and effectiveness between the proposed and predicate devices.
-
The proposed device has different material of nose wire and ear loop to the predicate device. However, biocompatibility test has been performed on the proposed device and the results does not show any adverse effect. Thus, this difference will not affect the safety and effectiveness between the proposed device and the two predicate devices.
-
The proposed device has different layers and material of the mask body to the predicate device, but the masks has been tested and the test results shown that the requirements of the medical mask. This difference do not affect the safety and effectiveness of the proposed device.
H. Summary of Non-Clinical Testing
Non-clinical tests were conducted to verify that the proposed device met all design specification. 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 Mask - Premarket Notification [510(K)] Submission issued on March 5, 2004:
-
ISO 10993-05:2009 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
- A 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)
-
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
- I. Clinical Test Conclusion
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No clinical study is included in this submission.
J. Conclusion
The conclusion drawn from the nonclinical tests demonstrates that the subject device in 510(K) submission, the Disposable Surgical Face Mask is as safe, as effective, and performs as well as or better than the legally marketed predicate device cleared under K210030.
K220597 510(k) Summary 6 / 6
§ 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.