(120 days)
The 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. They are 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 Surgical Face Masks 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 Spandex. 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 polypropylene (PP) and iron wire. The proposed device(s) are sold non-sterile and are intended to be single use, disposable device.
Acceptance Criteria and Device Performance for Surgical Face Mask (K212574)
The provided document describes the acceptance criteria and the results of non-clinical tests performed on the "Surgical Face Mask" (model DM-FM) submitted by Xiantao Deming Healthcare products Co., Ltd. for 510(k) clearance (K212574).
1. Table of Acceptance Criteria and Reported Device Performance
| Item | Acceptance Criteria: ASTM F2100 Level 2 | Reported Device Performance (K212574) | Result |
|---|---|---|---|
| Fluid Resistance | 29 out of 32 pass at 120 mmHg for Level 2 | 32 out of 32 pass at 120 mmHg, 3 lots | PASS |
| Particulate Filtration Efficiency | ≥ 98% | Min=98.38%; 98.03%; 98.90% (across 3 lots, implied from context) | PASS |
| Bacterial Filtration Efficiency | ≥ 98% | Min=99.43%; 99.74%; 99.74% (across 3 lots, implied from context) | PASS |
| Differential Pressure | < 6.0 mmH2O/cm² | Max=3.1 mm H2O/cm²; 3.0 mm H2O cm²; 3.1 mm H2O cm² (across 3 lots, implied) | PASS |
| Flammability | Class 1 | Class 1 | PASS |
| 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 and Data Provenance
- Sample Size for Test Set: Non-clinical tests were conducted using 3 nonconsecutive lots of the surgical face mask. The specific number of masks tested per lot for each parameter is not explicitly stated in the summary, however, for fluid resistance it states "32 out of 32", which indicates a sample size of 32 masks were tested for that specific parameter.
- Data Provenance: The document does not explicitly state the country of origin of the data or whether the study was retrospective or prospective. Given that it is a submission for device clearance, it is highly likely that the testing was conducted prospectively according to established standards.
3. Number of Experts and Qualifications for Ground Truth
- This document describes non-clinical performance testing of a physical medical device (surgical face mask) based on established international and national standards (e.g., ASTM F2100, ISO 10993). Therefore, no human experts were used to establish ground truth in the way they would be for an AI/ML-based diagnostic device. The "ground truth" here is determined by the objective measurements obtained through standardized laboratory test methods.
4. Adjudication Method
- As this section pertains to non-clinical laboratory testing of a physical device against objective standards, no adjudication method (like 2+1 or 3+1 consensus) was used. The test results are quantitative measurements against predefined thresholds.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No MRMC comparative effectiveness study was done. This is a submission for a physical medical device (surgical face mask) and not an AI/ML diagnostic or assistive technology. Therefore, the concept of human readers improving with or without AI assistance is not applicable here.
6. Standalone Performance Study
- A standalone performance study was done regarding the device's physical properties and biocompatibility. The results for each specific test (Fluid Resistance, Particulate Filtration Efficiency, Bacterial Filtration Efficiency, Differential Pressure, Flammability, Cytotoxicity, Irritation, and Sensitization) represent the standalone performance of the surgical face mask itself, independent of any human user interaction beyond typical mask wear.
7. Type of Ground Truth Used
- The ground truth used for this device is based on objective, standardized laboratory measurements and test methods. These methods are specified by recognized standards such as ASTM F2100, ASTM F1862, EN 14683, ASTM F2101, ASTM F2299, 16 CFR 1610, ISO 10993-5, and ISO 10993-10. The acceptance criteria represent the predefined thresholds or performance levels mandated by these standards for a Level 2 surgical face mask.
8. Sample Size for the Training Set
- Not applicable. This submission is for a physical medical device and does not involve an AI/ML algorithm or a training set in the computational sense.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. As no AI/ML algorithm or training set was used, the concept of establishing ground truth for a training set is not relevant to this device submission.
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December 14, 2021
Xiantao Deming Healthcare products Co., Ltd % Ivy Wang Technical Manager Shanghai Sungo Management Consulting Company Limited 14th Floor, 1500# Central Avenue Shanghai, Shanghai 200122 China
Re: K212574
Trade/Device Name: Surgical Face Mask Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: August 16, 2021 Received: August 16, 2021
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,
Clarence W. Murray, III, PhD 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) K212574
Device Name Surgical Face Mask
Indications for Use (Describe)
The 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. They are 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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510k Summary
A. Applicant:
Xiantao Deming Healthcare products Co., Ltd Address:198# Pengchang ave,Pengchang town,Xiantao City,Hubei province,China 433018 Contact person: Gan Jing Tel: +86-15908610172
Email: crazy.gan@xtdeming.net
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: Surgical Face Mask Common Name: SURGICAL MASK Model: DM-FM
Regulatory Information Classification Name: Surgical Face Mask Classification: Class II Product code: FXX Regulation Number: 878.4040 Review Panel: Surgical Apparel
C. Predicate device:
K182515 Surgical Face Mask Wuhan Dymex Healthcare Co., Ltd.
D. Indications for use of the device:
The 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. They are intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This is a single use,
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disposable device(s), provided non-sterile.
E. Device Description:
The Surgical Face Masks 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 Spandex. 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 polypropylene (PP) and iron wire. The proposed device(s) are sold non-sterile and are intended to be single use, disposable device.
| Device | Proposed Device | Predicate Device | Result | |
|---|---|---|---|---|
| 510K # | K212574 | K182515 | - | |
| Manufacturer | Xiantao Deming Healthcareproducts Co., Ltd | Wuhan Dymex Healthcare Co.,Ltd. | - | |
| Model Name | Surgical Face MaskDM-FM | SURGICAL FACE MASKEar loops | Similar | |
| Classification | Class II Device, FXX (21CFR878.4040) | Class II Device, FXX (21CFR878.4040) | Same | |
| Intend use | The Surgical Face Masks areintended to be worn to protectboth the patient and healthcarepersonnel from transfer ofmicroorganisms, body fluidsand particulate material. Theyare intended for use in infectioncontrol practices to reduce thepotential exposure to blood andbody fluids. This is a single use,disposable device(s), providednon-sterile. | The Surgical Face Masks areintended to be worn to protectboth the patient and healthcarepersonnel from transfer ofmicroorganisms, body fluids andparticulate material. These facemasks are intended for use ininfection control practices toreduce the potential exposure toblood and body fluids. This is asingle use, disposable device(s),provided non-sterile. | Same | |
| Design Features | Ear Loops, Flat-pleated, 3 layers | Ear Loops, Flat-pleated, 3 layers | Same | |
| Materials | Outer layer | Spunbond Polypropylene | Spunbond Polypropylene | Same |
| Inner layer | Spunbond Polypropylene | Spunbond Polypropylene | Same | |
| Filter layer | Melt-blown Polypropylene | Melt-blown Polypropylene | Same | |
| Nose wire | polypropylene (PP) and iron wire | Malleable polyethylene wire | Different |
Technological Characteristic Comparison with predicate device F.
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| Ear loops | Spandex | Spandex | Same | |
|---|---|---|---|---|
| Color | Blue | Yellow | Different | |
| Dimension(Length) | $175mm\pm5mm$ | $17.5cm\pm0.2cm$ | Similar | |
| Dimension(Width) | $95mm\pm5mm$ | $9.5cm\pm0.2cm$ | Similar | |
| OTC use | Yes | Yes | Same | |
| Sterility | Non-Sterile | Non-Sterile | Same | |
| Use | Single Use, Disposable | Single Use, Disposable | Same | |
| ASTM F2100Level | Level 2 | Level 2 | Same |
The proposed device has different material of nose piece and different color to the predicate device.
The proposed device is similar in design, intended use, technological characteristics, and is composed of the same or similar components as the predicate device.
G. Summary of Non-Clinical Test
Non-clinical tests were conducted using 3 nonconsecutive lots 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:
- A ISO 10993-5: 2009 Biological Evaluation of Medical Devices -- Part 5: Tests For In Vitro Cytotoxicity
-
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
-
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 TestMethods;
-
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 inmedical face masks to penetration by particulates using latex spheres;
-
16 CFR 1610, Standard for the Flammability of clothingtextiles;
| Item | Proposed device | Acceptance Criteria:ASTM F2100 Level 2 | Result |
|---|---|---|---|
| FluidResistance | 32 out of 32 pass at 120 mmHg, 3lots | 29 out of 32 pass at 120 mmHg forlevel 2 | PASS |
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| ParticulateFiltrationEfficiency | Min=98.38%;98.03%;98.90% | ≥ 98% | PASS |
|---|---|---|---|
| BacterialFiltrationEfficiency | Min=99.43%;99.74%;99.74% | ≥ 98% | PASS |
| DifferentialPressure | Max=3.1mm H2Ocm2 ;3.0mm H2O cm2;3.1mm H2O cm2 | < 6.0mmH2O/cm² | PASS |
| Flammability | Class 1 | Class 1 | PASS |
| 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. Summary of 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 K182515.
§ 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.