(45 days)
The surgical face mask is intended to be worn to protect both the patient and healthcare personnel from the transfer of microorganisms, body fluids and particulate material. The face mask is 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 surgical face mask is green color, and Flat Pleated type mask, utilizing Tie-On way for wearing, and it has a Nose Piece design for fitting the facemask around the nose. The surgical face masks are manufactured with three layers. The inner and outer layers are made of spun-bond polypropylene, and the middle layer is made of a melt-blown polypropylene filter. The model of the proposed device, tie-on, is held in place over the user's mouth and nose by four ties welded to the facemask. The tie is made of spunbond polypropylene. The nose piece contained in masks is in the layers of the facemask to allow the user to fit the facemask around their nose, which is made of malleable aluminum wire. The surgical face masks are sold non-sterile and are intended to be single-use, disposable devices. This product contains no components made with natural rubber latex.
The provided FDA 510(k) summary for the "Surgical Face Mask" (K202277) details performance testing against established acceptance criteria for medical face masks. Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance:
| Test | Acceptance Criteria for Level 2 Mask | Reported Device Performance (Subject Device) | Result |
|---|---|---|---|
| Bacterial Filtration Efficiency (BFE, %) ASTM F2101 | ≥ 98% | ≥ 98% | Pass |
| Particulate Filtration Efficiency (PFE, at 0.1µm, %) ASTM F2299 | ≥ 98% | ≥ 98% | Pass |
| Differential Pressure (Delta P, mm H2O/cm²) ASTM F2100-19 EN 14683:2019, Annex C | < 6.0 | < 6.0 | Pass |
| Resistance to penetration by synthetic blood ASTM F1862/F1862M-17 | 29 out of 32 passes in ≥ 120 mmHg | ≥ 120 mmHg | Pass |
| Flame Spread 16 CFR 1610 | Class 1 Non-Flammable | Class 1 Non-Flammable | Pass |
2. Sample size used for the test set and the data provenance:
The document does not explicitly state the sample sizes for each performance test. However, for "Resistance to penetration by synthetic blood," the acceptance criteria itself indicates a sample of 32 units (29 out of 32 passes). The provenance of the data is not specified (e.g., country of origin). The studies are non-clinical performance tests, not human participant studies, and are therefore not classified as retrospective or prospective in the typical medical research sense.
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 studies are non-clinical performance tests on a physical device. Ground truth, in the context of medical masks, is established by adherence to standardized testing protocols and objective measurement, not expert consensus in the interpretative sense.
4. Adjudication method for the test set:
This information is not applicable as the studies are non-clinical performance tests. Adjudication methods like 2+1 or 3+1 are typically used for medical image interpretation or clinical outcome assessment by human experts.
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 information is not applicable. The device is a surgical face mask, and the evaluation involves manufacturing performance characteristics, not an AI or diagnostic application requiring human reader performance studies.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
This information is not applicable. The device is a surgical face mask, not an algorithm.
7. The type of ground truth used:
The "ground truth" for the performance tests of the surgical face mask is based on objective measurements derived from standardized testing methods as defined by international and national standards such as ASTM F2100-19, ASTM F1862/F1862M-17, ASTM F2101-19, ASTM F2299-2003, EN 14683:2019 Annex C, and 16 CFR 1610. For biocompatibility, the ground truth is established by adherence to ISO 10993 series standards and the resultant "Pass" or "Non-cytotoxic," "Non-sensitizing," "Non-irritating" conclusions.
8. The sample size for the training set:
This information is not applicable. There is no "training set" in the context of physical medical device performance testing, as these are not machine learning or AI models.
9. How the ground truth for the training set was established:
This information is not applicable as there is no training set.
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September 25, 2020
Jiangxi 3L Medical Products Group Co., Ltd % Charles Mack Principal Engineer IRC 2950 E Lindrick Drive Chandler, Arizona 85249
Re: K202277
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 7, 2020 Received: T
Dear Charles Mack:
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 (OS) 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 Elizabeth F. Claverie-Williams, MS 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)
Device Name Surgical Face Mask
Indications for Use (Describe)
The surgical face mask is intended to be worn to protect both the patient and healthcare personnel from the transfer of microorganisms, body fluids and particulate material. The face mask is 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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K202277 510(k) SUMMARY
| Preparation Date: | September 24, 2020 |
|---|---|
| Manufacturer's Name and Address: | Jiangxi 3L Medical Products Group Co., Ltd No.599, Huoju Street, High-tech Development Zone, Nanchang City, Jiangxi Province, China 330029 |
| Corresponding Official: | Charles Mack |
| Telephone Number: | 931-625-4938 |
| Email Address: | charliemack@irc-us.com |
| Trade Name: | Surgical Face Mask |
| Common Name(s): | Surgical Face Mask |
| Regulation Name(s): | mask, surgical |
| Regulation Number(s): | 21CFR878.4040 |
| Product Code: | FXX |
| Device Class: | Class II |
| Predicate Device: | Xiantao Rayxin Medical Products Co., Ltd. Disposable Surgical Face Mask K153496 |
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Device Description:
The surgical face mask is green color, and Flat Pleated type mask, utilizing Tie-On way for wearing, and it has a Nose Piece design for fitting the facemask around the nose. The surgical face masks are manufactured with three layers. The inner and outer layers are made of spun-bond polypropylene, and the middle layer is made of a melt-blown polypropylene filter. The model of the proposed device, tie-on, is held in place over the user's mouth and nose by four ties welded to the facemask. The tie is made of spunbond polypropylene. The nose piece contained in masks is in the layers of the facemask to allow the user to fit the facemask around their nose, which is made of malleable aluminum wire. The surgical face masks are sold non-sterile and are intended to be single-use, disposable devices.
This product contains no components made with natural rubber latex.
Intended Use / Indications for Use
The surgical face mask is intended to be worn to protect both the patient and healthcare personnel from the transfer of microorganisms, body fluids, and particulate material. The face mask is 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.
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| Features | Subject Device | Predicate Device | Comparison |
|---|---|---|---|
| Device | Surgical Face Mask | Disposable Surgical Face Mask | N/A |
| Model | Tie on | Ear Loop and Tie-On | Identical |
| Manufacturer | JIANGXI 3L MEDICAL PRODUCTS GROUPCO., LTD | Xiantao Rayxin Medical Products Co., Ltd. | N/A |
| 510(k) | K202277 | K153496 | N/A |
| Indication for Use | The Surgical Face Mask is intended to beworn to protect both the patient andhealthcare personnel from the transfer ofmicroorganisms, body fluids and particulatematerial. The face mask is intended for use ininfection control practices to reduce thepotential exposure to blood and body fluids.This is a single-use, disposable device(s),provided non-sterile. | The Disposable Surgical Face Masks areintended to be worn to protect both the patientand healthcare personnel from transfer ofmicroorganisms, body fluids and particulatematerial. These face masks are intended foruse in infection control practices to reduce thepotential exposure to blood and body fluids.This is a single-use, disposable device(s),provided non-sterile. | Identical |
| OTC or Prescription | OTC | OTC | Identical |
| Product Code | FXX | FXX | Identical |
| Classification | Class 2, CFR878.4040 | Class 2, CFR878.4040 | Identical |
| Material: | |||
| Outer facing layer | Spun-bond polypropylene | Spun-bond polypropylene | Identical |
| Middle layer | Melt blown polypropylene filter | Melt blown polypropylene filter | Identical |
| Inner facing layer | Spun-bond polypropylene | Spun-bond polypropylene | Identical |
| Nose piece | Malleable aluminum wire | Malleable aluminum wire | Identical |
| Tie-on: | Spun-bond polypropylene | Spun-bond polypropylene | Identical |
| Colorant | Polypropylene (PP) masterbatch | Polypropylene (PP) masterbatch | Identical |
| Design features | Color: GreenTie on | Color: BlueTie on | The proposed deviceand the predicatedevices arebiocompatible andconform to ISO 10993series standards |
| Mask Style | Flat Pleated | Flat Pleated | Identical |
| Features | Subject Device | Predicate Device | Comparison |
| Specificationand Dimension | Length: 17.5cm±1cmWidth: 9.5cm±1cm | Length: 17.5cm±1cmWidth: 9.5cm±1cm | Identical |
| Sterility | Non-sterile | Non-sterile | Identical |
| Usage | Disposable, Single-Use | Disposable, Single-Use | Identical |
| PerformanceTesting (ASTM F2100-19) | Level 2 | Level 2 | Identical |
| Fluid ResistancePerformance ASTMF1862 | ≥ 120 mmHg | 32 out of 32 passes at 120mmHg | Meet ASTM F2100-19Requirements for Level 2Classification |
| Particulate FiltrationEfficiency ASTMF2299 | ≥ 98% | Average 98.46% | Meet ASTM F2100-19Requirements for Level 2Classification |
| Bacterial FiltrationEfficiency ASTMF2101 | ≥ 98% | Average 98.70% | Meet ASTM F2100-19Requirements for Level 2Classification |
| Differential Pressure(DeltaP) EN 14683:2019,Annex C | 3.0 mm H2O/cm² | 4.2 mm H2O/cm² | Meet ASTM F2100-19Requirements for Level 2Classification |
| Flammability 16 CFR1610 | Class 1Non-Flammable | Class 1Non-Flammable | Identical |
| Biocompatibility | Complies with ISO10993-1 | Complies with ISO10993-1 | Identical |
Comparison of Technological Characteristics with the Predicate Device
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Discussion:
There is a little difference in performance test results and the predicate device. Both the submitted device and the predicate omply with the same performance standards. The minor differences in the technological characteristics do not raise and the subject device.
The proposed device and the predicate device are biocompatible and conform to the same ISO 10993 series standards.
Therefore, the proposed device is as safe, as effective, and performs as well as the legally marketed predicate device.
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Performance Testing
Performance testing was provided in support of the substantial equivalence determination and to validate and verify that the Surgical Face Mask, non-sterile, tie on met all requirements of related international standards, including biocompatibility and product specifications. The results of these tests demonstrate compliance with the requirements of the consensus standards noted below.
Non-clinical Testing
Table of Conformity to Standards
| Standards | Scope |
|---|---|
| ASTM F2100-19Standard Specification for Performance of Materials Used in MedicalFace Masks | Performance |
| ASTM F1862/F1862M-17Standard Test Method for Resistance of Medical Face Masks toPenetration by Synthetic Blood (Horizontal Projection of Fixed Volume ata Known Velocity | Performance:Fluid ResistancePerformance |
| ASTM F2101-19Standard Test Method for Evaluating the Bacterial Filtration Efficiency(BFE) of Medical Face Mask Materials, Using a Biological Aerosol ofStaphylococcus aureus | Performance:Bacterial FiltrationEfficiency (BFE) |
| ASTM F2299-2003Standard Test Method for Determining the Initial Efficiency of MaterialsUsed in Medical Face Masks to Penetration by Particulates Using LatexSpheres | Performance:Particulate FiltrationEfficiency (PFE) |
| ASTM F2100-19EN14683: 2019 Annex C | Performance:Differential Pressure(Delta P) |
| 16 CFR 1610 | Performance:Flammability |
| ISO10993-1:2009Biological evaluation of medical devices--Part 1: Evaluation and testing | Biocompatibility |
| ISO10993-5:2009Biological Evaluation of Medical Devices - Part 5 Tests for In VitroCytotoxicity. | Biocompatibility |
| ISO10993-10:2002/Amd. 1:2006(E)Biological Evaluation of Medical Devices - Part 10: Tests for Irritationand Delayed-Type Hypersensitivity | Biocompatibility |
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| Test | Subject device | Acceptance Criteriafor Level 2 Mask | Test Result |
|---|---|---|---|
| Bacterial FiltrationEfficiency (BFE, %)ASTM F2101 | ≥ 98% | ≥ 98% | Pass |
| Particulate FiltrationEfficiency (PFE, at 0.1µm,%) ASTM F2299 | ≥ 98% | ≥ 98% | Pass |
| Differential Pressure(Delta P, mm H2O/cm2)ASTM F2100-19EN 14683:2019, Annex C | < 6.0 | < 6.0 | Pass |
| Resistance to penetrationby synthetic bloodASTM F1862/F1862M-17 | ≥ 120 mmHg | 29 out of 32 passes in≥ 120 mmHg | Pass |
| Flame Spread16 CFR 1610 | Class 1 Non-Flammable | Class 1 Non-Flammable | Pass |
Table of Biocompatibility Testing
Biocompatibility
The new device complies with the biocompatibility requirement defined in ISO10993-1. Patient contact classification: The subject device is a classified surface device and contact intact skin for limited contact duration. The verification tests show that the new devices comply with the biocompatibility requirement defined in ISO10993-1, the same as the predicate device.
| Standard | Device Tests | Test Results |
|---|---|---|
| In Vitro Cytotoxicity(ISO10993-5: 2009) | Following the standard'sdefined conditions, the deviceis non-cytotoxic. | Pass |
| Skin Sensitization (ISO10993-10: 2010) | Following the standard'sdefined conditions, the deviceis non-sensitizing. | Pass |
| Skin Irritation (ISO10993-10) | Following the standard'sdefined conditions, the deviceis non-irritating. | Pass |
All of the pre-determined acceptance criteria were met.
Clinical Test:
No clinical study is included in this submission.
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Conclusions:
The differences between the predicate and the subject device do not raise any new or different questions of safety or effectiveness. The Surgical Face Mask, nonsterile, tie on is as safe, as effective, and performs as well as the legally marketed predicate device Xiantao Rayxin Medical Products Co., Ltd. Disposable Surgical Face Mask cleared under K153496.
§ 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.