(67 days)
The Disposable Medical Face Mask is intended to be worn to protect 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.
Disposable Medical Face Mask is a blue flat-pleated mask, which is worn in the way of earrings and has a nose clip design to fit the mask around the nose. This product is composed of a mask body (three-layer structure: two layers of polypropylene adhesive nonwoven fabric with a layer of polypropylene melt-blown nonwoven fabric in the middle), a nose clip (made of polyethylene) and ear loops (made of polyester + spandex). The nose clip is located in the middle layer of the mask. Ear loops, string-like material, are attached to the mask and placed behind the ears. The proposed device(s) are sold non-sterile and are intended to be single use, disposable device.
The provided text describes the acceptance criteria and the results of a study for a Disposable Medical Face Mask (K223055) to demonstrate its substantial equivalence to a predicate device.
Here's the breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance:
| Item | Acceptance Criteria | Proposed Device Performance (Reported Result) | Result |
|---|---|---|---|
| Fluid Resistance (ASTM F1862) | 29 out of 32 pass at 160 mmHg for Level 3 | 32 out of 32 pass at 160 mmHg (across 3 non-consecutive lots) | PASS |
| Particulate Filtration Efficiency (ASTM F2299) | ≥ 98% | Lot1: 99.39%, Lot2: 99.54%, Lot3: 99.37% (across 3 non-consecutive lots) | PASS |
| Bacterial Filtration Efficiency (ASTM F2101) | ≥ 98% | Lot1: 99.01%, Lot2: 98.94%, Lot3: 99.06% (across 3 non-consecutive lots) | PASS |
| Differential Pressure (EN 14683 Annex C) | < 6.0 mmH2O/cm² | Lot1: 2.91 mmH2O/cm², Lot2: 2.67 mmH2O/cm², Lot3: 2.73 mmH2O/cm² (across 3 lots) | PASS |
| Flammability (16 CFR 1610) | Class I | Class I (across 3 non-consecutive lots) | PASS |
| Cytotoxicity (ISO 10993-5) | Non-Cytotoxic | Non-cytotoxic | PASS |
| Irritation (ISO 10993-10) | Non-Irritating | Non-irritating | PASS |
| Sensitization (ISO 10993-10) | Non-Sensitizing | Non-sensitizing | PASS |
2. Sample size used for the test set and the data provenance:
- Sample Size for performance tests (Fluid Resistance, Particulate Filtration, Bacterial Filtration, Differential Pressure, Flammability): 3 non-consecutive lots were tested. For each lot, a sample size of 32 was used.
- Data Provenance: The document does not explicitly state the country of origin of the data for these tests. However, the applicant is Xiantao Zhuobo Industrial Co., LTD, located in Hubei Province, China. The tests are non-clinical (laboratory tests) rather than retrospective or prospective clinical data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This device is a Disposable Medical Face Mask, and the evaluation is based on non-clinical performance testing against established industry standards (ASTM, EN, ISO, CFR). Therefore, the concept of "experts used to establish ground truth" as it would apply to a diagnostic imaging device, for example, is not applicable here. The "ground truth" is defined by the objective pass/fail criteria of the scientific/engineering standards themselves.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. The tests are objective measurements against predefined thresholds, not subjective assessments requiring adjudication by multiple readers.
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:
- Not applicable. This is a physical medical device (face mask) and not an AI/software as a medical device (SaMD) that would involve human readers or AI assistance. No MRMC study was performed.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. This is not an algorithm or AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The ground truth for this device's performance is based on established quantitative and qualitative criteria defined by international and national standards (e.g., ASTM F2100, ASTM F1862, ASTM F2299, ASTM F2101, EN 14683, 16 CFR 1610, ISO 10993). For biocompatibility, the ground truth is the classification as "non-cytotoxic," "non-irritating," and "non-sensitizing" as per ISO 10993 standards.
8. The sample size for the training set:
- Not applicable. There is no concept of a "training set" for physical medical devices being evaluated through non-clinical performance and biocompatibility testing. This is not an AI/machine learning device.
9. How the ground truth for the training set was established:
- Not applicable, as there is no training set for this type of device and study.
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Image /page/0/Picture/0 description: The image shows 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.
December 5, 2022
Xiantao Zhuobo Industrial Co., LTD % Mr. Jarvis Wu Consultant Shanghai SUNGO Management Consulting Company Limited 14th Floor, 1500# Central Avenue Shanghai, Shanghai 200122 China
Re: K223055
Trade/Device Name: Disposable Medical Face Mask Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: September 29, 2022 Received: September 29, 2022
Dear Mr. Wu:
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,
Brent Showalter -S
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
510(k) Number (if known) K223055
Device Name Disposable Medical Face Mask
Indications for Use (Describe)
The Disposable Medical Face Mask is intended to be worn to protect 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.
| 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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510(k) Summary
Document Date Prepared:2022/9/22
A. Applicant:
Name: Xiantao Zhuobo Industrial Co., LTD
Address: Building 1,Huanxi Road, Pengchang Town, Xiantao City, Hubei Province, China
Contact Person: Xiaodong Chen
Tel: +86 18500056172
Mail: 614086130@qq.com
Submission Correspondent:
Primary contact: Mr. Jarvis Wu
Shanghai SUNGO Management Consulting Co., Ltd.
14th floor, 1500# Century Ave., Shanghai 200122, China
Tel: +86-21-58817802
Email: haiyu.wang@sungoglobal.com
Secondary contact: Mr. Raymond Luo
14th floor, 1500# Century Ave., Shanghai 200122, China
Tel: +86-21-68828050
Email: fda.sungo@@gmail.com
B. Device:
Proprietary Name: Disposable Medical Face Mask Common Name: Surgical Face Mask Model(s): 17.5*9.5CM
Regulatory Information Classification Name: Surgical Face Mask Classification: Class II Product code: FXX Regulation Number: 878.4040 Review Panel: Surgical Apparel
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C. Predicate device:
| 510K | Device name | ASTM F2100-19level | Manufacturer |
|---|---|---|---|
| K213806 | Disposable Medical FaceMask | Level 3 | XIANTAO ZHIBO NONWOVENPRODUCTS CO., LTD. |
(Note: Predicate device has NOT been subject to any Medical Device Recalls, including design-related recall.)
D. Indications use of the device:
The Disposable 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. 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:
Disposable Medical Face Mask is a blue flat-pleated mask, which is worn in the way of earrings and has a nose clip design to fit the mask around the nose.
This product is composed of a mask body (three-layer structure: two layers of polypropylene adhesive nonwoven fabric with a layer of polypropylene melt-blown nonwoven fabric in the middle), a nose clip (made of polyethylene) and ear loops (made of polyester + spandex). The nose clip is located in the middle layer of the mask. Ear loops, string-like material, are attached to the mask and placed behind the ears. 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 | Predicate Device | Proposed device | Comparison |
|---|---|---|---|
| Manufacturer | XIANTAO ZHIBO NONWOVENPRODUCTS CO., LTD. | Xiantao Zhuobo Industrial Co.,LTD | - |
| 510K number | K213806 | - | |
| Classification | Class II Device,FXX (21CFR878.4040) | Class II Device,FXX (21CFR878.4040) | Same |
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| The Disposable Medical Face Maskis intended to be worn to | The Disposable Medical Face Maskis intended to be worn to protect | ||||
|---|---|---|---|---|---|
| protect both the patient and | both the patient and healthcare | ||||
| healthcare personnel from transfer | personnel from transfer of | ||||
| Indications for use | of microorganisms, body fluidsand particulate material. These | microorganisms, body fluids andparticulate material. These face | |||
| face masks are intended for use in | masks are intended for use in | Same | |||
| infection control practices toreduce the potential exposure to | infection control practices to reducethe potential exposure to blood and | ||||
| blood and body fluids. This is asingle use, disposable device(s), | body fluids. This is a single use,disposable device(s), provided non- | ||||
| provided non-sterile. | sterile. | ||||
| Outerlayer | Spun-bond polypropylene | Spun-bond polypropylene | Same | ||
| Material | Middlelayer | Melt blown polypropylene filter | Melt blown polypropylene filter | Same | |
| Innerlayer | Spun-bond polypropylene | Spun-bond polypropylene | Same | ||
| Noseclip | High Density Polyethylene(HDPE) | Polypropylene ,iron and zinc | Different | ||
| Earloops | Nylon and Spandex | Nylon and Spandex | Same | ||
| Color | White | Blue | Different | ||
| Dimension(length) | 175mm ±5mm | 175mm ±5mm | Same | ||
| Dimension(Width) | 95mm±5mm | 95mm±5mm | Same | ||
| OTC use | Yes | Yes | Same | ||
| Sterility | Non-Sterile | Non-Sterile | Same | ||
| Use | Single Use, Disposable | Single Use, Disposable | Same | ||
| ASTM F2100-19level | Level 3 | Level 3 | Same |
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| Biocompatibility | Meet ISO10993 ,proved non-cytotoxicity, non-irritating and non-sensitizing | Meet ISO10993 ,proved non-cytotoxicity, non-irritating and non-sensitizing | Same |
|---|---|---|---|
| ------------------ | ---------------------------------------------------------------------------- | ---------------------------------------------------------------------------- | ------ |
From the comparison we found the material of proposed device's nose clip and its color 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.
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:
- A ISO 10993-5: 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
- ASTM F1862, Standard Test Method for Resistance of Medical Face Masks To Penetration by A Synthetic Blood (Horizontal Projection of Fixed Volume At A Known Velocity);
- A EN 14683, Medical Face Masks-Requirements and Test Methods;
-
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;
Table 2 - Performance Testing
| Item | Purpose | Proposed device | AcceptanceCriteria | Result |
|---|---|---|---|---|
| Fluid ResistancePerformanceASTM F1862 | Assess theperformance of amask to resistanceto a synthetic bloodpreparationtargeted toward themask at a setpressure | 3 non-consecutivelots tested, using asample size of32/lot.32 out of 32 pass at160 mmHg | 29 out of 32 pass at160 mmHg forlevel 3 | PASS |
| ParticulateFiltrationEfficiency ASTMF2299 | Assess theperformance ofa mask topenetration bysub-micronpolystyrenelatex particles of0.1 micron | 3 non-consecutivelots tested, using asample size of32/lot.Lot1: 99.39%Lot2: 99.54%Lot3: 99.37% | ≥ 98% | PASS |
| BacterialFiltrationEfficiency ASTMF2101 | Assess theperformance ofa mask topenetration by aprepared solutionwith knownconcentration ofan indicatorbacterial organism | 3 non-consecutivelots tested, using asample size of32/lot.Lot1: 99.01%Lot2: 98.94%Lot3: 99.06% | ≥ 98% | PASS |
| DifferentialPressure (Delta P)EN 14683 AnnexC | Assess theperformance ofa mask forresistance toair movementthrough thematerials of theface of the mask | 3 non-consecutivelots tested, using asample size of32/lot.Lot1: 2.91mmH2O/cm²Lot2: 2.67mmH2O/cm²Lot3: 2.73mmH2O/cm² | < 6.0mmH2O/cm² | PASS |
| Flammability 16CFR 1610 | Assess theresistance of amask to ignition | 3 non-consecutivelots tested, using asample size of32/lot.Class I | Class I | PASS |
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Xiantao Zhuobo Industrial Co., LTD Building 1,Huanxi Road, Pengchang Town, Xiantao City, Hubei Province, China
Table 3 - Biocompatibility Testing
| Test Method | Purpose | Acceptance Criteria | Result |
|---|---|---|---|
| Cytotoxicity | Assess the potential risk of Cytotoxicity of mask material | Non-Cytotoxic | PASSUnder the conditions of thestudy, the device is non-cytotoxic. |
| Irritation | Assess the potential risk of Irritation of mask material | Non-Irritating | PASSUnder the conditions of thestudy, the device is non-irritating. |
| Sensitization | Assess the potential risk of Sensitization of mask material | Non-Sensitizing | PASSUnder the conditions of thestudy, the device is non-sensitizing |
H. Clinical Test Conclusion
No clinical study is included in this submission.
I. Conclusion
The conclusion drawn from the nonclinical tests demonstrates that the subject device in 510(K) submission, the Disposable Medical Face Mask (Model: 17.5*9.5CM) is as safe, as effective, and performs as well as or better than the legally marketed predicate device cleared under K213806.
§ 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.