(96 days)
Not Found
No
The device description and performance studies focus on the physical properties and filtration capabilities of a disposable face mask, with no mention of AI or ML technology.
No.
The device description and intended use focus on protection from microorganisms and fluids, not on treating a medical condition or restoring function.
No
Explanation: The device is a medical face mask intended to protect against the transfer of microorganisms and body fluids. It is a barrier device and does not diagnose any condition or disease.
No
The device description clearly outlines physical components (Nylon & Spandex Ear loops, High Density Polyethylene nose clip, Non-woven fabric, Melt-blown Non-woven fabric) and the performance studies focus on physical properties and biological interactions, not software functionality.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the mask is for protecting against the transfer of microorganisms, body fluids, and particulate material by being worn on the face. This is a physical barrier function, not a diagnostic test performed in vitro (outside the body).
- Device Description: The description details the physical components of the mask and its function as a filter. There is no mention of reagents, samples, or any process for analyzing biological specimens.
- Performance Studies: The performance studies focus on the physical properties of the mask, such as fluid resistance, filtration efficiency (particulate and bacterial), and breathability (differential pressure). They also include biocompatibility testing to ensure the material is safe for contact with skin. These are all relevant to a physical barrier device, not an IVD.
- Lack of IVD characteristics: There is no mention of analyzing biological samples, detecting specific analytes, or providing diagnostic information.
In summary, the Disposable Medical Face Mask functions as a physical barrier for protection, which is not the purpose of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes
FXX
Device Description
Disposable Medical Face Mask is composed of Nylon & Spandex Ear loops, High Density Polyethylene nose clip, Inner layer Non-woven fabric, Middle Melt-blown Non-woven fabric and outer Non-woven fabric. The melt-blown material acts as the filter that stops microbes from entering or exiting the mask. Disposable Medical Face Mask feature pleats. Three pleats are used to expand the mask such that it covers the area from the nose to the chin. The type is ear loop, where a string-like material is 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
healthcare personnel
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
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:
- 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
- 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;
- 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. Stand 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;
Performance Testing:
- Fluid Resistance Performance ASTM F1862: 3 non-consecutive lots tested, using a sample size of 32/lot. 32 out of 32 pass at 160 mmHg. Acceptance Criteria: 29 out of 32 pass at 160 mmHg for level 3. Result: PASS.
- Particulate Filtration Efficiency ASTM F2299: 3 non-consecutive lots tested, using a sample size of 32/lot. Lot1: 98.9%, Lot2: 99.3%, Lot3: 99.5%. Acceptance Criteria: >= 98%. Result: PASS.
- Bacterial Filtration Efficiency ASTM F2101: 3 non-consecutive lots tested, using a sample size of 32/lot. Lot1: 99.88%, Lot2: 99.95%, Lot3: 99.97%. Acceptance Criteria: >= 98%. Result: PASS.
- Differential Pressure (Delta P) EN 14683 Annex C: 3 non-consecutive lots tested, using a sample size of 32/lot. Lot1: 3.3 H2O/cm², Lot2: 3.4 H2O/cm², Lot3: 3.3 H₂O/cm². Acceptance Criteria: = 98%)
- Bacterial Filtration Efficiency: Lot1: 99.88%; Lot2: 99.95%; Lot3: 99.97% (acceptance criteria >= 98%)
- Differential Pressure (Delta P): Lot1: 3.3 H2O/cm²; Lot2: 3.4 H2O/cm²; Lot3: 3.3 H₂O/cm² (acceptance criteria
§ 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.
0
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March 12, 2022
Xiantao Zhibo Nonwoven Products Co., Ltd % Jarvis Wu Consultant Shanghai Sungo Management Consulting Company Limited 14th Floor, 1500# Century Ave. Shanghai, Shanghai 200122 China
Re: K213806
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: December 6, 2021 Received: December 13, 2021
Dear Jarvis 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
1
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,
For Clarence W. Murray, III, Ph.D. 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
2
Indications for Use
510(k) Number (if known) K213806
Device Name Disposable Medical Face Mask
Indications for Use (Describe)
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.
| 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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3
510(k) Summary
K213806
A. Applicant:
Name: XIANTAO ZHIBO NONWOVEN PRODUCTS CO., LTD. Address: NO.8, Hefeng industrial zone, Pengchang Town, Xiantao City, HUBEI, CHINA Contact Person: Fen Peng Tel: +86 18872609993 Mail: 260993463@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@sungogloba1.com Secondary contact: Mr. Raymond Luo 14th floor, 1500# Century Ave., Shanghai 200122, China Tel: +86-21-68828050 Email: fda.sungo@gmail.com Document Date Prepared: 2022/3/9 B. Device:
Proprietary Name: Disposable Medical Face Mask Common Name: Surgical Face Mask Model: FMZB3
Regulatory Information
Classification Name: Surgical Face Mask Classification: Class II Product code: FXX Regulation Number: 878.4040 Review Panel: Surgical Apparel
4
C. Predicate de vice:
| 510K | Device name | ASTM F2100-19
level | Manufacturer |
|---------|-----------------------------------------------------|------------------------|------------------------------------------|
| K211827 | Level 3 Fluid Resistant
Procedure/Surgical Mask | Level 3 | Zhejiang Lanhine Medical Products
LTD |
D. Indications for use/Intended Use:
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 composed of Nylon & Spandex Ear loops, High Density Polyethylene nose clip, Inner layer Non-woven fabric, Middle Melt-blown Non-woven fabric and outer Non-woven fabric. The melt-blown material acts as the filter that stops microbes from entering or exiting the mask. Disposable Medical Face Mask feature pleats. Three pleats are used to expand the mask such that it covers the area from the nose to the chin. The type is ear loop, where a string-like material is 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 de vice
Table 1 General Comparison
| Device | Proposed Device | Predicate device | Comparison | |
|---|---|---|---|---|
| Manufacturer | XIANTAO ZHIBO NONWOVEN | |||
| PRODUCTS CO., LTD. | Zhejiang Lanhine Medical | |||
| Products LTD. | - | |||
| 510K number | K213806 | K211827 | - | |
| Classification | Class II Device, FXX (21 | |||
| CFR878.4040) | Class II Device, FXX (21 | |||
| CFR878.4040) | Same | |||
| The Disposable Medical Face | The Level 3 Fluid Resistant | |||
| Procedure/Surgical Mask | ||||
| (model: 15604F, 15704F) | ||||
| Mask is intended to be worn to | ||||
| protect both the patient and | ||||
| healthcare personnel from transfer | are intended to be worn to protect | |||
| both the patient and healthcare | ||||
| personnel from transfer of | ||||
| of microorganisms, body fluids | ||||
| and particulate material. These | microorganisms, body fluids and | |||
| particulate material. These face | ||||
| Indications for use | 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. | 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. | ||||
| Material | Outer | |||
| layer | Spun-bond polypropylene | Non-woven Fabric | ||
| (Polypropylene) | Same | |||
| Middle | ||||
| layer | Melt blown polypropylene filter | Melton brown Fabric | ||
| (Polypropylene) | Same | |||
| Inner | ||||
| layer | Spun-bond polypropylene | Non-woven Fabric | ||
| (Polypropylene) | Same | |||
| Nose | ||||
| clip | High Density Polyethylene | |||
| (HDPE) | Polypropylene coating iron | Different | ||
| Ear | ||||
| loops | Nylon and Spandex | Polyurethane | Different | |
| Color | White | Blue | Different | |
| Dimension | ||||
| (length) | $175mm \pm 5mm$ | $17.5 cm +/- 0.5 cm$ | Same | |
| Dimension | ||||
| (Width) | $95mm \pm 5mm$ | $9.5 cm +/- 0.5 cm$ | Same | |
| OTC use | Yes | Yes | Same | |
| Sterility | Non-Sterile | Non-Sterile | Same | |
| Use | Single Use, Disposable | Single Use, Disposable | Same | |
| ASTM F2100-19 | ||||
| level | Level 3 | Level 3 | Same | |
| Biocompatibility | Meet ISO10993 ,proved non-cytotoxicity, non-irritating and non-sensitizing | Meet ISO10993 ,proved non-cytotoxicity, non-irritating and non-sensitizing | Same |
5
6
From the comparison we found the color, the material of the current nose clip and the ear loop were different from the predicate device. The biocompatibility tests were conducted to both components to ensure their compliance to the 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 Synthetic Blood (Horizontal Projection of Fixed Volume At A Known Velocity);
- A 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. 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;
7
Table 2 - Performance Testing
| Item | Purpose | Proposed device | Acceptance
Criteria | Result |
|--------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------|--------|
| Fluid Resistance
Performance
ASTM F1862 | Assess the performance of a
mask to resistance to a
synthetic blood preparation
targeted toward the mask at a
set pressure | 3 non-consecutive
lots tested, using a
sample size of
32/lot.
32 out of 32 pass at
160 mmHg | 29 out of 32 pass at
160 mmHg for
level 3 | PASS |
| Particulate
Filtration
Efficiency ASTM
F2299 | Assess the performance of
a mask to penetration by
sub-micron polystyrene
latex particles of 0.1 micron | 3 non-consecutive
lots tested, using a
sample size of
32/lot.
Lot1: 98.9%
Lot2: 99.3%
Lot3: 99.5 % | ≥ 98% | PASS |
| Bacterial
Filtration
Efficiency ASTM
F2101 | Assess the performance of
a mask to penetration by a
prepared solution with known
concentration of
an indicator bacterial
organism | 3 non-consecutive
lots tested, using a
sample size of
32/lot.
Lot1: 99.88%
Lot2: 99.95%
Lot3: 99.97% | ≥ 98% | PASS |
| Differential
Pressure (Delta P)
EN 14683 Annex C | Assess the performance of
a mask for resistance to
air movement through the
materials of the face of the
mask | 3 non-consecutive
lots tested, using a
sample size of
32/lot.
Lot1: 3.3 H2O/cm²
Lot2: 3.4 H2O/cm²
Lot3: 3.3 H₂O/cm² |