(84 days)
Not Found
No
The device description and performance studies focus on the physical properties and filtration capabilities of a standard surgical face mask, with no mention of AI or ML.
No.
The device's intended use is to protect from transfer of microorganisms, body fluids, and particulate material, not to treat or cure a disease or condition.
No
Explanation: The device is a surgical face mask, which is a barrier device intended to protect against the transfer of microorganisms and bodily fluids. It does not collect, analyze, or interpret data to diagnose a condition or disease.
No
The device description clearly outlines a physical, multi-layer face mask made of materials like polypropylene, polyester, and aluminum, with performance studies focused on physical properties and biocompatibility. There is no mention of software components or 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. This is a physical barrier function, not a diagnostic one.
- Device Description: The description details the physical construction and materials of the mask, which are consistent with a barrier device.
- Performance Studies: The performance studies focus on the mask's ability to filter particles and fluids, its breathability, flammability, and biocompatibility. These are all relevant to its function as a physical barrier and protective device, not a diagnostic test.
- Lack of Diagnostic Elements: There is no mention of the mask being used to analyze samples (like blood, urine, or tissue), detect specific analytes, or provide information for diagnosing a disease or condition.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, or treatment of a disease or condition. This surgical face mask does not perform any such function.
N/A
Intended Use / Indications for Use
The Surgical 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 (comma separated list FDA assigned to the subject device)
FXX
Device Description
The Surgical Face Mask is single use, three-layer, flat-pleated style with ear loops/tie-coverall and nose piece. The Surgical Face Mask is 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 ties/ear loops are held in place over the users' mouth and nose by two ties/ear loops welded to the facemask. The loops are made of polyester and spandex, the ties are made of spun-bond polypropylene.
The nose clamp in the layers of facemask is to allow the user to fit the facemask around their nose, which is made of polypropylene and aluminum.
The Surgical Face Mask will be provided in blue. The Surgical Face Mask is sold as non-sterile and are intended to be single use, disposable devices.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-Clinical Test Conclusion:
Tests conducted and standards conformed to:
- 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)
- 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 Results (key results):
- Synthetic Blood Penetration ASTM F1862: Pass (32 out of 32 pass at 80 mmHg, 3 lots; 32 out of 32 pass at 160 mmHg, 3 lots)
- Particulate Filtration Efficiency ASTM F2299: Pass (Average 98.50% for Level 1, Average 98.83% for Level 3)
- Bacterial Filtration Efficiency ASTM F2101: Pass (Average 99.27% for Level 1, Average 99.79% for Level 3)
- Differential Pressure (Delta P) EN 14683 Annex C: Pass (Average 3.11 mmH2O/cm² for Level 1, Average 3.97 mmH2O/cm² for Level 3)
- Flammability 16 CFR 1610: Pass (Class I)
Biocompatibility Testing Results (key results):
- Cytotoxicity ISO 10993-5: Pass (device is non-cytotoxic)
- Skin Irritation ISO10993-10: Pass (device is non-irritating)
- Skin Sensitization ISO10993-10: Pass (device is non-sensitizing)
No clinical study is included in this submission.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Synthetic Blood Penetration ASTM F1862:
- Level 1 pass at 80mmHg (Acceptance Criteria: 29 samples out of 32 pass (AQL 4%))
- Level 3 pass at 160mmHg (Acceptance Criteria: 29 samples out of 32 pass (AQL 4%))
Particulate Filtration Efficiency ASTM F2299:
- Level 1 pass at >=95%
- Level 3 pass at >=98%
Bacterial Filtration Efficiency ASTM F2101:
- Level 1 pass at >=95%
- Level 3 pass at >=98%
Differential Pressure (Delta P) EN 14683 Annex C:
- Level 1 pass at
§ 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
Image /page/0/Picture/0 description: The image contains 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 consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath.
November 14, 2022
Xiantao Rayxin Medical Products Co., Ltd. % Mr. Boyle Wang Consultant Shanghai Truthful Information Technology Co., Ltd. RM. 1801, No. 161 Lujiazui East Rd., Pudong Shanghai, Shanghai 200120 China
Re: K222529
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, 2022 Received: August 22, 2022
Dear Mr. 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
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,
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
2
Indications for Use
510(k) Number (if known) K222529
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 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
This summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of 21 CFR 807.92.
1.0 submitter's Information
Name: Xiantao Rayxin Medical Products Co., Ltd. Address: No. 258 Pengchang Road, Middle Street, Xiantao, Hubei 433018, China. Tel: +86 728 2617597 Contact: Maggie Dai Date of Preparation: Aug.16, 2022
Designated Submission Correspondent
Mr. Boyle Wang Shanghai Truthful Information Technology Co., Ltd. Room 1801, No. 161 East Lujiazui Rd., Pudong, Shanghai 200120 ,China Tel: +86-21-50313932 Email: Info@truthful.com.cn
2.0 Device Information
| Trade name: | Surgical Face Mask |
|---|---|
| Common name: | Surgical Face Mask |
| Classification name: | Surgical Face Mask |
| Model: | Ear loops, Tie-on |
3.0 Classification
| Production code: | FXX |
|---|---|
| Regulation number: | 21CFR 878.4040 |
| Classification: | Class II |
| Panel: | Surgical Apparel |
4.0 Primary Predicate Device Information
| Manufacturer: | Anhui Tiankang Medical Technology Co., Ltd. |
|---|---|
| Device: | Surgical Face Mask |
| 510(k) number: | K212368 |
5.0 Device Description
4
The Surgical Face Mask is single use, three-layer, flat-pleated style with ear loops/tie-coverall and nose piece. The Surgical Face Mask is 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 ties/ear loops are held in place over the users' mouth and nose by two ties/ear loops welded to the facemask. The loops are made of polyester and spandex, the ties are made of spun-bond polypropylene.
The nose clamp in the layers of facemask is to allow the user to fit the facemask around their nose, which is made of polypropylene and aluminum.
The Surgical Face Mask will be provided in blue. The Surgical Face Mask is sold as non-sterile and are intended to be single use, disposable devices.
| Models: | |
|---|---|
| Sr. No. | ASTM Level | Mask style | Color | Item Number |
|---|---|---|---|---|
| 1 | Level 1 | 3-ply Ear loops Mask | Blue | FM02-1 |
| 2 | Level 1 | 3-ply Tie-On Mask | Blue | FM01-1 |
| 3 | Level 3 | 3-ply Ear loops Mask | Blue | FM02-3 |
| 4 | Level 3 | 3-ply Tie-On Mask | Blue | FM01-3 |
6.0 Indication for Use Statement
The Surgical 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.
7.0 Comparison to the Predicate Device
| Item | Subject Device | Predicate Device
K212368 | Remark |
|--------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------|
| Product Name | Surgical Face Mask | Surgical Face Mask | -- |
| Product Code | FXX | FXX | Same |
| Regulation No. | 21 CFR 878.4040 | 21 CFR 878.4040 | Same |
| Class | II | II | Same |
| Intended Use&
Indications for use | The Surgical 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 | 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. These face masks
are intended for use | Same |
5
| ininfection control practices to reduce the potential exposure to blood and body fluids. This is a single use, disposable device(s), provided non-sterile. | ininfection control practices to reduce the potential exposure to blood and body fluids. This is a single use, disposable device(s), provided non-sterile. | ||||
|---|---|---|---|---|---|
| Design features | Ear loop, Tie-On, 3 layers | Ear loop, Tie-On, 3 layers | Same | ||
| Mask Styles | Flat pleated | Flat pleated | Same | ||
| Outer facing layer | spun-bond polypropylene | Spun-bond polypropylene | Same | ||
| Middle layer | Melt blown polypropylene filter | Melt blown polypropylene filter | Same | ||
| Material | Inner Facing layer | spun-bond polypropylene | Spun-bond polypropylene | Same | |
| Nose piece | polypropylene and aluminum | PP coated steel wire | Different | ||
| Analysis 1 | |||||
| Ear loops | |||||
| Ties | Ear loops: polyester and spandex; | ||||
| Ties: spun-bond polypropylene | Ear loops: Nylon and spandex; | ||||
| Ties: PP nonwoven | Different | ||||
| Analysis 1 | |||||
| Color | Blue | Blue | |||
| Dimension | Length: 175±5mm | ||||
| Width: 95±5mm | Length: 175±5mm | ||||
| Width: 95±2.85mm | Similar | ||||
| Analysis 2 | |||||
| OTC use | Yes | Yes | Same | ||
| Single Use | Yes | Yes | Same | ||
| Sterility | Non-sterile | Non-sterile | Same | ||
| ASTM F2100 Level | Level 1 | ||||
| Level 3 | Level 1 | ||||
| Level 2 | |||||
| Level 3 | Different | ||||
| Analysis 3 | |||||
| Biocompatibility | Cytotoxicity | ||||
| ISO10993-5 | Non-cytotoxic under the conditions of the study | Non-cytotoxic under the conditions of the study | Same | ||
| Skin Irritation | |||||
| ISO10993-10 | Non-irritating under the conditions of the study | Non-irritating under the conditions of the study | Same | ||
| Skin Sensitization | |||||
| ISO10993-10 | Non-sensitizer under the conditions of the study | Non-sensitizer under the conditions of the study | Same |
Analysis 1: The two devices have some difference in design features and materials, product materials safety is proved by its biocompatibility, and the difference does not raise additional questions for safety and effectiveness of device.
Analysis 2: The two devices share same dimensions otherwise the tolerance is
6
different, the little deviation in tolerance does not raise additional questions for safety and effectiveness of device.
Analysis 3: The subject device conducted testing to demonstrate compliance with ASTM F2100 with the different models meeting the Level 1and Level 3 criteria, while the predicate device met the ASTM F2100 Level 1, Level 2 and Level 3 criteria.
8.0 Non-Clinical Test Conclusion
The proposed device was tested and conformed to the following standards and the requirements stated in the Guidance for Industry and FDA Staff: Medical face 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);
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;
| Item | Purpose | Acceptance Criteria | Results |
|---|---|---|---|
| Synthetic | |||
| Blood | |||
| Penetration | |||
| ASTM | |||
| F1862 | Demonstrate | ||
| resistance | |||
| to liquid | |||
| penetration | 29 samples out of 32 | ||
| pass (AQL 4%) | |||
| Level 1 pass at 80mmHg | |||
| 29 samples out of 32 | |||
| pass (AQL 4%) | |||
| Level 3 pass at | |||
| 160mmHg | Pass | ||
| 32 out of 32 pass at 80 | |||
| mmHg, 3 lots | |||
| Pass | |||
| 32 out of 32 pass at 160 | |||
| mmHg, 3 lots | |||
| Particulate | |||
| Filtration | |||
| Efficiency | |||
| ASTM | |||
| F2299 | Demonstrate | ||
| particulate | |||
| filtration | Level 1 pass at ≥95% | ||
| Level 3 pass at ≥98% | Pass | ||
| Average 98.50% | |||
| Pass | |||
| Average 98.83% |
Table 2 - Performance Testing
7
| Bacterial
Filtration
Efficiency
ASTM
F2101 | Demonstrate
bacterial
filtration | Level 1 pass at $\ge$ 95% | Pass
Average 99.27% |
|--------------------------------------------------------------|----------------------------------------|-------------------------------------|--------------------------------|
| | | Level 3 pass at $\ge$ 98% | Pass
Average 99.79% |
| Differential
Pressure
(Delta P)
EN 14683
Annex C | Demonstrate
breathability | Level 1 pass at $\le$ 5.0 mmH2O/cm² | Pass
Average 3.11 mmH2O/cm² |
| | | Level 3 pass at $\le$ 6.0 mmH2O/cm² | Pass
Average 3.97 mmH2O/cm² |
| Flammability
16 CFR
1610 | Demonstrate
flame
resistance | Class I | Pass |
Table 3 - Biocompatibility Testing
| Item | Purpose | Subject Device | Results |
|---|---|---|---|
| Cytotoxicity | |||
| ISO 10993-5 | Demonstrate | ||
| cytotoxic | |||
| biocompatibility | Under the conditions of the | ||
| study, the device is | |||
| non-cytotoxic. | Pass | ||
| Skin Irritation | |||
| ISO10993-10 | Demonstrate | ||
| non irritability | Under the conditions of the | ||
| study, the device is | |||
| non-irritating. | Pass | ||
| Skin | |||
| Sensitization | |||
| ISO10993-10 | Demonstrate | ||
| non sensitization | Under the conditions of the | ||
| study, the device is | |||
| non-sensitizing | Pass |
9.0 _Clinical Test Conclusion
No clinical study is included in this submission.
10.0 Conclusion
The conclusion drawn from the non-clinical tests demonstrates that the subject device is as safe, as effective, and performs as well as or better than the legally marketed predicate device in K212368.