(230 days)
Not Found
No
The device description and performance studies focus solely on the physical properties and filtration capabilities of a surgical mask, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No
A surgical mask is a barrier for protection from transfer of microorganisms and fluids, not a device intended to treat or cure a disease or condition.
No
Explanation: The provided text clearly states that the Y ADU Surgical Masks are "intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids, and particulate material." It also specifies its use in "infection control practices to reduce the potential exposure to blood and body fluids." There is no mention of the device being used to identify, measure, or monitor a medical condition, which are characteristic functions of a diagnostic device.
No
The device description clearly outlines physical components like layers of polypropylene, ear loops/tie-on bands, and a nose piece, indicating it is a physical medical device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health, such as diagnosing a disease or monitoring a condition.
- Device Intended Use: The intended use of the Y ADU Surgical Masks is to protect both the patient and healthcare personnel from the transfer of microorganisms, body fluids, and particulate material. This is a barrier function, not a diagnostic function.
- Device Description: The description details the physical construction and materials of the mask, which are designed for physical protection and filtration, not for analyzing biological samples.
- Performance Studies: The performance studies focus on the mask's ability to filter particles, resist fluid penetration, and its biocompatibility (cytotoxicity, sensitization, irritation). These are all related to its function as a protective barrier, not as a diagnostic tool.
The information provided clearly indicates that this is a medical device intended for personal protection and infection control, not for performing diagnostic tests on biological samples.
N/A
Intended Use / Indications for Use
YADU Surgical Masks (Model E (ear loops, sterile), Model T (tie on straps, sterile/non-sterile/) are intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids, and particulate material. It is intended to be used in infection control practices to reduce the potential exposure to blood and body fluids. This is a single use, disposable device, provided sterile and non sterile.
Product codes (comma separated list FDA assigned to the subject device)
FXX
Device Description
The YADU Surgical Masks are single use, three-layer, flat-pleated style with ear loops and nose piece. They have three layers structure: inner layer, and outer layer. The inner and outer layers are made of spun-bond polypropylene (SPP), and the middle layer is made of melt blown polypropylene filter.
Y ADU Surgical Masks have two variants: The model with ear loop and the model with tie-on bands. The mask is held in place over the users' mouth and nose by two elastic ear loops or tie-on bands welded to the side of the mask. The ear loops are made from spandex and polyester elastic, while tie-on bands are made from SPP straps. Neither elastic ear loops nor tie-on bands are made with natural rubber latex.
Y ADU Surgical Masks also have nose piece that allows the user to fit the mask around his/her nose. The nose piece is made of polyvinyl chloride coated iron wire.
The Surgical Masks provide Level-1 protection per ASTM F2100 definition. They have blue color and are sold in both sterile and non-sterile versions 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
To protect both the patient and healthcare personnel from transfer of microorganisms, body fluids, and particulate material. It is intended to be used in infection control practices to reduce the potential exposure to blood and body fluids.
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 tests were conducted to verify that the proposed device met all design specifications. The test results demonstrated that the proposed device complies with the following standards:
- Sterilization Validation: ISO-11135-1: 2014
- ASTM F2100: 2018 Standard Specification for Performance of Materials Used in Medical Face Masks
- ASTM F2101-19 Standard Test Method for Evaluating the Bacterial Filtration ● Efficiency (BFE) of Medical Face Mask Materials, Using a Biological Aerosol of Staphylococcus aureus
- ASTM F1862-17 Standard Test Method for Resistance of Medical Face Masks to Penetration by Synthetic Blood (Horizontal Projection of Fixed Volume at a Known Velocity)
- ASTM F2299-03 (Reapproved 2017) Standard Test Method for Determining the ● Initial Efficiency of Materials Used in Medical Face Masks to Penetration by Particulates Using Latex Spheres
- EN 14683-2019 Medical Face Masks Requirements and Test Methods ●
- In Vitro Cytotoxicity Test: ISO 10993-5: 2009 ●
- Skin Irritation Test: ISO 10993-10: 2010 ●
- Skin Sensitization Test: ISO 10993-10: 2010
Testing for Level 1 performance included:
- Bacterial Filtration Efficiency (BFE) per ASTM F2101-19 for sterile ear loops (Lot 1: 95.1-97.4%, Lot 2: 95.1-98.4%, Lot 3: 95.1-98.4%) and non-sterile ear loops (Lot 1: 99.8-99.9%, Lot 2: 99.2-99.9%, Lot 3: 99.8-99.9%).
- Penetration by Particulates per ASTM F2299-03 for sterile ear loops (Lot 1: 95.1-97.9%, Lot 2: 95.1-99.6%, Lot 3: 95.1-97.4%) and non-sterile ear loops (Lot 1: 99.5 – 99.9%, Lot 2: 99.5 – 99.9%, Lot 3: 99.5 – 99.9%).
- Differential Pressure per EN 14683-2019 for sterile ear loops (3.7-4.2, 3.7-4.1, 3.7-4.1 mm H2O/cm²) and non-sterile ear loops (3.1 – 3.6, 3.1 – 3.5, 3.0 – 3. mm H2O/cm²).
- Resistance to penetration by Synthetic Blood per ASTM F1862-17 for sterile ear loops (32/32 pass) and non-sterile ear loops (32/32 pass).
- Flammability per 16 CFR part 1610 for sterile tie on straps (32/32 IBE) and non-sterile tie on straps (32/32 IBE).
Biocompatibility tests included:
- Cytotoxicity per ISO 10993-5: No Cytotoxicity for both sterile and non-sterile masks.
- Sensitization per ISO 10993-10: No Sensitization for both sterile and non-sterile masks.
- Irritation per ISO 10993-10: No Irritation for both sterile and non-sterile masks.
Clinical data is not needed for YADU Surgical Masks.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Bacterial Filtration Efficiency (BFE): $\geq$ 95%
Penetration by Particulates: $\geq$ 95%
Differential Pressure:
§ 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 14, 2022
HeNan YADU Industrial Co., Ltd. % Charles Shen Director Manton Business and Technology Services 37 Winding Ridge Oakland, New Jersey 07436
Re: K212330
Trade/Device Name: YADU Surgical Masks (Model E (ear loops, sterile/non-sterile), Model T (tie on straps, sterile/non-sterile)) Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical apparel Regulatory Class: Class II Product Code: FXX Dated: February 9, 2022 Received: February 17, 2022
Dear Charles Shen:
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.
1
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 (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, 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 Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K212330
Device Name
Y ADU Surgical Masks (Model E (ear loops, sterile), Model T (tie on straps, sterile/non-sterile/)
Indications for Use (Describe)
Y ADU Surgical Masks (Model E (ear loops, sterile), Model T (tie on straps, sterile/non-sterile/) are intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids, and particulate material. It is intended to be used in infection control practices to reduce the potential exposure to blood and body fluids. This is a single use, disposable device, provided sterile and non sterile.
Type of Use (Select one or both, as applicable):
| Registration Use (Part 21 CFR 201.2 Subpart D) | |
|---|---|
| Over-The-Counter Use (21 CFR 201.2 Subpart C) |
_ | 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-K212330:
This summary of 510k safety and effectiveness information is being submitted in accordance with the requirements of 21CFR 807.92
1.0 Submitter Information
HeNan YADU Industrial Co., Ltd. No.234, West Jianpu Road 453400 Changyuan, Henan Province, CHINA Tel: (086) 373-2157057 Submitter's FDA Registration Number:3016452400
Submission Correspondent
Charles Shen Manton Business and Technology Services 37 Winding Ridge Oakland, NJ 07436 Tel: 608-217-9358 Email: cyshen@aol.com
Date of Summary: March 13, 2022
2.0 Device Information
| Proprietary Name: | YADU Surgical Masks |
|---|---|
| Common Name: | Surgical Mask, Medical Face Mask |
| Models: | Model E (ear loop, sterile/non-sterile), Model T (tie on straps, sterile/non-sterile) |
3.0 Device Classification
| Classification Name: | Surgical Apparel |
|---|---|
| ---------------------- | ------------------ |
Classification Regulation: 21 CFR 878.4040 Class: Class II Product Code: FXX
4.0 Predicate Device Information:
| Manufacturer: | Hubei Xinxin Non-woven Co., Ltd. |
|---|---|
| Product Name: | Surgical Mask |
| 510(K)#: | K212120 |
4
5.0 Device description:
The YADU Surgical Masks are single use, three-layer, flat-pleated style with ear loops and nose piece. They have three layers structure: inner layer, and outer layer. The inner and outer layers are made of spun-bond polypropylene (SPP), and the middle layer is made of melt blown polypropylene filter.
Y ADU Surgical Masks have two variants: The model with ear loop and the model with tie-on bands. The mask is held in place over the users' mouth and nose by two elastic ear loops or tie-on bands welded to the side of the mask. The ear loops are made from spandex and polyester elastic, while tie-on bands are made from SPP straps. Neither elastic ear loops nor tie-on bands are made with natural rubber latex.
Y ADU Surgical Masks also have nose piece that allows the user to fit the mask around his/her nose. The nose piece is made of polyvinyl chloride coated iron wire.
The Surgical Masks provide Level-1 protection per ASTM F2100 definition. They have blue color and are sold in both sterile and non-sterile versions and are intended to be single use, disposable devices.
| Sterilization | Model |
|---|---|
| Non-sterile | Tie-on (Model T) |
| Ear loops (Model E) | |
| EO Sterile | Tie-on (Model T) |
| Ear loops (Model E) |
6.0 Indications for Use:
Y ADU Surgical Masks is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids, and particulate material. It is intended to be used in infection control practices to reduce the potential exposure to blood and body fluids. This is a single use, disposable device, provided sterile and non sterile.
7.1 Comparison to Predicate Devices
Y ADU Surgical Masks, manufactured by "HeNan YADU Industrial Co., Ltd." are compared with the following Predicate Devices in terms of intended use, design, material, specifications, and performance.
- (1) K212120, "Surgical Mask" Model XX009 Ear loop Level 1 and Model XX008 Tie-on Level 1, manufactured by "Hubei Xinxin Non-woven Co., Ltd."
5
The following table shows similarities and differences of use, design, and material between our device and the predicate devices.
| Description | Subject Device | Predicate Device (K212120) |
|---|---|---|
| Indication | ||
| for Use | YADU Surgical Masks is | |
| intended to be worn to protect | ||
| both the patient and healthcare | ||
| personnel from transfer of | ||
| microorganisms, body fluids and | ||
| particulate material. It 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, provided sterile and non | ||
| sterile. | The surgical masks are intended | |
| to be worn to protect both the | ||
| patient and healthcare personnel | ||
| from transfer of | ||
| microorganisms, body fluids, | ||
| and particulate material. These | ||
| 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, | ||
| provided non-sterile. | ||
| Layers | Three | Three |
| Materials | Outer layer is made of 100% | |
| spun- bond polypropylene. | ||
| Middle player is made of | ||
| 100% | ||
| meltblown | ||
| polypropylene filter media. | ||
| Inner layer is made of 100% | ||
| spun- bond polypropylene. | ||
| Ear-loops are made of polyester | ||
| and spandex. | ||
| Ties are made from Spunbond | ||
| Polypropylene | ||
| The nose piece is iron and plastics | Outer layer is made of 100% | |
| spun- bond polypropylene. | ||
| Middle player is made of | ||
| 100% meltblown | ||
| polypropylene filter media. | ||
| Inner layer is made of 100% | ||
| spun- bond polypropylene. | ||
| Ear-loops are made of | ||
| spandex | ||
| Ties are made from Spunbond | ||
| Polypropylene | ||
| The nose piece is iron and | ||
| plastics | ||
| Dimensions | 17.5 x 9.5cm | 17.5 x 9.5cm |
| Mask style | Flat Pleated | Flat Pleated |
| Design | Ear Loop and Tie-on Bands | Ear Loop (XX009) and Tie-on |
| (XX008) | ||
| Color | Blue | Blue |
| Sterility | Sterile and Non-sterile | Non-sterile |
| Shelf life | Sterile: 3 years | |
| Non-sterile: None stated | Sterile: N/A | |
| Non-sterile: 2 years | ||
| Single Use | Yes | Yes |
| ASTM | ||
| F2100 Level | Level 1 | Level 1 |
Table 1: Comparison of Intended Use, Design, and Material
6
The differences between the subject device and predicate device do not raise different questions of safety and effectiveness.
Non-Clinical Study Summary 8.1
Non-clinical tests were conducted to verify that the proposed device met all design specifications. The test results demonstrated that the proposed device complies with the following standards:
- . Sterilization Validation: ISO-11135-1: 2014
- ASTM F2100: 2018 Standard Specification for Performance of Materials Used in Medical Face Masks
- ASTM F2101-19 Standard Test Method for Evaluating the Bacterial Filtration ● Efficiency (BFE) of Medical Face Mask Materials, Using a Biological Aerosol of Staphylococcus aureus
- ASTM F1862-17 Standard Test Method for Resistance of Medical Face Masks to Penetration by Synthetic Blood (Horizontal Projection of Fixed Volume at a Known Velocity)
- ASTM F2299-03 (Reapproved 2017) Standard Test Method for Determining the ● Initial Efficiency of Materials Used in Medical Face Masks to Penetration by Particulates Using Latex Spheres
- EN 14683-2019 Medical Face Masks Requirements and Test Methods ●
- In Vitro Cytotoxicity Test: ISO 10993-5: 2009 ●
- Skin Irritation Test: ISO 10993-10: 2010 ●
- Skin Sensitization Test: ISO 10993-10: 2010 ●
ASTM F2100 Testing for Level 1
| Table 2 - Sterile masks, ear loops, 3 years real time aged | |
|---|---|
| -- | ------------------------------------------------------------ |
| Name of the test | Purpose | Acceptance
Criteria | Results | | |
|-----------------------------------------------------------------------|--------------------------------------------------------------|------------------------|------------|------------|------------|
| | | | Lot 1 | Lot 2 | Lot 3 |
| ASTM F2101-19
Bacterial Filtration
Efficiency (BFE) | To evaluate the
bacterial efficiency
of the mask | $\geq$ 95% | 95.1-97.4% | 95.1-98.4% | 95.1-98.4% |
| ASTM F2299– 03
(Reapproved 2017)
Penetration by
Particulates | To evaluate particle
filtration efficiency
of the mask | $\geq$ 95% | 95.1-97.9% | 95.1-99.6% | 95.1-97.4% |
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| EN 14683-2019
Differential
Pressure | To evaluate
differential
pressure of the
device |