(216 days)
Not Found
No
The device description and performance studies focus on the physical properties and filtration efficiency of a disposable medical mask, with no mention of AI or ML.
No
Explanation: A therapeutic device is designed to treat or alleviate a medical condition. This device, a medical mask, is primarily used for protection and infection control, not for treating a disease or condition.
No
Explanation: The device is a Disposable Medical Mask intended for infection control by protecting against transfer of microorganisms and body fluids. It does not perform any diagnostic function.
No
The device description clearly outlines a physical product (masks with layers, ear loops, and a nose clip) and the performance studies focus on material properties and physical performance, 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 masks are 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 construction of the mask (layers, materials, ear loops, nose clip). There is no mention of reagents, assays, or any components used for analyzing samples from the human body.
- Performance Studies: The performance studies focus on the physical properties and barrier effectiveness of the mask (fluid resistance, filtration efficiency, flammability, biocompatibility). These are not studies related to the accuracy or performance of a diagnostic test.
- Lack of IVD Characteristics: There are no mentions of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information about a patient's health status.
IVD devices are used to examine specimens taken from the human body to provide information for diagnosis, monitoring, or screening. This mask does not perform any such function.
N/A
Intended Use / Indications for Use
Disposable Medical 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 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 Masks are single use, three-layer, flat -folded masks with ear loops and nose clip.
The Disposable Medical Masks are 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 ear loops are held in place over the users' mouth and nose which are welded to the facemask. There are two types of ear loops for the disposable medical masks, one shaped in thin rope is made of Nylon and spandex, and the other shaped in narrow band is made of spun-bond polypropylene and elastic body. The ear loops are not made with natural rubber latex.
The nose clip in the layers of facemask is to allow the user to fit the facemask around their nose, which is made of malleable polypropylene coating with iron wire.
The medical masks will be provided in blue. The medical masks are sold 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 tests were conducted to verify that the proposed device met all design specifications as same or 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, Standard 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 (3 lots):
- Fluid Resistance Performance ASTM F1862: 32 out of 32 pass at 80 mmHg (Acceptance: 29 out of 32 pass at 80 mmHg) - PASS
- Particulate Filtration Efficiency ASTM F2299: 99.12%, 99.45%, 99.56% (Acceptance: ≥ 95%) - PASS
- Bacterial Filtration Efficiency ASTM F2101: 99.92%, 99.93%, 99.92% (Acceptance: ≥ 95%) - PASS
- Differential Pressure (Delta P) EN 14683 Annex C: 3.0mmH2O/cm², 4.2mmH2O/cm², 3.7mmH2O/cm² (Acceptance:
§ 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.
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March 4, 2021
U-Play Products Corporation % Ivy Wang Technical Manager Shanghai Sungo Management Consulting Company Limited 13th Floor, 1500# Central Avenue Shanghai, Shanghai 200122 China
Re: K202137
Trade/Device Name: Disposable medical mask Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: February 1, 2021 Received: February 9, 2021
Dear Ivy 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.
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 (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 Ryan Ortega, PhD Acting 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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3
510(K) Summary
K202137
Date of preparation: 2021-03-04
A. Applicant:
U-Play Products Corporation Address: No.7, Fumin Road, Jiujiang Economic and Technological Development Zone, Wuhu City, Anhui Province, China Contact Person: Jin Jing Tel: +86- 553-8516886 Fax: +86- 553-8516886
Submission Correspondent: Primary contact: Ms. Ivy Wang Shanghai SUNGO Management Consulting Co., Ltd. Room 1309, Dongfang Building, 1500# Century Ave., Shanghai 200122, China Tel: +86-21-58817802 Email: haiyu.wang@sungoglobal.com Secondary contact: Mr. Raymond Luo Room 1309, Dongfang Building, 1500# Century Ave., Shanghai 200122, China Tel: +86-21-68828050 Email: fda.sungo@gmail.com
B. Device:
Trade Name: DISPOSABLE MEDICAL MASK Common Name: MEDICAL FACE MASK Model: Y01, Y02
Regulatory Information Classification Name: Surgical Face Mask Classification: Class II Product code: FXX Regulation Number: 878.4040 Review Panel: Surgical Apparel
C. Predicate device:
K110455 Kimberly-Clark KC100 Mask Kimberly-Clark
D. Intended use of the device:
Disposable Medical Masks are intended to be worn to protect both the patient and healthcare
4
U-Play Products Corporation
No.7, Fumin Road, Jiujiang Economic and Technological Development Zone, Wuhu City, Anhui Province, China 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 Masks are single use, three-layer, flat -folded masks with ear loops and nose clip.
The Disposable Medical Masks are 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 ear loops are held in place over the users' mouth and nose which are welded to the facemask. There are two types of ear loops for the disposable medical masks, one shaped in thin rope is made of Nylon and spandex, and the other shaped in narrow band is made of spun-bond polypropylene and elastic body. The ear loops are not made with natural rubber latex.
The nose clip in the layers of facemask is to allow the user to fit the facemask around their nose, which is made of malleable polypropylene coating with iron wire.
The medical masks will be provided in blue. The medical masks are sold non-sterile and are intended to be single use, disposable devices.
| Table 1 General Comparison | |||
|---|---|---|---|
| Device | Proposed Device | Predicate Device | Result |
| Manufacturer | U-Play Products Corporation | Kimberly-Clark | - |
| 510K number | K202137 | K110455 | - |
| Model Name | DISPOSABLE MEDICAL MASK | Kimberly-Clark KC100 Mask | Similar |
| Classification | Class II Device, FXX (21 CFR878.4040) | Class II Device, FXX (21 CFR878.4040) | Same |
| Intend use | Disposable Medical 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 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 Kimberly-Clark KC100 Procedure Mask(s) 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. The Kimberly-Clark KC100 Procedure Mask(s) is a single use, disposable devices, provided non-sterile. | Same |
| Design Features | Ear Loops, Flat Pleated, 3 layers | Ear Loops, Tie-On, Flat Pleated, 3 layers | Similar |
| Material | |||
| Outer facing | Spun-bond polypropylene | Spun-bond polypropylene | Same |
F. Comparison with predicate device
5
| No.7, Fumin Road, Jiujiang Economic and Technological Development Zone, Wuhu City, Anhui Province, China | ||
|---|---|---|
| ---------------------------------------------------------------------------------------------------------- | -- | -- |
| layer | |||
|---|---|---|---|
| Middle layer | Melt blown polypropylene | ||
| filter | Melt blown polypropylene filter | Same | |
| Inner facing layer | Spun-bond polypropylene | Spun-bond polypropylene | Same |
| Nose clip | Polypropylene + steel wire | NA | Different* |
| Ear loops | Nylon and Spandex; | ||
| elastic nonwoven fabrics | |||
| (spun-bond polypropylene | |||
| and elastic body) | Polyester/ lycra knitted | Different* | |
| Color | Blue | Variety (include blue) | Similar |
| Dimension | |||
| (Length) | 175±10mm | 165±19mm | Similar |
| Dimension | |||
| (Width) | 95±10mm | 102 ± 19mm | Similar |
| OTC use | Yes | Yes | Same |
| Sterility | Non-Sterile | Non-Sterile | Same |
| Use | Single Use, Disposable | Single Use, Disposable | Same |
| ASTM F2100 | |||
| Level | Level 1 | Level 1 | Same |
| Fluid Resistance | |||
| Performance | |||
| ASTM F1862 | 32 out of 32 pass at 80 mmHg, | ||
| 3 lots | Meet the requirements | Similar | |
| Particulate | |||
| Filtration | |||
| Efficiency ASTM | |||
| F2299 | 99.12%, 99.45%, 99.56% | Meet the requirements | Similar |
| Bacterial | |||
| Filtration | |||
| Efficiency ASTM | |||
| F2101 | 99.92%, 99.93%, 99.92% | Meet the requirements | Similar |
| Differential | |||
| Pressure (Delta | |||
| P) EN 14683 | |||
| Annex C | 3.0mmH2O/cm², | ||
| 4.2mmH2O/cm², | |||
| 3.7mmH2O/cm² | Meet the requirements | Similar | |
| Flammability 16 | |||
| CFR 1610 | Class 1 | Meet the requirements | Similar |
| Biocompatibility | ISO10993 | ISO10993 | Same |
| Cytotoxicity | Under the conditions of the | ||
| study, the device is | |||
| non-cytotoxic. | Meet the requirements | Similar | |
| Irritation | Under the conditions of the | ||
| study, the device is | |||
| non-irritating. | Meet the requirements | Similar | |
| Sensitization | Under the conditions of the | ||
| study, the device is | |||
| non-sensitizing. | Meet the requirements | Similar |
6
U-Play Products Corporation
No.7, Fumin Road, Jiujiang Economic and Technological Development Zone, Wuhu City, Anhui Province, China
| device |
|---|
Different*:
The proposed device has different material of nose clamp and ear loop to the predicate device, but the material has been tested and the test results shown that the material differences do not affect the safety of the proposed device
G. Non-Clinical Test Conclusion
Non-clinical tests were conducted to verify that the proposed device met all design specifications as same or 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
-
ASTM F2100, Standard Specification for Performance of Materials Used In Medical Face Masks
- A 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;
- 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, Standard 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;
| Item | Proposed device (3 lots) | Acceptance (level 1) | Criteria | Result |
|---|---|---|---|---|
| Fluid Resistance | ||||
| Performance ASTM | ||||
| F1862 | 32 out of 32 pass at 80 mmHg | 29 out of 32 pass at 80 mmHg | PASS | |
| Particulate Filtration | ||||
| Efficiency ASTM | ||||
| F2299 | 99.12%, 99.45%, | |||
| 99.56% | ≥ 95% | PASS | ||
| Bacterial Filtration | ||||
| Efficiency ASTM | ||||
| F2101 | 99.92%, 99.93%, | |||
| 99.92% | ≥ 95% | PASS | ||
| Differential Pressure | ||||
| (Delta P) EN 14683 | ||||
| Annex C | 3.0mmH2O/cm², 4.2mmH2O/cm², | |||
| 3.7mmH2O/cm² |