(125 days)
Not Found
No
The device description and performance studies focus on the physical properties and filtration capabilities of a surgical mask, with no mention of AI or ML technology.
No
The device is described as a "Medical Surgical Mask" intended for infection control by protecting against the transfer of microorganisms, body fluids, and particulate material. Its function is protective, not therapeutic (i.e., it does not treat or cure a disease or condition).
No
The device, a Medical Surgical Mask, is designed for infection control by preventing the transfer of microorganisms and particulate material, not for diagnosing medical conditions.
No
The device description clearly outlines a physical medical device (a mask) made of specific materials and dimensions, intended for physical protection. There is no mention of software components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "infection control practices in the health care industry" to "protect both patient and wearer from the transfer of microorganisms, body fluids and particulate material." This describes a physical barrier function, not a diagnostic test performed on a sample from the human body.
- Device Description: The description details the physical construction of a mask (layers, materials, ear loops/ties, nose clip). This is consistent with a personal protective equipment (PPE) device, not an IVD.
- Performance Studies: The performance studies listed (biocompatibility, synthetic blood penetration, bacterial filtration efficiency, particulate filtration efficiency, flame spread) are all tests related to the physical barrier and safety properties of a mask. They are not diagnostic performance metrics like sensitivity, specificity, or accuracy in detecting a disease or condition.
- Key Metrics: The key metrics (Bacterial filtration efficiency, Differential pressure, etc.) are measures of the mask's physical performance as a barrier, not diagnostic test results.
IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for the diagnosis, monitoring, or treatment of a disease or condition. This surgical mask does not perform any such function.
N/A
Intended Use / Indications for Use
This product is indicated for infection control practices in the health care industry. When worn properly, The Medical Surgical Mask is intended to protect both patient and wearer from the transfer of microorganisms, body fluids and particulate material.
Product codes (comma separated list FDA assigned to the subject device)
FXX
Device Description
The Medical Surgical Mask is flat style mask, model MP002-5 utilizing tie-on and model MP002-6 utilizing ear Loops way for wearing, and they all has nose clip design for fitting the face mask around the nose.
The Medical Surgical Masks are manufactured with three layers, the inner and outer layers are made of polypropylene, and the middle layer is made of polypropylene melt-blown. The color of the outer layer is blue (colorant: Copper phthalocyanine/ CAS number: 147-14-8)
The models of mask are ear loops and tie-on, masks are held in place over the users' mouth and nose by two high elastic spandex ear loops or bands welded to the face mask.
The nose clip contained in the Medical Surgical Mask is in the layers of face mask to allow the user to fit the mask around their nose, which is made of plastic environmental protection line.
The Medical Surgical Mask are sold non-sterile and are intended to be single use, disposable device.
The dimension of the tie-on band (Model: MP002-5) is 25cm±2cm1cm±0.2cm (LW), and the dimension of the ear loop (Model: MP002-6) is 17cm±0.5cm0.4cm(LW). What's more, the dimension of the nose clip (Model: MP002-5, MP002-6) is 90mm2.5mm 0.45mm (LWH).
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
health care industry
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 Performed:
- Biocompatibility test according to ISO 10993-5 and ISO 10993-10 standards
- In vitro Cytotoxicity Test per ISO 10993-5:2009. Test results: Under the conditions of the study, the device is non-cytotoxic.
- Skin Sensitization Tests per ISO 10993-10:2010. Test results: Under the conditions of the study, the device is non-sensitizing.
- Skin Irritation Tests per ISO 10993-10:2010. Test results: Under the conditions of the study, the device is non-irritating.
- 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). Test results: Fluid Resistant claimed at 160 mm Hg/ Pass.
- ASTM F2101 Standard Test Method For Evaluating The Bacterial Filtration Efficiency (BFE) Of Medical Face Mask Materials, Using A Biological Aerosol Of Staphylococcus Aureus. Test results: >99.9% / Pass.
- ASTM F2100 Standard Specification For Performance Of Materials Used In Medical Face Masks.
- Differential pressure (Delta-P) test according to EN 14683: 2019, Annex C Medical face masks - Requirements and test methods according to ASTM F2100:2019. Test results: 99.9%
- Differential pressure (Delta-P):
§ 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 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.
January 11, 2021
Jiangmen Sure&Me Medical Product CO., LTD % Cassie Lee Manager Share Info (Guangzhou) Medical Consultant Ltd. No. 1919-1920. Building D3, Miniie Plaza, Shuixi Road, Huangpu District Guangzhou, Guangdong 510700 China
Re: K202577
Trade/Device Name: Medical Surgical Mask-Model MP002-5, MP002-6 Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: December 18, 2020 Received: December 22, 2020
Dear Cassie Lee:
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 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 CAPT Elizabeth Claverie, M.S. 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) Applying
Device Name
Medical Surgical Mask (Model: MP002-5, MP002-6)
Indications for Use (Describe)
This product is indicated for infection control practices in the health care industry. When worn properly, The Medical Surgical Mask is intended to protect both patient and wearer from the transfer of microorganisms, body fluids and particulate material.
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
510(k) Summary for K202577
1. Submitter's Information
510(k) Owner's Name: JIANGMEN SURE&ME MEDICAL PRODUCT CO., LTD,
Address: Jingshuiwan, Chakeng Village Committee, Huicheng Town, Xinhui District, Jiangmen City, Guangdong Province, China
Post Code: 529000
Contact Person: Liang Meixia
Phone: +86 18138977291
Fax: 0750-6393444
E-mail: mxliang1974@126.com
Application Correspondent:
Contact Person: Ms. Cassie Lee
Share Info (Guangzhou) Medical Consultant Ltd.
Address: No. 1919-1920, Building D3, Minjie Plaza, Shuixi Road, Huangpu District, Guangzhou, China
Tel: +86 20 8266 2446
Email: regulatory@glomed-info.com
2. Date of the summary prepared: 2021-01-09
3. Subject Device Information
Type of 510(k): Traditional
Classification Name: Mask, Surgical
Common name: Surgical Mask
4
Trade Name: Medical Surgical Mask Models: MP002-5, MP002-6 Review Panel: General Hospital Product Code: FXX Regulation Number: 878.4040 Regulatory Class: II
4. Predicate Device Information
Sponsor: H&H RESEARCH COMPANY Trade Name: The New Medical Mask Classification Name: Mask, Surgical 510(K) Number: K093179 Review Panel: General Hospital Product Code: FXX Regulation Number: 878.4040 Regulatory Class: II
5. Device Description
The Medical Surgical Mask is flat style mask, model MP002-5 utilizing tie-on and model MP002-6 utilizing ear Loops way for wearing, and they all has nose clip design for fitting the face mask around the nose.
The Medical Surgical Masks are manufactured with three layers, the inner and outer layers are made of polypropylene, and the middle layer is made of polypropylene melt-blown. The color of the outer layer is blue (colorant: Copper phthalocyanine/ CAS number: 147-14-8)
The models of mask are ear loops and tie-on, masks are held in place over the users' mouth and nose by two high elastic spandex ear loops or bands welded to the face mask.
5
The nose clip contained in the Medical Surgical Mask is in the layers of face mask to allow the user to fit the mask around their nose, which is made of plastic environmental protection line.
The Medical Surgical Mask are sold non-sterile and are intended to be single use, disposable device.
The dimension of the tie-on band (Model: MP002-5) is 25cm±2cm1cm±0.2cm (LW), and the dimension of the ear loop (Model: MP002-6) is 17cm±0.5cm0.4cm(LW). What's more, the dimension of the nose clip (Model: MP002-5, MP002-6) is 90mm2.5mm 0.45mm (LWH).
6. Intended Use / Indications for Use
This product is indicated for infection control practices in the health care industry. When worn properly, The Medical Surgical Mask is intended to protect both patient and wearer from the transfer of microorganisms, body fluids and particulate material.
7. Comparison to predicate device and conclusion
The differences between the subject device and predicate devices do not raise new issues of safety or effectiveness.
| Elements of
| Comparison | Subject Device | Predicate Device | Verdict |
|---|---|---|---|
| Company | JIANGMEN SURE&ME | ||
| MEDICAL PRODUCT CO., LTD | H&H RESEARCH | ||
| COMPANY | -- | ||
| 510 (k) | K202577 | K093179 | -- |
| Trade Name | Medical Surgical Mask | The New Medical Mask | -- |
| Classification | |||
| Name | Mask, Surgical | Mask, Surgical | Identical |
| Classification | Class II Device, FXX (21 | ||
| CFR878.4040) | Class II Device, FXX (21 | ||
| CFR878.4040) | Identical | ||
| Elements of | |||
| Comparison | Subject Device | Predicate Device | Verdict |
| Intended use | This product is indicated for | ||
| infection control practices in the | |||
| health care industry. When worn | |||
| properly, The Medical Surgical | |||
| Mask is intended to protect both | |||
| patient and wearer from the | |||
| transfer of microorganisms, body | |||
| fluids and particulate material. | This product is indicated for | ||
| infection control practices in | |||
| the health care industry. | |||
| When worn properly, The | |||
| New Medical Mask is | |||
| intended to protect both | |||
| patient and wearer from the | |||
| transfer of microorganisms, | |||
| body fluids and particulate | |||
| material. | Identical | ||
| Material | |||
| Outer facing | |||
| layer | Polypropylene | Polypropylene | Identical |
| Middle layer | Polypropylene melt-blown | Polypropylene | Identical |
| Note 1 | |||
| Inner facing | |||
| layer | Polypropylene | Polypropylene | Identical |
| Nose clip | Plastic environmental protection | ||
| line | Adhesive tape | Identical | |
| Note 1 | |||
| Ear Loops/ | |||
| Tie-on | Ear Loops/ Tie-on: | ||
| High elastic spandex | Ear Loops: Non-latex elastic | ||
| ear bands | Similar | ||
| Note 1 | |||
| Design | |||
| features | Color: blue | Color: blue | Identical |
| Mask Style | Ear Loops (model: MP002-6) | ||
| and Tie-on (model: MP002-5) | |||
| flat style | Ear loop | ||
| flat style | Identical | ||
| Note 3 | |||
| Specification | |||
| and | 17.5cm x 9.5 cm | Length: 7.1 inches (18 cm) | Similar |
| Elements of | |||
| Comparison | Subject Device | Predicate Device | Verdict |
| Dimension | Width: 3.9 inches (10 cm) | Note 3 | |
| OTC use | Yes | Yes | Identical |
| Sterility | Non-Sterile | Non-Sterile | Identical |
| Use | Single Use, Disposable | Single Use, Disposable | Identical |
| Performance | |||
| Testing | Level 3 | Level 3 | Identical |
| Fluid | |||
| Resistance | |||
| Performance | 160 mmHg | 160 mmHg | Identical |
| Particulate | |||
| Filtration | |||
| Efficiency | ≥98% | 99.9% | Identical |
| Note 2 | |||
| Bacterial | |||
| Filtration | |||
| Efficiency | >99.9% | >99.9% | Identical |
| Differential | |||
| Pressure | 99.9% / Pass | ||
| Differential | |||
| pressure (Delta-P) | EN 14683: 2019, | ||
| Annex C Medical | |||
| face masks - | |||
| Requirements and | |||
| test methods | |||
| according to ASTM | |||
| F2100:2019 | 24 h to 30 d). The |
11
following tests for the subject device were conducted to demonstrate that the subject device is biocompatible and safe for its intended use:
-
In vitro Cytotoxicity Test per ISO 10993-5:2009 Biological evaluation of medical devices-Part 5: Tests for in vitro cytotoxicity,
-
Skin Sensitization Tests per ISO 10993-10:2010 Biological evaluation of medical devices-Part 10: Tests for irritation and skin sensitization,
-
Skin Irritation Tests per ISO 10993-10:2010 Biological evaluation of medical devices— Part 10: Tests for irritation and skin sensitization.
8.2 Summary of Clinical Performance Test
No clinical study is included in this submission.
9. Final Conclusion:
The conclusion drawn from the nonclinical tests demonstrates that the subject device Medical surgical mask in 510(k) K202577, is as safe, as effective, and performs as well as or better than the legally marketed predicate device cleared under K093179.