(60 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 AI or ML technology.
No
Explanation: This device is a surgical mask intended for infection control by creating a barrier to protect against microorganisms and fluids. It does not provide any therapeutic effect or treatment for a disease or condition.
No
Explanation: The device is a surgical mask intended to protect against the transfer of microorganisms and body fluids. It is a protective barrier, not a diagnostic tool used to identify or determine the nature of a disease or condition.
No
The device description clearly outlines a physical mask made of various materials (polypropylene, iron wire) and includes performance testing related to filtration, pressure, and flame spread, indicating it is a hardware device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the mask is for protecting both the patient and healthcare personnel from the transfer of microorganisms, body fluids, and particulate material. This is a physical barrier function, not a diagnostic function.
- Device Description: The description details the physical construction and materials of the mask. There are no components or mechanisms described that would be used to perform a diagnostic test on a sample from the human body.
- Performance Studies: The performance studies focus on the physical properties and barrier effectiveness of the mask (filtration efficiency, pressure resistance, flame spread, biocompatibility). These are relevant to its function as a protective barrier, not as a diagnostic tool.
- Key Metrics: The key metrics measured (filtration efficiency, differential pressure, resistance to penetration) are all related to the mask's ability to filter and block substances, not to detect or measure substances in a biological sample.
An In Vitro Diagnostic (IVD) device is used to examine specimens taken 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
The MEDICAL SURGICAL MASK is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids, and particulate material. The MEDICAL SURGICAL MASK 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 non-sterile.
Product codes (comma separated list FDA assigned to the subject device)
FXX
Device Description
The subject device is a non-sterile, single-use, and flat pleated mask with ear loops and a Nose piece. The product is manufactured with three layers, the inner and outer layer is made of polypropylene spunbond, the middle layer is made of melt blown polypropylene. The elastic ear loops are not made with natural rubber latex. The Nose piece in the facemask is to allow the user to fit the facemask around their nose, which is made of polyethylene coated iron wire.
The mask will be provided in black and blue color, the colorant for the model JM92B is Carbon black (CAS No.1333-86-4), and for the model JM92 is Pigment Blue 15 (CAS No.147-14-8). The model JM92 will be provided in blue and labeled in Level 3, the model JM92B will be provided in black and labeled in Level 1.
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
patient and healthcare personnel / infection control practices
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 Performance Testing:
Test items included Bacterial filtration efficiency (ASTM F2101-19), Differential pressure (EN 14683: 2019, Annex C and ASTM F2100: 2019), Sub-micron particulate filtration efficiency at 0.1 µm of Polystyrene Latex Spheres (ASTM F2299 and ASTM F2100: 2019), Resistance to penetration by synthetic blood (ASTM F1862/F1862M-17 and ASTM F2100:2019), and Flame spread (16 CFR Part 1610 and ASTM F2100:2019). All tests resulted in "Pass".
Biocompatibility Testing:
Tests included In vitro Cytotoxicity Test per ISO 10993-5: 2009, Skin Sensitization Tests per ISO 10993-10: 2010, and Skin Irritation Tests per ISO 10993-10: 2010. These tests demonstrated that the device is biocompatible and safe for its intended use.
No clinical study was included in the submission.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Key metrics from non-clinical performance testing:
- Bacterial filtration efficiency: ≥ 95% (Level 1), ≥ 98% (Level 3)
- 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.
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March 25, 2022
Guangdong Jia Mei Biological technology Co.Ltd % Ms. Cassie Lee Manager Share Info (Guangzhou) Medical Consultant Ltd. No. 1919-1920, Building D3, Minjie Plaza, Shuixi Road, Huangpu District Guangzhou, Guangdong China
Re: K220187
Trade/Device Name: Medical Surgical Mask (Model: JM92, JM92B) Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical apparel Regulatory Class: Class II Product Code: FXX Dated: January 21, 2022 Received: January 24, 2022
Dear Ms. 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 (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 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.
Brent L. 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
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Indications for Use
510(k) Number (if known) K220187
Device Name MEDICAL SURGICAL MASK (Model: JM92, JM92B)
Indications for Use (Describe)
The MEDICAL SURGICAL MASK is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids, and particulate material. The MEDICAL SURGICAL MASK is intended for use in infection control practices to reduce the posure to blood and body fluids. This is a single-use, disposable device, provided non-sterile.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D) | |
---|---|
Over-The-Counter Use (21 CFR 801 Subpart C) |
|X Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirement of 21 CFR 807.92.
1. Submitter's Information
Sponsor Name: Guangdong Jia Mei Biological technology Co.Ltd Address: 3/F, Block 1, No.356 Qinglan Road, Jianghai, Jiangmen City, Guangdong Province, China Post Code: 529040 Contact name: Jiali Chen Tel: +86-0750-3835982 E-mail: jmjaymei@163.com
Application Correspondent:
Contact Person: Ms. Cassie Lee Company: 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@share-info.com
2. Date of the summary prepared: November 26, 2020
Revision date: January 21, 2022 3.
4. Subject Device Information
Type of 510(k): Traditional Classification Name: Mask, Surgical Trade Name: MEDICAL SURGICAL MASK Model Name: JM92, JM92B Review Panel: General Hospital Product Code: FXX Regulation: 21 CFR 878.4040 - Surgical apparel Regulatory Class: II
5. Predicate Device Information
Predicate Device 1 (Primary Predicate):
Sponsor: Jiangmen Ningrui Medical Supplies Co., Ltd.
4
Trade Name: Surgical Mask (Model: WK1701-02A, WK1701-03A, WK1701-04A) Classification Name: Mask, Surgical 510(K) Number: K212293 Review Panel: General Hospital Product Code: FXX Regulation Number: 21 CFR 878.4040 Regulation Class: II
Predicate Device 2:
Sponsor: Shandong Shengquan New Materials Co., Ltd. Trade Name: Surgical mask (Model: SMDP20608) Classification Name: Surgical Apparel 510(K) Number: K211552 Review Panel: General Hospital Product Code: FXX Regulation Number: 21 CFR 878.4040 Regulation Class: II
6. Device Description
The subject device is a non-sterile, single-use, and flat pleated mask with ear loops and a Nose piece. The product is manufactured with three layers, the inner and outer layer is made of polypropylene spunbond, the middle layer is made of melt blown polypropylene. The elastic ear loops are not made with natural rubber latex. The Nose piece in the facemask is to allow the user to fit the facemask around their nose, which is made of polyethylene coated iron wire.
The mask will be provided in black and blue color, the colorant for the model JM92B is Carbon black (CAS No.1333-86-4), and for the model JM92 is Pigment Blue 15 (CAS No.147-14-8). The model JM92 will be provided in blue and labeled in Level 3, the model JM92B will be provided in black and labeled in Level 1.
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7. Intended Use / Indications for Use
The MEDICAL SURGICAL MASK is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids, and particulate material. The MEDICAL SURGICAL MASK 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 non-sterile.
8. 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 1 | Predicate Device 2 | Remark |
---|---|---|---|---|
Company | Guangdong Jia Mei | |||
Biological | ||||
technology Co.Ltd | Jiangmen Ningrui Medical | |||
Supplies Co., Ltd. | Shandong | |||
Shengquan New | ||||
Materials Co., Ltd. | -- | |||
510 (k) | Applying | K212293 | K211552 | -- |
Trade Name | MEDICAL | |||
SURGICAL MASK | Surgical Mask | Surgical mask | -- | |
Model | JM92, JM92B | WK1701-02A, WK1701-03A, | ||
WK1701-04A | SMDP20608 | -- | ||
Classification | ||||
Name | Mask, Surgical | Mask, Surgical | Surgical Apparel | SE |
Classification | Class II | Class II | Class II | SE |
Product Code | FXX | FXX | FXX | SE |
Intended use | The MEDICAL | |||
SURGICAL 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 Mask is intended | |||
to be worn to protect both the | ||||
patient and healthcare | ||||
personnel from the transfer of | ||||
microorganisms, body fluids, | ||||
and particulate material. The | ||||
Surgical Mask 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(s), provided | ||||
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 surgical | ||||
masks are intended | ||||
for use in infection | ||||
control practices to | SE | |||
Elements of | ||||
Comparison | Subject Device | Predicate Device 1 | Predicate Device 2 | Remark |
in infection control | ||||
practices to reduce | ||||
the potential | ||||
exposure to blood | ||||
and body fluids. This | ||||
is a single-use, | ||||
disposable device, | ||||
provided non-sterile. | reduce the potential | |||
exposure to blood | ||||
and body fluids. This | ||||
is a single use, | ||||
disposable device, | ||||
and provided non-sterile. | ||||
Materials | ||||
Outer facing | ||||
layer | Polypropylene | |||
spunbond | Polypropylene spunbond fabric | Polypropylene | ||
Spunbond | SE | |||
Middle filter | ||||
layer | Melt blown | |||
polypropylene | Polypropylene meltblown fabric | Melt blown | ||
polypropylene filter | SE | |||
Inner facing | ||||
layer | Polypropylene | |||
spunbond | Polypropylene spunbond fabric | Polypropylene | ||
Spunbond | SE | |||
Nose piece | Polyethylene coated | |||
iron wire | Polypropylene coated | |||
galvanized iron wire | Malleable | |||
polyethylene | SE | |||
Note 1 | ||||
Ear loops | Spandex | Nylon, spandex | Spandex, Polyester | SE |
Note 1 | ||||
Mask Style | Flat-pleated | Flat-pleated | Flat-pleated | SE |
Color | Blue (JM92), Black | |||
(JM92B) | Blue | Black and White | SE | |
Dimensions | Length: 17.5 cm | |||
$\pm$ 5% | ||||
Width: 9.5 cm $\pm$ 5% | Length: 17.5 cm $\pm$ 5mm | |||
Width: 9.5 cm $\pm$ 3mm | Length: | |||
17.5cm $\pm$ 0.88cm | ||||
Width: | ||||
9.5cm $\pm$ 0.48cm | SE | |||
OTC use | Yes | Yes | Yes | SE |
Sterility | Non-Sterile | Non-Sterile | Non-Sterile | SE |
Single-use | Yes | Yes | Yes | SE |
Performance | ||||
Testing | Level 1, Level 3 | Level 1; Level 2; Level 3 | Level 3 | SE |
Level | Level 1 | |||
(JM92B) | Level 1 | Level 3 | / | |
Fluid | Pass at | Pass at | Passed at 29 out of | SE |
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Elements of Comparison | Subject Device | Predicate Device 1 | Predicate Device 2 | Remark | ||
---|---|---|---|---|---|---|
Resistance Performance (ASTM F1862) | 80 mmHg | 160 mmHg | 80 mm Hg | 120 mm Hg | 160 mm Hg | 32 pass at 160 mmHg |
Particulate Filtration Efficiency (ASTM F1215) | Pass at ≥ 95% | Pass at ≥ 98% | Pass at ≥ 99% | Pass at ≥ 99% | Pass at ≥ 99% | ≥98% SE Note 2 |
Bacterial Filtration Efficiency (ASTM F2101) | Pass at ≥ 95% | Pass at ≥ 98% | Pass at ≥ 99% | Pass at ≥ 99% | Pass at ≥ 99% | ≥98% SE Note 2 |
Differential Pressure (ASTM F2100) | Pass at |