(218 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.
No.
The device is a surgical mask intended for barrier protection, not for treating or diagnosing a medical condition.
No
A diagnostic device is used to identify or monitor medical conditions. This device, a surgical mask, is for protection from transfer of microorganisms and fluids, not for diagnosis.
No
The device description clearly outlines physical components (spun-bond polypropylene, meltblown polypropylene, nylon, spandex, galvanized iron wire) and performance testing related to material properties and physical barriers, indicating it is a physical device, not software.
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 both the patient and healthcare personnel from the transfer of microorganisms, body fluids, and particulate material. This is a barrier function, not a diagnostic one.
- Device Description: The description details the physical construction and materials of the mask, which are designed for filtration and barrier protection.
- Performance Studies: The performance studies focus on the mask's ability to filter particles, resist fluid penetration, and ensure biocompatibility (cytotoxicity, irritation, sensitization). These are all related to its function as a physical barrier.
- Lack of Diagnostic Elements: There is no mention of the device being used to analyze samples (like blood, urine, or tissue) or to provide information about a patient's health status or disease.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or screening purposes. This surgical mask does not perform any such function.
N/A
Intended Use / Indications for Use
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 potential exposure to blood and body fluids. This is a single use, disposable device, provided non-sterile.
Product codes
FXX
Device Description
The surgical masks are three-layer, flat-pleated style mask with ear loops and nose clip design for fitting the mask around the nose and mouth. The proposed device is manufactured with three layers, the inner and outer layers are made of spun-bond polypropylene, and the middle layer (Filter layer) is made of meltblown polypropylene. The ear loops are made of nylon and spandex and the nose clip is made of galvanized iron wire. The masks not made with natural rubber latex materials, and all materials are being used in currently marketed devices. The masks will be provided in blue and the model CR02-2 will be labeled to Level 2, the CRO2 will be labeled to Level 3. The masks are single-use, disposable devices, provided non-sterile.
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 from transfer of microorganisms, body fluids, and particulate material.
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:
- Study Type: Performance testing and Biocompatibility testing.
- Performance Tests:
- Bacterial filtration efficiency (ASTM F2101-14)
- Differential pressure (EN 14683: 2019, Annex C)
- Sub-micron particulate filtration efficiency at 0.1 um of Polystyrene Latex Spheres (ASTM F2299-03)
- Resistance to penetration by synthetic blood (ASTM F1862/F1862M-17)
- Flame spread (16 CFR Part 1610)
- Biocompatibility Tests (according to ISO 10993-1: 2018 for Surface Device, Skin Contact, prolonged duration):
- In vitro Cytotoxicity Test (ISO 10993-5: 2009)
- Skin Sensitization Tests (ISO 10993-10: 2010)
- Skin Irritation Tests (ISO 10993-10: 2010)
- Key Results: All performance and biocompatibility tests passed, demonstrating that the device is as safe and effective as the predicate device.
Clinical Performance Test:
No clinical study is included in this submission.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
- Bacterial filtration efficiency: ≥ 98% (Pass for Level 2 and Level 3)
- 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
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March 31, 2021
Foshan Xinbao Technology Co., Ltd. % Cassie Lee Manager Share Info (Guangzhou) Medical Consultant Ltd. No. 1919-1920, Building D3, Minjie Plaza, Shuixi Road, Huangpu District Guangzhou, Guangdong 510700 China
Re: K202424
Trade/Device Name: Surgical Mask-Model CR02-2, CR02 Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: August 21, 2020 Received: August 25, 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 (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.
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
2
Indications for Use
510(k) Number (if known) K202424
Device Name Surgical Mask (Model: CR02-2, CR02)
Indications for Use (Describe)
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 potential exposure 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)
X Over-The-Counter Use (21 CFR 801 Subpart C)
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3
510(k) Summary for K202424
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
510(k) Owner's Name: Foshan Xinbao Technology Co., Ltd. Establishment Registration Number: Applying Address: No. 20 Changjiang Road, Sanshan New Town, Nanhai District, Foshan City, Guangdong, China Contact Person: Weishan Peng Email: pengweishan1120@foxmail.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
Date of the summary prepared: November 26, 2020 2.
3. Revision date: March 4, 2021
4. Subject Device Information
Type of 510(k): Traditional Classification Name: Mask, Surgical Common Name: Surgical apparel Trade Name: Surgical Mask Model Name: CR02-2, CR02 Review Panel: General Hospital Product Code: FXX Regulation Number: 878.4040 Requlatory Class: II
5. Predicate Device Information
Sponsor: San-M Package Co., Ltd. Trade Name: Surgical Face Masks (Ear Loops And Tie-On) Classification Name: Mask, Surgical Common Name: Surgical apparel 510(K) Number: K160269 Review Panel: General Hospital Product Code: FXX Regulation Number: 878.4040 Regulation Class: II
6. Device Description
4
The surgical masks are three-layer, flat-pleated style mask with ear loops and nose clip design for fitting the mask around the nose and mouth. The proposed device is manufactured with three layers, the inner and outer layers are made of spun-bond polypropylene, and the middle layer (Filter layer) is made of meltblown polypropylene. The ear loops are made of nylon and spandex and the nose clip is made of galvanized iron wire. The masks not made with natural rubber latex materials, and all materials are being used in currently marketed devices. The masks will be provided in blue and the model CR02-2 will be labeled to Level 2, the CRO2 will be labeled to Level 3. The masks are single-use, disposable devices, provided non-sterile.
7. Intended Use / Indications for Use
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 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 | Remark |
|---|---|---|---|
| Company | Foshan Xinbao Technology Co., Ltd. | San-M Package Co., Ltd. | -- |
| 510 (k) | K202424 | K160269 | -- |
| Trade Name | Surgical Mask | Surgical Face Masks (Ear Loops | |
| And Tie-On) | -- | ||
| Model | CR02-2 | ||
| CR02 | EL 10000 | ||
| EL 20000 | |||
| EL 30000 | -- | ||
| Classification | |||
| Name | Mask, Surgical | Mask, Surgical | Same |
| Classification | Class II Device, FXX (21 FR | ||
| 78.4040) | Class II Device, FXX (21 CFR | ||
| 78.4040) | Same | ||
| Intended use | 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 | |||
| potential exposure to blood and | |||
| body fluids. This is a single use, | |||
| disposable device, provided non- | |||
| sterile. | 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 in | |||
| infection control practices to reduce | |||
| the potential exposure to blood and | |||
| body fluids. This is a single use, | |||
| disposable device, provided non- | |||
| sterile. | Same | ||
| Material | |||
| Outer facing | |||
| layer | Spun-bond polypropylene | Polypropylene | Same |
| Middle layer | Melt blown polypropylene | 1. Polypropylene spunbond |
- Polypropylene meltblown | Similar
Note 1 |
| Inner facing
layer | Spun-bond polypropylene | Polypropylene | Same |
| Nose clip | Galvanized iron wire | Polyethylene coated steel wire | Similar
Note 1 |
| Ear loops | Nylon and Spandex | Ear loops: Polyester,
polyurethane | Similar
Note 1 |
5
| | | | Side tapes: Polyester spunbond
(ear loops mask only) | | | |
|-----------------------------------------|------------------------------------------------------------------------------------------------------------------------------------|----------------------------|------------------------------------------------------------------------------------------------------------------------------------|------------------------------|------------------------------|-------------------|
| Color | Blue | | White, Blue | | | Same |
| Mask Style | Flat Pleated | | Flat Pleated | | | Same |
| Specification
and Dimension | Length: 17.5cm±1cm
Width: 9.5cm±1cm | | Length: 90 ± 3 mm
Width:175 ± 5 mm | | | Similar
Note 1 |
| OTC use | Yes | | Yes | | | Same |
| Sterility | Non-Sterile | | Non-Sterile | | | Same |
| Use | Single Use, Disposable | | Single Use, Disposable | | | Same |
| ASTM F2100
Level | Level 2 | Level 3 | Level 1 | Level 2 | Level 3 | Same |
| Fluid
Resistance
Performance | Pass at 120
mmHg | Pass at 160
mmHg | Pass at 80
mmHg | Pass at
120
mmHg | Pass at
160
mmHg | Same |
| Particulate
Filtration
Efficiency | Pass at ≥98% | Pass at ≥98% | Pass at
99.6% | Pass at
99.6% | Pass at
99.7% | Similar
Note 2 |
| Bacterial
Filtration
Efficiency | Pass at ≥98% | Pass at ≥98% | Pass
at >98% | Pass
at >98% | Pass
at >99% | Similar
Note 2 |
| Differential
Pressure | Pass at 24 h to 30 d). The 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.
10. Summary of Clinical Performance Test
No clinical study is included in this submission.
11. Final Conclusion:
7
The conclusion drawn from the nonclinical tests demonstrate that the subject device is as safe, as effective, and performs as well as the legally marketed device identified in K160269.