(123 days)
Not Found
No
The device description and performance studies focus on the physical properties and filtration capabilities of a surgical face mask, with no mention of AI or ML.
No
The device is a surgical face mask intended for infection control by protecting against the transfer of microorganisms, body fluids, and particulate material; it does not directly treat or cure a disease or condition.
No
The device description clearly states its purpose is to protect from microorganisms, body fluids, and particulate material, and its function relates to filtration and fluid resistance. There is no mention of it being used to diagnose conditions or diseases.
No
The device description clearly outlines the physical components of a surgical face mask (polypropylene layers, nose clip, ear straps) and the performance studies focus on material properties and physical barriers, 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, and for use in infection control practices. This is a physical barrier function, not a diagnostic one.
- Device Description: The description details the physical construction and materials of the mask. There is no mention of components or mechanisms for analyzing biological samples or providing diagnostic information.
- Lack of IVD Characteristics: IVD devices are designed to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not perform any such function.
- Performance Studies: The performance studies focus on the physical and filtration properties of the mask (fluid resistance, filtration efficiency, pressure, flammability, biocompatibility), which are relevant to its function as a barrier, not a diagnostic tool.
Therefore, the Surgical Face Masks described are not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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(s), provided sterile.
Product codes (comma separated list FDA assigned to the subject device)
FXX
Device Description
The Surgical Face Masks are Flat Pleated type mask, utilizing Ear straps way for wearing, and they all have Nose clip design for fitting the face mask around the nose. The Surgical Face Masks are manufactured with three layers. The outer layer is made of polypropylene spun-bond non-woven fabric. The middle layer with filtration function is made of polypropylene melt-blown non-woven fabric. The inner layer contact with face is made of polypropylene spun-bond non-woven fabric. The nose clip is made of polyethylene strip with iron wire inside. The ear straps are made of spandex polyester fiber.
The Surgical Masks are single use, disposable device, provided 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
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 was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards:
- 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 F2100-19, Standard Specification for Performance of Materials Used In Medical Face Masks.
- ASTM F1862M-17, Standard Test Method For Resistance Of Medical Face . Masks To Penetration By Synthetic Blood (Horizontal Projection Of Fixed Volume At A Known Velocity)
- EN 14683:2019, Medical Face Mask-Test-Requirements and Test Methods; ●
- 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 F2299-03, Stand 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;
Key results as per the table:
- Fluid Resistance Performance (ASTM F2100-19): 29 out of 32 pass at 160mmHg. Results: Meet the requirement.
- Particulate Filtration Efficiency: >=98%. Results: Meet the requirement.
- Bacterial Filtration Efficiency: >=98%. Results: Meet the requirement.
- Differential Pressure: =98%
Bacterial Filtration Efficiency: >=98%
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
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 14, 2022
Jiangxi Ganlong Pharmaceutical Co.,Ltd. % Stuart Situ Director Landlink Healthcare Technology (Shanghai) Co., Ltd. Room 1308, Baohua International Plaza, West Guangzhong Road Shanghai, 200071 China
Re: K212913
Trade/Device Name: Surgical Face Mask Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: September 7, 2021 Received: September 13, 2021
Dear Stuart Situ:
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
Page 2
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.
for Clarence W. Murray, III, Ph.D. 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) K212913
Device Name Surgical Face Mask
Indications for Use (Describe)
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(s), provided 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 (K212913)
l Submitter
Jiangxi Ganlong Pharmaceutical Co.,Ltd. No. 164 Xiangjiang Ave. Ganzhou Economic and Technology Development Zone, Ganzhou City, Jiangxi Province, China
Establishment Registration Number: Not yet registration
Contact Person: Niansheng Liao Position: Manager Tel.: +86-18907977486 E-mail: Daniel.Liao@glpharma.cn
Preparation date: Sep.07, 2021
II Proposed Device
| Trade Name of Device: | Surgical Face Mask |
|---|---|
| Model: | SMSE01 |
| Common name: | Surgical Mask |
| Regulation Number: | 21 CFR 878.4040 |
| Regulatory Class: | Class II |
| Product code: | FXX |
| Review Panel | General Hospital |
III Predicate Devices
| 510(k) Number: | K202354 |
|---|---|
| Trade name: | Surgical Mask |
| Common name: | Surgical Mask |
| Classification: | Class II |
| Product Code: | FXX |
| Manufacturer: | Hunan Heng Chang Pharmaceutical Co., Ltd |
IV Device description
The Surgical Face Masks are Flat Pleated type mask, utilizing Ear straps way for wearing, and they all have Nose clip design for fitting the face mask around the nose. The Surgical Face Masks are manufactured with three layers. The outer layer is made
4
of polypropylene spun-bond non-woven fabric. The middle layer with filtration function is made of polypropylene melt-blown non-woven fabric. The inner layer contact with face is made of polypropylene spun-bond non-woven fabric. The nose clip is made of polyethylene strip with iron wire inside. The ear straps are made of spandex polyester fiber.
The Surgical Masks are single use, disposable device, provided sterile.
V Indication for use
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(s), provided sterile.
| VI Comparison of technological characteristics with the predicate devices
Item | Proposed device | Predicate device
(K202354) | Discussion | |
|-----------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------|------------|
| Product name | Surgical Face Mask | Surgical Mask | Same | |
| Product Code | FXX | FXX | Same | |
| Regulation No. | 21 CFR 878.4040 | 21 CFR 878.4040 | Same | |
| Class | Class II | Class II | Same | |
| Mask style | Flat-pleated, ear strap, 3
layers | Flat-pleated, ear strap, 3
layers | Same | |
| Indication for use | 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(s), | 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 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/ | Same | |
| | | provided sterile. | sterile. | |
| Materi
al | Inner
layer | Spun-bond polypropylene | Spun-bond polypropylene | Same |
| | Middle
layer | Melt blown polypropylene
filter | Melt blown polypropylene
filter | Same |
| | Outer
layer | Spun-bond polypropylene | Spun-bond polypropylene | Same |
| | Ear strap | spandex polyester fiber | Spandex + Polyester | Different1 |
| | Nose clip | polyethylene strip with iron
wire inside | malleable polyethylene | Different1 |
| Color | | Blue | Blue | Same |
| Length | | 17.5 cm±5% | 17.5 cm±5% | Same |
| Width | | 9.5 cm±5% | 9.5 cm±5% | Same |
| OTC use | | Yes | Yes | Same |
| sterile | | sterile | Non-sterile, sterile | Similar |
| Sterilization
method | | EO | EO | Same |
| Single for use | | Yes | Yes | Same |
| | ASTM F2100
Level | Level 3 | Level 1 | Different2 |
| | Biocompatibility | Confirm to the
requirements of ISO 10993
series standards | Confirm to the
requirements of ISO 10993
series standards | Same |
VI Comparison of technological characteristics with the predicate devices
5
1 The difference in the materials does not raise additional questions for safety and effectiveness of the device. The biocompatibility evaluation test of the subject devices have been performed on the final finished device which includes all construction materials and color additives. The test results shows pass the requirements.
² The different level of specification does not affect the indications of the products.
VII Non-Clinical Testing
Non clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test
6
results demonstrated that the proposed device complies with the following standards:
- 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 F2100-19, Standard Specification for Performance of Materials Used In Medical Face Masks.
- ASTM F1862M-17, Standard Test Method For Resistance Of Medical Face . Masks To Penetration By Synthetic Blood (Horizontal Projection Of Fixed Volume At A Known Velocity)
- EN 14683:2019, Medical Face Mask-Test-Requirements and Test Methods; ●
- 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 F2299-03, Stand test method for determining the initial efficiency of . materials used in medical face masks to penetration by particulates using latex spheres;
| Test Purpose | ISO/ASTM
standard | Acceptance criteria | Results |
|-----------------------------------------|-----------------------|----------------------------------------------------------------------------------|-------------------------|
| Fluid Resistance
Performance | ASTM F2100-
19 | 29 out of 32 pass at
160mmHg | Meet the
requirement |
| Particulate
Filtration
Efficiency | | ≥98% | Meet the
requirement |
| Bacterial Filtration
Efficiency | | ≥98% | Meet the
requirement |
| Differential
Pressure | |