(120 days)
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 infection control by protecting against the transfer of microorganisms and fluids, not for treating a disease or condition.
No
The device is a medical surgical mask intended to protect against the transfer of microorganisms, body fluids, and particulate material, not to diagnose a condition.
No
The device description clearly outlines physical components (polypropylene non-woven fabric, melt-blown fabric, elastic ear loops, nose piece made of polypropylene and iron wire) and performance testing related to these physical properties (fluid resistance, filtration efficiency, flammability, dimensions). This indicates it is a physical medical device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health, such as diagnosing a disease or monitoring a condition.
- Device Function: The description clearly states the device is a Medical Surgical Mask. Its intended use is to create a physical barrier to protect the wearer and others from the transfer of microorganisms, body fluids, and particulate material. It is a barrier device used externally.
- No Specimen Analysis: The device does not interact with or analyze any specimens taken from the body.
- Performance Metrics: The performance metrics listed (Fluid Resistance, Filtration Efficiency, Differential Pressure, Flammability, etc.) are related to the physical barrier properties of the mask, not to the analysis of biological samples.
The information provided describes a standard medical device used for infection control, not an IVD.
N/A
Intended Use / Indications for Use
The Medical Surgical Masks-Non Sterile is intended to be worn to protect both the patient and healthcare personnel from the transfer of microorganisms, body fluids, and particulate material. The Medical Surgical Masks-Non Sterile 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.
Product codes
FXX
Device Description
The Medical Surgical Masks-Non Sterile is intended to be worn to protect both the patient and healthcare personnel from the transfer of microorganisms, body fluids, and particulate material. The Medical Surgical Masks-Non Sterile 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 proposed device(s) are White color, and Flat Pleated type mask, utilizing Ear Loops' way for wearing, and they all have Nose Piece design for fitting the facemask around the nose.
The proposed device(s) are manufactured with three layers, the inner and outer layers are made of polypropylene non-woven fabric, and the middle layer is made of polypropylene melt-blown fabric.
The Medical Surgical Masks-Non Sterile is held in place over the user's mouth and nose by two elastic ear loops welded to the facemask. The elastic ear loops are made with 30% polyamide and 70% polyurethane.
The nose piece contained in the proposed device(s) is in the layers of the facemask to allow the user to fit the facemask around their nose, which is made of polypropylene and iron wire.
The proposed device(s) 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 Test Conclusion:
Applied Standards List:
- 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 F1862-17, Standard Test Method For Resistance Of Medical Face Masks To Penetration By Synthetic Blood (Horizontal Projection Of Fixed Volume At A Known Velocity)
- MIL-M-36945C, Method 1 Military Specifications: Surgical Mask disposable;
- 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;
- Bench Testing for the performance of Dimensions.
Results:
- In Vitro Cytotoxicity: Under the conditions of the study, not cytotoxicity effect
- Skin Irritation: Under the conditions of the study, not an irritant
- Skin Sensitization: Under conditions of the study, not a sensitizer.
- Fluid Resistance: 120 mmHg
- Particulate Filtration Efficiency: ≥99%
- Bacterial Filtration Efficiency: ≥99%
- 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 6, 2021
Shandong T&F Nonwoven Co., LTD % Ray Wang General Manager Beijing Believe-Med Technology Service Co., Ltd. Rm. 912, Building #15, XiYueHui, No. 5, YiHe North Rd., FangShan District Beijing, Beijing 102401 China
Re: K202594
Trade/Device Name: Medical Surgical Masks-Non Sterile Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical apparel Regulatory Class: Class II Product Code: FXX Dated: December 3, 2020 Received: December 7, 2020
Dear Ray 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.
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) K202594
Device Name Medical Surgical Masks-Non Sterile
Indications for Use (Describe)
The Medical Surgical Masks-Non Sterile is intended to be worn to protect and healthcare personnel from the transfer of microorganisms, body fluids, and particulate material. The Medical Surgical Masks-Non Sterile 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.
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
The assigned 510(k) Number: K202594
510(k) Summary
This 510(k) Summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of SMDA 1990 and Title 21, CFR Section 807.92.
-
- Date of Preparation:2021/01/06
-
- Sponsor Identification
SHANDONG T&F NONWOVEN CO., LTD.
SOUTH OF SHUANGYONG ROAD, CHENGYANG DIST. QINGDAO SHANDONG PROVINCE, 266100, CHINA
Contact Person: Minsheng Zhao Position: General Manager Tel: +86-18005326009 Fax: +86-0532-55676260 Email: mins 01@126.com
-
- Designated Submission Correspondent
Mr. Ray Wang
- Designated Submission Correspondent
Beijing Believe-Med Technology Service Co., Ltd.
Rm.912, Building #15, XiYueHui, No.5, YiHe North Rd., FangShan District, Beijing, 102401, China
Tel: +86-18910677558 Fax: +86-10-56335780 Email: Ray.Wang(@believe-med.com
4
4. Identification of Proposed Device
Trade Name: Medical Surgical Masks-Non Sterile Common Name: Mask, Surgical
Regulatory Information Classification Name: Mask, Surgical Classification: 2 Product Code: FXX Regulation Number: 878.4040 Review Panel: General Hospital
Indication for use Statement:
The Medical Surgical Masks-Non Sterile is intended to be worn to protect both the patient and healthcare personnel from the transfer of microorganisms, body fluids, and particulate material. The Medical Surgical Masks-Non Sterile 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.
Device Description
The Medical Surgical Masks-Non Sterile is intended to be worn to protect both the patient and healthcare personnel from the transfer of microorganisms, body fluids, and particulate material. The Medical Surgical Masks-Non Sterile 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 proposed device(s) are White color, and Flat Pleated type mask, utilizing Ear Loops' way for wearing, and they all have Nose Piece design for fitting the facemask around the nose.
The proposed device(s) are manufactured with three layers, the inner and outer layers are made of polypropylene non-woven fabric, and the middle layer is made of polypropylene melt-blown fabric.
The Medical Surgical Masks-Non Sterile is held in place over the user's mouth and nose by two elastic ear loops welded to the facemask. The elastic ear loops are made with 30% polyamide and 70% polyurethane.
The nose piece contained in the proposed device(s) is in the layers of the facemask to allow the user to fit the facemask around their nose, which is made of polypropylene and iron wire.
The proposed device(s) are sold non-sterile and are intended to be single-use, disposable devices.
- Identification of Predicate Device(s) న్.
Predicate Device
5
K153496 Disposable Surgical Face Mask Xiantao Rayxin Medical Products Co., ltd.
-
Non-Clinical Test Conclusion 6.
Applied Standards List: -
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 F1862-17, Standard Test Method For Resistance Of Medical Face Masks To Penetration By Synthetic Blood (Horizontal Projection Of Fixed Volume At A Known Velocity)
-
MIL-M-36945C, Method 1 Military Specifications: Surgical Mask disposable;
-
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;
-
A 16 CFR 1610, Standard for the Flammability of clothing textiles;
-
Bench Testing for the performance of Dimensions.
| Title of the Test | Purpose of the Test | Acceptance criteria and
source of references | Results |
|--------------------------------------|-----------------------------------------------------------------------------------|-----------------------------------------------------------------|------------------------------------------------------------------|
| In Vitro
Cytotoxicity | Verify the Biological performance
of proposed device | No cytotoxicity effect as the
test method of ISO
10993-10 | Under the conditions of
the study, not cytotoxicity
effect |
| Skin Irritation | Verify the Biological performance
of proposed device | No irritation effect as the
test method of ISO 10993-5 | Under the conditions of
the study, not an irritant |
| Skin Sensitization | Verify the Biological performance
of proposed device | No sensitization effect as the
test method of ISO 10993-5 | Under conditions of the
study, not a sensitizer. |
| Fluid Resistance | Verify the fluid resistance
performance of proposed device | 120 mmHg as the test
method of ASTM F1862 | 120 mmHg |
| Particulate
Filtration Efficiency | Verify the Particulate filtration
efficiency performance of proposed
device | ≥98% as the test method of
ASTM F2299 | ≥99% |
| Bacterial Filtration
Efficiency | Verify the bacterial filtration
efficiency performance of proposed
| ≥98% as the test method of
ASTM F2101 | ≥99% |
Test Result Summary:
6
| device | |||
|---|---|---|---|
| Differential | |||
| Pressure (Delta P) | Verify the differential pressure | ||
| performance of proposed device |