(43 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
A therapeutic device is used to treat or cure a disease or condition. This device is a surgical mask intended for infection control and protection from transfer of microorganisms, not for treating any condition.
No
Explanation: The device, a surgical mask, is intended for infection control by preventing the transfer of microorganisms and particulate material. It does not perform any diagnostic function.
No
The device description clearly outlines physical components made of materials like polypropylene, nylon, spandex, and steel wire, and the performance studies focus on physical properties like filtration efficiency and resistance to penetration. There is no mention of software as a component or function of the device.
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 "Disposable medical surgical mask" intended to be worn on the face to protect against the transfer of microorganisms, body fluids, and particulate material. It acts as a physical barrier.
- Lack of Specimen Analysis: The device does not interact with or analyze any specimens taken from the body. Its function is external and protective.
- Intended Use: The intended use is for infection control practices and reducing exposure, not for diagnosing or monitoring a medical condition through the analysis of biological samples.
The information provided describes a standard medical device used for personal protection, not an IVD.
N/A
I
Intended Use / Indications for Use
The Disposable medical surgical mask is intended to be worn to protect 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.
Product codes
FXX
Device Description
The Disposable medical 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 proposed device(s) are Blue 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 spunbond fabric, and the middle layer is made of polypropylene meltblown fabric.
The Disposable medical surgical mask 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 nylon and spandex.
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 coated steel 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
Not Found
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: 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 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)
- EN 14683-2019+AC:2019 Annex C, Medical face masks - 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 include:
- ASTM F1862 (Resistance to penetration by synthetic blood): 160 mm Hg (Acceptance Criteria: 160 mm Hg)
- ASTM F2299 (Sub-micron particulate filtration efficiency at 0.1 micron): ≥ 99% (Acceptance Criteria: ≥ 98%)
- ASTM F2101 (Bacterial Filtration Efficiency): ≥ 99% (Acceptance Criteria: ≥ 98%)
- EN 14683 Annex C (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.
August 18, 2021
Hebei Titans Hongsen Medical Technology 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: K212097
Trade/Device Name: Disposable medical surgical mask Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: June 30, 2021 Received: July 6, 2021
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 (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.
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
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K212097
Device Name Disposable medical surgical mask
Indications for Use (Describe)
The Disposable medical surgical mask is intended to be worn to protect 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.
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 - K212097
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:2021/08/18
-
- Sponsor Identification
Hebei Titans Hongsen Medical Technology Co., Ltd
East Industrial Concentration Zone, Nangong City, Xingtai City, 055750, Hebei Province, China.
Contact Person: Chai Wu Position: Production Manager Tel: +86-17769045117 Fax: +86-0319-7295811 Email: 846920354@qq.com
-
Designated Submission Correspondent 3.
Mr. Ray Wang 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 -
- Identification of Proposed Device
Trade Name: Disposable medical surgical mask Common Name: Mask, Surgical
- Identification of Proposed Device
Regulatory Information Classification Name: Mask, Surgical Classification: II Product Code: FXX Regulation Number: 878.4040 Review Panel: General Hospital
Indication for use Statement:
4
The Disposable medical 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.
Device Description:
The Disposable medical 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 proposed device(s) are Blue 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 spunbond fabric, and the middle layer is made of polypropylene meltblown fabric.
The Disposable medical surgical mask 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 nylon and spandex.
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 coated steel wire.
The proposed device(s) are sold non-sterile and are intended to be single-use, disposable devices.
- ડ. Identification of Predicate Device(s)
510(k) number: K202511 Device Name: Disposable Medical Surgical Mask Manufacturer: Improve Medical (HuNan) Co., Ltd.
Technological Characteristics Comparison 6.
Table 1 General Comparison
| ITEM | Proposed Device K212097 | Predicate Device K202511 | Remark |
|---|---|---|---|
| ASTM F2100 Level 3 | ASTM F2100 Level 3 |
5
| Indication for use | | The Disposable medical 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 Disposable Medical 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 |
|--------------------|--------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------|
| Basic Design | | Ear Loops, Flat Pleated, 3 layers | Ear loops, Flat Pleated, 3 layers | SAME |
| Materials | Outer Facing Layer | polypropylene spunbond fabric | Spun-bond polypropylene | Analysis |
| | Middle Layer | polypropylene meltblown fabric | Melt-blown polypropylene filter | |
| | Inner Facing Layer | polypropylene spunbond fabric | Spun-bond polypropylene | |
| | Nose Piece | polypropylene coated steel wire | Polyethylene coated steel wire | |
| | Ear Loops | nylon , spandex | Polyester | |
| Color | | Blue | Blue | SAME |
| Dimension | | $17.5 \pm 5% \text{ cm}$ | $17.5 \text{cm} \pm 0.2 \text{cm}$ | Similar |
| | (Length, Width) | $9.5 \pm 5% \text{cm}$ | $9.5 \pm 0.2 \text{cm}$ | |
| OTC use | | Yes | Yes | SAME |
| Single Use | | Single use, disposable | Single use, disposable | SAME |
| Sterile | | Non-sterile | Non-sterile | SAME |
Table 2 Performance Characteristic Comparison
| ITEM | Proposed Device
K212097 | Predicate Device
K202511 | ASTM F2100
Requirements | Remark |
|-------------------------------------------------------------------------|----------------------------------|-------------------------------|----------------------------|--------|
| ASTM F2100 Level | Level 3 | Level 3 | Level 3 | SAME |
| Fluid Resistance
Performance ASTM
F1862 | 32 out of 32 pass at
160 mmHg | 32 out of 32 pass at 160 mmHg | 160 mmHg | SAME |
| Particulate Filtration
Efficiency ASTM
F2299 | ≥99% | Pass at 98.6% | ≥ 98% | |
| Bacterial Filtration
Efficiency ASTM
F2101 | ≥99% | Pass at 99.9% | ≥ 98% | |
| Differential
Pressure (Delta P)
EN 14683:2019+
AC:2019 Annex C | 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)
-
EN 14683-2019+AC:2019 Annex C, Medical face masks - 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;
| Test Method | Purpose | Acceptance Criteria | Results |
|---|---|---|---|
| ASTM F1862 | Resistance to penetration | ||
| by synthetic blood | 160 mm Hg | 160 mm Hg |
7
| ASTM F2299 | Sub-micron particulate
filtration efficiency at 0.1
micron | $\geq 98%$ | $\geq 99%$ |
|---------------------|------------------------------------------------------------------|----------------------------|-----------------------------------------------------------------|
| ASTM F2101 | Bacterial Filtration
Efficiency | $\geq 98%$ | $\geq 99%$ |
| EN 14683
Annex C | Differential Pressure | $