(248 days)
Not Found
No
The device is a surgical mask, a physical barrier device, and the description focuses on materials, construction, and performance metrics related to filtration and barrier properties. There is no mention of any computational or analytical functions that would utilize AI/ML.
No.
A therapeutic device is typically used to treat, cure, or alleviate a disease or condition, or to restore normal function. This device, a surgical mask, is intended for protection and infection control, not for therapeutic purposes.
No
Explanation: The device is a surgical mask intended for protection and infection control, not for diagnosing medical conditions.
No
The device description clearly outlines physical components (fabric layers, ear loops, nose piece) and performance testing related to material properties and physical barriers, indicating it is a hardware device. There is no mention of software as a component or function.
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 mask is for protecting against the transfer of microorganisms, body fluids, and particulate material, and for reducing exposure to blood and body fluids. This is a physical barrier function, not a diagnostic test performed in vitro (outside the body).
- Device Description: The description details the physical construction and materials of the mask. There is no mention of reagents, assays, or any components used to analyze biological samples.
- Performance Studies: The performance studies focus on the physical barrier properties and biocompatibility of the mask (filtration efficiency, fluid resistance, flammability, irritation, etc.). These are not diagnostic performance metrics.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information about a patient's health status.
In summary, the device is a physical barrier intended for infection control, not a diagnostic tool.
N/A
Intended Use / Indications for Use
The Single-Use 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 Single-Use Surgical Mask 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. Model: M and L, blue color, and Level 3 barrier level as ASTM F2100.
Product codes (comma separated list FDA assigned to the subject device)
FXX
Device Description
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 meet Level 3 requirements per ASTM F2100.
The proposed device(s) are manufactured with three layers, the inner and outer layers are made of PP spun-bond non-woven fabric, and the middle layer is made of Melt-blown non-woven fabric. The blue colorant is blue masterbatch.
The Single-Use 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 not made with Polypropylene fiber.
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 malleable aluminum wire.
The proposed device(s) are sold non-sterile and are intended to be single-use, disposable devices.
There are two models included, Model M and L. The two models share the same indication for use, instruction for use, material used, and structure. The dimension, the model L is bigger than model M.
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)
Summary of Non-Clinical Testing
The following performance data has been provided to demonstrate that the subject device meet the acceptance criteria in the standard.
Name of the Test Methodology/standard: ASTM F1862
Purpose: Resistance to penetration by synthetic blood
Acceptance Criteria: 160 mm Hg
Results: 160 mm Hg
Name of the Test Methodology/standard: ASTM F2299
Purpose: Sub-micron particulate filtration efficiency at 0.1 micron
Acceptance Criteria: >= 98%
Results: >= 99.03%
Name of the Test Methodology/standard: ASTM F2101
Purpose: Bacterial Filtration Efficiency
Acceptance Criteria: >= 98%
Results: >= 99.50%
Name of the Test Methodology/standard: MIL-M-36954C
Purpose: Differential Pressure
Acceptance Criteria:
§ 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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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.
March 15, 2021
Qiqihar Hengxin Medical Supplies, 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: K201924
Trade/Device Name: Single-Use Surgical Mask Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: February 23, 2021 Received: February 26, 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 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
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Indications for Use
510(k) Number (if known) K201924
Device Name Single-Use Surgical Mask
Indications for Use (Describe)
The Single-Use 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 Single-Use Surgical Mask 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.
Model: M and L, blue color, and Level 3 barrier level as ASTM F2100
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) |
|---|---|
| -------------------------------------------------------------- | ------------------------------------------------------------- |
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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.
The 510(k) Number: K201924
-
- Date of Preparation:2021/03/13
-
- Sponsor Identification
Oigihar Hengxin Medical Supplies, Ltd.
10th Beijiang Road in Tiefeng Industrial Park, North Shuguang Ave. Tiefeng District, Qiqihar, Heilongjiang Province, China, 161000
Contact Person: Sihui Xiong Position: Commercial Manager Tel: +86-452-5656959 Email: 476923513@qq.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
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4. Identification of Proposed Device
Trade Name: Single-Use Surgical Mask Common Name: Surgical Face Mask Model(s): M, L
Regulatory Information Classification Name: Surgical Face Mask Classification: II Product Code: FXX Regulation Number: 878.4040 Review Panel: Surgical Apparel
Indication for use Statement:
The Single-Use 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 Single-Use Surgical Mask 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. Model: M and L, blue color, and Level 3 barrier level as ASTM F2100.
Device Description
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 meet Level 3 requirements per ASTM F2100.
The proposed device(s) are manufactured with three layers, the inner and outer layers are made of PP spun-bond non-woven fabric, and the middle layer is made of Melt-blown non-woven fabric. The blue colorant is blue masterbatch.
The Single-Use 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 not made with Polypropylene fiber.
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 malleable aluminum wire.
The proposed device(s) are sold non-sterile and are intended to be single-use, disposable devices.
There are two models included, Model M and L. The two models share the same indication for use, instruction for use, material used, and structure. The dimension, the model L is bigger than model M.
5. Identification of Predicate Device(s)
5
Predicate Device K191355 3M High Fluid-Resistant Procedure Mask 3M Health Care
- Summary of Non-Clinical Testing 6.
The following performance data has been provided to demonstrate that the subject device meet the acceptance criteria in the standard.
| Name of the Test
| Methodology/standard | Purpose | Acceptance Criteria | Results |
|---|---|---|---|
| ASTM F1862 | Resistance to penetration | ||
| by synthetic blood | 160 mm Hg | 160 mm Hg | |
| ASTM F2299 | Sub-micron particulate | ||
| filtration efficiency at 0.1 | |||
| micron | $\geq 98%$ | $\geq99.03%$ | |
| ASTM F2101 | Bacterial Filtration | ||
| Efficiency | $\geq 98%$ | $\geq99.50%$ | |
| MIL-M-36954C | Differential Pressure | $ |