(119 days)
Not Found
No
The device description and performance metrics relate to the physical properties and filtration capabilities of a surgical mask, with no mention of AI or ML.
No.
This device is a surgical mask intended for barrier protection against microorganisms, body fluids, and particulate material, not for treating a disease or condition.
No
The device, a surgical mask, is intended to protect from transfer of microorganisms and body fluids, not to diagnose medical conditions.
No
The device description clearly outlines physical components (spun-bond polypropylene, melt blown polypropylene filter, elastic ear loops/ties, malleable aluminum wire nose piece) and performance testing related to material properties and physical barriers, indicating it is a physical medical device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the surgical 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 function.
- Device Description: The description details the physical construction of the mask (layers, materials, straps, nose piece). There is no mention of any components or mechanisms used for testing or analyzing samples from the human body.
- Lack of IVD Characteristics: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This surgical mask does not perform any such function.
- Performance Studies: The performance studies listed (Fluid Resistance, Particulate Filtration Efficiency, Bacterial Filtration Efficiency, etc.) are all related to the physical barrier properties and safety of the mask, not to diagnostic accuracy or performance.
In summary, the surgical mask described is a medical device intended for physical protection and infection control, not for in vitro diagnostic testing.
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 the potential exposure to blood and body fluids. This is a single use ,disposable device, provided non-sterile.
Product codes (comma separated list FDA assigned to the subject device)
FXX
Device Description
The proposed devices are single use, three-layer, flat masks with straps and nose piece. The Surgical Masks are manufactured with three layers, the inner and outer layers are made of spun-bond polypropylene, and the middle layer is made of melt blown polypropylene filter.
The proposed device is held in place over the user's mouth and nose by two elastic ear loops or four ties welded to the face mask. The elastic ear loops are not made with natural rubber latex.
The nose piece contained in the proposed device is in the layers of face mask to allow the user to fit the face mask around their nose, which is made of Malleable aluminum wire.
The proposed devices 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 tests were conducted and conformed to the following standards and the requirements state in the Guidance for Industry and FDA Staff: Surgical Masks -Premarket Notification [510(k)] Submission issued on March 05, 2004.
Tests performed:
- Fluid Resistance Performance (ASTM F1862): Pass at 160 mmHg
- Particulate Filtration Efficiency (ASTM F2299): > 98%
- Bacterial Filtration Efficiency (ASTM F2101): > 98%
- Differential Pressure (EN 14683:2019): 98%
Bacterial Filtration Efficiency (ASTM F2101): > 98%
Differential Pressure (EN 14683:2019):
§ 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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June 7, 2021
Dongguan Shin Yi Healthcare Products Factory % Joyce Yang Consultant Shenzhen Jovantech Consulting Co., Ltd. 1713A, 17th Floor, Block A, Zhongguan Times Square Nanshan District Shenzhen, Guangdong 51800 China
Re: K210372
Trade/Device Name: Disposable Surgical Mask Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX, Dated: April 25, 2021 Received: May 3, 2021
Dear Joyce Yang:
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 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,
Clarence W. Murray III -S
Clarence W. Murray, III, 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
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Indications for Use
510(k) Number (if known) K210372
Device Name Disposable Surgical Mask
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 the 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
510(k) Number: K210372
Date Prepared: June 5, 2021
1.Submission Sponsor
| Manufacturer information | Company: Dongguan Shin Yi Healthcare
Products Factory |
|--------------------------|----------------------------------------------------------------------------------------------------------|
| | Company address: No. 17 Ban Hu Road, Huang
Jiang Town, Dong Guan City, Guang Dong
Province, China. |
| | Contact person: Zhao Shuge |
| | Phone: +86-769-83361381 |
| | Fax: +86-769-83631102 |
| | E-mail: zhaosg.dg@master-frank.cn |
2. Submission correspondent
| Name Address | Shenzhen Joyantech Consulting Co., Ltd
1713A, 17th Floor, Block A, Zhongguan Times Square,
Nanshan District, Shenzhen |
|---------------------|-----------------------------------------------------------------------------------------------------------------------------|
| Post Code Phone No. | 518000
86-755-86069197 |
| Contact Person | Joyce Yang |
| Email | joyce@cefda.com |
3. Device Identification
| Type of 510(k) submission: | Traditional |
|---|---|
| Trade Name: | Disposable Surgical Mask |
| Model: | MFA05004, MFA05005, MFA05007, MFA05008 |
| Classification name: | Mask, Surgical |
| Review Panel: | Surgical Apparel |
| Product Code: | FXX |
| Device Class: | II |
| Regulation Number: | 21 CFR 878.4040 |
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4. Legally Marketed Predicate Device
| Trade Name | Single-use Surgical Mask |
|---|---|
| Regulation number | 21 CFR 878.4040 |
| Regulation class | II |
| Regulation name | Surgical Apparel |
| 510(k) Number | K200923 |
| Product Code | FXX |
| Manufacturer | BYD Precision Manufacturer Co.,Ltd. |
5. Device Description
The proposed devices are single use, three-layer, flat masks with straps and nose piece. The Surgical Masks are manufactured with three layers, the inner and outer layers are made of spun-bond polypropylene, and the middle layer is made of melt blown polypropylene filter.
The proposed device is held in place over the user's mouth and nose by two elastic ear loops or four ties welded to the face mask. The elastic ear loops are not made with natural rubber latex.
The nose piece contained in the proposed device is in the layers of face mask to allow the user to fit the face mask around their nose, which is made of Malleable aluminum wire.
The proposed devices are sold non-sterile and are intended to be single use, disposable devices.
6. 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 the potential exposure to blood and body fluids. This is a single use, disposable device, provided non-sterile.
7. Technological characteristics comparison
| Comparison
item | Subject Device: Disposable
Surgical Mask(K210372) | Predicate Device: Single-
use Surgical Mask
(K200923) | Comments |
|----------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------|
| Product Code | FXX | FXX | Same |
| Regulation Number | 21 CFR § 878.4040 | 21 CFR § 878.4040 | Same |
| Classification n | Class II | Class II | Same |
| OTC use | Yes | Yes | Same |
| Intended use & | The Surgical Masks are | The Single-use Surgical | Same |
| Comparison
item | Subject Device: Disposable
Surgical Mask(K210372) | Predicate Device: Single-
use Surgical Mask
(K200923) | Comments |
| Indication
s for Use | 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
the potential exposure to
blood and body fluids. This is
a single use ,disposable
device, provided non-sterile. | 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. | |
| Design
feature | Ear-loop, Tie-on | Ear-loop | Similar
(Issue 1) |
| Usage | Single use | Single use | Same |
| Color | Blue | Blue | Same |
| Size | $(18±1)cm×(9±1)cm$
$(14.5±1)cm×(9±1)cm$ | $(17.5±1)cm×(9.5±1)cm$ | Similar
(Issue 2) |
| Sterile | Non-sterile | Non-sterile | Same |
| Material | Outer layer: Spun-bond
polypropylene | Outer layer: Spun-bond
polypropylene | Same |
| | Middle layer: Melt blown
polypropylene filter | Middle layer: Melt blown
polypropylene filter | Same |
| | Inner layer: Spun-bond
polypropylene | Inner layer:Spun-bond
polypropylene | Same |
| | Nose piece:Malleable
aluminum wire | Nose piece:Metal Core
Plastic | Different
(Issue 3) |
| Comparison
item | Subject Device: Disposable
Surgical Mask(K210372) | Predicate Device: Single-
use Surgical Mask
(K200923) | Comments |
| | Ear-loops: Elastic fiber
Tie-on:Spun-bond
polypropylene | Ear-loops: Polyester | Similar
(Issue 3) |
| ASTM F
2100 Level | Level 3 | Level 3 | Same |
| Fluid
Resistance
Performance
ASTM F
1862-13 | Pass at 160 mmHg | Pass at 160 mmHg | Same |
| Particulate
Filtration
Efficiency
ASTM F
2299 | > 98% | > 98% | Same |
| Bacterial
Filtration
Efficiency
ASTM F
2101 | > 98% | > 98% | Same |
| Differential
Pressure
(Delta P) EN
14683:2019+
AC : 2019 | 98% | > 98% |
| Bacterial Filtration
Efficiency
(ASTM F2101) | For evaluating the ability of
the mask's material to
prevent the passage of
aerosolized bacteria | > 98% | > 98% |
| Differential Pressure
(EN 14683:2019) | For evaluating the
breathability and comfort of
the surgical mask |