(129 days)
Not Found
No
The device description and performance studies focus on material properties and filtration efficiency, with no mention of AI or ML.
No
The device is a medical surgical mask intended to prevent the transfer of microorganisms and fluids, primarily for infection control and protection, not for treating a disease or condition.
No
The device is a medical surgical mask intended to protect from microorganisms and body fluids, not to diagnose a condition.
No
The device description clearly outlines physical components (polypropylene layers, spandex/nylon ear loops, steel wire nose piece) and performance studies related to material properties and physical filtration, indicating it is a hardware device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, or tissue) to detect diseases, conditions, or infections.
- Device Function: The description clearly states the device is a "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 Testing on Samples: The device does not perform any tests on samples taken from the body. Its function is external and protective.
- Performance Studies: The performance studies listed (Flammability, Filtration Efficiency, Pressure, Resistance to Penetration) are all related to the physical properties and barrier function of the mask, not diagnostic testing.
Therefore, based on the provided information, this medical surgical mask is a Class II medical device (as indicated by the predicate device K number which is for surgical face masks), but it is not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The medical surgical mask is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids, and particulate material. This face mask is intended for use in infection control practices to reduce the potential exposure to blood 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 medical surgical mask is designed and manufactured by Shenzhen Everwin Precision Technology Co, Ltd. It is non-sterile and for single use. It's a disposable device. The medical surgical mask is manufactured with three-layers, the inner and outer layers are made of polypropylene, and the middle layer is made of melt blown polypropylene. The elastic ear loop of proposed device is made of spandex and nylon, not made with natural rubber latex. The nose piece contained in the proposed device allows the user to fit the face mask around their nose, which is made from steel wire.
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 were performed.
Biocompatibility evaluation was conducted in accordance with the International Standard ISO 10993-1:2018. Tests included Cytotoxicity, Sensitization, and Skin Irritation. All tests resulted in "Same" with the predicate device, indicating non-cytotoxic, non-sensitizing, and non-irritating results for the subject device.
Performance testing was conducted, and all tested parameters met predefined acceptance criteria. Tests included:
- Flammability: Class I (Same as predicate)
- Bacterial Filtration Efficiency: >=98% (Same as predicate)
- Differential Pressure: = 98% (Similar to predicate)
- Resistance to Penetration by Synthetic Blood: 29 out of 32 passes at 160mmHg (Same as predicate)
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Flammability: Class I
Bacterial Filtration Efficiency: >=98%
Differential Pressure: = 98%
Resistance to Penetration by Synthetic Blood: 29 out of 32 at passes 160mmHg
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
November 23, 2020
Shenzhen Everwin Precision Technology Co., Ltd. % Olivia Meng Regulatory Affairs Manager Guangzhou Osmunda Medical Device Technical Services Co. Ltd. 8-9th Floor, R&D Building, No.26 Qinglan Street, Panyu District Guangzhou, Guangdong 510006 China
Re: K201991
Trade/Device Name: Medical surgical mask Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical apparel Regulatory Class: Class II Product Code: FXX Dated: July 10, 2020 Received: July 17, 2020
Dear Olivia Meng:
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.
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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 and Part 809); 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-reporting-
combination-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.
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) K201991
Device Name Medical surgical mask
Indications for Use (Describe)
The medical surgical mask is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids, and particulate material. This face mask is intended for use in infection control practices to reduce the potential exposure to blood 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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510(k) Summary K201991
1. SUBMITTER
Shenzhen Everwin Precision Technology Co., Ltd. Building 3, Third Industrial Zone, FuqiaoQiaotou, Fuyong town, Bao'an district, Shenzhen, China Phone: +86-13925511162 Fax: +86-755-27343466
| Primary Contact | Olivia Meng |
|---|---|
| Person: | Regulatory Affairs Manager |
| Guangzhou Osmunda Medical Device Technical Service | |
| Co., Ltd. | |
| Tel: (+86)-20-6231 6262 | |
| Fax: (+86) -20-8633 0253 | |
| Secondary Contact | Guoshun Shi |
| Person: | Quality System Senior Manager |
Shenzhen Everwin Precision Technology Co., Ltd. Phone: +86-13925511162 Fax: +86-755-27343466
November 23, 2020 Date prepared
-
- DEVICE
| Trade Name: | Medical Surgical Mask |
|---|---|
| Common name: | Surgical Mask |
| Model: | EWPT0005 |
| Classification name | Mask, Surgical |
| Regulation number | 21 CFR 878.4040 |
| Regulation Class: | Class II |
| Product Code: | FXX |
- PREDICATEDEVICE
K160269, Surgical Face Masks (Ear loops and Tie-on)
4. DEVICE DESCRIPTION
The medical surgical mask is designed and manufactured by Shenzhen Everwin
4
Precision Technology Co, Ltd. It is non-sterile and for single use. It's a disposable device. The medical surgical mask is manufactured with three-layers, the inner and outer layers are made of polypropylene, and the middle layer is made of melt blown polypropylene. The elasticear loop of proposed device is made of spandex and nylon, not made with natural rubber latex. The nose piece contained in the proposed device allows the user to fit the face mask around their nose, which is made from steel wire.
5. INDICATIONS FOR USE
The medical surgical mask is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids, and particulate material. This face 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, provided non-sterile.
| Comparison Item | Proposed device | Predicate device | Comparison
result |
|-----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------|
| 510k number | K201991 | K160269 | - |
| Intended Use | The medical surgical mask is
intended to be worn to protect
both the patient and healthcare
personnel from transfer of
microorganisms, body fluids, and
particulate material. This face
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,
provided non-sterile. | 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,
provided non-sterile. | Same |
| Mask style | Flat pleated | Flat pleated | Same |
| Design feature | Ear loop | Earloop or tie-on | Similar |
| Material of outer
facing layer | Polypropylene | Polypropylene | Same |
| Material of
middle layer | Melt blown polypropylene | Polypropylene meltblown
and
polypropylene | Similar |
6. Summary of Technological Characteristics
5
| spunbond | |||
|---|---|---|---|
| Material of inner | |||
| facing layer | Polypropylene | Polypropylene | Same |
| Nosepiece | Polypropylene coated steel wire | Polypropylene coated | |
| steel wire | Same | ||
| Attachment | Ear loops: Spandex and nylon | Ear loops: Polyester, | |
| polyurethane Side tapes: | |||
| Polyester spunbond (ear | |||
| loops mask only) Tie tapes: | |||
| Polypropylene spunbondor | |||
| polyester spunbond | Similar | ||
| Dimension | |||
| (Length × Width) | 17.5 cm × 9.5 cm | 17.5 cm × 9.0 cm | |
| 18.0 cm × 9.0 cm | Similar | ||
| OTC use | Yes | Yes | Same |
| Sterility | Non-sterile | Non-sterile | Same |
| Single use | Yes | Yes | Same |
| ASTM F 2100 | |||
| level | Level 3 | Level 1 | |
| Level 2 | |||
| Level 3 | Similar | ||
| Biocompatibility | Pass ISO 10993cytotoxicity, skin | ||
| irritation and skin sensitivity | |||
| tests | Pass ISO | ||
| 10993cytotoxicity, skin | |||
| irritation and skin | |||
| sensitivity tests | Same |
The subject device is the same as the predicate device in the intended use, material, ASTM F2100 level and biocompatibility, and similar in mask style, design feature and dimension. So the subject device is identical to the predicate device.
PERFORMANCE DATA 7.
7.1. Non-clinical test performed on the proposed device
The following performance data were provided in support of the substantial equivalence determination.
Biocompatibility testing
The biocompatibility evaluation for the medical surgical mask was conducted in accordance with the International Standard ISO 10993-1:2018, "Biological evaluation of
6
medical devices - Part 1: Evaluation and testing within a risk management process" as recognized by FDA. The biocompatible testing included the following tests:
| Item | Acceptance
Criteria | Proposed
device | Predicate
device | Result |
|-----------------|---------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------|--------|
| Cytotoxicity | Under the
conditions of the
study, the subject
device was non-
cytotoxic. | Under the
conditions of the
study, the subject
device was non-
cytotoxic. | Under the
conditions of the
study, the subject
device was non-
cytotoxic | Same |
| Sensitization | Under the
conditions of the
study, the subject
device was
non-sensitizing | Under the
conditions of the
study, the subject
device was non-
sensitizing. | Under the
conditions of the
study, the subject
device was non-
sensitizing. | Same |
| Skin Irritation | Under the
conditions of the
study, the subject
device was
non-irritating. | Under the
conditions of the
study, the
subject device was
non-irritating. | Under the
conditions of the
study, the subject
device was non-
irritating. | Same |
Performance testing
Performance testing was conducted on the medical surgical mask. All of the tested parameters met the predefined acceptance criteria.
| Item | Proposed
device | Predicate
device | Acceptance
Criteria | Result |
|---------------------------------------|--------------------|---------------------|------------------------|--------|
| Flammability | Class I | Class I | Class I | Same |
| Bacterial
Filtration
Efficiency | >=98% | 98% | >=98% | Same |
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| K201991 | ||||
|---|---|---|---|---|
| Item | Proposed device | Predicate device | Acceptance Criteria | Result |
| Differential | ||||
| Pressure, mm | ||||
| H2O/cm2 | = 98% | Average 99.8% | >= 98% | Similar |
| Resistance to | ||||
| Penetration | ||||
| by Synthetic | ||||
| Blood | ||||
| (mmHg) | 29 out of 32 at | |||
| passes | ||||
| 160mmHg | 29 out of 32 passes | |||
| at | ||||
| 160mmHg | 29 out of 32 passes | |||
| at 160mmHg | Same |
7.2. Clinical test conclusion
No clinical study is included in this submission.
8. CONCLUSION
8.1. Conclusion
The conclusions drawn from the nonclinical tests demonstrate that the subject device is as safe, as effective, and performs as well as or better than the legally marketed predicate device, Surgical Face Mask (K160269).