(257 days)
Not Found
No
The device description and performance studies focus on the physical properties and filtration capabilities of a surgical face mask, with no mention of AI or ML.
No.
The device, a surgical face mask, is intended for infection control to protect against fluid and particulate transfer, not for treating a disease or condition.
No
Explanation: The device is a surgical face mask, which is used for protection from transfer of microorganisms, body fluids, and particulate material, not for diagnosing a condition or disease.
No
The device description clearly outlines a physical, multi-layered mask with ear loops and a nose piece, and the performance studies are based on physical properties like fluid resistance and filtration efficiency, not software performance.
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. They are used outside the body (in vitro).
- Device Description and Intended Use: The description clearly states that the Surgical Face Masks are worn on the face to protect against the transfer of microorganisms, body fluids, and particulate material. They are a physical barrier used on the body, not for analyzing samples taken from the body.
- Lack of IVD Characteristics: The document does not mention any analysis of biological samples, reagents, or laboratory procedures, which are hallmarks of IVD devices.
The device described is a medical device, specifically a surgical face mask, intended for personal protection and infection control.
N/A
Intended Use / Indications for Use
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(s), provided non-sterile.
Product codes
FXX
Device Description
The Surgical Face Masks are single use, three-layer, flat –folded masks with ear loops and nose piece. The Surgical Face Masks are manufactured with three layers, the inner and outer layers are made of spunbond polypropylene, and the middle layer is made of melt blown polypropylene filter. The ear loops are held in place over the users' mouth and nose by two elastic ear loops welded to the facemask. The elastic ear loops are not made with natural rubber latex. The nose piece in the layers of facemask is to allow the user to fit the facemask around their nose, which is made of malleable polyethylene wire. The surgical face masks will be provided in yellow. The surgical face masks 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
Non-clinical tests were performed on the proposed device.
Fluid Resistance (ASTM F1862): 32 out of 32 samples passed at 120 mmHg, meeting the acceptance criterion of 29 out of 32 pass at 120 mmHg.
Particulate Filtration Efficiency (ASTM F2299): 99.7%, meeting the acceptance criterion of >= 98%.
Bacterial Filtration Efficiency (ASTM F2101): 99.9%, meeting the acceptance criterion of >= 98%.
Differential Pressure (MIL-M-36954C): 4.0mmH2O/cm², meeting the acceptance criterion of
§ 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.
May 27, 2019
Wuhan Dymex Healthcare Co., Ltd % Ivy Wang Technical Manager Shanghai Sungo Management Consulting Company Limited 4th Floor, 1500# Central Avenue Shanghai, 200122 Cn
Re: K182515
Trade/Device Name: Surgical Face Mask Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: April 4, 2019 Received: April 29, 2019
Dear Ivy 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.
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
1
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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/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 David Krause, PhD Acting Division Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: 0MB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.
510(k) Number (if known) K182515
Device Name Surgical Face Mask
Indications for Use (Describe)
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(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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510(K) Summary
K182515 Date Summary Prepared: 2019-05-22
A. Applicant:
WUHAN DYMEX HEALTHCARE CO., LTD Address: Room 1701, Unit 2, Building 5, Jingsegangwan Phase 5, Dongfeng Avenus, Wuhan, Hubei, China Contact Person: Ms. Ada Liu Tel: +86- 15172402381/+86-27-8462 1898-8003
Submission Correspondent: Primary contact: Ms. Ivy Wang Shanghai SUNGO Management Consulting Co., Ltd. Room 1309, Dongfang Building, 1500# Century Ave., Shanghai 200122, China Tel: +86-21-58817802 Email: haiyu.wang@sungoglobal.com Secondary contact: Mr. Raymond Luo Room 1309, Dongfang Building, 1500# Century Ave., Shanghai 200122, China Tel: +86-21-68828050 Email: fda.sungo@gmail.com
B. Device:
Trade Name: SURGICAL FACE MASK Common Name: SURGICAL FACE MASK Model(s): Ear Loop
Regulatory Information Classification Name: Surgical Face Mask Classification: Class II. Product code: FXX Regulation Number: 878.4040 Review Panel: Surgical Apparel
c. Predicate device:
K153496 Disposable Surgical Face Mask Xiantao Rayxin Medical Products Co., Ltd.
D. Indications for Use:
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
4
use, disposable device(s), provided non-sterile.
E. Device Description:
The Surgical Face Masks are single use, three-layer, flat –folded masks with ear loops and nose piece. The Surgical Face Masks are manufactured with three layers, the inner and outer layers are made of spunbond polypropylene, and the middle layer is made of melt blown polypropylene filter. The ear loops are held in place over the users' mouth and nose by two elastic ear loops welded to the facemask. The elastic ear loops are not made with natural rubber latex. The nose piece in the layers of facemask is to allow the user to fit the facemask around their nose, which is made of malleable polyethylene wire. The surgical face masks will be provided in yellow. The surgical face masks are sold non-sterile and are intended to be single use, disposable devices.
Table 1 General Comparison Device Proposed Device Predicate Device Result Manufacturer WUHAN DYMEX HEALTHCARE Xiantao Rayxin Medical Products Co., -CO., LTD ltd. K182515 K153496 -510K number Model Name SURGICAL FACE MASK SURGICAL FACE MASK Same Classification ll Device, (21 Class II Device, FXX (21 CFR878.4040) Class FXX Same CFR878.4040) Intend use The Surgical Face Masks are The Disposable Surgical Face Masks Same intended to be worn to are intended to be worn to protect protect both the patient and both the patient and healthcare healthcare personnel from personnel from transfer of transfer of microorganisms, microorganisms, body fluids and body fluids and particulate particulate material. These face material. These face masks masks are intended for use in are intended for use in infection control practices to reduce infection control practices to the potential exposure to blood and reduce the potential body fluids. This is a single use, exposure to blood and body disposable device(s), provided nonfluids. This is a single use, sterile. disposable device(s), provided non-sterile. Model Ear Loops, Flat Pleated, 3 Ear Loops, Tie-On, Flat Pleated, 3 Same layers lavers Outer Spun-bond polypropylene Spun-bond polypropylene Same facing layer Middle Melt blown polypropylene filter Melt blown polypropylene filter Same Material layer Inner Spun-bond polypropylene Spun-bond polypropylene Same facing
F. Summary of Technological Characteristic
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| layer | ||||
|---|---|---|---|---|
| Nose piece | Malleable polyethylene wire | Malleable aluminum wire | Similar | |
| Ear loops | Spandex | Polyester | Different* | |
| Color | Yellow | Blue | Different* | |
| Dimension (Width) | 17.5cm±0.2cm | 17.5cm±1cm | Same | |
| Dimension (Length) | 9.5cm±0.2cm | 9.5cm±1cm | Same | |
| OTC use | Yes | Yes | Same | |
| Sterility | Non-Sterile | Non-Sterile | Same | |
| Use | Single Use, Disposable | Single Use, Disposable | Same | |
| ASTM F2100 Level | Level 2 | Level 2 | Same |
*The difference in the materials and colors does not raise additional questions for safety and effectiveness. Performance testing including biocompatibility evaluation has been performed on the final finished device which includes all construction materials and color additives.
G. Non-clinical Test performed on the proposed device
The proposed devices were tested and conformed to the following standards and the requirements stated in the Guidance for Industry and FDA Staff: Surgical Masks – Premarket Notification [510(k)] Submission issued on March 5, 2004.
| Item | Proposed device | Acceptance Criteria | Result |
|---|---|---|---|
| Fluid Resistance | |||
| Performance | |||
| ASTM F1862 | 32 out of 32 pass at 120 mmHg | 29 out of 32 pass at 120 mmHg | Pass |
| Particulate | |||
| Filtration Efficiency | |||
| ASTM F2299 | 99.7% | $\ge$ 98% | Pass |
| Bacterial Filtration | |||
| Efficiency | |||
| ASTM F2101 | 99.9% | $\ge$ 98% | Pass |
| Differential | |||
| Pressure (Delta P) | |||
| MIL-M-36954C | 4.0mmH2O/cm² |