(88 days)
No
The device description and performance studies focus solely on the physical and filtration properties of a standard surgical face mask, with no mention of AI or ML.
No
A surgical face mask is primarily a barrier device to prevent the transfer of microorganisms and fluids, rather than to treat or cure a disease or condition.
No
The device is a surgical face mask intended to protect against transfer of microorganisms and particulate material, not to diagnose a condition.
No
The device description clearly outlines a physical, multi-layer mask made of nonwoven fabrics, a nose piece, and ear loops. The performance studies focus on physical properties and biocompatibility, not software validation.
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. This information is used for diagnosis, monitoring, or screening.
- Device Function: The description clearly states the device is a Surgical Face Mask. Its intended use is to be worn on the face to filter microorganisms, body fluids, and particulate material, protecting both the wearer and others. It acts as a physical barrier.
- No Specimen Analysis: The device does not interact with or analyze any specimens taken from the body. It does not provide diagnostic information based on biological samples.
The information provided describes a medical device used for infection control and personal protection, not for in vitro diagnostic testing.
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 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 proposed devices are three-layer, flat pleated masks. A Surgical Face Mask is composed of a mask body, a nose piece and two ear loops. The mask body is manufactured with three layers, the inner layer and the outer layer are made of spunbond polypropylene nonwoven fabric, and the middle layer is made of meltblown polypropylene nonwoven fabric.
The model of proposed device, ear-loop, is held in place over the user's mouth and nose by two elastic ear loops welded to the mask body. The elastic ear loops are knitted elastic loops (made of polyester and spandex).
The nose piece is in the layers of face mask to allow the user to fit the face mask around their nose, which is a steel wire with polyethylene covering.
The proposed devices are provided 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 testing was performed.
7.1 Physical performance testing
The performances of Surgical Face Mask conform to ASTM F 2100-19 and the following performance tests have been conducted to demonstrate the effectiveness of device.
- Bacterial filtration efficiency (BFE): pass (ASTM F2101)
- Particulate filtration efficiency (PFE): pass (ASTM F2299)
- Differential pressure (Delta-P): pass (EN 14683)
- Fluid Resistance: pass (ASTM F1862)
- Flammability: Class 1 (16 CFR Part 1610)
7.2 Biocompatibility testing
Surgical Face Mask has been subjected to biocompatibility studies to demonstrate the safety according to ISO 10993-1, "Biological evaluation of medical devices -- Part 1: Evaluation and testing within a risk management process". The following tests have been conducted.
- In Vitro Cytotoxicity (ISO 10993-5): non-cytotoxic;
- Skin Irritation (ISO 10993-10): non-irritating;
- Skin Sensitization (ISO 10993-10): non-sensitizing.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is a seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" arranged in a circular pattern. To the right of the seal, there is the FDA logo in blue, with the words "U.S. FOOD & DRUG" on top and "ADMINISTRATION" below. The logo is simple and professional, reflecting the FDA's role in regulating food and drugs.
April 2, 2021
Guangdong Winsun Personal Care Products Co.,Ltd % Grace Liu Consultant Shenzhen Joyantech Consulting Co., Ltd 1713A, 17th Floor, Block A, Zhongguan Times Square, Nanshan District Shenzhen, Guangdong 518000 China
Re: K210023
Trade/Device Name: Surgical Face Mask Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: December 28, 2020 Received: January 4, 2021
Dear Grace Liu:
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.
For Ryan Ortega Ph. D 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
2
Indications for Use
510(k) Number (if known) K210023
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 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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
510(k) Summary
1. Contact Details
1.1 Applicant information
| Applicant Name | Guangdong Winsun Personal Care Products Co.,Ltd |
|---|---|
| Address | No.1 Guangxing Road, Xiqiao Sci-Tec Industrial Park, Xiqiao |
| Town, Nanhai District, Foshan City, Guangdong Province, | |
| P.R.China | |
| Contact person | Dong Pingping |
| Phone No. | +86-139 2990 4428 |
| dongpingping@gdwinsun.cn | |
| Date Prepared | 2020-12-12 |
1.2 Submission Correspondent
| | Shenzhen Joyantech Consulting Co., Ltd
1713A, 17th Floor, Block A, Zhongguan Times Square,
Nanshan District, Shenzhen, Guangdong Province, China |
|-------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------|
| 卓远天成 | |
| Phone No. | +86-755-86069197 |
| Contact person | Grace Liu; Field Fu; |
| Contact person's e-mail | grace@cefda.com; field@cefda.com |
| Website | http://www.cefda.com |
2. Device Information
| Trade name | Surgical Face Mask |
|---|---|
| Common name | Surgical Face Mask |
| Model | YS0002 |
| Classification name | Mask, Surgical |
| Review Panel | General Hospital |
| Product code | FXX |
| Device Class | II |
| Regulation No. | 21 CFR 878.4040 |
3. Legally Marketed Predicate Device
| Trade Name | Surgical Face Mask, Ear Loops, Model
101B, 101G, 136B, 136G, 137B, 137G |
| ------------ | ---------------------------------------------------------------------------- |
|---|
4
| | Surgical Face Mask, Tie-on, Model
145B, 145G, 143B, 143G, 138B, 138G, 142B, 142G, 151B,
151G |
|----------------------|----------------------------------------------------------------------------------------------------|
| 510(k) Number | K133070 |
| Product Code | FXX |
| Manufacturer | BH Medical Products Co., Ltd. |
4. Device Description
The proposed devices are three-layer, flat pleated masks. A Surgical Face Mask is composed of a mask body, a nose piece and two ear loops. The mask body is manufactured with three layers, the inner layer and the outer layer are made of spunbond polypropylene nonwoven fabric, and the middle layer is made of meltblown polypropylene nonwoven fabric.
The model of proposed device, ear-loop, is held in place over the user's mouth and nose by two elastic ear loops welded to the mask body. The elastic ear loops are knitted elastic loops (made of polyester and spandex).
The nose piece is in the layers of face mask to allow the user to fit the face mask around their nose, which is a steel wire with polyethylene covering.
The proposed devices are provided non-sterile and are intended to be single use, disposable devices.
5. Intended Use/Indication 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 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.
6. Substantial Equivalence Comparison
| Comparison
| item | Proposed Device | Predicate Device (K133070) | Comment |
|---|---|---|---|
| Manufacturer | Guangdong Winsun Personal | ||
| Care Products Co., Ltd | BH Medical Products Co., Ltd. | None | |
| Product name | Surgical Face Mask | Surgical Face Mask, Ear Loops, | |
| Model | |||
| 101B, 101G, 136B, 136G, 137B, | |||
| 137G | |||
| Surgical Face Mask, Tie-on, Model | |||
| 145B, 145G, 143B, 143G, 138B, | |||
| 138G, 142B, 142G, 151B, 151G | None | ||
| Product Code | FXX | FXX | Same |
5
| Regulation
| Number | 21 CFR § 878.4040 | 21 CFR § 878.4040 | Same | ||
|---|---|---|---|---|---|
| Classification | Class II | Class II | Same | ||
| OTC use | Yes | Yes | Same | ||
| 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 | |||||
| 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. | 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 | |||||
| facemasks 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 | ||||
| Design feature | Ear-loop | Ear-loop/Tie-on | Similar | ||
| Mask style | 3 flat pleated | 3 flat pleated | Same | ||
| Single use | Yes | Yes | Same | ||
| Color | Blue | Blue, Green | Similar | ||
| Specifications | |||||
| and | |||||
| dimensions | $(17.5±1)cm×(9.5±0.5)cm$ | ||||
| $(6.9" ±0.39") × (3.7" ±0.20")$ | $(6.8"±0.25")×(3.5"±0.25")$ | ||||
| $(6.8"±0.25")×(4.2"±0.25")$ | Similar | ||||
| Sterility | Non-sterile | Non-sterile | Same | ||
| Mater | |||||
| ials | Outer | ||||
| layer | Spunbond Polypropylene | Spunbond Polypropylene | Same | ||
| Middl | |||||
| e | |||||
| layer | Meltblown Polypropylene | Meltblown Polypropylene | Same | ||
| Inner | |||||
| layer | Spunbond Polypropylene | Spunbond Polypropylene | Same | ||
| Nose | |||||
| piece | Steel wire with polyethylene | ||||
| covering | Aluminum wire | Different | |||
| (Issue 1) | |||||
| Ear | |||||
| loop | Polyester and spandex | Polyester | Different | ||
| (Issue 2) | |||||
| ASTM F2100 | |||||
| Level | Level 1 | Level 2 | Level 3 | Same | |
| Fluid | |||||
| Resistance | Meet ASTM F1862 | Meet ASTM F1862-07 | Same | ||
| Particulate | Meet ASTM F2299 | Meet ASTM F2299-03 | Same |
6
| Filtration
| Efficiency | |||
|---|---|---|---|
| Bacterial | |||
| Filtration | |||
| Efficiency | Meet ASTM F2101 | Meet ASTM F2101-07 | Same |
| Differential | |||
| Pressure | |||
| (Delta P) | Meet EN 14683 | Meet MIL-M-36954C | Different |
| (Issue 3) | |||
| Flammability | |||
| (16CFR 1610) | Class 1 | Class 1 | Same |
| Biocompatibility | |||
| y | Non-cytotoxic, non-sensitizing, | ||
| non-irritating | Non-cytotoxic, Non-sensitizer, | ||
| non-irritant | Same |
lssue 1 and Issue 2: The differences in the materials do 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.
lssue 3: The Differential Pressure test of the proposed device was conducted in accordance with the method specified in EN 14683:2019, Annex C that is the test method specified in ASTM F2100-19. ASTM F2100-19 is the recognized consensus standard [Rec# 6-425] which is the standard specification for performance of materials used in medical face masks. And the Differential Pressure performance of the proposed device meets the requirement of ASTM F2100-19.
7. Non-clinical Testing
7.1 Physical performance testing
The performances of Surgical Face Mask conform to ASTM F 2100-19 and the following performance tests have been conducted to demonstrate the effectiveness of device.
-
Bacterial filtration efficiency (BFE): pass (ASTM F2101)
- A Particulate filtration efficiency (PFE): pass (ASTM F2299)
- A Differential pressure (Delta-P): pass (EN 14683)
- Fluid Resistance: pass (ASTM F1862) A
-
Flammability: Class 1 (16 CFR Part 1610)
7.2 Biocompatibility testing
Surgical Face Mask has been subjected to biocompatibility studies to demonstrate the safety according to ISO 10993-1, "Biological evaluation of medical devices -- Part 1: Evaluation and testing within a risk management process". The following tests have been conducted.
- A In Vitro Cytotoxicity (ISO 10993-5): non-cytotoxic;
-
Skin Irritation (ISO 10993-10): non-irritating;
7
Skin Sensitization (ISO 10993-10): non-sensitizing. >
There is no additional safety risk for the proposed device when compared with the predicate device.
8. Clinical testing
Clinical testing was not performed for the proposed device.
9. Conclusion
Indications for Use, material, design feature, specifications and technological characteristics for the proposed device are similar to the predicate device (K133070). The non-clinical performance testing demonstrates that the proposed device is substantially equivalent to the legally marketed predicate device (K133070). Therefore, the results show that it is Substantially Equivalent (SE) between the proposed device and the predicate device.