(100 days)
No
The document describes a standard surgical mask and its physical properties and performance testing. There is no mention of AI or ML technology.
No.
This device is a surgical mask intended for barrier protection, not for treating a disease or condition.
No
The device description clearly states it is a surgical mask intended for protection and infection control, not for diagnosing conditions.
No
The device is a physical surgical mask made of various materials like polypropylene, steel wire, polyester, and polyurethane. The description details its physical components and performance testing related to material properties and filtration, not software functionality.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Definition of IVD: In Vitro Diagnostic devices are used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information about a person's health. This testing is performed outside of the body (in vitro).
- Intended Use of the Device: The provided text clearly states the surgical masks are intended to be worn to protect from the transfer of microorganisms, body fluids, and particulate material. They are used in infection control practices to reduce exposure. This is a physical barrier function, not a diagnostic test performed on a specimen.
- Device Description: The description details the physical components of the mask (mask body, nose piece, ear loops/ties) and the materials used. There is no mention of reagents, assays, or any components typically associated with diagnostic testing.
- Performance Studies: The performance studies focus on physical properties like filtration efficiency, fluid resistance, and biocompatibility, which are relevant to a barrier device, not a diagnostic test.
The device described is a surgical mask, which is a personal protective equipment (PPE) device used for infection control.
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 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, and provided as sterile.
Level 3 Surgical mask model (Ear-loop): XT10A1 Level 3 Surgical mask model (Tie-on): XT10B1
Product codes
FXX
Device Description
The surgical mask consists of a mask body, a nose piece, and ear loops or ties. The mask body is divided into three layers, the inner and outer layers are made of polypropylene materials; the middle layer is composed of melt-blown cloth (polypropylene); the nose piece is made of polyethylene coated steel wire, the ear loops are made of polyester silk & polyurethane filament, and the ties are made of polypropylene.
The size specification of the surgical mask:
- Mask body for ear-loop type: 17.5cm×9.5cm & 14.5cm×9.5cm;
- Mask body for Tie-on type: 17.5cm×9.5cm
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 testing was performed including biocompatibility testing, physical performance testing, and ethylene oxide sterilization validation.
Biocompatibility testing:
- Cytotoxicity: Under the conditions of the study, the subject device was non-cytotoxic.
- Skin Sensitization: Under the conditions of the study, the subject device was non-sensitizing.
- Skin Irritation: Under the conditions of the study, the subject device was non-irritating.
Physical performance testing in accordance with ASTM F2100-19:
- Fluid Resistance: 32 out of 32 pass at 160mmHg (ASTM F1862).
- Bacterial Filtration Efficiency Performance: Pass at ≥ 98% (ASTM F2101). Results for Lot 1#, 2#, and 3# were 99.7%-99.9%.
- Differential Pressure (Delta-P): Pass at
§ 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 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.
August 18, 2021
Jiangsu Xingtong Biotechnology Group Co., Ltd. % James Tsai Consultant Shenzhen Joyantech Consulting Co., Ltd. 1713A, 17th Floor, Block A, Zhongguan Times Square, Nanshan District Shenzhen, Guangdong 518000 China
Re: K211454
Trade/Device Name: Surgical mask Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: July 6, 2021 Received: July 12, 2021
Dear James Tsai:
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 Clarence W. Murray, III, Ph.D. 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) K211454
Device Name 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 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, and provided as sterile.
Level 3 Surgical mask model (Ear-loop): XT10A1 Level 3 Surgical mask model (Tie-on): XT10B1
| 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
K211454
1. Administrative Information
| Date of Summary prepared | August 5, 2021 |
|---|---|
| Manufacturer information | Company: Jiangsu Xingtong Biotechnology Group |
| Co., Ltd. | |
| Company address: | |
| No.8, Kele road, Touqiao Area, Beizhou Industrial | |
| Park, Guangling Zone, Yangzhou City, China | |
| Contact person: Li Hua | |
| Tel: +86-0514-87485222 | |
| Fax: +86-0514-87481010 | |
| E-mail: 920740335@qq.com | |
| Submission Correspondent | Shenzhen Joyantech Consulting Co., Ltd. |
| Address: 1713A, 17th Floor, Block A, Zhongguan | |
| Times Square, Nanshan District, Shenzhen | |
| Contact person: James Tsai | |
| E-Mail: james tsai@cefda.com; field@cefda.com |
2. Device Information
| Type of 510(k) submission: | Traditional |
|---|---|
| Trade Name: | Surgical mask |
| Classification name: | Surgical Face Mask, Apparel |
| Review Panel: | General and plastic surgery devices |
| Product Code: | FXX |
| Common name | Surgical mask |
| Device Class: | II |
| Regulation Number: | 878.4040 |
3. Predicate Device Information
| Sponsor: | SAN-M PACKAGE CO., LTD. |
|---|---|
| Device trade name: | Surgical face mask (Ear loops and Tie-on) |
| Device Class: | II |
| 510(K) Number: | K160269 |
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| Regulation name | Masks, Surgical |
|---|---|
| Production regulation: | 21 CFR §878.4040 |
| Product code: | FXX |
| Review Panel: | General and plastic surgery device |
4. Device Descriptions
The surgical mask consists of a mask body, a nose piece, and ear loops or ties. The mask body is divided into three layers, the inner and outer layers are made of polypropylene materials; the middle layer is composed of melt-blown cloth (polypropylene); the nose piece is made of polyethylene coated steel wire, the ear loops are made of polyester silk & polyurethane filament, and the ties are made of polypropylene.
The size specification of the surgical mask:
- Mask body for ear-loop type: 17.5cm×9.5cm & 14.5cm×9.5cm;
- Mask body for Tie-on type: 17.5cm×9.5cm
5. 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 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 as sterile.
6. Technological Characteristics Comparison
| Comparison
item | Proposed Device
(Jiangsu Xingtong
Biotechnology Group Co.,
Ltd.) | Predicate Device
(K160269, SAN-M
PACKAGE CO., LTD.) | Remark |
|---------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------|
| Product name | Surgical mask | Surgical face mask | Similar |
| Product model | Ear loops: XT10A1;
Tie-on: XT10B1 | Ear loops: EL 30000;
Tie-on: TO 30000 | Similar |
| Product Code | FXX | FXX | Same |
| Classification | Class II (21 CFR
878.4040) | Class II (21 CFR
878.4040) | Same |
| 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 | 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 | Similar |
| | | | |
| | 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 as sterile. | 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. | |
| Mask features | Ear Loops and Tie-on;
Flat Pleated | Ear Loops and Tie-on;
Flat Pleated | Same |
| Layers | 3 layers | 4 layers | Different |
| Outer layer | Polypropylene | Polypropylene | Same |
| Filter media | Melt-blown cloth
(polypropylene) | Polypropylene spunbond
Polypropylene meltblown | Different |
| Inner layer | Polypropylene | Polypropylene | Same |
| Ear loops | -Ear loops: Polyester silk &
Polyurethane filament
-Ties: Polypropylene | -Ear loops: Polyester,
polyurethane
-Side tapes: Polyester
spunbond (ear loops mask
only)
-Tie tapes: Polypropylene
spunbond or polyester
spunbond | Similar |
| Nose piece | Polyethylene coated
steel wire | Polyethylene coated
steel wire | Same |
| Color | Blue | White or Blue | Similar |
| Dimension | Mask body for ear-loop
type: 17.5cm×9.5cm &
14.5cm×9.5cm
Mask body for Tie-on type:
17.5cm×9.5cm | Mask body for both ear-
loop and tie-on types:
17.5cm×9.0cm &
18.0cm×9.0cm | Different |
| OTC Use | Yes | Yes | Same |
| Sterility | Sterile | Non-sterile | Different |
| Packaging
material | Paper plastic bag | Not publicly available | Different |
| Sterilization
method and
S.A.L. | Sterilized by ethylene
oxide gas, SAL= $10-6$ | Not applied | Different |
| Shelf life | 2 years | No shelf life claim | Different |
| Use | Single-use, disposable | Single-use, disposable | Same |
| Performance | Level 3 | Level 3 | Same |
| | | | |
| level | | | |
| Fluid
Resistance
Performance | 32 Out of 32 pass at
160mmHg
(ASTM F1862) | 32 Out of 32 pass at
160mmHg
(ASTM F1862) | Same |
| Particulate
Filtration
Efficiency | Pass at ≥ 98%
(ASTM F2299) | Pass at ≥ 98%
(ASTM F2299) | Same |
| Bacterial
Filtration
Efficiency | Pass at ≥ 98%
(ASTM F2101) | Pass at ≥ 98%
(ASTM F2101) | Same |
| Differential
Pressure
(Delta-P) | Pass at