(87 days)
Not Found
No
The device description and performance studies focus on material properties and filtration efficiency, with no mention of AI/ML technologies.
No
The device is a surgical mask intended for protection against transfer of microorganisms and fluids, not for treating a disease or condition.
No
Explanation: The provided text describes surgical masks intended for protection against microorganisms and fluids, not for diagnosing medical conditions.
No
The device description clearly indicates it is a physical product (surgical masks) made of non-woven fabrics, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the 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 one.
- Device Description: The description details the physical construction and materials of the mask, which are designed for filtration and barrier protection.
- Lack of Diagnostic Elements: There is no mention of the device being used to test samples (like blood, urine, or tissue) or to provide information about a patient's health status or disease.
- Performance Studies: The performance studies focus on barrier and filtration properties (fluid resistance, particulate filtration efficiency, bacterial filtration efficiency, differential pressure, flammability), which are relevant to personal protective equipment, not diagnostics.
- Predicate Device: The predicate device is also a surgical face mask, further indicating its classification as a protective device.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This surgical mask does not perform any such function.
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(s), provided non-sterile.
Product codes (comma separated list FDA assigned to the subject device)
FXX
Device Description
The Surgical Masks are Flat Pleated type mask, utilizing Ear Loops way for wearing, and they all have Nose Piece design for fitting the face mask around the nose. The Medical Procedure Masks are manufactured with three layers. The outer layer is made of double spun-bonded polypropylene (PP) non-woven fabric. The middle layer with filtration function is made of melt blown polypropylene (PP) non-woven fabric. The inner layer which contacts with face is made of double spun-bonded polypropylene (PP) non-woven fabric.
The Surgical Masks are single use, disposable device, provided non-sterile.
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 performance tests were conducted to verify that the proposed device met all design specifications. The below table shows the test results of test article, which demonstrated that the proposed device complies with the standards of ASTM F2100-19:
| Methodology | Purpose | Acceptance Criteria | Results |
|---|---|---|---|
| ASTM F1862M-17 | Fluid Resistance Performance | 29 out of 32 pass at 160mmHg | Pass at 160mmHg |
| ASTM F2299 | Particulate Filtration Efficiency | >= 98% | Pass |
| ASTM F2101-19 | Bacterial Filtration Efficiency | >=98% | Pass |
| EN 14683:2019 Annex C | Differential Pressure |
§ 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 square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
June 10, 2021
Hunan Triplex Precision Medical Devices Co., Ltd % Amber Pang Director Landlink Healthcare Technology (Shanghai) Co., Ltd. Room 703, 705, Building 1, West Guangzhong Road 555, Shanghai, 200072 China
Re: K210767
Trade/Device Name: Surgical Masks, Model:FE-1 Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: March 9, 2021 Received: March 15, 2021
Dear Amber Pang:
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.
Ryan Ortega, 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
2
Indications for Use
510(k) Number (if known) K210767
Device Name Surgical Masks
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(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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3
Section 3-510(k) Summary
l. Submitter
Hunan Triplex Precision Medical Devices Co., Ltd. Room 612 & 613, Building No.5~8, SUNVO Health & Medicine Industrial Park, No.1048 Zhongqing Road, Kaifu District, Changsha, Hunan, China
Establishment Registration Number: 3017420299
Contact person: Huangkai Position: Manager Tel.: +86 0731-86780069 Fax: +86-0731-86780069 E-mail: Hwangkay@tom.com
Preparation date: Jun. 01, 2021
II. Proposed Device
| Trade Name of Device: | Surgical Masks |
|---|---|
| Common name: | Surgical Mask |
| Regulation Number: | 21 CFR 878.4040 |
| Regulatory Class: | Class II |
| Product code: | FXX |
| Review Panel | General Hospital |
III. Predicate Devices
| 510(k) Number: | K160269 |
|---|---|
| Trade name: | Surgical Face masks (Ear loops and Tie-on) |
| Common name: | Surgical Mask |
| Classification: | Class II |
| Product Code: | FXX |
| Manufacturer | San-M Package Co., Ltd. |
IV. Device Description
The Surgical Masks are Flat Pleated type mask, utilizing Ear Loops way for wearing, and they all have Nose Piece design for fitting the face mask around the nose. The
4
Medical Procedure Masks are manufactured with three layers. The outer layer is made of double spun-bonded polypropylene (PP) non-woven fabric. The middle layer with filtration function is made of melt blown polypropylene (PP) non-woven fabric. The inner layer which contacts with face is made of double spun-bonded polypropylene (PP) non-woven fabric.
The Surgical Masks are single use, disposable device, provided non-sterile.
V. Indication 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(s), provided non-sterile.
VI. Comparison of Technological Characteristics with the Predicate Devices
| Item | Proposed Device | Predicate Device
(K160269) |
|-----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Trade Name | Surgical Masks | Surgical Face masks (Ear
loops and Tie-on) |
| Product Code | FXX | FXX |
| Regulation No. | 21 CFR 878.4040 | 21 CFR 878.4040 |
| Class | Class II | Class II |
| Mask Style | Flat-pleated, ear loops,
3 layers | Flat-pleated, ear loops or
tie-on, 4 layers |
| Indication 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(s), | The Surgical facemasks are
intended to be worn to protect
the patient and healthcare
personnel from transfer of
microorganisms, blood fluid,
and particulate material. These
face masks are intended for
use in infection control
practices to reduce the
potential exposure to blood
and body fluid. This is a
single-use, disposable devices |
Table 10-1 General Comparison
5
| provided non-sterile. | provided non-sterile. | ||
|---|---|---|---|
| Mat | |||
| erial | Inner | ||
| layer | White double spun-bond | ||
| polypropylene | Polypropylene | ||
| Middle | |||
| layer | Melt blown polypropylene filter | 1. Polypropylene spun-bond |
- Polypropylene melt blown |
| | Outer
layer | Blue double spun-bond
polypropylene | Polypropylene |
| | Ear loops | 85% Polyester +15% Spandex
3.0 Latex – free white elastic
band | Ear loops: Polyester, polyurethane;
Side tapes: Polyester spun-bond (ear loops mask only)
Ties tapes: Polypropylene spun-bond or polyester spun-bond |
| | Nose
piece | Iron wire covered by
polypropylene | Polyethylene coated
steel wire |
| | Color | Blue | Blue ,white |
| | Dimension | 17.5cmx9.5cm | 17.5cmx9.0cm
18.0cmx9.0cm |
| | OTC Use | Yes | Yes |
| | Sterile | Non-sterile | Non-sterile |
| | For single Use | Yes | Yes |
| | ASTM F2100
Level | Level 3 | Level 1, Level 2, Level 3 |
| | Biocompatibility | Confirm to the requirements of
ISO 10993 series standards | Confirm to the requirements of
ISO 10993 series standards |
VII. Non-Clinical Testing
Non clinical performance tests were conducted to verify that the proposed device met all design specifications. The below table shows the test results of test article, which demonstrated that the proposed device complies with the standards of ASTM F2100-19:
| Methodology | Purpose | Acceptance Criteria | Results |
|---|---|---|---|
| ASTM F1862M-17 | Fluid Resistance | ||
| Performance | 29 out of 32 pass | ||
| at 160mmHg | Pass at 160mmHg | ||
| ASTM F2299 | Particulate Filtration | $\geq$ 98% | Pass |
6
| Efficiency | ||||
|---|---|---|---|---|
| ASTM F2101-19 | Bacterial Filtration | |||
| Efficiency | ≥98% | Pass | ||
| EN | ||||
| Annex C | 14683:2019 | Differential | ||
| Pressure |