(163 days)
No
The device description and performance studies focus on the physical properties and filtration capabilities of a face mask, with no mention of AI or ML.
No.
The device description and intended use focus on protection and prevention of microorganism transfer, not on treating a medical condition or disease.
No
The device is a protective face mask intended for use in infection control practices to prevent the transfer of microorganisms and particulate material, not to diagnose a condition or disease.
No
The device description clearly outlines a physical product made of multiple layers of material with a nose piece and ear loops. The performance studies focus on physical properties like fluid resistance, filtration efficiency, and flammability, which are characteristic of hardware devices. There is no mention of software components, algorithms, or data processing.
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 provide information about a person's health. They are used outside the body.
- Device Intended Use: The intended use of this device is to be worn by healthcare personnel to protect against the transfer of microorganisms, body fluids, and particulate material. It acts as a physical barrier.
- Device Description: The description details the physical construction of a face mask.
- Lack of IVD Characteristics: The provided information does not mention any testing of samples, analysis of biological markers, or any other function related to diagnosing or monitoring a medical condition through in vitro means.
This device is a medical device, specifically a surgical mask, but it falls under a different regulatory category than IVDs.
N/A
Intended Use / Indications for Use
The Protective Face Mask for Medical Use is intended to worn by the healthcare personnel during procedure to protect both the patient and the healthcare personnel from the 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/sterile.
Product codes
FXX
Device Description
The Protective Face Masks for Medical Use are flat-folded masks are three layers of materials consisting of polypropylene spun-bond (outer layer and inner layer), polypropylene melt-blown (middle layers). The masks contain a conformable nose piece enclosed in a binding tape welding the top edge to conform to the contours of the face. In addition, the masks contain an ultrasonically welded, elastic ear loops not made with natural rubber latex, to secure the masks in place on the wearer. The masks are offered in white.
The Protective Face Masks for Medical Use are single use, disposable device, provided non-sterile/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
Non clinical performance tests were conducted to verify that the proposed device met all design specifications.
Tests performed:
- ASTM F1862M-17 Fluid Resistance Performance: 32 out of 32 pass at 120mmHg (Acceptance Criteria: 29 out of 32 pass at 120mmHg)
- ASTM F2299 Particulate Filtration Efficiency: 98.9~99.9% (Acceptance Criteria: >= 98%)
- ASTM F2101-19 Bacterial Filtration Efficiency: 98.9~99.9% (Acceptance Criteria: >= 98%)
- EN 14683:2019 Annex C Differential Pressure: 4.0~5.6 mmH2O/cm² (Acceptance Criteria:
§ 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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January 29, 2021
Hunan Heng Chang Pharmaceutical Co., Ltd. % Shelley Li Director Shanghai Landlink Medical Information Technology Co., Ltd. Room 703, 705, Baohua International Plaza, West Guangzhong Road 555, Jingan Shanghai, 200071 China
Re: K202358
Trade/Device Name: Protective Face Mask for Medical Use Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: December 23, 2020 Received: December 28, 2020
Dear Shelley Li:
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); 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 (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) K202358
Device Name Protective Face Mask for Medical Use
Indications for Use (Describe)
The Protective Face Mask for Medical Use is intended to worn by the healthcare personnel during procedure to protect both the patient and the healthcare personnel from the transfer of microorganisms, body fluids, and particulate material. These face masks are intended for use in infection control practices to reduce the posure to blood and body fluids. This is a single use, disposable device(s), provided non-sterile/sterile.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | |
| Over-The-Counter Use (21 CFR 801 Subpart C) | ☒ |
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510(k) summary: K202358
I. Submitter
Hunan Heng Chang Pharmaceutical Co., Ltd.
Floor 2,3,102 of Building 16, Standard Plant of Shanhe Pharmaceutical and Health Industrial Park, No. 1048, Zhongqing Road, Kaifu District, Changsha 410000, China
Contact person: Tao jingfeng Position: QC Manager Tel.: +86-18774961605 E-mail: taojingfeng@hcyy.com Preparation date: Dec.23, 2020
II. Proposed Device
| Trade Name of Device: | Protective Face Mask for Medical Use |
|---|---|
| Common name: | Surgical Mask |
| Regulation Number: | 21 CFR 878.4040 |
| Regulatory Class: | Class II |
| Product code: | FXX |
| Review Panel: | General Hospital |
| 510(k) Number: | K202358 |
III. Predicate Devices and Reference Device
Predicate device
| 510(k) Number: | K143287 |
|---|---|
| Trade name: | FLUIDSHIELD Surgical Mask with Expanded Chamber |
| Common name: | Surgical Mask |
| Classification: | Class II |
| Product Code: | FXX |
| Manufacturer: | Halyard Health, Inc. |
Reference Device
| 510(k) Number: | K160271 |
|---|---|
| Trade name: | N95 Particulate and Surgical Mask, Models TN01-11 and |
| TN01-12 | |
| Common name: | Surgical Respirator |
4
| Classification: | Class II |
|---|---|
| Product Code: | MSH |
| Manufacturer | San-M Package Co., Ltd. |
IV. Device description
The Protective Face Masks for Medical Use are flat-folded masks are three layers of materials consisting of polypropylene spun-bond (outer layer and inner layer), polypropylene melt-blown (middle layers). The masks contain a conformable nose piece enclosed in a binding tape welding the top edge to conform to the contours of the face. In addition, the masks contain an ultrasonically welded, elastic ear loops not made with natural rubber latex, to secure the masks in place on the wearer. The masks are offered in white.
The Protective Face Masks for Medical Use are single use, disposable device, provided non-sterile/sterile.
V. Indication for use
The Protective Face Mask for Medical Use is intended to worn by the healthcare personnel during procedure to protect both the patient and the healthcare personnel from the 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/sterile.
VI. Comparison of technological characteristics with the predicate devices
| Item | Proposed device
(K202358) | Predicate device
(K143287) | Reference device
(K160271) | Discussion |
|----------------|-----------------------------------------|-------------------------------------------------------|------------------------------------------------------------------------|------------|
| Product name | Protective Face Mask
for Medical Use | FLUIDSHIELD
Surgical Mask with
Expanded Chamber | N95 Particulate and
Surgical Mask,
Models TN01-11 and
TN01-12 | - |
| Product Code | FXX | FXX | MSH | Similar |
| Regulation No. | 21 CFR 878.4040 | 21 CFR 878.4040 | 21 CFR 878.4040 | Same |
| Class | Class II | Class II | Class II | Same |
Table 1-Comparison of proposed device and predicate devices
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| Mask style | | Expanded Chamber
(Duckbill) Flat-fold,
headband ties , 4
Layers | Flat-fold, Headband, 4
Layers | Similar1 | |
|--------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------|
| Indication
for use | The Protective Face
Mask for Medical Use
is intended to worn by
the healthcare
personnel during
procedure to protect
both the patient and
the healthcare
personnel from the
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/sterile. | The Expanded
Chamber Surgical
Face Mask is
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. | The N95 Particulate
Respirator and
Surgical Mask,
Models TN01-11 and
TN01-12 are single
use , disposable
devices, provided
non-sterile and are
intended to be worn
by operating room
personnel or other
healthcare workers to
protect both the
patient and operating
room personnel from
of microorganisms,
body fluids and
particulate material. | Similar to
predicate
device
Different
from
reference
device | |
| Material | Inner
layer | Spun-bond
polypropylene | Polyethylene/Polyester | Polypropylene and
polyethylene | Different2 |
| | Middle
layer | Melt blown
polypropylene filter | Middle layer #1:
Polypropylene
Spunbond
Middle layer #2:
Polypropylene
Meltblown | Two filter layers
Polypropylene
meltblown | Similar |
| | Outer
layer | Spun-bond
polypropylene | Top Half: Blue
Polypropylene
Spunbond (w Print)
Bottom Half: White
Polypropylene | Polypropylene
spunbond | Similar |
| | Ear loop/head band | Spandex + Polyester | Polyester Spunlace or
Polypropylene
Spunbond | Polyurethane, not
made with natural
rubber latex | Different2 |
| | Nose piece | Outer plastic, inner
aluminum wire,
Sponge strips | Unknown | Polyethylene coated
steel wire | Different2 |
| Offered with Visor | | No | Yes | No | Different |
| Color | | White | Top Half: Blue
Bottom Half: White | Orange / White | Different2 |
| Dimensions | | Length: 16cm
Width: 20cm | Length: 19cm
Width: 21cm | TN01-12 (Small):
Length: 205 ± 5 mm
Width: 75 ± 5 mm
Band length: 205 ± 5 mm
TN01-11 (Medium):
Length: 240 ± 5 mm
Width: 75 ± 5 mm
Band length: 240 ± 5 mm | Different3 |
| OTC use | | Yes | Yes | Yes | Same |
| Sterility | | Non-sterile/sterile | Non-sterile | Non-sterile | Different4 |
| For single use | | Yes | Yes | Yes | Same |
| ASTM
F2100 Level | | ASTM F 2100-19,
Level 2 | ASTM F2100-11,
Level 2 | ASTM F2100-11,
Level 3 | Similar4 |
| Fluid Resistance
Performance | | pass at 120mmHg | pass at 120mmHg | pass at 160mmHg | Same as the
predicate device |
| Particulate Filtration
Efficiency | | ≥98% | ≥98% | NIOSH Certification
#TC 84A-3348
(includes TN01-11 &
TN01-12) | Same as the
predicate device |
| Bacterial | | ≥98% | ≥98% | NIOSH Certification | Same as the |
| Filtration
Efficiency | | | #TC 84A-3348
(includes TN01-11 &
TN01-12) | predicate
device | |
| Differential
Pressure |