(199 days)
Not Found
No
The device is a simple physical barrier (face mask) and the description focuses on material composition and physical performance tests, with no mention of AI/ML terms or functionalities.
No.
The device, a fluid-resistant procedure mask, is intended for infection control by creating a physical barrier to protect against splashes and particles; it does not directly treat or mitigate a disease or condition.
No
The device description indicates it is a "Fluid Resistant Procedure Mask" intended for protection from transfer of microorganisms and fluids, not for diagnosing medical conditions.
No
The device description clearly outlines a physical product made of non-woven fabrics and includes performance testing related to material properties and physical barriers, not software functionality.
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 patients and healthcare personnel from the transfer of microorganisms, blood fluids, and particulate material. This is a physical barrier function, not a diagnostic test performed in vitro (outside the body).
- Device Description: The description details the physical construction and materials of the mask, which are consistent with a barrier device.
- Performance Studies: The performance studies focus on the physical properties and barrier effectiveness of the mask (fluid resistance, filtration efficiency, differential pressure, flammability) and biocompatibility. These are not diagnostic performance metrics.
- Lack of Diagnostic Elements: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information about a patient's health condition.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This mask does not perform any of these functions.
N/A
Intended Use / Indications for Use
The Fluid Resistant Procedure Masks are intended to be worn to protect the patient and healthcare personnel from transfer of microorganisms, blood 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 non-sterile.
Product codes (comma separated list FDA assigned to the subject device)
FXX
Device Description
The Fluid Resistant Procedure 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 Fluid Resistant Procedure Masks are manufactured with three layers. The outer layer is made of spun-bond polypropylene non-woven fabric. The middle layer with filtration function is made of melt blown polypropylene non-woven fabric. The inner layer which contacts with face is made of spun-bond polypropylene non-woven fabric. The Fluid Resistant Procedure 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
patient and healthcare personnel / infection control practices
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
Non-clinical performance tests were conducted. Each type of performance testing used 32 samples in each of 3 non-consecutive lots (totally 96 samples).
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical performance tests were conducted. Each type of performance testing used 32 samples in each of 3 non-consecutive lots (totally 96 samples).
Results:
Fluid Resistance Performance (ASTM F1862M-17): Pass (95/96)
Particulate Filtration Efficiency (ASTM F2299): Pass (96/96) Average 99.9% at 0.1µm
Bacterial Filtration Efficiency (ASTM F2101-19): Pass (96/96) Average 99.9%
Differential Pressure (EN 14683:2019 Annex C): Pass (96/96) Average 3.52 mmH2O/cm²
Flammability (16 CFR 1610): Pass (96/96) Meet Class I
Cytotoxicity (ISO 10993-5:2009): Under the conditions of the study, the subject device was non-cytotoxic.
Skin Irritation (ISO 10993-10:2010): Under the conditions of the study, the subject device was non-irritating.
Skin Sensitization (ISO 10993-10:2010): Under the conditions of the study, the subject device was non-sensitizing.
No clinical study is included in this submission.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Fluid Resistance Performance: 95/96 pass at 160mmHg
Particulate Filtration Efficiency: Average 99.9% at 0.1µm
Bacterial Filtration Efficiency: Average 99.9%
Differential Pressure: Average 3.52 mmH2O/cm²
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services seal on the left and the FDA acronym with the words "U.S. Food & Drug Administration" on the right. The FDA part of the logo is in blue, with the acronym in a solid blue square and the words in a lighter blue.
February 25, 2021
LHM Medical Technology (Hong Kong) Limited Frank Cheng Senior Manager of Quality Control Unit No. 2. 3/F., Block A. Ko Fai Industrial Building, 7 Ko Fai Road,Yau Tong HongKong, 999077 China
Re: K202240
Trade/Device Name: Disposable Surgical Mask/Fluid Resistant Procedure Mask Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: February 6, 2021 Received: February 9, 2021
Dear Frank Cheng:
We have reviewed vour 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/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,
Ryan Ortega -S
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 Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K202240
Device Name Disposable Surgical Mask Fluid Resistant Procedure Mask
Indications for Use (Describe)
The Fluid Resistant Procedure Masks are intended to be worn to protect the patient and healthcare personnel from transfer of microorganisms, blood 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 nonsterile.
| 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: K202240
l. Submitter
LHM Medical Technology (Hong Kong) Limited Unit No. 2, 3/F., Block A, Ko Fai Industrial Building, No. 7 Ko Fai Road, Yau Tong, Kowloon, Hong Kong
Establishment Registration Number: 3016866341
Contact person: Frank Cheng Position: Senior Manager of Quality Control Tel.: +852-27558748- Ext1169 E-mail: frank.cheng@liphing.com
Preparation date: Feb.15, 2021
II. Proposed Device
| Trade Name of Device: | Disposable Surgical Mask / Fluid Resistant Procedure Mask |
|---|---|
| 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 Fluid Resistant Procedure 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 Fluid Resistant Procedure Masks are manufactured with three layers.
4
The outer layer is made of spun-bond polypropylene non-woven fabric. The middle layer with filtration function is made of melt blown polypropylene non-woven fabric. The inner layer which contacts with face is made of spun-bond polypropylene non-woven fabric.
The Fluid Resistant Procedure Masks are single use, disposable device, provided non-sterile.
V. Indication for Use
The Fluid Resistant Procedure Masks are intended to be worn to protect the patient and healthcare personnel from transfer of microorganisms, blood 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 non-sterile.
| Item | Proposed Device (K202240) | Predicate Device (K160269) | Comparison |
|---|---|---|---|
| Trade Name | Disposable Surgical Mask/ Fluid Resistant Procedure Mask | Surgical Face masks (Ear loops and Tie-on) | - |
| Product Code | FXX | FXX | Same |
| Regulation No. | 21 CFR 878.4040 | 21 CFR 878.4040 | Same |
| Class | Class II | Class II | Same |
| Mask Style | Flat-pleated, ear loops, 3 layers | Flat-pleated, ear loops or tie-on, 4 layers | Different² |
| Indication for Use | The Fluid Resistant Procedure Masks are intended to be worn to protect the patient and healthcare personnel from transfer of microorganisms, blood fluids, and particulate material. These face masks are intended for use in infection control | 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 | Same |
VI. Comparison of Technological Characteristics with the Predicate Devices
Table 1 General Comparison
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| | | practices to reduce the
potential exposure to
blood and body fluids.
This is a single-use,
disposable device,
provided non-sterile. | potential exposure to
blood and body fluid.
This is a single-use,
disposable devices
provided non-sterile. | | |
|-----------------------------------------------|-----------------|----------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------|------------|
| Material | Inner
layer | Spun-bond
polypropylene | Polypropylene | | Same |
| | Middle
layer | Melt blown
polypropylene filter | 1. Polypropylene
spun-bond
2. Polypropylene melt
blown | | Different1 |
| | Outer
layer | Spun-bond
polypropylene | Polypropylene | | Same |
| | Ear
loops | 88% Nylon + 12%
Spandex | Ear loops: Polyester,
polyurethane;
Side tapes: Polyester
spun-bond (ear loops
mask only)
Ties tapes:
Polypropylene
spun-bond or polyester
spun-bond | | Different1 |
| | Nose
piece | Iron wire covered by
polypropylene | Polyethylene coated
steel wire | | Different1 |
| Color | | Blue | Blue ,white | | Different1 |
| Length | | 17.5cm | 17.5cm | 18.0cm | Different2 |
| Width | | 9.5cm | 9.0cm | 9.0cm | |
| OTC Use | | Yes | Yes | | Same |
| Sterile | | Non-sterile | Non-sterile | | Same |
| Single for Use | | Yes | Yes | | Same |
| Fluid Resistance
Performance
ASTM F1862 | | Pass at 160mmHg | Level 1: Pass at
80mmHg
Level 2: Pass at
120mmHg
Level 3: Pass at
160mmHg | | Different2 |
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| Particulate
Filtration
Efficiency
| ASTM F2299 | >99.9% at 0.1μm | ≥98.0% | |
|---|---|---|---|
| Bacterial | |||
| Filtration | |||
| Efficiency | |||
| ASTM F2101 | >99.9% | ≥98% | |
| Differential | |||
| Pressure | Average 3.52 mmH2O/cm² | Level 1: |