(202 days)
Not Found
No
The device description and performance studies focus on the physical properties and filtration capabilities of a surgical mask, with no mention of AI or ML.
No
The device is a surgical mask intended for protection and infection control, not for treating a disease or health condition.
No
Explanation: The document describes medical surgical masks intended for protection against transfer of microorganisms and fluids. There is no mention of the device being used to diagnose any medical condition or to provide information for diagnosis.
No
The device description clearly outlines physical components (mask body, nose piece, ear loops) made of materials like polypropylene, nylon, spandex, and galvanized wire. The testing described focuses on the physical performance and biocompatibility of these materials and the assembled mask, 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 against the transfer of microorganisms, body fluids, and particulate material, and for use in infection control practices. This is a physical barrier function, not a diagnostic function performed in vitro (outside the body).
- Device Description: The description details the physical construction of a mask, not a device designed to analyze biological samples.
- Performance Studies and Metrics: The performance studies focus on physical properties like filtration efficiency, fluid resistance, and flammability, as well as biocompatibility. These are relevant to the protective function of a mask, not to diagnostic accuracy (like sensitivity, specificity, etc., which are key metrics for IVDs).
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting specific analytes, or providing diagnostic information about a patient's health status.
In summary, the device is a medical surgical mask intended for physical protection and infection control, which falls under the category of a medical device, but not specifically an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The medical 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 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 proposed device is a three-layer, flat pleated mask. Each 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 the 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 made of knitted elastic loops (made of nylon and spandex).
The nose piece is in the layers of face mask to allow the user to fit the face mask around his nose, which is a galvanized wire with polyethylene covering.
The proposed device is provided non-sterile and is intended to be a single use, disposable device.
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
Not Found
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 conducted to verify that the proposed device met all design specifications as similar to the predicate device. The tests were conducted according to the following standards, and the results demonstrated that the proposed device complies with the following standards:
- A ISO 10993-1:2018 Biological evaluation of medical devices - Part 1: Evaluation and testing within a riskmanagement process
- A ISO 10993-5:2009 Biological Evaluation of Medical Devices - Part 5: Tests for in Vitro cytotoxicity
- A ISO 10993-10:2010 Biological Evaluation of Medical Devices - Part 10: Tests for irritation and skin sensitization
- A ASTM F2100-19 Standard Specification for Performance of Materials Used in Medical Face Masks
- A ASTM F1862/F1862M-17 Standard Test Method for Resistance of Medical Face Masks to Penetration by Synthetic Blood (Horizontal Projection of Fixed Volume at a Known Velocity)
- ASTM F2101-19 Standard Test Method for Evaluating the Bacterial Filtration Efficiency (BFE) of Medical Face Mask Materials, Using a Biological Aerosol of Staphylococcus aureus
- A EN 14683:2019+AC:2019 Medical Face Masks - Requirements and Test Methods
- A ASTM F2299/F2299M-03(R2017) Standard Test Method for Determining the Initial Efficiency of Materials Used in Medical Face Masks to Penetration by Particulates Using Latex Spheres
- A 16 CFR 1610 Standard for the Flammability of Clothing Textiles
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Fluid Resistance (ASTM F1862):
- Level 1: 32 out of 32 pass at 80 mmHg
- Level 2: 32 out of 32 pass at 120 mmHg
- Level 3: 32 out of 32 pass at 160 mmHg
Bacterial filtration efficiency (BFE) (ASTM F2101):
- 99.56%~99.99% (for Level 1, Level 2, and Level 3)
Particulate filtration efficiency (PFE) (ASTM F2299):
- 98.07%~99.24% (for Level 1, Level 2, and Level 3)
Differential pressure (Delta-P) (EN 14683):
- (3.4~3.9) mmH2O/cm2 (for Level 1, Level 2, and Level 3)
Flammability (16 CFR 1610):
- Class 1 (for Level 1, Level 2, and Level 3)
Biocompatibility Testing:
- In vitro Cytotoxicity (ISO 10993-5): Pass (non-cytotoxic)
- Skin Irritation (ISO 10993-10): Pass (non-irritating)
- Skin Sensitization (ISO 10993-10): Pass (non-sensitizing)
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 contains the logo of the U.S. Food & Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG ADMINISTRATION' in blue text.
April 11, 2021
Guangdong GoodFeeling Hygiene Material Tec 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: K202761
Trade/Device Name: Medical Surgical Mask (Non-sterile) Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: September 15, 2020 Received: September 21, 2020
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,
Rvan-O
Ryan Ortega, PhD Acting Assistant Director THT4B2: Personal Protective Equipment, Reprocessing & Disinfection Devices Team DHT4B: Division of Infection Control and Plastic Surgerv Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality
Enclosure
2
Indications for Use
510(k) Number (if known) K202761
Device Name Medical Surgical Mask (Non-sterile)
Indications for Use (Describe)
The medical 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 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)
Over-The-Counter Use (21 CFR 801 Subpart C)
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Version: A/0
510(k) Summary
K202761
1. Contact Details
1.1 Applicant information
| Applicant Name | Guangdong GoodFeeling Hygiene Material Tec Co., Ltd. |
|---|---|
| Address | No.10 Phoenix Avenue Eco-industrial Park, Danzao Town, |
| Nanhai, Foshan City, Guangdong Province, China | |
| Contact person | Zheng Zhijin |
| Phone No. | +86-15860481335 |
| / | |
| Date Prepared | Apr. 2, 2021 |
1.2 Submission Correspondent
| Image: Company Logo | 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 | Medical Surgical Mask (Non-sterile) |
|---|---|
| Common name | Medical Surgical Mask |
| Model | GFYY95 |
| Classification | II |
| Classification name | Mask, Surgical |
| Product code | FXX |
| 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
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. |
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4. Device Description
The proposed device is a three-layer, flat pleated mask. Each 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 the 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 made of knitted elastic loops (made of nylon and spandex).
The nose piece is in the layers of face mask to allow the user to fit the face mask around his nose, which is a galvanized wire with polyethylene covering.
The proposed device is provided non-sterile and is intended to be a single use, disposable device.
5. Intended Use/Indication for Use
The medical 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 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
| Item | Proposed Device
(K202761) | Predicate Device (K133070) | Comment |
|---------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------|
| Product name | Medical Surgical Mask (Non-
sterile) | 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 |
| Manufacturer | Guangdong GoodFeeling
Hygiene Material Tec Co., Ltd. | BH Medical Products Co., Ltd. | None |
| Product Code | FXX | FXX | Same |
| 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 medical 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
masks are intended for use in
infection control practices to
reduce the potential exposure to | 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 face
masks are intended for use in
infection control practices to
reduce the potential exposure to | Same |
Table 1 Substantial Equivalence Comparison
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Version: A/0
| | | blood and body fluids. This is a
single use, disposable device(s),
provided non-sterile. | | blood and body fluids. This is a
single use, disposable device(s),
provided non-sterile. | | | | |
|--------------------------------------|-----------------|------------------------------------------------------------------------------------------------|---------|------------------------------------------------------------------------------------------------|---------|------------------------|---------|------|
| 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 | | Length: 18cm±1cm
(7.1"±0.39")
Width: 9.5cm(3.7")±1cm
(3.7"±0.39") | | Length: 6.8" ±0.25"
Width:3.5"+/-0.25"
4.2"+/-0.25" | | Similar | | |
| Sterility | | Non-Sterile | | Non-Sterile | | Same | | |
| Materials | Outer
layer | Spunbond polypropylene | | Spunbond polypropylene | | Same | | |
| | Middle
layer | Meltblown polypropylene | | Meltblown polypropylene | | Same | | |
| | Inner
layer | Spunbond polypropylene | | Spunbond polypropylene | | Same | | |
| | Nose
piece | Galvanized wire with
polyethylene covering | | Aluminum wire | | Different
(Issue 1) | | |
| | Ear loop | Nylon and spandex | | Polyester | | Different
(Issue 2) | | |
| ASTM Level (ASTM
F2100-19) | | Level 1 | Level 2 | Level 3 | Level 1 | Level 2 | Level 3 | Same |
| Fluid Resistance | | Pass at 80 mmHg, 120 mmHg
and 160 mmHg
(ASTM F1862) | | Meet ASTM F1862-07 | | Similar | | |
| Bacterial Filtration
Efficiency | | Pass at 99.56%~99.99%
(ASTM F2101) | | Meet ASTM F2101-07 | | Similar | | |
| Particulate Filtration
Efficiency | | Pass at 98.07%99.24%3.9) mmH2O/cm2
(ASTM F2299) | | Meet ASTM F2299-03 | | Similar | | |
| Differential Pressure
(Delta-P) | | Pass at (3.4
(EN 14683) | | Meet MIL-M-36954C | | Different
(Issue 3) | | |
| Flammability | | Pass at Class 1
(16 CFR 1610) | | Class 1 | | Same | | |
| Biocompatibility | | 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
Non-clinical testing was conducted to verify that the proposed device met all design specifications as
6
similar to the predicate device. The tests were conducted according to the following standards, and the results demonstrated that the proposed device complies with the following standards:
- A ISO 10993-1:2018 Biological evaluation of medical devices - Part 1: Evaluation and testing within a riskmanagement process
- A ISO 10993-5:2009 Biological Evaluation of Medical Devices - Part 5: Tests for in Vitro cytotoxicity
- A ISO 10993-10:2010 Biological Evaluation of Medical Devices - Part 10: Tests for irritation and skin sensitization
- A ASTM F2100-19 Standard Specification for Performance of Materials Used in Medical Face Masks
- A ASTM F1862/F1862M-17 Standard Test Method for Resistance of Medical Face Masks to Penetration by Synthetic Blood (Horizontal Projection of Fixed Volume at a Known Velocity)
-
ASTM F2101-19 Standard Test Method for Evaluating the Bacterial Filtration Efficiency (BFE) of Medical Face Mask Materials, Using a Biological Aerosol of Staphylococcus aureus
- A EN 14683:2019+AC:2019 Medical Face Masks - Requirements and Test Methods
- A ASTM F2299/F2299M-03(R2017) Standard Test Method for Determining the Initial Efficiency of Materials Used in Medical Face Masks to Penetration by Particulates Using Latex Spheres
- A 16 CFR 1610 Standard for the Flammability of Clothing Textiles
Table 2 Performance Testing
| Test | Purpose | Acceptance Criteria | Results
(Statistics of
three lots) | Verdict |
|---------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------|------------------------------------------|---------|
| Fluid
Resistance
(ASTM F1862) | Verify the fluid resistance of
the proposed device can
simultaneously meet the
requirements for Level 1, Level
2 and Level 3 specified in
ASTM F2100-19. | Level 1: 29 out of 32
pass at 80 mmHg | 32 out of 32 pass
at 80 mmHg | Pass |
| | | Level 2: 29 out of 32
pass at 120 mmHg | 32 out of 32 pass
at 120 mmHg | Pass |
| | | Level 3: 29 out of 32
pass at 160 mmHg | 32 out of 32 pass
at 160 mmHg | Pass |
| Bacterial
filtration
efficiency (BFE)
(ASTM F2101) | Verify that bacterial filtration
efficiency of the proposed
device can simultaneously
meet the requirements for
Level 1, Level 2 and Level 3
specified in ASTM F2100-19. | Level 1: ≥95% | 99.56%~99.99% | Pass |
| | | Level 2: ≥98% | | Pass |
| | | Level 3: ≥98% | | Pass |
| Particulate
filtration
efficiency (PFE)
(ASTM F2299) | Verify that particulate filtration
efficiency of the proposed
device can simultaneously
meet the requirements for
Level 1, Level 2 and Level 3
specified in ASTM F2100-19. | Level 1: ≥95% | 98.07%~99.24% | Pass |
| | | Level 2: ≥98% | | Pass |
| | | Level 3: ≥98% | | Pass |
| Differential
pressure (Delta- | Verify that differential pressure
of the proposed device can | Level 1: