(86 days)
The Fluid Resistant Procedure/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 intection control practices to reduce the potential exposure to blood and body fluids. This a single use, disposable device(s), provided non-sterile.
The proposed device (model: 15603F) is blue color, and Flat Pleated type mask, utilizing Ear Loops way for wearing, and it has Nose clips design for fitting the face mask around the nose.
The proposed device (model: 15703F) is blue color, and Flat Pleated type mask, utilizing tie-on way for wearing, and it has Nose clips design for fitting the face mask around the nose.
The proposed devices are manufactured with three layers, the inner and outer layers are made of Non-woven Fabric(polypropylene), and the middle layer is made of Melton brown Fabric (Polypropylene). The 15603F model of proposed device, ear loops, is held in place over the users' mouth and nose by two elastic ear loops welded to the face mask. The elastic ear loops are made of polyurethane. The nose piece contained in the proposed device(s) is in the layers of face mask to allow the user to fit the face mask around their nose, which is made of Polypropylene coating iron. The 15703F model of proposed device, tie-on, is held in place over the users' mouth and nose by two tie-on bands welded to the face mask. The tie-on bands are made of non-woven Fabric (Polypropylene). The nose piece contained in the proposed device(s) is in the layers of face mask to allow the user to fit the face mask around their nose, which is made of Polypropylene coating iron. The proposed devices are sold non-sterile and are intended to be single use, disposable device.
This appears to be a 510(k) summary for a medical device (Fluid Resistant Procedure/Surgical Mask), which focuses on demonstrating substantial equivalence to a predicate device rather than a comprehensive comparative effectiveness study with human readers or clinical outcomes. Therefore, many of the requested points related to AI/human reader studies, expert ground truth, and training data will not be applicable.
However, based on the provided document, here's an analysis of the acceptance criteria and the study that proves the device meets them:
1. A table of acceptance criteria and the reported device performance
| Item | Acceptance Criteria | Proposed Device (Model: 15603F) Performance | Proposed Device (Model: 15703F) Performance | Result (for both models) |
|---|---|---|---|---|
| Fluid Resistance (ASTM F1862) | 29 out of 32 pass at 120 mmHg for level 2 | 3 non-consecutive lots tested, using a sample size of 32/lot. 32 out of 32 pass at 120 mmHg. | 3 non-consecutive lots tested, using a sample size of 32/lot. 32 out of 32 pass at 120 mmHg. | PASS |
| Particulate Filtration Efficiency (ASTM F2299) | ≥ 98% | 3 non-consecutive lots tested, using a sample size of 32/lot. Lot1: 99.15%, Lot2: 99.22%, Lot3: 99.22%. | 3 non-consecutive lots tested, using a sample size of 32/lot. Lot1: 99.03%, Lot2: 99.10%, Lot3: 99.30%. | PASS |
| Bacterial Filtration Efficiency (ASTM F2101) | ≥ 98% | 3 non-consecutive lots tested, using a sample size of 32/lot. Lot1: 99.40%, Lot2: 99.50%, Lot3: 99.60%. | 3 non-consecutive lots tested, using a sample size of 32/lot. Lot1: 99.20%, Lot2: 99.30%, Lot3: 99.30%. | PASS |
| Differential Pressure (Delta P) (EN 14683 Annex C) | < 6.0 mmH2O/cm2 | 3 non-consecutive lots tested, using a sample size of 32/lot. Lot1: 3.55 mmH2O/cm2, Lot2: 3.59 mmH2O/cm2, Lot3: 3.60 mmH2O/cm2. | 3 non-consecutive lots tested, using a sample size of 32/lot. Lot1: 3.59 mmH2O/cm2, Lot2: 3.58 mmH2O/cm2, Lot3: 3.56 mmH2O/cm2. | PASS |
| Flammability (16 CFR 1610) | Class 1 | 3 non-consecutive lots tested, using a sample size of 32/lot. Class 1. | 3 non-consecutive lots tested, using a sample size of 32/lot. Class 1. | PASS |
| Cytotoxicity (ISO 10993-5) | Non-Cytotoxic | "Under the conditions of the study, the device is non-cytotoxic." (Summary of biological evaluation, implying a test was performed according to ISO 10993-5) | "Under the conditions of the study, the device is non-cytotoxic." (Summary of biological evaluation, implying a test was performed according to ISO 10993-5) | PASS |
| Irritation (ISO 10993-10) | Non-Irritating | "Under the conditions of the study, the device is non-irritating." (Summary of biological evaluation, implying a test was performed according to ISO 10993-10) | "Under the conditions of the study, the device is non-irritating." (Summary of biological evaluation, implying a test was performed according to ISO 10993-10) | PASS |
| Sensitization (ISO 10993-10) | Non-Sensitizing | "Under the conditions of the study, the device is non-sensitizing." (Summary of biological evaluation, implying a test was performed according to ISO 10993-10, as irritation and sensitization are often evaluated together or in closely related parts of the ISO 10993 series). | "Under the conditions of the study, the device is non-sensitizing." (Summary of biological evaluation, implying a test was performed according to ISO 10993-10, as irritation and sensitization are often evaluated together or in closely related parts of the ISO 10993 series). | PASS |
2. Sample size used for the test set and the data provenance
- Sample Size for performance tests (Fluid Resistance, PFE, BFE, Differential Pressure, Flammability): For each performance test, 3 non-consecutive lots were tested, with a sample size of 32 per lot. This means a total of 96 samples per test (3 lots * 32 samples/lot).
- Sample Size for biocompatibility tests (Cytotoxicity, Irritation, Sensitization): The document states "Under the conditions of the study," implying standard sample sizes for these in vitro/in vivo biological tests as per ISO 10993, but the exact number for this specific submission is not explicitly stated.
- Data Provenance: The tests were conducted by Zhejiang Lanhine Medical Products LTD, located in Cixi City, Zhejiang Province, China, as part of their 510(k) submission to the FDA. The data is retrospective in the sense that the tests were performed on manufactured devices and the results are reported.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable as this is a submission for a physical medical device (surgical mask) based on performance testing against international standards, not an AI software where expert-established ground truth is typically required. The "ground truth" here is the established performance standard itself (e.g., ≥ 98% BFE).
4. Adjudication method for the test set
This information is not applicable for the same reasons as point 3. The results are quantitative measurements against predefined thresholds, not subjective interpretations requiring adjudication.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This information is not applicable. This submission is for a physical medical device, not an AI software device. Therefore, no MRMC study or assessment of human reader improvement with AI assistance was performed or is relevant.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
This information is not applicable. This is not an AI algorithm.
7. The type of ground truth used
The ground truth used for this device's acceptance is based on established international and national performance standards and regulatory requirements. Specifically:
- Performance Standards: ASTM F1862, ASTM F2299, ASTM F2101, EN 14683, 16 CFR 1610 (flammability). These standards define the acceptable range for the physical and filtration properties of the mask.
- Biocompatibility Standards: ISO 10993-5, ISO 10993-10. These standards define the acceptable limits for biological responses to materials.
The "ground truth" is therefore objective, measurable criteria defined by these standards.
8. The sample size for the training set
This information is not applicable. This is a physical medical device, not a machine learning model; therefore, there is no "training set."
9. How the ground truth for the training set was established
This information is not applicable as there is no training set for this type of device.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services - USA seal. To the right of the seal is the FDA logo in blue, with the words "U.S. FOOD & DRUG" on top of the word "ADMINISTRATION".
September 8, 2021
Zhejiang Lanhine Medical Products LTD % Ivy Wang Consultant Shanghai Sungo Management Consulting Company Limited 14th Floor, 1500# Central Avenue Shanghai, Shanghai 200122 China
Re: K211832
Trade/Device Name: Fluid Resistant Procedure Mask/Surgical Mask Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX, Dated: June 14, 2021 Received: June 14, 2021
Dear Ivy Wang:
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 (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 Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K211832
Device Name Fluid Resistant Procedure/Surgical Mask
Indications for Use (Describe)
The Fluid Resistant Procedure/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 intection control practices to reduce the potential exposure to blood and body fluids. This 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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510(K) Summary
K211832
Document prepared date: 9/8/2021
A. Applicant:
Name: Zhejiang Lanhine Medical Products LTD. Address: 1989 Cidong Road, Cidongbinhai District, 315300 Cixi City, Zhejiang Province, China Contact Person: Jerry Gu Tel: +86-015255006789 Mail: mark@kanghuimedical.com
Submission Correspondent: Primary contact: Ivy Wang Shanghai SUNGO Management Consulting Co., Ltd. 14th floor 1500# Century Ave., Shanghai 200122, China Tel: +86-21-58817802 Email: haiyu.wang@sungoglobal.com Secondary contact: Mr. Raymond Luo 14th floor 1500# Century Ave., Shanghai 200122, China Tel: +86-21-68828050 Email: fda.sungo@gmail.com
B. Device:
Trade Name: Fluid Resistant Procedure/Surgical Mask Common Name: Surgical Face Mask Model(s): 15603F, 15703F
Regulatory Information Classification Name: Surgical Face Mask Classification: Class II Product code: FXX Regulation Number: 878.4040 Review Panel: Surgical Apparel
C. Predicate device:
| 510K | Device name | ASTM F2100level | Manufacturer |
|---|---|---|---|
| K153496 | Disposable Surgical FaceMasks | Level2 | Xiantao Rayxin Medical Products Co.,Ltd. |
D. Indications for use of the device:
The Fluid Resistant Procedure/Surgical Masks (model: 15603F, 15703F) are intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and
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particulate material. These face masks are intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This a single use, disposable device(s), provided non-sterile.
E. Device Description:
The proposed device (model: 15603F) is blue color, and Flat Pleated type mask, utilizing Ear Loops way for wearing, and it has Nose clips design for fitting the face mask around the nose.
The proposed device (model: 15703F) is blue color, and Flat Pleated type mask, utilizing tie-on way for wearing, and it has Nose clips design for fitting the face mask around the nose.
The proposed devices are manufactured with three layers, the inner and outer layers are made of Non-woven Fabric(polypropylene), and the middle layer is made of Melton brown Fabric (Polypropylene). The 15603F model of proposed device, ear loops, is held in place over the users' mouth and nose by two elastic ear loops welded to the face mask. The elastic ear loops are made of polyurethane. The nose piece contained in the proposed device(s) is in the layers of face mask to allow the user to fit the face mask around their nose, which is made of Polypropylene coating iron. The 15703F model of proposed device, tie-on, is held in place over the users' mouth and nose by two tie-on bands welded to the face mask. The tie-on bands are made of non-woven Fabric (Polypropylene). The nose piece contained in the proposed device(s) is in the layers of face mask to allow the user to fit the face mask around their nose, which is made of Polypropylene coating iron. The proposed devices are sold non-sterile and are intended to be single use, disposable device.
F. Comparison with predicate device/
Table 1 General Comparison
| Device | Proposed Device | Predicate Device | Comparison | |
|---|---|---|---|---|
| Manufacturer | Zhejiang Lanhine Medical Products LTD. | Xiantao Rayxin Medical Products Co., Ltd. | - | |
| 510K number | K211832 | K153496 | - | |
| Classification | Class II Device, FXX (21 CFR878.4040) | Class II Device, FXX (21 CFR878.4040) | Same | |
| Indications for use | The Fluid Resistant Procedure/Surgical Mask (model: 15603F, 15703F) are intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. | The Disposable 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 | Similar | |
| Styles | Ear Loops, Tie-On,Flat Pleated, 3 layers | Ear Loops, Flat Pleated,3 layers | Different | |
| Outer layer | Non-woven Fabric(Polypropylene) | Spun-bondpolypropylene | ||
| Material | Middlelayer | Melton brown Fabric(Polypropylene) | Melt blownpolypropylene filter | Same |
| Inner layer | Non-woven Fabric(Polypropylene) | Spun-bondpolypropylene | Same | |
| Nose clip | Polypropylenecoating iron | Malleable aluminumwire | Different | |
| Tie-onbands | Non-woven Fabric(Polypropylene) | / | -- | |
| Ear loops | Polyurethane | Polyester | Different | |
| Color | Blue | Blue | Same | |
| Dimension(Length) | $17.5 cm +/- 0.5 cm$ | $17.5 cm +/- 0.1 cm$ | Different | |
| Dimension (Width) | $9.5 cm +/- 0.5 cm$ | $9.5 cm +/- 0.1 cm$ | Different | |
| OTC use | Yes | Yes | Same | |
| Sterility | Non-Sterile | Non-Sterile | Same | |
| Use | Single Use | Single Use, Disposable | Same | |
| ASTM F2100 level | Level 2 | Level 2 | Same | |
| Biocompatibility | ISO10993 | ISO10993 | Same |
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Difference analysis: The proposed device has different nose clip & ear loops material as well as dimension to the predicate device, but the performance and biocompatibility of the device has been tested.
G. Non-Clinical Test Conclusion
Non-clinical tests were conducted to verify that the proposed device met all design specifications as was similar to the predicate device. The test results demonstrated that the proposed device complies
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1989 Cidong Road, Cidongbinhai District, 315300 Cixi City, Zhejiang Province, China
with the following standards and the requirements stated in the Guidance for Industry and FDA Staff: Surgical Masks - Premarket Notification [510(k)] Submission issued on March 5, 2004:
- ISO 10993-5: 2009 Biological Evaluation of Medical Devices -- Part 5: Tests For In Vitro A Cytotoxicity
-
ISO 10993-10: 2010 Biological Evaluation of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization
-
ASTM F2100, Standard Specification for Performance of Materials Used In Medical Face Masks
-
ASTM F1862, Standard Test Method for Resistance of Medical Face Masks To Penetration by Synthetic Blood (Horizontal Projection of Fixed Volume At A Known Velocity);
-
EN 14683, Medical Face Masks-Requirements and Test Methods;
-
ASTM F2101, Standard Test Method for Evaluating the Bacterial Filtration Efficiency (BFE) Of Medical Face Mask Materials, Using A Biological Aerosol of Staphylococcus Aureus;
-
ASTM F2299, Stand 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;
| Item | Purpose | Proposed device(model: 15603F) | Proposed device(model: 15703F) | AcceptanceCriteria | Result |
|---|---|---|---|---|---|
| FluidResistancePerformanceASTM F1862 | 3 non-consecutive lotstested, using a samplesize of 32/lot.32 out of 32 pass at 120mmHg | 3 non-consecutive lotstested, using a samplesize of 32/lot.32 out of 32 pass at 120mmHg | 29 outof 32passat 120mmHg forlevel2 | PASS | |
| ParticulateFiltrationEfficiencyASTM F2299 | The purposeof theperformancetesting is todemonstratethefunctionalityof thesubject | 3 non-consecutive lotstested, using a samplesize of 32/lot.Lot1: 99.15%Lot2: 99.22%Lot3: 99.22% | 3 non-consecutive lotstested, using a samplesize of 32/lot.Lot1: 99.03%Lot2: 99.10%Lot3: 99.30% | ≥ 98% | PASS |
| BacterialFiltrationEfficiencyASTM F2101 | 3 non-consecutive lotstested, using a samplesize of 32/lot.Lot1: 99.40%Lot2: 99.50% | 3 non-consecutive lotstested, using a samplesize of 32/lot.Lot1: 99.20%Lot2: 99.30% | ≥ 98% | PASS |
Table 2 - Performance Testing
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Zhejiang Lanhine Medical Products LTD 1989 Cidong Road, Cidongbinhai District, 315300 Cixi City, Zhejiang Province, China
| device. | Lot3: 99.60% | Lot3: 99.30% | |||
|---|---|---|---|---|---|
| DifferentialPressure (DeltaP) EN 14683Annex C | 3 non-consecutive lotstested, using a samplesize of 32/lot.Lot1: 3.55 mmH2O/cm2Lot2: 3.59 mmH2O/cm2Lot3: 3.60 mmH2O/cm2 | 3 non-consecutive lotstested, using a samplesize of 32/lot.Lot1: 3.59 mmH2O/cm2Lot2: 3.58 mmH2O/cm2Lot3: 3.56 mmH2O/cm2 | < 6.0mmH2O/cm2 | PASS | |
| Flammability16 CFR 1610 | 3 non-consecutive lotstested, using a samplesize of 32/lot.Class 1 | 3 non-consecutive lotstested, using a samplesize of 32/lot.Class 1 | Class 1 | PASS |
Table 3 Biocompatibility Comparison
| Item | Proposed device | Predicate device | Acceptance Criteria | Result |
|---|---|---|---|---|
| Cytotoxicity | Under the conditions ofthe study, the device isnon-cytotoxic. | Under the conditionsof the study, thedevice isnon-cytotoxic. | Non-Cytotoxic | PASS |
| Irritation | Under the conditions ofthe study, the device isnon-irritating. | Under the conditionsof the study, thedevice isnon-irritating. | Non-Irritating | PASS |
| Sensitization | Under the conditions ofthe study, the device isnon-sensitizing | Under the conditionsof the study, thedevice isnon-sensitizing | Non-Sensitizing | PASS |
H. Clinical Test Conclusion
No clinical study is included in this submission.
I. Conclusion
Based on the nonclinical tests performed, the subject devices (Model:15603F & 15703F) are as safe, as effective, and performs as well as the legally marketed predicate device, K153496, BYD Precision Manufacturer Co. Ltd, Single-use Surgical Masks.
§ 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.