(86 days)
Not Found
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 clearly state that these are "Fluid Resistant Procedure/Surgical Masks" intended to protect from "transfer of microorganisms, body fluids and particulate material" and to "reduce the potential exposure to blood and body fluids." This indicates a barrier function for infection control, not a device that treats or diagnoses a disease/condition in a patient.
No
The device is a face mask intended for protection against microorganisms, body fluids, and particulate material, not for diagnosing medical conditions.
No
The device description clearly outlines physical components like non-woven fabric, meltblown fabric, ear loops, tie-on bands, and a nose piece, indicating it is a physical medical device, not software only.
No, 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 function performed in vitro (outside the body).
- Device Description: The description details the physical construction and materials of a face mask, which is a physical barrier.
- Lack of Diagnostic Components: There are no mentions of reagents, assays, or any components designed to analyze biological samples or provide diagnostic information.
- Performance Studies: The performance studies focus on physical properties like fluid resistance, filtration efficiency, breathability, and flammability – all relevant to a barrier device, not a diagnostic one.
- Predicate Device: The predicate device is a "Disposable Surgical Face Mask," which is also a barrier device, not an IVD.
IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not perform any such function.
N/A
Intended Use / 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. 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.
Product codes (comma separated list FDA assigned to the subject device)
FXX
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.
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 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 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 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;
Performance Testing Results:
Fluid Resistance Performance ASTM F1862:
Proposed device (model: 15603F): 3 non-consecutive lots tested, using a sample size of 32/lot. 32 out of 32 pass at 120 mmHg.
Proposed device (model: 15703F): 3 non-consecutive lots tested, using a sample size of 32/lot. 32 out of 32 pass at 120 mmHg.
Acceptance Criteria: 29 out of 32 pass at 120 mmHg for level 2.
Result: PASS
Particulate Filtration Efficiency ASTM F2299:
Proposed device (model: 15603F): 3 non-consecutive lots tested, using a sample size of 32/lot. Lot1: 99.15%, Lot2: 99.22%, Lot3: 99.22%.
Proposed device (model: 15703F): 3 non-consecutive lots tested, using a sample size of 32/lot. Lot1: 99.03%, Lot2: 99.10%, Lot3: 99.30%.
Acceptance Criteria: >= 98%
Result: PASS
Bacterial Filtration Efficiency ASTM F2101:
Proposed device (model: 15603F): 3 non-consecutive lots tested, using a sample size of 32/lot. Lot1: 99.40%, Lot2: 99.50%, Lot3: 99.60%.
Proposed device (model: 15703F): 3 non-consecutive lots tested, using a sample size of 32/lot. Lot1: 99.20%, Lot2: 99.30%, Lot3: 99.30%.
Acceptance Criteria: >= 98%
Result: PASS
Differential Pressure (Delta P) EN 14683 Annex C:
Proposed device (model: 15603F): 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.
Proposed device (model: 15703F): 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.
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.
0
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.
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.
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
2
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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3
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 F2100
level | Manufacturer |
|---------|-----------------------------------|---------------------|----------------------------------------------|
| K153496 | Disposable Surgical Face
Masks | 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
4
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-bond | |||
| polypropylene | ||||
| Mat | ||||
| erial | Middle | |||
| layer | Melton brown Fabric | |||
| (Polypropylene) | Melt blown | |||
| polypropylene filter | Same | |||
| Inner layer | Non-woven Fabric | |||
| (Polypropylene) | Spun-bond | |||
| polypropylene | Same | |||
| Nose clip | Polypropylene | |||
| coating iron | Malleable aluminum | |||
| wire | Different | |||
| Tie-on | ||||
| bands | 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 |
5
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
6
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) | Acceptance
Criteria | Result |
|-------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------|--------|
| Fluid
Resistance
Performance
ASTM F1862 | | 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 | 29 out
of 32
pass
at 120
mmH
g for
level
2 | PASS |
| Particulate
Filtration
Efficiency
ASTM F2299 | The purpose
of the
performance
testing is to
demonstrate
the
functionality
of the
subject | 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% | ≥ 98% | PASS |
| Bacterial
Filtration
Efficiency
ASTM F2101 | | 3 non-consecutive lots
tested, using a sample
size of 32/lot.
Lot1: 99.40%
Lot2: 99.50% | 3 non-consecutive lots
tested, using a sample
size of 32/lot.
Lot1: 99.20%
Lot2: 99.30% | ≥ 98% | PASS |
Table 2 - Performance Testing
7
Zhejiang Lanhine Medical Products LTD 1989 Cidong Road, Cidongbinhai District, 315300 Cixi City, Zhejiang Province, China
| device. | Lot3: 99.60% | Lot3: 99.30% | |||
|---|---|---|---|---|---|
| Differential | |||||
| Pressure (Delta | |||||
| P) EN 14683 | |||||
| Annex C | 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 |