(94 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 to protect against transfer of microorganisms and body fluids. It is not designed to treat or alleviate a disease or condition, which is the primary function of a therapeutic device.
No
The device, a medical surgical mask, is intended for protection from transfer of microorganisms, body fluids, and particulate material, not for diagnosing any medical condition.
No
The device description clearly outlines a physical medical surgical mask made of various fabric layers, ear loops, and a nose piece. There is no mention of software as a component or the primary function of the device.
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 mask is for protecting both the patient and healthcare personnel from the transfer of microorganisms, body fluids, and particulate material. This is a physical barrier function, not a diagnostic one.
- Device Description: The description details the physical construction and materials of the mask. There is no mention of components designed to analyze biological samples or provide diagnostic information.
- Performance Studies: The performance studies focus on the physical properties and barrier effectiveness of the mask (filtration efficiency, breathability, fluid resistance, flammability, biocompatibility). These are relevant to its function as a protective barrier, not as a diagnostic tool.
- Lack of Diagnostic Elements: There are no mentions of analyzing samples, detecting biomarkers, or providing any form of diagnostic result.
IVD devices are specifically designed to be used in vitro (outside the body) to examine specimens derived from the human body (like blood, urine, tissue) to provide information for the diagnosis, prevention, or treatment of a disease or condition. This surgical mask does not perform any of these functions.
N/A
Intended Use / Indications for Use
The medical surgical mask 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
FXX
Device Description
The medical surgical mask is pleated three-layer mask with ear loops and nose piece. The inner and outer layers are made of spun-bond non-woven fabric. The middle layer is made of melt blown non-woven fabric. only the outer layers' color is blue (colorant: Pigment Blue 15:3 /CAS number: 147-14-8), which is held to cover the users' mouth and nose by two spandex elastic bands ultrasonic welded to the medical surgical mask. The elastic ear loops are not made with natural rubber latex. The nose piece contained in the medical surgical mask is in the middle layer of medical surgical mask to allow the user to fit the medical surgical mask around their noses, which is made of malleable aluminum wire coated with plastic materials. The dimensions of each medical surgical mask are length 175±5 mm and width 95±5 mm, The dimensions of nose piece is length 110±20 mm, and the ear loop is length 165±10 mm. The medical surgical mask are sold non-sterile and are intended to be single use, disposable devices.
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 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:
- ASTM F2299-03, Standard Test Method for Determining the Initial Efficiency of Materials Used in Surgical face masks to Penetration by Particulates Using Latex Spheres.
- A EN 14683:2019, Annex C. Method for determination of breathability (differential pressure)
- ASTM F1862/ASTM F1862M-17, Standard test method for resistance of Surgical 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 Surgical face mask Materials, Using A Biological Aerosol Of Staphylococcus Aureus.
- 16 CFR Part 1610, Standard for the flammability of clothing textiles.
- 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.
Results: All tests were passed.
Biocompatibility evaluation conducted in accordance with the FDA's 2016 guidance and ISO10993-1:2018 supports that the subject devices are biocompatible.
The biocompatibility test includes the following tests:
- In vitro Cytotoxicity Test per ISO 10993-5:2009 Biological evaluation of medical devices Part 5: Tests for in vitro cytotoxicity.
- Skin Sensitization Tests per ISO 10993-10:2010 Biological evaluation of medical devices —Part 10: Tests for irritation and skin sensitization
- Skin Irritation Tests per ISO 10993-10:2010 Biological evaluation of medical devices- Part 10: Tests for irritation and skin sensitization.
No clinical study is included in this submission.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
- Bacterial filtration efficiency (BFE) ASTM F2101-19: BFE≥98%. Test results: 3 non-consecutive lots tested, using a sample size of 32/lot. Level 2: Lot A: 99.9%, Lot B: 99.875%, Lot C: 99.9%
- Differential pressure mm, (Delta-P) EN 14683:2019, Annex C: Delta P
§ 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 logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
December 11, 2021
Nanchang Kanghua Health Materials Co., Ltd % Doris Chen Regulatory Affairs Staff Shanghai Jiushun Enterprise Management Technology Service Co., Ltd. Room 1502,BaoAn Building,No.800 Dongfang Road Shanghai, 200122 China
Re: K212867
Trade/Device Name: Medical Surgical Mask Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: August 25, 2021 Received: September 8, 2021
Dear Doris Chen:
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.
Clarence W. Murray, III, PhD Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K212867
Device Name Medical Surgical Mask
Indications for Use (Describe)
The medical surgical mask 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)
X Over-The-Counter Use (21 CFR 801 Subpart C)
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3
510(k) Summary K212867
This summary of 510(k) is being submitted in accordance with the requirements of 21 CFR 807.92.
Applicant 1.
Sponsor Name: Nanchang Kanghua Health Materials Co., Ltd
Address: Moonlight Road,Medical Device Technology Park, Jinxian County,Nanchang
City,Jiangxi Province, 331700,China.
- � Contact Person (including title): Jiamin Wang (Manager)
- ◆ Phone:+86-791-85621388
2. Submission Correspondent
Contact Person: Doris Chen
Shanghai Jiushun Enterprise Management Technology Service Co., Ltd. Address: Room 1502,BaoAn
Buiding,No.800 Dongfang Road,Shanghai,China. Tel: +86-21-50931939
Email: doris-chen@isosh.com
3. Subject Device Information
| Type of 510(k): | Traditional |
|---|---|
| Common Name: | Medical Face Mask |
| Trade Name: | Medical Surgical Mask |
| Classification Name: | Mask,Surgical |
| Review Panel: | General Hospital |
| Product Code: | FXX |
| Regulation Number: | 21 CFR 878.4040 |
| Regulation Class: | II |
4
Predicate Device Information 4.
Predicate Device
| Sponsor: | Xiantao Rayxin Medical Products Co., Ltd. |
|---|---|
| Common Name: | Surgical Face Mask |
| Trade Name: | Disposable Surgical Face Mask |
| 510(k) number: | K153496 |
| Review Panel: | General Hospital |
| Product Code: | FXX |
| Regulation Number: | 21 CFR 878.4040 |
| Regulation Class: | II |
5. Device Description
The medical surgical mask is pleated three-layer mask with ear loops and nose piece. The inner and outer layers are made of spun-bond non-woven fabric. The middle layer is made of melt blown non-woven fabric. only the outer layers' color is blue (colorant: Pigment Blue 15:3 /CAS number: 147-14-8), which is held to cover the users' mouth and nose by two spandex elastic bands ultrasonic welded to the medical surgical mask. The elastic ear loops are not made with natural rubber latex. The nose piece contained in the medical surgical mask is in the middle layer of medical surgical mask to allow the user to fit the medical surgical mask around their noses, which is made of malleable aluminum wire coated with plastic materials. The dimensions of each medical surgical mask are length 175±5 mm and width 95±5 mm, The dimensions of nose piece is length 110±20 mm, and the ear loop is length 165±10 mm. The medical surgical mask are sold non-sterile and are intended to be single use, disposable devices.
6. Intended Use / Indications for Use
The medical surgical mask are intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. These masks
5
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.
Comparison with predicate device 7.
Table 1 General Comparison
| Elements of
| Comparison | Subject Device | Predicate Device | Comparison | ||
|---|---|---|---|---|---|
| Manufacturer | Nanchang Kanghua Health | ||||
| Materials Co., Ltd | Xiantao Rayxin Medical | ||||
| Products Co., Ltd. | -- | ||||
| Product Name | Medical Surgical Mask | Disposable Surgical Face | |||
| Masks | -- | ||||
| K Number | K212867 | K153496 | -- | ||
| Product Code | FXX | FXX | Same | ||
| Regulation | |||||
| Number | 21 CFR 878.4040 | 21 CFR 878.4040 | Same | ||
| Intended use/ | |||||
| Indications for Use | The medical surgical mask 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. | 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 control practices to | |||||
| reduce the potential | |||||
| exposure to blood and body | |||||
| fluids. This is a single use, | |||||
| disposable device(s), | |||||
| provided nonsterile. | Same | ||||
| Mask style | Flat pleated, 3 layers. | Flat pleated,3 layers. | Same | ||
| Design feature | Ear loop | Ear Loop and Tie-On | Similar | ||
| Material | Outer | ||||
| facing | |||||
| layer | Spun-bond non-woven fabric | Spun-bond polypropylene | Similar | ||
| Middle | |||||
| layer | Melt blown non-woven fabric | Melt blown polypropylene | |||
| filter | Similar | ||||
| Inner | |||||
| facing | |||||
| layer | Spun-bond non-woven fabric | Spun-bond polypropylene | Similar | ||
| Nose | Outer plastic, inner aluminum | Malleable aluminum wire | Different | ||
| piece | wire | Note 1 | |||
| Ear | |||||
| loops | Spandex | Polyester | Different | ||
| Note 1 | |||||
| Color | Blue | Blue | Same | ||
| Dimension (Width) | 17.5cm±0.5cm | 17.5cm±1cm | Different | ||
| Note 2 | |||||
| Dimension | |||||
| (Length) | 9.5cm±0.5cm | 9.5cm±1cm | Different | ||
| Note 2 | |||||
| OTC use | Yes | Yes | Same | ||
| Sterility | Non-Sterile | Non-Sterile | Same | ||
| Use | Single Use, Disposable | Single Use, Disposable | Same | ||
| ASTM | |||||
| Level | F2100 | ||||
| Level 2 | Level 2 | Same | |||
| Fluid resistance | |||||
| Performance | |||||
| ASTM F1862 | Level 2:32 out of 32 pass at | ||||
| 120mmHg,3non-consecutive | |||||
| lots tested. | 32 out of 32 pass at 120 | ||||
| mmHg | Similar | ||||
| Particle Filtration | |||||
| Efficiency | |||||
| ASTM F2299 | 3 non-consecutive lots tested, | ||||
| using a sample size of 32/lot. | |||||
| Level 2: | |||||
| Lot A: 98.55% | |||||
| Lot B: 98.63% | |||||
| Lot C: 98.53% | 98.46% | Similar Note 3 | |||
| Bacterial Filtration | |||||
| Efficiency | |||||
| ASTM F2101 | 3 non-consecutive lots tested, | ||||
| using a | |||||
| sample size of 32/lot. | |||||
| Level 2: | |||||
| Lot A: 99.9% | |||||
| Lot B: 99.875% | |||||
| Lot C: 99.9% | 98.7% | Similar Note 3 | |||
| Flammability | |||||
| Class | |||||
| 16 CFR 1610 | Class1, 3 non-consecutive lots | ||||
| tested, using a sample size of | |||||
| 32/lot. | Class 1 | ||||
| Non Flammable | Similar | ||||
| Differential | |||||
| Pressure (Delta -P) | 3 non-consecutive lots tested, | ||||
| using a sample size of 32/lot. | |||||
| Level 2: | |||||
| Lot A: 3.4 mm H2O/cm² | |||||
| Lot B: 3.4 mm H2O/cm² | |||||
| Lot C: 3.4 mm H2O/cm² | |||||
| (EN 14683:2019, Annex C) | 4.2mmH2O/cm² | ||||
| (MIL-M-36954C) | Similar Note 3 |
6
7
| Biocompatibility | ISO10993-5 and
ISO10993-10;Under the
conditions of the studies
employed, the device is
non-cytotoxic, non-sensitizing,
and non-irritating. | ISO10993-5 and
ISO10993-10;
Under the conditions of the
studies employed, the
device is non-cytotoxic,
non-sensitizing, and
non-irritating. | Same |
| ------------------ | ----------------------------------------------------------------------------------------------------------------------------------------------------------- | --------------------------------------------------------------------------------------------------------------------------------------------------------------- | ------ |
|---|
Note 1
The difference in the materials of the current nose piece and the ear loop were different from the predicate device. The biocompatibility evaluation test of the subject devices have been performed on the final finished device.
Note 2
Compare with the predicate and reference device, the different of the physical feature or size does not affect the intended use of the subject device.
Note 3
For the Performance testing, the test results are not identical to each other, but they are similar and they both meet the requirement of Level 2 medical mask according to the ASTM F 2100.
8. Summary of Non-Clinical Tests Performed
Non-clinical tests were conducted to verify that the proposed device met all design specifications as 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:
-
ASTM F2299-03, Standard Test Method for Determining the Initial Efficiency of Materials Used in Surgical face masks to Penetration by Particulates Using Latex Spheres.
- A EN 14683:2019, Annex C. Method for determination of breathability (differential pressure)
-
ASTM F1862/ASTM F1862M-17, Standard test method for resistance of Surgical face masks to penetration by synthetic blood (Horizontal projection of fixed volume at a known velocity)
8
- ア ASTM F2101-19, Standard Test Method For Evaluating The Bacterial Filtration Efficiency (BFE) Of Surgical face mask Materials, Using A Biological Aerosol Of Staphylococcus Aureus.
-
16 CFR Part 1610, Standard for the flammability of clothing textiles.
-
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.
|--|
| Test item | Purpose | Acceptance | Test results |
|---|---|---|---|
| (Performance Level 2) | criteria | ||
| (Level 2) | |||
| Bacterial | |||
| filtration | |||
| efficiency (BFE) | |||
| ASTM F2101-19 | The purpose of this testing | ||
| was to evaluate the Bacterial | |||
| filtration efficiency. | BFE≥98%. | 3 non-consecutive lots tested, | |
| using a sample size of 32/lot. | |||
| Level 2: | |||
| Lot A: 99.9% | |||
| Lot B: 99.875% | |||
| Lot C: 99.9% | |||
| Differential pressure mm, | |||
| (Delta-P) | |||
| EN 14683:2019, Annex C | The purpose of this testing | ||
| was to evaluate the | |||
| Differential pressure. | Delta P Skin Sensitization Tests per ISO 10993-10:2010 Biological evaluation of medical devices —Part 10: Tests for irritation and skin sensitization |
- ハ Skin Irritation Tests per ISO 10993-10:2010 Biological evaluation of medical devices-
Part 10: Tests for irritation and skin sensitization.
9. Summary of Clinical Performance Test
No clinical study is included in this submission.
10. Final Conclusion
The conclusions drawn from the nonclinical tests demonstrate that the subject device, Medical surgical mask is as safe, as effective, and performs as well as or better than the legally marketed predicate device, Disposable Surgical Face Masks (K153496).
11. Summary Prepared Date
9/2/2021