(204 days)
The DISPOSABLE SURGICAL MASK is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids, and particulate materials in infection control practices to reduce the potential exposure to blood and body fluids. It is for single- use and provided non-sterile.
The "DISPOSABLE SURGICAL MASK" is single use, blue color, without face shield, Flat Pleated type, utilizing elastic ear loops for wearing, and it has a Nose Piece design for fitting the facemask around the nose. The "DISPOSABLE SURGICAL MASK" is manufactured with three layers. The inner and outer layers are made of Non-woven fabric (Polypropylene), and the middle filter layer is made of a melt blown fabric (Polypropylene). The subject device is held in place over the user's mouth and nose by two ear loops welded to the facemask. The elastic ear loop is made of Polyester and Spandex. The nose piece contained in masks is in the layers of the facemask to allow the user to fit the facemask around their nose, which is made of iron strip and polypropylene. The"DISPOSABLE SURGICAL MASK" is sold non-sterile and are intended to be single-use, disposable devices. This product contains no components made with natural rubber latex.
The provided text describes the performance data and acceptance criteria for a Disposable Surgical Mask (Model: YYKZ-01) in a 510(k) summary. Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
| Test Item | Acceptance Criteria (ASTM F2100-19 Level 1) | Reported Device Performance |
|---|---|---|
| Bacterial Filtration Efficiency (BFE) | ≥95% | Accepted (Average 99.9%) |
| Particulate Filtration Efficiency (PFE) | ≥95% | Accepted (Average 99.8%) |
| Differential Pressure | <5.0 mm H2O/cm² | Accepted (Average 2.7) |
| Synthetic Blood Penetration Resistance | 80 mmHg | Accepted (80) |
| Flammability | Class 1 | Class 1 |
| In Vitro Cytotoxicity | Viability ≥70% of blank | Non-cytotoxic |
| Skin Sensitization | No sensitization (Magnusson and Kligman grades <1 for test group if control <1) | Non-sensitizing |
| Skin Irritation | Low primary irritation score | Non-irritating |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample sizes for each specific test within the performance and biocompatibility sections. However, it indicates standard test methods were used (e.g., ASTM F2101-19 for BFE, ASTM F2299-03(2017) for PFE, ISO 10993-5:2009 for Cytotoxicity, ISO 10993-10:2010 for Sensitization and Irritation). These methods typically specify minimum sample sizes for reliable results.
The data provenance is retrospective, as the tests were conducted on the device to demonstrate equivalence to a predicate device for marketing approval. The source of the data is implied to be from testing facilities in China, as the submitter, Jiaxing Amazing Travel-Ware CO., LTD, is located in Jiaxing, Zhejiang, China.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the document. The "ground truth" for these tests comes directly from the established technical standards and the objective measurements performed in a laboratory setting, rather than expert interpretation of medical images or diagnoses.
4. Adjudication Method for the Test Set
This is not applicable as the evaluation involves objective laboratory testing against defined criteria, not subjective interpretation requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
This is not applicable. The device is a physical product (Disposable Surgical Mask), not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study is not relevant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This is not applicable. The device is a physical product, not an algorithm.
7. The Type of Ground Truth Used
The ground truth for the performance tests (BFE, PFE, Differential Pressure, Synthetic Blood Penetration, Flammability) is based on objective measurements against established industry standards and specifications (ASTM F2100-19 Level 1 criteria).
For biocompatibility tests (Cytotoxicity, Skin Sensitization, Skin Irritation), the ground truth is established through biological assays using established protocols (ISO 10993-5 and ISO 10993-10) with clearly defined pass/fail criteria based on observed biological responses (e.g., cell viability, skin reactions).
8. The Sample Size for the Training Set
This is not applicable. The device is a physical product, not a machine learning model that requires a training set.
9. How the Ground Truth for the Training Set Was Established
This is not applicable for the same reason as above.
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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 logo. To the right of that 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.
October 12, 2021
Jiaxing Amazing Travel-Ware CO., LTD Jiang Tao Head of Firm No.2196 Honggao Road, Xiuzhou Industrial Park Jiaxing, Zhejiang 314015 China
Re: K210845
Trade/Device Name: Disposable Surgical Mask (Model: YYKZ-01) Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: September 6, 2021 Received: September 13, 2021
Dear Jiang Tao:
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.
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
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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 (OS) 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 Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K210845
Device Name DISPOSABLE SURGICAL MASK(Model: YYKZ-01)
Indications for Use (Describe)
The DISPOSABLE SURGICAL MASK is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids, and particulate materials in infection control practices to reduce the potential exposure to blood and body fluids. It is for single- use and 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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Image /page/3/Picture/1 description: The image shows the word "JEGUN" in a stylized font. The letters are white and have a unique, interconnected design. The background is a light blue color, providing a clean and contrasting backdrop for the text. The overall design is modern and eye-catching.
510(K) Summary
Prepared in accordance with the requirements of 21 CFR Part 807.92
Prepared Date: Sep. 23, 2021
1. Submitter's Information
The submitter of this pre-market notification is:
| Name: | JIAXING AMAZING TRAVEL-WARE CO.,LTD |
|---|---|
| Address: | No.2196 Honggao Road, Xiuzhou Industrial ParkJiaxing, Zhejiang, China 314015 |
| Contact person: | Jiang Tao |
| Title: | Head of Firm |
| E-mail: | 175556919@qq.com |
| Tel: | +86-13957376195 |
2. Device Identification
| 510(k) Number: | K210845 |
|---|---|
| Trade/Device Name: | DISPOSABLE SURGICAL MASK |
| Models: | YYKZ-01 |
| Common name: | Mask, Surgical |
| Regulation Number: | 878.4040 |
| Regulation Name: | Surgical apparel |
| Regulation Class: | Class II |
| Panel: | General Hospital |
| Product Code: | FXX |
3. Predicate Device
| 510(K) number: | K202061 |
|---|---|
| Device Name: | Medical Face mask |
| Manufacturer: | Jiangsu Province Jianerkang Medical Dressing Co., Ltd |
| Common name | Mask, Surgical |
| Regulation Number: | 878.4040 |
| Regulation Name: | Surgical apparel |
| Regulation Class: | Class II |
| Panel: | General Hospital |
| Product Code: | FXX |
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Image /page/4/Picture/1 description: The image shows the word "JEGUN" in a stylized, sans-serif font. The letters are white against a light blue background. The "G" in "JEGUN" is particularly distinctive, with a unique, geometric design that sets it apart from the other letters.
4. Device Description
The "DISPOSABLE SURGICAL MASK" is single use, blue color, without face shield, Flat Pleated type, utilizing elastic ear loops for wearing, and it has a Nose Piece design for fitting the facemask around the nose. The "DISPOSABLE SURGICAL MASK" is manufactured with three layers. The inner and outer layers are made of Non-woven fabric (Polypropylene), and the middle filter layer is made of a melt blown fabric (Polypropylene). The subject device is held in place over the user's mouth and nose by two ear loops welded to the facemask. The elastic ear loop is made of Polyester and Spandex. The nose piece contained in masks is in the layers of the facemask to allow the user to fit the facemask around their nose, which is made of iron strip and polypropylene. The"DISPOSABLE SURGICAL MASK" is sold non-sterile and are intended to be single-use, disposable devices. This product contains no components made with natural rubber latex.
5. Indication for use
The DISPOSABLE SURGICAL MASK is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids, and particulate materials in infection control practices to reduce the potential exposure to blood and body fluids. It is for single-use and provided non-sterile.
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Image /page/5/Picture/0 description: The image is a logo for JEGUN. The logo is white text on a blue background. The text is stylized and appears to be a custom font.
6. Comparison to Predicate Device
Comparison to the predicate devices, the subject device has same intended use, similar product design, same performance effectiveness, performance safety as the predicate device as summarized in the following table
| SEComparisons | Proposed DeviceK210845 | Predicate DeviceK202061 | Similarities/Differences |
|---|---|---|---|
| Name | DISPOSABLE SURGICALMASK | Single-use Surgical Mask | / |
| Model | YYKZ-01 | FE2311 | / |
| Classification | Class II | Class II | Same |
| Intended use/Indications forUse | The DISPOSABLESURGICAL MASK isintended to be worn toprotect both the patient andhealthcare personnel fromtransfer of microorganisms,body fluids, and particulatematerials in infection controlpractices to reduce thepotential exposure to bloodand body fluids. It is forsingle-use and providednon-sterile. | The medical face mask isintended to be worn toprotect both the patient andhealthcare personnel fromtransfer of microorganisms,body fluids, and particulatematerials in infection controlpractices to reduce thepotential exposure to bloodand body fluids. It is forsingle-use and providednon-sterile. | Same |
| ASTM F2100Level | Level 1 | Level 1 | Same |
| Mask Styles | Flat Pleated | Flat Pleated | Same |
| Design features | Ear loop | Ear loop | Same |
| Layers | 3 | 3 | Same |
| Color | Blue | Blue | Same |
| Targetpopulation | Adults | Adults | Same |
| Dimension(length) | $175 \pm 5$ mm | 175 mm | Same |
| Dimension(width) | $95 \pm 5$ mm | 95 mm | Same |
| Sterile | Non-sterile | Non-sterile | Same |
| Use | Single use, disposable | Single use, disposable | Same |
| Anatomical site | Nose and mouth | Nose and mouth | Same |
| Technology | Self-suction filter mask | Self-suction filter mask | Same |
| Environment ofuse | OTC | OTC | Same |
| Material ofOuter layer | Non-woven fabric(Polypropylene) | polypropylene | Same |
| Material ofmiddle layer | Melt blown fabric(Polypropylene) | Melt blown polypropylene | Same |
| Material ofinner layer | Non-woven fabric(Polypropylene) | polypropylene | Same |
| Material ofear loops | Spandex and nylon | Spandex and nylon | Same |
| Material ofNose piece | Iron strip and Polypropylene | Polypropylene coated steelwire | Note 1 |
| Performance testing Data comparison | |||
| BFE | Average 99.9% | Average 99.8% | Meet level 1 |
| PFE | Average 99.8% | Average 96.09% | Meet level 1 |
| DifferentialPressure | Average 2.7 | Average 3.9 | Meet level 1 |
| Synthetic BloodPenetrationResistance | 80 | 80 | Meet level 1 |
| Flammability | Class 1 | Class 1 | Meet level 1 |
| Biocompatibility comparison | |||
| In VitroCytotoxicity | Under the conditions of thetest, the test article wasfound to be non- cytotoxic | Under the conditions of thetest, the test article wasfound to be non- cytotoxic | Same |
| SkinSensitization | Under the conditions of thetest, the test article wasfound to be non- sensitizing | Under the conditions of thetest, the test article wasfound to be non- sensitizing | Same |
| Skin Irritationtest | Under the conditions of thetest, the test article wasfound to be non- irritating | Under the conditions of thetest, the test article wasfound to be non- irritating | Same |
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Image /page/6/Picture/0 description: The image shows the word "JEGUN" in a stylized, sans-serif font. The letters are white and the background is a light blue color. The letters are connected to each other, and the overall design is modern and sleek. The logo is simple and easy to read.
Note 1: The nose piece material of the subject device is iron with polypropylene covering. The predicate device uses polypropylene coated steel wire. The nose piece does not directly contact the user's skin. Biocompatibility testing was conducted on the final device, and the tests showed there was no biocompatibility risk. Performance testing was conducted according to ASTM F2100-19, and the test results show that the proposed device meets the level 1 requirements.
Otherwise, all of the specifications and materials of the subject device, DISPOSABLE SURGICAL MASK (model: YYKZ-01), are the same as the predicate device K202061 with no identified new risks.
7. Performance Data Clinical test:
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Image /page/7/Picture/1 description: The image shows the word "JEGUN" in a stylized font. The letters are white and the background is light blue. The letters are connected to each other, and the overall design is modern and sleek.
Clinical testing is not required.
Non-clinical data
The proposed device DISPOSABLE SURGICAL MASK:
Performance:
-
ASTM F2100-19 Standard Specification for Performance of Materials Used in Medical Face Masks.
-
Bacterial Filtration Efficiency-Determine the bacterial filtration efficiency as directed in Test method F2101.
-
- Differential Pressure -Determine breathing resistance or differential pressure as directed in
EN 14683:2019,Annex C.
- Sub-Micron Particulate Filtration-Determine particulate filtration efficiency as directed in Test 4.
Method F2299
-
- Resistance to Penetration by Synthetic Blood-Determine synthetic blood penetration resistance as specified in Test Method F1862.
-
- Flammability-Determine flammability as specified in 16 CFR Part 1610.
| standard | Test item | Test method | Criteria | Results |
|---|---|---|---|---|
| ASTMF2100-19 | BFE | ASTM F2101-19 | ≥95% | Accepted |
| PFE | ASTM F2299-03(2017) | ≥95% | Accepted | |
| DifferentialPressure | EN14683 :2019+AC (2019)(E),Annex C | <5.0 | Accepted | |
| SyntheticBloodPenetrationResistance | ASTM F1862M-17 | 80mmHg | Accepted | |
| Flammability | 16 CFR Part 1610(As Amendment In 2008) | (A) There are no burn times;or(B) There is only one burntime and it is equal to orgreater than 3.5 seconds; or(C) The average burn time oftwo or more specimens isequal to or greater than 3.5seconds | Class 1 |
Biocompatibility:
-
- ISO 10993-5:2009 Biological evaluation of medical devices - Part 5: Tests for in vitro
- ISO 10993-10:2010 Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization.
| Stand ard | Test item | Test method | Criteria | Results |
|---|---|---|---|---|
| AVI |
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Image /page/8/Picture/1 description: The image shows the word "JEGUN" in white letters against a blue background. The font is stylized and modern, with rounded edges and a slightly futuristic look. The letters are connected to each other, creating a sense of unity and flow. The overall design is clean and simple, making it easy to read and remember.
| ISO10993-5:2009 | In VitroCytotoxicity | In this study, mammalian L-929 cells were cultured invitro according to ISO 10993-5:2009 to test the potentialcytotoxicity of the test article.The test articles and thecontrol material wereseparately placed in MEMmedium containing 10% fetalbovine serum, and extractedin a 37 °C incubator for 24hours. After the end of theextraction, the cell culturemedium in the 96-well plate(104 cells/well) cultured for 24hours was removed andreplaced with thecorresponding extract,cultured in 37 °C, 5%CO2, >90% humidity for 24hours. After the culture, themorphology and cell lysis ofthe cells were observedunder the microscope, andthe cytotoxicity of the testsamples was determined byMTT assay. | The 50% extract of the testarticle should have at leastthe same or a higher viabilitythan the 100% extract.Otherwise the test should berepeated.The lower the Viab. % value,the higher the cytotoxicpotential of the test article is.If viability is reduced to <70%of the blank, it has acytotoxic potential.The Viab.% of the 100%extract of the test article isthe final result. | Under theconditionsof thetest, thetest articlewas foundto be non-cytotoxic |
|---|---|---|---|---|
| ISO10993-10:2010 | SkinSensitization | we took guinea pigs toobserve the skin sensitizationof the test article according toISO 10993-10: 2010.The test article wereextracted in ConstantTemperature Vibrator at50 °C, 60 rpm for 72 h by0.9 % Sodium ChlorideInjection and Sesame Oil.Mix 50:50 (by volume) stableemulsion of Freund'scomplete adjuvant withselected solvent. Intradermalinduction and topicalinduction were operated inthe clipped intrascapularregion of each animal. Afterthe topical induction phasewas completed on day 14, alltest and control animals werechallenged with the testsample. The erythema andedema of the challenge site | Magnusson and Kligmangrades of 1 or greater in thetest group generally indicatesensitization, providedgrades of less than 1 areseen in control animals.If grades of 1 or greater arenoted in control animals, thenthe reactions of test animalswhich exceed the mostsevere reaction in controlanimals are presumed to bedue to sensitization.If the response is equivocal,rechallenge is recommendedto confirm the results fromthe first challenge. Theoutcome of the test ispresented as the frequencyof positive challenge resultsin test and control animals. | Under theconditionsof thetest, thetest articlewas foundto be non-sensitizing |
| sensitization response of thetest article. According to theMagnusson and Kligmanscales, the response toerythema and edema at eachapplication site of the skinwas described and scored 24hours and 48 hours after thechallenge phase. | ||||
| SkinIrritation test | we took New Zealand whiteRabbits to observe the skinirritation of the test articleaccording to ISO10993-10:2010.The test article wereextracted in ConstantTemperature Vibrator at50 °C, 60 rpm for 72 h by0.9 % Sodium ChlorideInjection and SesameOil.Apply 0.5 ml extracts oftest article or control to2.5 cm x 2.5 cm absorbentgauze patches, and thenapply the patch soaked withthe extract of test article orcontrol directly to the skin oneach side of each rabbit, andthen wrap the applicationsites with a bandage for aminimum of 4 h.At the end ofthe contact time, remove thedressing. The describe andscore the skin reaction forerythema and oedema foreach application site at eachtime interval. Record theappearance of eachapplication site at (1±0.1) h,(24±2) h, (48±2) h and(72±2)h following removal ofthe patches. | Use only (24±2) h, (48±2) hand (72±2) h observations forcalculation.After the 72 h grading, allerythema grades plusoedema grades (24±2) h,(48±2) h and (72±2) h weretotalled separately for eachtest article and blank for eachanimal. The primary irritationscore for an animal wascalculatedby dividing the sum of all thescores by 6 (twotest/observation sites, threetime points).To obtain the primaryirritation index for the testarticle, add all the primaryirritation scores of theindividualanimals and divide by thenumber of animals.When blank or negativecontrol was used, calculatethe primary irritation score forthe controls and subtractthat score from the scoreusing the test material toobtain the primary irritationscore. | Under theconditionsof thetest, thetest articlewas foundto be non-irritating |
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Image /page/9/Picture/0 description: The image features the word "JEGUN" in a stylized, sans-serif font. The letters are white and have a unique, interconnected design, giving the word a modern and somewhat futuristic appearance. The background is a solid light blue color, which provides a clean and contrasting backdrop for the white text, making it easily readable.
8. Conclusion
The conclusions drawn from the nonclinical tests demonstrates that the subject device in 510(k) submission K210845, the DISPOSABLE SURGICAL MASK is as safe, as effective, and performs as well as or better than the legally marketed device predicate cleared under K202061.
§ 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.