(111 days)
Surgical Mask is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. It is 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 Surgical Mask is single use, three-layer, flat-pleated style with ear straps and nose piece. The mask is manufactured with three layers, the inner and outer layers are made of nonwoven fabrics, and the middle layer is made of melt blown fabrics. The ear straps are held in place over the users' mouth and nose by two elastic ear straps welded to the facemask. The elastic ear straps are not made with natural rubber latex. The nose piece on the layers of facemask is to allow the user to fit the facemask around their nose, which is made of Polypropylene+Galvanized-iron dual core. The Surgical Mask will be provided in blue. The masks are sold non-sterile and are intended to be single use, disposable devices.
The provided document, a 510(k) summary for a Surgical Mask (K212344), outlines the non-clinical tests conducted to demonstrate the device's substantial equivalence to a legally marketed predicate device.
Here's an analysis of the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance:
| No. | Name of the Test Methodology / Standard | Purpose | Acceptance Criteria | Results |
|---|---|---|---|---|
| 1 | ISO 10993-10:2010 Biological Evaluation Of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization. (Sensitization Test) | Assess possible contact hazards from chemicals released from medical devices, which may produce skin and mucosal irritation, eye irritation or skin sensitization. | Skin Sensitization Test: provided grades less than 1, otherwise sensitization. | All grades are 0. All animals were survived and no abnormal signs were observed during the study. (Pass) |
| 2 | ISO 10993-10:2010 Biological Evaluation Of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization. (Irritation Test) | Assess possible contact hazards from chemicals released from medical devices, which may produce skin and mucosal irritation, eye irritation or skin sensitization. | Skin Irritation Test: If the primary irritation index is 0-0.4, the response category is Negligible. 0.5-1.9 means slight, 2-4.9 means moderate, 5-8 means severe. | The primary irritation index is 0. The response of the proposed device was categorized as negligible under the test condition. (Pass) |
| 3 | ISO 10993-5:2009 Biological Evaluation Of Medical Devices - Part 5: Tests For In Vitro Cytotoxicity | Describe test methods to assess the in vitro cytotoxicity of medical devices. | The viab.% of the 100% extract of the test article is the final result, and if viability is reduced to <70% of the blank, it has cytotoxic potential. | Viab.% of 100% test article extract is 90.4%. It means the proposed device has no potential toxicity to L-929 in the MTT method. (Pass) |
| 4 | Bacterial filtration efficiency (BFE) (%) ASTM F2101-19 | Evaluate the Bacterial filtration efficiency (BFE) (%) | ≥98% | Average Lot 1: 99.3%, Average Lot 2: 99.2%, Average Lot 3: 99.3%. (Pass) |
| 5 | Differential pressure (mmH2O/cm²) EN 14683 | Evaluate the Differential pressure (mmH2O/cm²) | <6.0 mmH2O/cm² | Average Lot 1: 4.4 mmH2O/cm², Average Lot 2: 4.6 mmH2O/cm², Average Lot 3: 4.6 mmH2O/cm². (Pass) |
| 6 | Sub-micron particulate filtration efficiency at 0.1 micron, % (PFE) | Evaluate the Sub-micron particulate filtration efficiency at 0.1 micron, % (PFE) | ≥98% | Average Lot 1: 98.44%, Average Lot 2: 98.26%, Average Lot 3: 98.30%. (Pass) |
| 7 | Resistance to penetration by synthetic blood, Minimum pressure in mmHg for pass result (ASTM F1862-17) | Evaluate the Resistance to penetration by synthetic blood, Minimum pressure in mmHg for pass result | 29 of 32 test articles passed at 160mmHg | Lot 1: 31 of 32 test articles passed at 160mmHg; Lot 2: 32 of 32 test articles passed at 160mmHg; Lot 3: 32 of 32 test articles passed at 160mmHg. (Pass) |
| 8 | Flammability (16 CFR Part 1610(a)) | Evaluate the Flammability | Class 1 | Class 1, Non Flammable. (Pass) |
| 9 | Tensile strength of Ear Straps | Evaluate the tensile strength | >10 N | Average Lot 1: Left: 14.3 N, Right: 14.4N; Average Lot 2: Left: 14.1 N, Right: 14.7N; Average Lot 3: Left: 14.6 N, Right: 13.9N. (Pass) |
| 10 | Product dimensions | Evaluate the product dimensions | Length: 17.5cm ± 0.5cm; Width: 9.5cm ± 0.5cm | Average Lot 1: (Length): 17.7 cm, (Width): 9.8 cm; Average Lot 2: (Length): 17.8 cm, (Width): 9.6 cm; Average Lot 3: (Length): 17.4 cm, (Width): 9.6 cm. (Pass) |
2. Sample Size Used for the Test Set and Data Provenance:
The document mentions "Lot 1," "Lot 2," and "Lot 3" for several tests (BFE, Differential Pressure, PFE, Synthetic Blood Penetration, Tensile Strength, Product Dimensions). This implies that a sample of masks from at least three different manufacturing lots was used for testing. However, the precise number of individual masks from each lot for each specific test is not explicitly stated, except for the "Resistance to penetration by synthetic blood" test, which used 32 test articles per lot.
The data provenance is from non-clinical testing performed on the device itself, rather than human subject data. The testing was conducted to conform to international standards such as ASTM, EN, and ISO, and potentially US regulations (16 CFR Part 1610(a)). There is no information about the country of origin of the data beyond the manufacturer being in China. The data is prospective in the sense that it was generated specifically for this 510(k) submission.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
These are non-clinical hardware performance tests. No human experts or ground truth establishment by experts were involved in the traditional sense of clinical studies. The "ground truth" for these tests is defined by the objective, quantitative criteria established in the referenced international standards (ASTM, EN, ISO). The results are based on laboratory measurements and observations performed by accredited testing facilities.
4. Adjudication Method for the Test Set:
Not applicable. As these are non-clinical performance tests, there is no need for an adjudication method by human experts. The results are directly compared to the established numerical acceptance criteria.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No. The document explicitly states: "No clinical study implemented for the Surgical Mask." Therefore, no MRMC study was conducted, and no effect size for human readers with or without AI assistance is reported.
6. Standalone (Algorithm Only Without Human-in-the-Loop) Performance:
Not applicable. This device is a physical product (a surgical mask), not an algorithm or AI system. Therefore, standalone algorithm performance is not relevant.
7. Type of Ground Truth Used:
The "ground truth" for the non-clinical tests is based on defined performance standards and specifications from recognized organizations (e.g., ASTM, EN, ISO) and regulatory bodies (e.g., 16 CFR). For example, for Bacterial Filtration Efficiency, the ground truth is "≥98% filtration." For Biocompatibility, it's defined by specific cellular viability percentages or irritation indices.
8. Sample Size for the Training Set:
Not applicable. As this is a physical medical device and not an AI/ML algorithm requiring training data, there is no "training set."
9. How the Ground Truth for the Training Set Was Established:
Not applicable. There is no training set for this device.
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Image /page/0/Picture/0 description: The image contains two logos. On the left is the logo for the Department of Health & Human Services - USA, featuring a stylized human figure. To the right is the logo for the U.S. Food & Drug Administration (FDA), with the FDA acronym in a blue square and the full name "U.S. FOOD & DRUG ADMINISTRATION" in blue text next to it.
November 16, 2021
Xiantao Dingcheng Non-woven Product Co., Ltd Boyle Wang General Manager Shanghai Truthful Information Technology Co., Ltd. Room608, No.738, Shangcheng Rd., Pudong Shanghai, Shanghai China
Re: K212344
Trade/Device Name: Surgical Mask Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical apparel Regulatory Class: Class II Product Code: FXX Dated: September 30, 2021 Received: October 18, 2021
Dear Boyle 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.
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
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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 (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,
Liqun Zhao -S
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) K212344
Device Name Surgical Mask
Indications for Use (Describe)
Surgical Mask is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. It is 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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510(k) Summary
This summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of SMDA 1990 and 21 CFR 807.92.
1.0 Submitter's information
Name: Xiantao Dingcheng Non-woven Product Co., Ltd Address: Liukou Industrial Park, Xiantao City, Hubei Province, CHINA Phone Number: +86-18007229722 Contact: Ms. Cheng Qin Date of Preparation: 21/07/2021
Designated Submission Correspondent
Mr. Boyle Wanq Shanghai Truthful Information Technology Co., Ltd. Room 608, No. 738 Shangcheng Rd., Pudong Shanghai, 200120 China Tel: +86-21-50313932 Email: Info@truthful.com.cn
2.0 Device information
Surgical Mask Trade name: Common name: Surqical Mask Classification name: Mask, Surgical Model(s): ear strap, 175×95mm
3.0 Classification
Production code: FXX Regulation number: 21CFR 878.4040 Classification: Class II Panel: Surgical apparel
4.0 Predicate device information
Manufacturer: Wuhan Dymex Healthcare Co., Ltd Surgical Face Mask Device: 510(k) number: K182515 This device has not been subject to a design-related recall.
5.0 Device description
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The Surgical Mask is single use, three-layer, flat-pleated style with ear straps and nose piece. The mask is manufactured with three layers, the inner and outer layers are made of nonwoven fabrics, and the middle layer is made of melt blown fabrics. The ear straps are held in place over the users' mouth and nose by two elastic ear straps welded to the facemask. The elastic ear straps are not made with natural rubber latex. The nose piece on the layers of facemask is to allow the user to fit the facemask around their nose, which is made of Polypropylene+Galvanize d-iron dual core. The Surgical Mask will be provided in blue. The masks are sold non-sterile and are intended to be single use, disposable devices.
6.0 Indication for Use Statement
Surgical Mask is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. It is 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.
7.0 Comparison of Technological Characteristics
| Item | Proposed device | Predicated device | Remark |
|---|---|---|---|
| Product Code | FXX | FXX | Same |
| Regulation No. | 21 CFR 878.4040 | 21 CFR 878.4040 | Same |
| Class | II | II | Same |
| Product name | Surgical Mask | Surgical Face Mask | - |
| 510(k) No. | K212344 | K182515 | - |
| Models | ear strap, 175×95mm | ear strap | - |
| Intended Use | The Surgical Mask isintended to be worn to protectboth the patient andhealthcare personnel fromtransfer of microorganisms,body fluids and particulatematerial. It is intended for usein infection control practicesto reduce the potentialexposure to blood and bodyfluids. This is a single use,disposable device(s),provided non sterile. | The Surgical Face Masksare intended to be worn toprotect both the patient andhealthcare personnel fromtransfer ofmicroorganisms,body fluids and particulatematerial. These face masksare intended for use ininfection control practices toreduce the potentialexposure to blood and bodyfluids. This is a single use,disposable device(s),provided non-sterile. | Same |
| OTC use | Yes | Yes | Same |
| Composite | Flat Pleated, 3 layers | Flat Pleated, 3 layers | Same |
| Internal layer | Spun-bond polypropylene | Spun-bond polypropylene | Same |
| Middle layer | Melt blown polypropylene | Melt blown polypropylene | Same |
Table 1 Technological Characteristic Comparison Table
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| Material | External layer | Spun-bond polypropylene | Spun-bond polypropylene | Same |
|---|---|---|---|---|
| Nose piece | Polypropylene+Galvanized-iron dual core | Malleable polyethylene wire | * Different 1 | |
| ear strap | Polyester, spandex | spandex | * Different 2 | |
| Color | Blue | Yellow | * Different 3 | |
| Dimension (Length) | $17.5cm\pm0.5cm$ | $17.5cm\pm0.2cm$ | * Different 4 | |
| Dimension (Width) | $9.5cm\pm0.5cm$ | $9.5cm\pm0.2cm$ | * Different 5 | |
| Sterility | Non-Sterile | Non-Sterile | Same | |
| Single Use | Yes | Yes | Same | |
| Sterile | No | No | Same | |
| ASTM F2100 Level | Level 3 | Level 2 | * Different 6 |
- Different analysis:
Different 1-3: the two devices have some difference in materials and product color, product materials safety is proved by its biocompatibility, and the difference does not raise additional questions for safety and effectivenessof device.
Different 4-5: the two devices share same dimensions otherwise the tolerance is different, the little deviation in tolerance does not raise additional questions for safety and effectiveness of device.
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Different 6: the two devices in different levels, the difference does not raise additional questions for safety and effectiveness of device.
8.0 Non-Clinical Test Conclusion
The proposed device was tested and conformed to 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.
Following standards are applicable for the device of Surgical Mask:
- ASTM F2100-19 Standard Specification for Performance of Materials Used in Medical Face Masks
- ASTM F2101-19 Standard Test Method for Evaluating the Bacterial Filtration Efficiency (BFE) of Medical Face Mask Materials, Using a Biological Aerosol of Staphylococcus aureus
- ASTM F1862-17 Standard Test Method for Resistance of Medical Face Masks to Penetration by Synthetic Blood (Horizontal Projection of Fixed Volume at a Known Velocity)
- ASTM F2299- 03 (Reapproved 2017) Standard Test Method for Determining the Initial Efficiency of Materials Used in Medical Face Masks to Penetration by Particulates Using Latex Spheres
- EN 14683-2019 Medical Face Masks – Requirements and Test Methods
- 16 CFR Part 1610(a) Standard for The Flammability of Clothing Textiles
- ISO 10993-1:2018 Biological evaluation of medical devices -- Part 1: Evaluation and testing
- O ISO 10993-5 Third edition 2009-06-01, Biological evaluation of medical devices - Part 5: Tests for In Vitro cytotoxicity.
- ISO 10993-10 Third Edition 2010-08-01, Biological evaluation of medical devices - Part 10: Tests for irritation and skinsensitization.
Table 2 Summary of Non-Clinical Performance Testing
| No. | Name of the TestMethodology / Standard | Purpose | Acceptance Criteria | Results |
|---|---|---|---|---|
| 1 | ISO 10993-10:2010Biological EvaluationOf Medical Devices -Part 10: Tests ForIrritation And Skin | This part of ISO10993 assessespossible contacthazards fromchemicals releasedfrom medicaldevices, which may | Skin SensitizationTest:provided grades lessthan 1, otherwisesensitization. | All grades are 0.All animals were survived and noabnormal signs were observedduring the study. |
| 2 | Sensitization. | produce skin and mucosal irritation, eye irritation or skin sensitization. | Skin Irritation Test: If the primary irritation index is 0-0,4, the response category is Negligible. 0,5-1,9 means slight 2-4,9 means moderate 5-8 means severe | The primary irritation index is 0. The response of the proposed device was categorized as negligible under the test condition |
| 3 | ISO 10993-5:2009Biological Evaluation Of Medical Devices - Part 5: Tests For In Vitro Cytotoxicity | This part of ISO 10993 describes test methods to assess the in vitro cytotoxicity of medical devices. | The viab.% of the 100% extract of the test article is the final result, and if viability is reduced to <70% of the blank, it has cytotoxic potential. | Viab.% of 100% test article extract is 90.4%It means the proposed device have no potential toxicity to L-929 in the MTT method |
| 4 | Bacterial filtration efficiency (BFE) (%)ASTM F2101-19 | The purpose of the test is to evaluate the Bacterial filtration efficiency (BFE) (%) | ≥98 | Average Lot 1: 99.3%Average Lot 2: 99.2%Average Lot 3: 99.3%Pass |
| 5 | Differential pressure (mmH2O/cm²)EN 14683 | The purpose of the test is to evaluate the Different pressure (mmH2O/cm²) | <6.0 mmH2O/cm² | Average Lot 1: 4.4 mmH2O/cm²Average Lot 2: 4.6 mmH2O/cm²Average Lot 3: 4.6 mmH2O/cm²Pass |
| 6 | Sub-micronparticulate filtrationefficiency at 0.1micron, % (PFE) | The purpose ofthe test is toevaluate theSub-micronparticulatefiltrationefficiency at0.1micron, %(PFE) | ≥98 | Average Lot 1: 98.44%Average Lot 2: 98.26%Average Lot 3: 98.30%Pass |
| 7 | Resistance topenetration bysynthetic blood,Minimumpressure in | The purpose ofthe test is toevaluate theResistance topenetration bysynthetic | 29 of 32 testarticles passed at160mmHg | Lot 1: 31 of 32 testarticles passed at160mmHg;Lot 2: 32 of 32 testarticles passed at |
| mmHg for passresult | blood,Minimumpressure inmmHg for passresult | 160mmHg;Lot 3: 32 of 32 testarticles passed at160mmHg Pass | ||
| 8 | Flammability | The purpose ofthe test is toevaluate theFlammability | Class 1 | Class 1, Non FlammablePass |
| 9 | Tensile strength ofEar Straps | to evaluate thetensile strength | >10 N | Average Lot 1:Left: 14.3 NRight: 14.4NAverage Lot 2:Left: 14.1 NRight: 14.7NAverage Lot 3:Left: 14.6 NRight: 13.9N |
| 10 | Product dimensions | to evaluate the | Length: | PassAverage Lot 1: |
| Product dimensions | $17.5cm\pm0.5cm$Width: $9.5cm\pm0.5cm$ | (Length): 17.7 cm(Width): 9.8 cm | ||
| Average Lot 2:(Length): 17.8 cm(Width): 9.6 cm | ||||
| Average Lot 3:(Length): 17.4 cm(Width): 9.6 cm |
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8.0 Clinical Test Conclusion
No clinical study implemented for the Surgical Mask.
9.0 Conclusion
The conclusions drawn from the nonclinical tests demonstrate that the device is as safe, as effective, and performs as well as or better the legally marketed device..
§ 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.