(203 days)
The Disposable Medical Mask is 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 potential exposure to blood and body fluids. The face mask is single use, disposable device, provided non-sterile.
The Disposable Medical Mask is flat pleated style mask, utilizing ear Loops way for wearing, and they all have nose piece design for fitting the Disposable Medical Mask around the nose. The Disposable Medical Mask is manufactured with three layers, the inner and outer layers are made of spun-bond polypropylene, only the outer layers' color is blue (colorant: 29H,31H-phthalocyaninato(2-)-N29,N30,N31,N32 copper, CAS number: 147-14-8), and the middle layer is made of Melt blown polypropylene filter. Ear loops, which is held to cover the users' mouth and nose by two Spandex and nylon bands ultrasonic welded to the Disposable Medical Mask. The elastic ear loops are not made with natural rubber latex. The nose piece contained in the Disposable Medical Mask is in the middle layer of Disposable Medical Mask to allow the user to fit the Medical surgical mask around their noses, which is made of polypropylene coated iron wire. The Medical surgical mask is sold non-sterile and is intended to be single use, disposable device. The dimensions of each Disposable Medical Mask is length 17.5cm±1cm and width 9.5cm±1cm. The dimensions of nosepiece is length 85±1 mm and width 3.0±0.5 mm, and the ear loop is length 180±10 mm and width 3.0±0.5 mm.
The provided text describes the 510(k) summary for a Disposable Medical Mask (Model: Rlp001) seeking substantial equivalence to a predicate device (3M™ High Fluid-Resistant Procedure Mask, K191355). The acceptance criteria are based on recognized performance standards for medical face masks.
Here's a breakdown of the requested information:
1. A table of acceptance criteria and the reported device performance
| Test Item (Performance Level 3) | Test Method | Acceptance Criteria | Reported Device Performance / Verdict |
|---|---|---|---|
| Bacterial filtration efficiency (BFE) | ASTM F2101-14 Standard Test Method for Evaluating the Bacterial Filtration Efficiency (BFE) of Medical Face Mask Materials, Using a Biological Aerosol of Staphylococcus aureus according to ASTM F2100:2019 | ≥ 98% | 32/32 Passed at ≥98% / Pass |
| Differential pressure (Delta-P) | EN 14683: 2019, Annex C Medical face masks - Requirements and test methods according to ASTM F2100:2019 | < 6.0 mm H2O/cm² | 32/32 Passed at < 6 mmH2O/cm² / Pass |
| Sub-micron particulate filtration efficiency at 0.1 µm of Polystyrene Latex Spheres | ASTM F2299-03 Standard Test Method for Determining the Initial Efficiency of Materials Used in Medical Face Masks to Penetration by Particulates Using Latex Spheres according to ASTM F2100:2019 | ≥ 98% | 32/32 Passed at ≥98% / Pass |
| Resistance to penetration by synthetic blood | ASTM F1862/F1862M-17 Standard Test Method for Resistance of Medical Face Masks to Penetration by Synthetic Blood (Horizontal Projection of Fixed Volume at a Known Velocity) | Fluid resistant claimed at 160 mm Hg | 32/32 Passed at 160 mmHg / Pass |
| Flame spread | according to ASTM F2100:2019 16 CFR Part 1610 Standard for the Flammability of Clothing according to ASTM F2100:2019 | Class 1 | 32/32 Passed ≥3 Seconds burn Time-Class 1 / Pass |
| Biocompatibility (Cytotoxicity) | ISO 10993-5:2009 Biological evaluation of medical devices- Part 5: Tests for in vitro cytotoxicity | Non-cytotoxic | Determined to be non-cytotoxic |
| Biocompatibility (Irritation) | ISO 10993-10:2010 Biological evaluation of medical devices— Part 10: Tests for irritation and skin sensitization | Non-irritating | Determined to be non-irritating |
| Biocompatibility (Sensitization) | ISO 10993-10:2010 Biological evaluation of medical devices— Part 10: Tests for irritation and skin sensitization | Non-sensitizing | Determined to be non-sensitizing |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
For performance tests (BFE, Delta-P, Particulate Filtration, Fluid Resistance, Flammability): The sample size appears to be 32 for most tests, with flammability having a sub-sample of 5 (for the predicate device only, the subject device shows 32).
For biocompatibility tests (Cytotoxicity, Irritation, Sensitization): The sample size is not explicitly stated as a number, but the results refer to "the subject device extract." These tests are typically in vitro or in vivo (animal) studies, not typically involving human data directly.
- Data Provenance: The document does not specify the country of origin of the test data or whether the studies were retrospective or prospective, but it's reasonable to assume the non-clinical tests were conducted in a laboratory setting, likely in China given the manufacturer's location.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This section is not applicable. The tests performed are non-clinical, laboratory-based performance and biocompatibility tests for a medical mask. Ground truth is established by adherence to recognized international standards (ASTM, EN, ISO) and the physical measurements of the device properties, not through expert consensus on medical images or clinical outcomes.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This section is not applicable. As these are non-clinical laboratory tests, there is no expert adjudication process like those used in clinical reader studies. The "verdict" is a direct outcome of the test measurements against predefined criteria.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This section is not applicable. The device is a Disposable Medical Mask, and the submission is a 510(k) for substantial equivalence based on non-clinical performance and biocompatibility. It is not an AI-assisted diagnostic or therapeutic device, and therefore, no MRMC study was performed.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This section is not applicable. The device is a Disposable Medical Mask. There is no algorithm or AI component involved.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device is based on established international consensus standards (ASTM, EN, ISO) for the performance characteristics of medical face masks (e.g., filtration efficiency, differential pressure, fluid resistance, flammability) and biocompatibility. The pass/fail criteria are defined by these standards.
8. The sample size for the training set
This section is not applicable. This is a physical medical device (mask), not an AI/ML algorithm. Therefore, there is no "training set" in the context of machine learning.
9. How the ground truth for the training set was established
This section is not applicable for the same reason as point 8.
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April 5, 2021
Dongguan Runlin Medical Supplies Technology Co., LTD % Cassie Lee Manager Share Info (Guangzhou) Medical Consultant Ltd. No. 1919-1920, Building D3, Minjie Plaza, Shuixi Road, Huangpu District Guangzhou, Guangdong 510700 China
Re: K202655
Trade/Device Name: Disposable Medical Mask (Model: Rlp001) Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: March 5, 2021 Received: March 9, 2021
Dear Cassie Lee:
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 de vice, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies.combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801 ): medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 53 1 -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/cdrl-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-ind-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,
Bifena O
For Ryan Ortega, PhD Acting 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) K202655
Device Name Disposable Medical Mask (Model: Rlp001)
Indications for Use (Describe)
The Disposable Medical Mask is 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 potential exposure to blood and body fluids. The face mask is single use, disposable device, provided nonsterile.
| 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 for K202655
This summary of 510(K) safety and effectiveness information is being submitted in accordance with the requirement of 21 CFR 807.92.
1. Submitter's Information
510(k) Owner's Name: Dongguan Runlin Medical Supplies Technology Co., LTD Establishment Registration Number: 3016965344 Address: No.6, longzhou wei street, liaobu town, dongguan city, guangdong province, China. Contact Person: Weiming Chen Email: weiming c@126.com
Application Correspondent:
Contact Person: Ms. Cassie Lee Share Info (Guangzhou) Medical Consultant Ltd. Address: No. 1919-1920, Building D3, Minije Plaza, Shuixi Road, Huangpu District, Guangzhou, China Tel: +86 20 8266 2446 Email: regulatory@glomed-info.com
2. Date of the summary prepared: September 9, 2020 Revision date: April 3, 2021
3. Subject Device Information
Type of 510(k): Traditional Classification Name: Mask, Surgical Common name: Surgical Mask Trade Name: Disposable Medical Mask Model Name: Rlp001 Review Panel: General Hospital Product Code: FXX Regulation Number: 878.4040 Regulatory Class: II
4. Predicate Device Information
Sponsor: 3M Health Care
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| Sponsor: | Dongguan Runlin Medical Supplies Technology Co., LTD |
|---|---|
| Subject Device: | Disposable Medical Mask (Model: Rlp001) |
| Document Name: | 510(k) Summary |
Trade Name: 3M™ High Fluid- Resistant Procedure Mask Classification Name: Mask, Surgical Common name: Surgical Mask 510(K) Number: K191355 Review Panel: General Hospital Product Code: FXX Regulation Number: 878.4040 Regulation Class: II
5. Device Description
The Disposable Medical Mask is flat pleated style mask, utilizing ear Loops way for wearing, and they all have nose piece design for fitting the Disposable Medical Mask around the nose. The Disposable Medical Mask is manufactured with three layers, the inner and outer layers are made of spun-bond polypropylene, only the outer layers' color is blue (colorant:
29H,31H-phthalocyaninato(2-)-N29,N30,N31,N32 copper, CAS number: 147-14-8), and the middle layer is made of Melt blown polypropylene filter.
Ear loops, which is held to cover the users' mouth and nose by two Spandex and nylon bands ultrasonic welded to the Disposable Medical Mask. The elastic ear loops are not made with natural rubber latex.
The nose piece contained in the Disposable Medical Mask is in the middle layer of Disposable Medical Mask to allow the user to fit the Medical surgical mask around their noses, which is made of polypropylene coated iron wire.
The Medical surgical mask is sold non-sterile and is intended to be single use, disposable device. The dimensions of each Disposable Medical Mask is length 17.5cm±1cm and width 9.5cm±1cm. The dimensions of nosepiece is length 85±1 mm and width 3.0±0.5 mm, and the ear loop is length 180±10 mm and width 3.0±0.5 mm.
6. Intended Use / Indications for Use
The Disposable Medical Mask is 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 potential exposure to blood and body fluids. The face mask is single use, disposable device, provided non-sterile.
7. Comparison of Technological Characteristics
The differences between the subject device and predicate devices do not raise new issues of safety or effectiveness.
| Elements ofComparison | Subject Device | Predicate Device | Verdict |
|---|---|---|---|
| --------------------------- | ---------------- | ------------------ | --------- |
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| Sponsor: | Dongguan Runlin Medical Supplies Technology Co., LTD |
|---|---|
| Subject Device: | Disposable Medical Mask (Model: Rlp001) |
| Document Name: | 510(k) Summary |
| Elements of | Subject Device | Predicate Device | Verdict |
|---|---|---|---|
| Comparison | |||
| Company | Dongguan Runlin MedicalSupplies Technology Co., LTD | 3M Health Care | -- |
| 510 (k) | K202655 | K191355 | -- |
| Trade Name | Disposable Medical Mask | 3M™ High Fluid- ResistantProcedure Mask | -- |
| ClassificationName | Mask, Surgical | Mask, Surgical | Same |
| Classification | Class II Device, FXX (21CFR878.4040) | Class II Device, FXX (21CFR878.4040) | Same |
| Intended use | The Disposable Medical Mask isintended to be worn to protectboth the patient and healthcarepersonnel from transfer ofmicroorganisms, body fluids,and particulate material. Theseface masks are intended for usein infection control practices toreduce potential exposure toblood and body fluids. The facemask is single use, disposabledevice, provided non-sterile. | 3M™ High Fluid- ResistantProcedure Mask is intended tobe worn to protect both thepatient and healthcarepersonnel from transfer ofmicroorganisms, body fluids,and particulate material. Theseface masks are intended for usein infection control practices toreduce potential exposure toblood and body fluids. This is asingle use, disposable device,provided non-sterile. | Same |
| Material | |||
| Outer facinglayer | Spun-bond polypropylene | Spun-bond polypropylene | Same |
| Middle layer | Melt blown polypropylene filter | Melt blown polypropylene filter | Same |
| Inner facinglayer | Spun-bond polypropylene | Spun-bond polypropylene | Same |
| Nose piece | Polypropylene coated iron wire | Polyethylene coated steel wire | DifferentNote 1 |
| Ear loops | Spandex and nylon | Spandex elastic cord(polyurethane core withpolyethylene terephthalate/nylon cover) | DifferentNote 1 |
| Designfeatures | Color: Blue (Outer) | Color: Green (Outer) | DifferentNote 1 |
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| Sponsor: | Dongguan Runlin Medical Supplies Technology Co., LTD |
|---|---|
| Subject Device: | Disposable Medical Mask (Model: Rlp001) |
| Document Name: | 510(k) Summary |
| Elements ofComparison | Subject Device | Predicate Device | Verdict |
|---|---|---|---|
| Mask Style | Flat Pleated | Flat Pleated | Same |
| SpecificationandDimension | Length: 17.5cm±1cmWidth: 9.5cm±1cm | Length: 17.5cm±0.5cmWidth: 9.0cm±0.75cm | DifferentNote 1 |
| OTC use | Yes | Yes | Same |
| Sterility | Non-Sterile | Non-Sterile | Same |
| Use | Single Use, Disposable | Single Use, Disposable | Same |
| PerformanceTesting | Level 3 | Level 3 | Same |
| FluidResistancePerformance | 32/32 Passed at 160 mmHgASTM F1862 | 32/32 Passed at 160mm HgASTM F1862 | Same |
| ParticulateFiltrationEfficiency | 32/32 Passed at ≥98%ASTM F2299-03 | 32/32 Passed at ≥98% @ 0.1Micron ASTM F2299 | Same |
| BacterialFiltrationEfficiency | 32/32 Passed at ≥98%ASTM F2101-14 | 31/32 Passed at ≥98%ASTM F2101 | Same |
| DifferentialPressure | 32/32 Passed at <6 mmH2O/cm2EN 14683: 2019, Annex C | 32/32 Passed at <5 mmH2O/cm2MIL-M36954C | SimilarNote 2 |
| Flammability | 32/32 Passed ≥3 Seconds burnTime-Class 1 16 CFR Part 1610 | 5/5 Passed ≥3 Seconds burntime - Class 1 CFR 16 1610 | Same |
| Shelf life | 2 years | Not public | DifferentNote 3 |
| Biocompatibility | |||
| Cytotoxicity | Under the conditions of thestudy, the subject device extractwas determined to benon-cytotoxic. | Under the conditions of thestudy, the subject device extractwas determined to benon-cytotoxic. | Same |
| Irritation | Under the conditions of thestudy, the subject devicenon-polar and polar extractswere determined to benon-irritating. | Under the conditions of thestudy, the subject devicenon-polar and polar extractswere determined to benon-irritating. | Same |
| Sensitization | Under the conditions of thestudy, the subject device | Under the conditions of thestudy, the subject device | Same |
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| Sponsor: | Dongguan Runlin Medical Supplies Technology Co., LTD |
|---|---|
| Subject Device: | Disposable Medical Mask (Model: Rlp001) |
| Document Name: | 510(k) Summary |
| Elements ofComparison | Subject Device | Predicate Device | Verdict |
|---|---|---|---|
| non-polar and polar extractswere determined to benon-sensitizing. | non-polar and polar extractswere determined to benon-sensitizing. |
Comparison in Detail(s):
Note 1:
Although the "Nose piece", "Ear loops", "Design features" and "Specification and Dimension" of subject device is little difference with predicate device, it meets the requirement of essential performance standard ISO 10993. The differences between the predicate device and subject device will not affect the safety and effectiveness of the subject device.
Note 2:
Although the "Differential Pressure" of subject device is little difference with predicate device, and they all meet the requirements of essential performance standard ASTM F2100. So, the differences between the predicate device and subject device will not affect the safety and effectiveness of the subject device.
Note 3:
Although the "Shelf life" of subject device is difference with predicate device, the aging test showed that the requirements of essential performance standard ASTM F2100. So, the differences between the predicate device and subject device will not affect the safety and effectiveness of the subject device.
| Performance Testing summary | |||
|---|---|---|---|
| Test item(PerformanceLevel 3) | Test method | Pass criteria | Test results/Verdict |
| Bacterial filtrationefficiency | ASTM F2101-14Standard TestMethod forEvaluating theBacterial Filtration | ≥ 98% | 32/32 Passed at≥98% / Pass |
5
8. Summary of Non-Clinical Performance Testing
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| Sponsor: | Dongguan Runlin Medical Supplies Technology Co., LTD |
|---|---|
| Subject Device: | Disposable Medical Mask (Model: Rlp001) |
| Document Name: | 510(k) Summary |
| Efficiency (BFE) ofMedical Face MaskMaterials, Using aBiological Aerosolof Staphylococcusaureus accordingto ASTMF2100:2019 | |||
|---|---|---|---|
| Differentialpressure (Delta-P) | EN 14683: 2019,Annex C Medicalface masks -Requirements andtest methodsaccording to ASTMF2100:2019 | <6.0 mm H2O/cm² | 32/32 Passed at<6 mmH2O/cm² /Pass |
| Sub-micronparticulate filtrationefficiencyat 0.1 µm ofPolystyrene LatexSpheres | ASTM F2299-03Standard TestMethod forDetermining theInitial Efficiency ofMaterials Used inMedical FaceMasks toPenetration byParticulates UsingLatex Spheresaccording to ASTMF2100:2019 | ≥ 98% | 32/32 Passed at≥98% / Pass |
| Resistance topenetration bysyntheticblood, minimumpressure in mm Hgfor pass result | ASTMF1862/F1862M-17Standard TestMethod forResistance ofMedical Face Masksto Penetration bySynthetic Blood(Horizontal Projectionof Fixed Volume at aKnown Velocity) | Fluid resistantclaimedat 160 mm Hg | 32/32 Passed at160 mmHg/ Pass |
| Flame spread | according to ASTM F2100:201916 CFR Part 1610 Standard for the Flammability of Clothing according to ASTM F2100:2019 | Class 1 | 32/32 Passed ≥3 Seconds burn Time-Class 1 / Pass |
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Sponsor: Dongguan Runlin Medical Supplies Technology Co., LTD Subject Device: Disposable Medical Mask (Model: Rlp001) Document Name: 510(k) Summary
● Biocompatibility Testing
According to ISO 10993-1:2009, the nature of body contact for the subject device is Surface Device category, Skin Contact and duration of contact is A-Limited (≤24h). The following tests for the subject device were conducted to demonstrate that the subject device is biocompatible and safe for its intended use:
-
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.
9. Summary of Clinical Performance Test
No clinical study is included in this submission.
10. Final Conclusion:
The conclusion drawn from the nonclinical tests demonstrates that the subject device in 510(K) submission K202655, the Disposable Medical Mask is as safe, as effective, and performs as well as or better than the legally marketed predicate device cleared under K191355.
§ 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.