(109 days)
A powder-free patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. The glove was tested for use with Chemotherapy Drugs and Fentanyl Citrate as per ASTM D6978-05 Standard Practice for Assessment for Medical Gloves to Permeation by Chemotherapy Drugs.
The Sapphire Pro Powder-Free Royal Blue Nitrile Exam Gloves are non-sterile, single use, disposable gloves intended for medical purposes to be worn on the hands of examiners to prevent contamination between a patient and an examiner. The gloves are nitrile, powder-free, ambidextrous, and blue-colored with a beaded cuff. The range of sizes includes small, medium, large, and extra-large.
The provided document is a 510(k) summary for the Sapphire Pro Powder-Free Royal Blue Nitrile Exam Gloves, detailing their substantial equivalence to a predicate device. It includes information on acceptance criteria and performance for various tests relevant to examination gloves, particularly concerning permeation by chemotherapy drugs and fentanyl.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based solely on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document provides a "Summary of Nonclinical Testing" table. This section outlines the tests performed, their purpose, acceptance criteria, and the results for the Sapphire Pro Powder-Free Royal Blue Nitrile Exam Gloves.
| Name of Test / Standard | Purpose | Acceptance Criteria | Reported Device Performance (Results) |
|---|---|---|---|
| ISO 10993-10:2010 (2014) | Irritation | Pass / Fail | Pass – Under the conditions of the study, the subject device is not a primary skin irritant. |
| ISO 10993-10:2010 (2014) | Sensitization | Pass / Fail | Pass - Under the conditions of the study, the subject device is not a primary skin sensitizer. |
| ISO 10993-5:2009 (2014) | Cytotoxicity | Pass / Fail | Fail – Under the conditions of the study, the subject device is cytotoxic. |
| ISO 10993-11:2017 | Acute Systemic Toxicity | Pass / Fail | Pass - Under the conditions of the study, the subject device is not toxic. |
| ASTM D6319-19 ASTM D3767-03 (2020) | Physical Dimensions | Length: 220 mm min.Width: 70 mm min.Thickness – Palm and Finger: 0.05 mm min. | Pass |
| ASTM D6978-05 (2019) | Permeation of Fentanyl | 240 minutes breakthrough time min. | Pass (>240 minutes breakthrough time for Fentanyl Citrate 100mcg/2ml) |
| ASTM D6978-05 (2019) | Permeation of Chemotherapy Drugs | 240 minutes breakthrough time min. | Mixed Results (See breakdown below) |
| ASTM D5151-19 | Detection of Holes | Leakage detection, AQL 2.5 | Pass |
| ASTM D6124-06 (2017) | Residual Powder | Max 2.0 mg / glove | Pass |
| ASTM D6319-19 ASTM D412-16 (2021) ASTM D573-04 (2019) | Physical Properties (Tensile Strength & Elongation) | Tensile Strength: Before Aging ≥ 14 MPa, min; After Aging ≥ 14 MPa, minElongation: Before Aging 500%, min.; After Aging 400%, min. | Pass |
Detailed Chemotherapy Drug Permeation Results (from "Indications for Use" section):
| Chemotherapy Drug and Concentration | Breakthrough Time (minutes) | Acceptance Criteria (from table above) |
|---|---|---|
| Carmustine (BNCU) (3.3 mg/ml) | 25.5 | < 240 minutes (did not meet 240 min min.) |
| Cyclophosphamide (20.0 mg/ml) | >240 | Pass |
| Doxorubicin HCl (2.0 mg/ml) | >240 | Pass |
| Etoposide (20.0 mg/ml) | >240 | Pass |
| 5-Fluorouracil (50.0 mg/ml) | >240 | Pass |
| Methotrexate (25.0 mg/ml) | >240 | Pass |
| Paclitaxel (6.0 mg/ml) | >240 | Pass |
| Thiotepa (10.0 mg/ml) | 47.7 | < 240 minutes (did not meet 240 min min.) |
| Vincristine Sulfate (1.0 mg/ml) | >240 | Pass |
Note on Cytotoxicity: The device failed the cytotoxicity test ("Fail – Under the conditions of the study, the subject device is cytotoxic."). However, the conclusion states that the device is "as safe, as effective, and performs as well as or better than the legally marketed predicate device." The comparative table indicates the predicate device was also "cytotoxic," suggesting this is an anticipated characteristic for this type of nitrile glove and not a disqualifying factor for substantial equivalence in this context.
2. Sample size used for the test set and the data provenance
The document specifies the tests conducted according to various ASTM and ISO standards for medical gloves. While the standards imply established testing methodologies and sample sizes (e.g., AQL 2.5 for hole detection typically involves specific sample sizes), the exact numerical sample sizes used for each specific test (e.g., for biocompatibility, physical properties, or permeation tests) are not explicitly stated in this summary.
Data provenance: The tests were conducted according to internationally recognized standards (ASTM, ISO). The document does not specify the country of origin of the data collectors or if the data was retrospective or prospective. It is implied to be prospective testing carried out for the device's clearance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This section is not applicable to this document. The "ground truth" for medical gloves like these is established through standardized laboratory testing procedures (e.g., ASTM D6978-05 for permeation, ASTM D6319-19 for physical dimensions, ISO 10993 series for biocompatibility). There are no human "experts" establishing a "ground truth" for classification or diagnosis in the way one would for an AI CAD system for medical imaging. The performance is measured against objective, measurable criteria defined by the standards.
4. Adjudication method for the test set
This concept is not applicable as the "test set" involves objective performance testing against established standards, not subjective expert reviews or diagnostic interpretations.
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 concept is not applicable as the device is a medical glove, not an AI-assisted diagnostic tool requiring human reader studies.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This concept is not applicable as the device is a medical glove, not an AI algorithm. Its performance is inherent to its physical and chemical properties.
7. The type of ground truth used
The "ground truth" for the performance claims of these gloves is based on standardized laboratory test results defined by the relevant ASTM (American Society for Testing and Materials) and ISO (International Organization for Standardization) standards. These include:
- Physical measurements (e.g., length, width, thickness).
- Mechanical properties (e.g., tensile strength, elongation).
- Barrier integrity (e.g., freedom from holes).
- Chemical resistance (e.g., breakthrough time for drugs).
- Biocompatibility (e.g., irritation, sensitization, cytotoxicity, systemic toxicity).
8. The sample size for the training set
This concept is not applicable as the device is a medical glove, not a machine learning model that requires a training set.
9. How the ground truth for the training set was established
This concept is not applicable as the device is a medical glove, not a machine learning model.
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July 8, 2022
American Nitrile Operations LLC Stephen Perrin Manager of Quality Assurance & Regulatory Affairs 3500 Southwest Blvd Grove City, Ohio 43123
Re: K220825
Trade/Device Name: Sapphire Pro Powder-Free Royal Blue Nitrile Exam Gloves Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I, reserved Product Code: LZA, LZC, QDO Dated: June 8, 2022 Received: June 13, 2022
Dear Stephen Perrin:
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,
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
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Indications for Use
510(k) Number (if known) K220825
Device Name
Sapphire Pro Powder-Free Royal Blue Nitrile Exam Gloves
Indications for Use (Describe)
A powder-free patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. The glove was tested for use with Chemotherapy Drugs and Fentanyl Citrate as per ASTM D6978-05 Standard Practice for Assessment for Medical Gloves to Permeation by Chemotherapy Drugs.
The list of Fentanyl and Chemotherapy Drugs tested (with breakthrough times) are:
| Chemotherapy Drug and Concentration | Breakthrough Time (minutes) |
|---|---|
| Carmustine (BNCU) (3.3 mg/ml) | 25.5 |
| Cyclophosphamide (20.0 mg/ml) | >240 |
| Doxorubicin HCl (2.0 mg/ml) | >240 |
| Etoposide (20.0 mg/ml) | >240 |
| 5-Fluorouracil (50.0 mg/ml) | >240 |
| Methotrexate (25.0 mg/ml) | >240 |
| Paclitaxel (6.0 mg/ml) | >240 |
| Thiotepa (10.0 mg/ml) | 47.7 |
| Vincristine Sulfate (1.0 mg/ml) | >240 |
| Fentanyl (100mcg/2ml) | >240 |
CAUTION: Testing showed an average breakthrough time of 25.5 min for Carmustine and 47.7 min for Thiotepa.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(K) SUMMARY
K220825
AMERICAN NITRILE OPERATIONS LLC SAPPHIRE PRO POWDER-FREE ROYAL BLUE NITRILE EXAM GLOVES
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Image /page/4/Picture/0 description: The image shows the words "AMERICAN NITRILE" in large, bold, blue font. The words are all capitalized and evenly spaced. The background is white, which makes the blue text stand out. The text appears to be the name of a company.
Image /page/4/Picture/1 description: The image shows a logo of a stylized bird with its wings spread. The bird's body and head are red, while the wings are blue with a grid pattern. The logo has a modern and abstract design, with clean lines and a symmetrical composition. The bird's wings are angled upwards, suggesting flight or progress.
510(k) Summary
(In accordance with 21 CFR 807.92)
Submitter
American Nitrile Operations LLC 3500 Southwest Blvd Grove City, OH 43123
Contact Person: Stephen R Perrin Jr Manager of Quality Assurance and Regulatory Affairs sperrin@aamericannitrile.com
Summary Preparation Date
08 JUN 2022
Type of 510(k) Submission
Abbreviated
Device Name & Classification
| Device Name & Classification | |
|---|---|
| Trade Name | Sapphire Pro Powder-Free Royal Blue Nitrile Exam Gloves |
| Common Name | Non-powdered patient examination glove |
| Classification Name | Nitrile Blue Chemo and Fentanyl Tested Patient Examination Gloves |
| Product Code | LZA, LZC, QDO |
| Review Panel | General Hospital |
| Regulatory Class | Class I |
| Regulation Number | 21 CFR 880.6250 |
| Predicate Device | |
|---|---|
| Device Name | Medline Powder-Free Orange Nitrile Patient Examination Gloves |
| (Tested for use with Fentanyl) | |
| 510k Number | K200150 |
| 510k Owner | Medline Industries, Inc. |
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Image /page/5/Picture/1 description: The image shows a logo with a stylized eagle design. The eagle's head and upper body are depicted in red, while the wings are blue with a grid-like pattern. The overall design is symmetrical and modern, with clean lines and a bold color scheme.
Device Description:
The Sapphire Pro Powder-Free Royal Blue Nitrile Exam Gloves are non-sterile, single use, disposable gloves intended for medical purposes to be worn on the hands of examiners to prevent contamination between a patient and an examiner. The gloves are nitrile, powder-free, ambidextrous, and blue-colored with a beaded cuff. The range of sizes includes small, medium, large, and extra-large.
Indications for Use:
A powder-free patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. The glove was tested for use with Chemotherapy Drugs and Fentanyl Citrate as per ASTM D6978-05 Standard Practice for Assessment for Medical Gloves to Permeation by Chemotherapy Drugs.
| Fentanyl and Chemotherapy Drug Permeation Resistance | ||
|---|---|---|
| Drug Tested | Concentration | Breakthrough Detection Time (minutes) |
| Carmustine (BNCU) | 3.3 mg/ml | 25.5 |
| Cyclophosphamide | 20.0 mg/ml | >240 |
| Doxorubicin HCl | 2.0 mg/ml | >240 |
| Etoposide | 20.0 mg/ml | >240 |
| 5-Fluorouracil | 50.0 mg/ml | >240 |
| Methotrexate | 25.0 mg/ml | >240 |
| Paclitaxel | 6.0 mg/ml | >240 |
| Thiotepa | 10.0 mg/ml | 47.7 |
| Vincristine Sulfate | 1.0 mg/ml | >240 |
| Fentanyl Citrate | 100mcg/2ml | >240 |
The list of Chemotherapy Drugs tested (with breakthrough times) are as follows:
- CAUTION: Testing showed an average breakthrough time of 25.5 min for Carmustine and 47.7 min for ● Thiotepa.
Summary of Technological Characteristics
The technological characteristics of the Sapphire Pro Powder-Free Royal Blue Nitrile Exam Gloves are summarized within the following table comparing subject gloves to the predicate device under ASTM or equivalent standards:
| Device Characteristic | Proposed DeviceK220825 | Predicate DeviceK200150 | ComparisonAnalysis |
|---|---|---|---|
| Product Name | Sapphire Pro Powder-FreeRoyal Blue Nitrile ExamGloves | Medline Powder-Free OrangeNitrile Patient ExaminationGloves (Tested for use withFentanyl) | N/A |
| Product Code | LZA, LZC, QDO | LZA, QDO | Similar |
| Intended Use | A powder-free patientexamination glove is adisposable device intended | A patient examination gloveis a disposable deviceintended for medical purposes | Similar |
| Device Characteristic | Proposed DeviceK220825 | Predicate DeviceK200150 | ComparisonAnalysis |
| for medical purposes that isworn on the examiner's handto prevent contaminationbetween patient andexaminer. The glove wastested for use withChemotherapy Drugs andFentanyl Citrate as perASTM D6978-05 StandardPractice for Assessment forMedical Gloves toPermeation by ChemotherapyDrugs. | that is worn on theexaminer's hand to preventcontamination betweenpatient and examiner. Thesegloves were Tested for usewith Fentanyl Citrate as perASTM D6978-05(Reapproved 2019) | ||
| Regulation Number | 21 CFR 880.6250 | 21 CFR 880.6250 | Same |
| Material Composition | Synthetic Nitrile Rubber | Powder free Nitrile | Same |
| Color | Blue | Orange | Different |
| Sizes | Small, Medium, Large, Extra-Large | Small, Medium, Large, Extra-Large, Extra-Extra Large | Similar |
| Dimensions - Length | Meets Requirements ofASTM D6319-19:220 mm minimum | Meets Requirements ofASTM D6319-19:220 mm minimum | Same |
| Dimensions - Width | Meets Requirements ofASTM D6319-19:70 mm minimum | Meets Requirements ofASTM D6319-19:70 mm minimum | Same |
| Dimensions -Thickness | Meets Requirements ofASTM D6319-19:0.05 mm minimum (Finger orPalm) | Meets Requirements ofASTM D6319-19:0.05 mm minimum (Fingerand Palm) | Same |
| Physical Properties -Tensile Strength | Complies with: ASTMD6319-10 minimum:Tensile Strength:Before Aging ≥14 MPa. | Complies with: ASTMD6319-10 minimum:Tensile Strength:Before Aging ≥14 MPa. | Same |
| Physical Properties -Elongation | After Aging ≥14 MPa.Elongation:Before Aging 500%, min.After Aging 400%, min. | After Aging ≥14 MPa.Elongation:Before Aging 500%, min.After Aging 400%, min. | |
| Freedom from Holes | Meets Requirements ofASTM D6319-19 and D5151-19:G-1, AQL 2.5 | Meets Requirements ofASTM D6319-19 and D5151-19:G-1, AQL 2.5 | Same |
| Powder or Powder Free | Powder-Free | Powder-Free | Same |
| Residual Powder | Meets Requirements ofASTM D6319-19 and D6124-06:< 2 mg per glove | Meets Requirements ofASTM D6319-10:< 2 mg per glove | Same |
| Contact classification | Surface Contacting, less than24-hour duration | Surface Contacting, less than24-hour duration | Same |
| Biocompatibility -Irritation | ISO 10993-10: Under theconditions of the study, notan irritant. | ISO 10993-10: Under theconditions of the study, notan irritant. | Same |
| Device Characteristic | Proposed DeviceK220825 | Predicate DeviceK200150 | ComparisonAnalysis |
| Biocompatibility –Sensitization | ISO 10993-10: Under theconditions of the study, not asensitizer | ISO 10993-10: Under theconditions of the study, not asensitizer | Same |
| Biocompatibility –Cytotoxicity | ISO 10993-5: Under theconditions of the study,100%, 66.7%, 44.4%specimens were cytotoxic,29.6%, 19.8% and 13.2%specimens are not cytotoxic | ISO 10993-5: Under theconditions of the study,cytotoxic | Similar |
| Biocompatibility –Acute SystemicToxicity | ISO 10993-11: Under theconditions of the study, noevidence of systemic toxicity | ISO 10993-11: Under theconditions of the study, noevidence of systemic toxicity | Same |
| Chemotherapy DrugsTesting | The following drugs showedno breakthrough at 240minutes:Cyclophosphamide (20mg/mL)Doxorubicin HCl (2 mg/mL)Etoposide (20 mg/mL)5-Fluorouracil (50 mg/mL)Methotrexate (25 mg/mL)Paclitaxel (6 mg/mL)Vincristine Sulfate (1mg/mL)The following drugs showedbreakthrough in less than 60minutes:Carmustine (3.3 mg/mL) 25.5minutesThiotepa (10 mg/mL) 47.7minutes | None | Expandedefficacy ofthe proposeddevice. |
| Fentanyl Testing | Fentanyl Citrate 100mcg/2ml>240 min | Fentanyl Citrate 100mcg/2ml>240 min | Same |
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AMERICAN NITRILE
Image /page/6/Picture/1 description: The image shows a logo with a stylized eagle design. The eagle's head and body are outlined in red, while its wings are blue with a grid-like pattern. The overall design is symmetrical and evokes a sense of flight or freedom. The logo is simple, yet striking, with a clear and recognizable shape.
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AMERICAN NITRILE
Image /page/7/Picture/1 description: The image shows a logo of a stylized bird with its wings spread. The bird's head and upper body are outlined in red, while the wings are filled with blue lines that create a feathered effect. The bird's body is formed by a red, diamond-like shape, and the overall design is symmetrical and modern. The logo is set against a white background, which makes the colors stand out.
Summary of Nonclinical Testing
Non-Clinical Testing was conducted to demonstrate that the Sapphire Pro Powder-Free Royal Blue Nitrile Exam Gloves met all required design specifications. The test results demonstrated that the proposed device did meet the performance criteria as specified utilizing the following test method standards and specifications:
| Name of Test /Standard | Purpose | Acceptance Criteria | Results |
|---|---|---|---|
| ISO 10993-10:2010(2014) | Irritation | Pass / Fail | Pass – Under the conditions ofthe study, the subject device isnot a primary skin irritant. |
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AMERICAN NITRILE
Image /page/8/Picture/1 description: The image shows a logo with a stylized bird design. The bird's head and body are outlined in red, while its wings are blue with a grid-like pattern. The overall design is symmetrical and evokes a sense of flight or aviation.
| Name of Test /Standard | Purpose | Acceptance Criteria | Results |
|---|---|---|---|
| ISO 10993-10:2010(2014) | Sensitization | Pass / Fail | Pass - Under the conditions ofthe study, the subject device isnot a primary skin sensitizer. |
| ISO 10993-5:2009(2014) | Cytotoxicity | Pass / Fail | Fail – Under the conditions ofthe study, the subject device iscytotoxic. |
| ISO 10993-11:2017 | Acute SystemicToxicity | Pass / Fail | Pass - Under the conditions ofthe study, the subject device isnot toxic. |
| ASTM D6319-19ASTM D3767-03(2020) | Physical Dimensions | Length: 220 mm min.Width: 70 mm min.Thickness – Palm andFinger: 0.05 mm min. | Pass |
| ASTM D6978-05(2019) | Permeation of Fentanyl | 240 minutes breakthroughtime min. | Pass |
| ASTM D6978-05(2019) | Permeation ofChemotherapy Drugs | 240 minutes breakthroughtime min. | Pass |
| ASTM D5151-19 | Detection of Holes | Leakage detection, AQL2.5 | Pass |
| ASTM D6124-06(2017) | Residual Powder | Max 2.0 mg / glove | Pass |
| ASTM D6319-19ASTM D412-16 (2021)ASTM D573-04 (2019) | Physical Properties | Tensile Strength:Before Aging ≥ 14 MPa,minAfter Aging ≥ 14 MPa, minElongation:Before Aging 500%, min.After Aging 400%, min | Pass |
Conclusion
The conclusions drawn from the nonclinical test demonstrates that the device, Sapphire Pro Powder-Free Royal Blue Nitrile Exam Gloves, is as safe, as effective, and performs as well as or better than the legally marketed predicate device, the Medline Powder-Free Orange Nitrile Patient Examination Gloves (Tested for use with Fentanyl) – K200150
§ 880.6250 Non-powdered patient examination glove.
(a)
Identification. A non-powdered patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. A non-powdered patient examination glove does not incorporate powder for purposes other than manufacturing. The final finished glove includes only residual powder from manufacturing.(b)
Classification. Class I (general controls). The device, when it is a finger cot, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 880.9.