(30 days)
A 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. Gloves have been tested for use with chemotherapy drugs per ASTM D6978-05 (Reapproved 2019) Standard Practice for Assessment of Resistance of Medical Cloves to Permeation by Chemotherapy Drugs.
The Harbour Health Powder Free Nitrile Examination Glove, Blue (Tested for Use with Chemotherapy Drugs) is a non-sterile, single use only, disposable examination glove intended for medical purposes to be worn by examiners to prevent contamination between the examiner. The gloves are nitrile, powder free, and blue in color. They feature an ambidextrous design with textured fingertips, straight fingers, and a beaded cuff. The gloves are available in sizes small, medium, large, and extra-large, packaged in a chipboard box.
The provided text describes the regulatory clearance (K210944) for a Powder Free Nitrile Examination Glove, Blue (Tested for Use with Chemotherapy Drugs) manufactured by Harbour Health LLC. This document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a full clinical study for a novel device.
Therefore, the requested information pertaining to acceptance criteria and performance studies for an AI/ML-driven medical device, such as sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth establishment for training and test sets, is not relevant to this document. This document describes the bench testing and biocompatibility assessments of a physical medical device (gloves), not an AI/ML system.
However, I can extract the acceptance criteria and reported performance related to the glove's resistance to chemotherapy drug permeation, as this is the primary performance claim highlighted in the document.
Acceptance Criteria and Reported Device Performance for Chemotherapy Drug Permeation
The device's performance regarding chemotherapy drug permeation is established by testing according to ASTM D6978-05 (Reapproved 2019) Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs. The acceptance criteria are implicitly defined by the reported "Breakthrough Detection Time" for each drug, with the maximum testing time being 240 minutes. Gloves are generally considered resistant if the breakthrough time is longer, ideally exceeding the 240-minute timeframe. A warning is given for drugs with significantly lower breakthrough times.
1. Table of Acceptance Criteria and Reported Device Performance:
| No. | Chemotherapy Drug Tested | Concentration | Acceptance Criteria (Breakthrough Detection Time - Minutes) | Reported Device Performance (Breakthrough Detection Time - Minutes) |
|---|---|---|---|---|
| 1 | Busulfan | 6 mg/ml (6,000 ppm) | > 240 (Ideal) | > 240 |
| 2 | Carboplatin | 10 mg/ml (10,000 ppm) | > 240 (Ideal) | > 240 |
| 3 | Carmustine (BCNU) | 3.3 mg/ml (3,300 ppm) | > 240 (Ideal) | 14.5* |
| 4 | Cisplatin | 1.0 mg/ml (1,000 ppm) | > 240 (Ideal) | > 240 |
| 5 | Cyclophosphamide (Cytoxan) | 20.0 mg/ml (20,000 ppm) | > 240 (Ideal) | > 240 |
| 6 | Cytarabine | 100 mg/ml (100,000 ppm) | > 240 (Ideal) | > 240 |
| 7 | Dacarbazine | 10.0 mg/ml (10,000 ppm) | > 240 (Ideal) | > 240 |
| 8 | Docetaxel | 10 mg/ml (10,000 ppm) | > 240 (Ideal) | > 240 |
| 9 | Doxorubicin HCI | 2.0 mg/ml (2,000 ppm) | > 240 (Ideal) | > 240 |
| 10 | Etoposide | 20.0 mg/ml (20,000 ppm) | > 240 (Ideal) | > 240 |
| 11 | Fluorouracil | 50.0 mg/ml (50,000 ppm) | > 240 (Ideal) | > 240 |
| 12 | Ifosfamide | 50 mg/ml (50,000 ppm) | > 240 (Ideal) | > 240 |
| 13 | Mechlorethamine HCI | 1 mg/ml (1,000 ppm) | > 240 (Ideal) | > 240 |
| 14 | Methotrexate | 25 mg/ml (25,000 ppm) | > 240 (Ideal) | > 240 |
| 15 | Mitomycin C | 0.5 mg/ml (500 ppm) | > 240 (Ideal) | > 240 |
| 16 | Mitoxantrone | 2 mg/ml (2,000 ppm) | > 240 (Ideal) | > 240 |
| 17 | Paclitaxel | 6.0 mg/ml (6,000 ppm) | > 240 (Ideal) | > 240 |
| 18 | Thiotepa | 10.0 mg/ml (10,000 ppm) | > 240 (Ideal) | 47.4* |
| 19 | Vincristine Sulfate | 1.0 mg/ml (1,000 ppm) | > 240 (Ideal) | > 240 |
* WARNING: Not recommended for use with Carmustine and Thiotepa due to low permeation times. The acceptance criteria for these specific drugs are effectively the reported breakthrough times, with the caveat that they are deemed insufficient for recommended use.
2. Sample size used for the test set and the data provenance:
For the chemotherapy drug permeation testing (ASTM D6978-05), the document does not specify the exact sample size (number of gloves tested) per drug, nor the country of origin of the test samples. The testing described is bench testing, not involving human data. The data provenance is laboratory-based testing data, not clinical. The nature of the testing is analogous to prospective testing for product quality control.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. The ground truth for chemotherapy drug permeation testing is established by direct measurement using specified laboratory methods and instrumentation (ASTM D6978-05), not by expert consensus or interpretation of medical images.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable, as the "ground truth" is determined by objective physical measurements per a standard test method (ASTM D6978-05), not by human interpretation requiring adjudication.
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:
Not applicable. This is a physical medical device (glove), not an AI/ML-driven device that assists human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is a physical medical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The ground truth is established through standardized laboratory-based physical and chemical property testing as defined by ASTM D6978-05 (for chemotherapy permeation) and other ASTM standards (e.g., D6319-19 for general glove properties).
8. The sample size for the training set:
Not applicable. This is a physical medical device; there is no "training set" in the context of machine learning. The manufacturing process and formulation could be considered analogous to a "training" phase in a very abstract sense, where product development aims to meet performance specifications.
9. How the ground truth for the training set was established:
Not applicable. In the context of a physical medical device, "ground truth" is established by adherence to recognized voluntary consensus standards and validated test methods (e.g., ASTM standards) throughout manufacturing and quality control.
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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 the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
April 29, 2021
Harbour Health LLC % Dave Yungvirt CEO Third Party Review Group, LLC 25 Independence Blvd Warren, New Jersey 07059
Re: K210944
Trade/Device Name: Powder Free Nitrile Examination Glove, Tested for Use with Chemotherapy Drugs (Blue) Regulation Number: 21 CFR 880.6250 Regulation Name: Non-powdered patient examination glove Regulatory Class: Class I. reserved Product Code: LZA, LZC, OPJ Dated: March 28, 2021 Received: March 30, 2021
Dear Dave Yungvirt:
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.
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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 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, Ph.D. 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)
Device Name
Powder Free Nitrile Examination Glove, Blue (Tested for Use with Chemotherapy Drugs)
Indications for Use (Describe)
A 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. Gloves have been tested for use with chemotherapy drugs per ASTM D6978-05 (Reapproved 2019) Standard Practice for Assessment of Resistance of Medical Cloves to Permeation by Chemotherapy Drugs.
Chemotherapy Drug Permeation:
| No. | Chemotherapy Drug Tested | Concentration | Breakthrough Detection Time (Minutes |
|---|---|---|---|
| 1 | Busulfan | 6 mg/ml (6,000 ppm) | > 240 |
| 2 | Carboplatin | 10 mg/ml (10,000 ppm) | > 240 |
| 3 | Carmustine (BCNU) | 3.3 mg/ml (3,300 ppm) | 14.5* |
| 4 | Cisplatin | 1.0 mg/ml (1,000 ppm) | > 240 |
| 5 | Cyclophosphamide (Cytoxan) | 20.0 mg/ml (20,000 ppm) | > 240 |
| 6 | Cytarabine | 100 mg/ml (100,000 ppm) | > 240 |
| 7 | Dacarbazine | 10.0 mg/ml (10,000 ppm) | > 240 |
| 8 | Docetaxel | 10 mg/ml (10,000 ppm) | > 240 |
| 9 | Doxorubicin HCI | 2.0 mg/ml (2,000 ppm) | > 240 |
| 10 | Etoposide | 20.0 mg/ml (20,000 ppm) | > 240 |
| 11 | Fluorouracil | 50.0 mg/ml (50,000 ppm) | > 240 |
| 12 | Ifosfamide | 50 mg/ml (50,000 ppm) | > 240 |
| 13 | Mechlorethamine HCI | 1 mg/ml (1,000 ppm) | > 240 |
| 14 | Methotrexate | 25 mg/ml (25,000 ppm) | > 240 |
| 15 | Mitomycin C | 0.5 mg/ml (500 ppm) | > 240 |
| 16 | Mitoxantrone | 2 mg/ml (2,000 ppm) | > 240 |
| 17 | Paclitaxel | 6.0 mg/ml (6,000 ppm) | > 240 |
| 18 | Thiotepa | 10.0 mg/ml (10,000 ppm) | 47.4* |
| 19 | Vincristine Sulfate | 1.0 mg/ml (1,000 ppm) | > 240 |
- WARNING: Not recommended for use with Carmustine and Thiotepa.
The maximum testing time is 240 minutes. Please note that the following drugs have low permeation times:
| Carmustine (BCNU) | 3.3 mg/ml (3,300 ppm) | 14.5 minutes |
|---|---|---|
| Thiotepa | 10.0 mg/ml (10,000 ppm) | 47.4 minutes |
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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Image /page/4/Picture/0 description: The image shows the logo for Harbour Health. The logo consists of a yellow symbol on the left and the words "HARBOUR HEALTH" on the right. The symbol is made up of two vertical lines with a dotted cross in the middle.
510(k) Summary
510(k) Summary [As required by 21 CFR 807.92(c)] K210944
Submitter / 510(k) Sponsor Harbour Health LLC 4590 MacArthur Boulevard, Suite 500 Newport Beach, CA 92660
Registration Number: 3017153466
Contact Person Jared Koenig CEO Tel: (949) 629-5068 Email: jared@factorydirecthealth.com
Summary Preparation Date 19 April 2021
Type of 510(k) Submission Traditional
Device Name / Classification Trade Name: Harbour Health Powder Free Nitrile Examination Glove, Blue (Tested for Use with Chemotherapy Drugs) Common Name: Non-powdered patient examination glove Classification Name: Medical Gloves with Chemotherapy Labeling Claims - Test For Use with Chemotherapy Drugs Product Code: LZA, LZC, OPJ Review Panel: General Hospital Regulatory Class: Class 1 Regulation Number: 21 CFR 880.6250 Predicate Device Powder Free Nitrile Examination Glove, Tested for Use with Chemotherapy Device Name: Drugs (Blue) 510(k) Number: K182600
510(k) Owner: Better Care Plastic Technology Co., Ltd
Device Description
The Harbour Health Powder Free Nitrile Examination Glove, Blue (Tested for Use with Chemotherapy Drugs) is a non-sterile, single use only, disposable examination glove intended for medical purposes to be worn by examiners to prevent contamination between the examiner. The gloves are nitrile, powder free, and blue in color. They feature an ambidextrous design with textured fingertips,
Harbour Health LLC 4590 MacArthur Boulevard. Suite 500 Newport Beach, CA 92660
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Image /page/5/Picture/0 description: The image shows the logo for Harbour Health. The logo consists of a stylized "H" formed by two vertical lines with a series of dots in the center, resembling a plus sign. To the right of the symbol, the words "HARBOUR HEALTH" are written in a simple, sans-serif font.
straight fingers, and a beaded cuff. The gloves are available in sizes small, medium, large, and extralarge, packaged in a chipboard box.
The gloves are designed and manufactured in accordance with ASTM D6319-19 and tested for use with chemotherapy drugs per ASTM D6978-05(2019).
Indications for Use
A 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.
Summarized in Table 1 below, the proposed device was tested for use with chemotherapy drugs per ASTM D6978-05 (Reapproved 2019) Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs.
| Chemotherapy Drug Tested | Concentration | Breakthrough DetectionTime (Minutes) |
|---|---|---|
| Busulfan | 6 mg/ml (6,000 ppm) | > 240 |
| Carboplatin | 10 mg/ml (10,000 ppm) | > 240 |
| Carmustine (BCNU) | 3.3 mg/ml (3,300 ppm) | 14.5* |
| Cisplatin | 1.0 mg/ml (1,000 ppm) | > 240 |
| Cyclophosphamide (Cytoxan) | 20.0 mg/ml (20,000 ppm) | > 240 |
| Cytarabine | 100 mg/ml (100,000 ppm) | > 240 |
| Dacarbazine | 10.0 mg/ml (10,000 ppm) | > 240 |
| Docetaxel | 10 mg/ml (10,000 ppm) | > 240 |
| Doxorubicin HCI | 2.0 mg/ml (2,000 ppm) | > 240 |
| Etoposide | 20.0 mg/ml (20,000 ppm) | > 240 |
| Fluorouracil | 50.0 mg/ml (50,000 ppm) | > 240 |
| Ifosfamide | 50 mg/ml (50,000 ppm) | > 240 |
| Mechlorethamine HCI | 1 mg/ml (1,000 ppm) | > 240 |
| Methotrexate | 25 mg/ml (25,000 ppm) | > 240 |
| Mitomycin C | 0.5 mg/ml (500 ppm) | > 240 |
| Mitoxantrone | 2 mg/ml (2,000 ppm) | > 240 |
| Paclitaxel | 6.0 mg/ml (6,000 ppm) | > 240 |
| Thiotepa | 10.0 mg/ml (10,000 ppm) | 47.4* |
| Vincristine Sulfate | 1.0 mg/ml (1,000 ppm) | > 240 |
Table 1: Chemotherapy Drug Permeation
- WARNING: Not recommended for use with Carmustine and Thiotepa.
The maximum testing time is 240 minutes. Please note that the following drugs have low permeation times:
| Carmustine (BCNU) | 3.3 mg/ml (3,300 ppm) | 14.5 minutes |
|---|---|---|
| Thiotepa | 10.0 mg/ml (10,000 ppm) | 47.4 minutes |
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Image /page/6/Picture/1 description: The image shows the logo for Harbour Health. The logo consists of a yellow symbol on the left and the words "HARBOUR HEALTH" on the right. The symbol is made up of two vertical lines with a plus sign in the middle, formed by small yellow dots.
Summary of Technological Characteristics
| Characteristic | Proposed Device | Predicate Device | ComparisonAnalysis |
|---|---|---|---|
| Device Name | Harbour Health Powder FreeNitrile Examination Glove, Blue(Tested for Use withChemotherapy Drugs) | Powder Free Nitrile ExaminationGlove, Tested for Use withChemotherapy Drugs (Blue) | N/A |
| 510(k) Reference | K210944 | K182600 | N/A |
| Product Owner | Harbour Health LLC | Better Care Plastic TechnologyCo., Ltd. | N/A |
| Product Code | LZA, LZC, OPJ | LZA, LZC | Similar |
| Intended Use | The Harbour Health Powder FreeNitrile Examination Glove, Blue(Tested for Use withChemotherapy Drugs) is adisposable device intended formedical purposes that is worn onthe examiner's hand to preventcontamination between patient andexaminer. The proposed devicewas tested for use withchemotherapy drugs per ASTMD6978-05(2019), Standard Practicefor Assessment of Medical Glovesto Permeation by ChemotherapyDrugs | Powder Free Nitrile ExaminationGloves, Tested for Use withChemotherapy Drugs (Blue) is adisposable device intended formedical purposes that is worn onthe examiner's hand to preventcontamination between patient andexaminer. Gloves have been testedfor use with chemotherapy drugsusing ASTM D6978-05(2013) andwill be labeled with a statement ofcompliance and a summary of thetesting results. Chemotherapy DrugPermeation. | Same |
| Regulation Number | 21 CFR 880.6250 | 21 CFR 880.6250 | Same |
| Material | Nitrile | Nitrile | Same |
| Color | Blue | Blue | Same |
| Design Features | AmbidextrousTextured fingertipsBeaded cuffStraight fingers | Ambidextrous | Similar |
| Sizes | Small, Medium, Large, ExtraLarge | Extra Small, Small, Medium,Large, Extra Large | Same |
| Rx vs OTC | OTC | OTC | Same |
| Sterile vs Non-Sterile | Non-Sterile | Non-Sterile | Same |
| Disposable vs Non-Disposable | Disposable | Disposable | Same |
| Single Use vsReusable | Single Use | Single Use | Same |
| Characteristic | Proposed Device | Predicate Device | ComparisonAnalysis |
| Dimensions - Width | Complies with ASTM D6319-19Small:80 ±10mmMedium:95 ±10mmLarge:110 ±10mmExtra Large:120 ±10mm | Complies with ASTM D6319-19Extra Small:70 ±10mmSmall:80 ±10mmMedium:95 ±10mmLarge:110 ±10mmExtra Large:120 ±10mm | Same |
| Dimensions -Thickness | Complies with ASTM D6319-19Palm:0.05mmmin.Finger:0.05mmmin. | Complies with ASTM D6319-19Palm:0.05mmmin.Finger:0.05mmmin. | Same |
| Dimensions - Length | Complies with ASTM D6319-19Small:220mm min.Medium/Large/Extra Large: | Complies with ASTM D6319-19Small: 220mm min.Medium/Large/Extra Large:230mm min. | Similar |
| Physical Properties -Tensile Strength | Complies with ASTM D6319-19Before Aging:$\ge$ 14 MPa,min.After Aging:$\ge$ 14 MPa,min. | Complies with ASTM D6319-19Before Aging:$\ge$ 14 MPa,min.After Aging:$\ge$ 14 MPa,min. | Same |
| Physical Properties -Elongation | Complies with ASTM D6319-19Before Aging:500%min.After Aging:400%min. | Complies with ASTM D6319-19Before Aging:500%min.After Aging:400%min. | Same |
| Freedom from Holes | Complies with ASTM D6319-19and ASTM D5151-19G-1, AQL 2.5 | In accordance with ASTM D 5151-06, following ASTM D6319- 10,G-1, AQL 2.5 | Similar |
| Powder or PowderFree | Powder Free | Powder Free | Same |
| Residual Powder | Complies with ASTM D6319-19$\le$ 2 mg per glove | In accordance with ASTM D6124-06 (Reapproved 2017), followingASTM D6319-10$\le$ 2 mg per glove | Same |
| Characteristic | Proposed Device | Predicate Device | ComparisonAnalysis |
| Biocompatibility | Complies with ANSI/AAMI/ISO10993-5 (2009)• Under the conditions of thestudy, the device is potentiallycytotoxic.Complies with ANSI/AAMI/ISO10993-10 (2010)• Under the conditions of thestudy, the device is a non-irritant and a non-sensitizer.Complies with ANSI/AAMI/ISO10993-11 (2017)• Under the conditions of thestudy, the device does not elicita systemic toxicity response inthe model animal. | Complies with ANSI/AAMI/ISO10993-10 (2010)• Not a skin irritant• Not a skin sensitizer | Similar |
| Chemotherapy Drugs Tested with Minimum Breakthrough Detection Time as testedper ASTM D6978-05 (2019) | |||
| Bleomycin | Not tested | 15.0 mg/ml (15,000 ppm)> 240 minutes | Different |
| Busulfan | 6.0 mg/ml (6,000 ppm)> 240 minutes | 6.0 mg/ml (6,000 ppm)> 240 minutes | Same |
| Carboplatin | 10.0 mg/ml (10,000 ppm)> 240 minutes | 10.0 mg/ml (10,000 ppm)> 240 minutes | Same |
| Carmustine(BCNU) | 3.3 mg/ml (3,300 ppm)14.5 minutes | 3.3 mg/ml (3,300 ppm)11.0 minutes | Same |
| Chloroquine | Not tested | 50.0 mg/ml (50,000 ppm)> 240 minutes | Different |
| Cisplatin | 1 mg/ml (1,000 ppm)> 240 minutes | 1 mg/ml (1,000 ppm)> 240 minutes | Same |
| Cyclophosphamide(Cytoxan) | 20 mg/ml (20,000 ppm)> 240 minutes | 20 mg/ml (20,000 ppm)> 240 minutes | Same |
| Cyclosporin | Not tested | 100.0 mg/ml (100,000 ppm)> 240 minutes | Different |
| Cytarabine | 100.0 mg/ml (100,000 ppm)> 240 minutes | 100.0 mg/ml (100,000 ppm)> 240 minutes | Same |
| Dacarbazine | 10 mg/ml (10,000 ppm)> 240 minutes | 10 mg/ml (10,000 ppm)> 240 minutes | Same |
| Daunorubicin | Not tested | 5.0 mg/ml (5,000 ppm)> 240 minutes | Different |
| Docetaxel | 10.0 mg/ml (10,000 ppm)> 240 minutes | 10.0 mg/ml (10,000 ppm)> 240 minutes | Same |
| Characteristic | Proposed Device | Predicate Device | ComparisonAnalysis |
| Doxorubicin HCI | 2 mg/ml (2,000 ppm)> 240 minutes | 2 mg/ml (2,000 ppm)> 240 minutes | Same |
| Epirubicin(Ellence) | Not tested | 2.0 mg/ml (2,000 ppm)> 240 minutes | Different |
| Etoposide | 20 mg/ml (20,000 ppm)> 240 minutes | 20 mg/ml (20,000 ppm)> 240 minutes | Same |
| Fludarabine | Not tested | 25.0 mg/ml (25,000 ppm)> 240 minutes | Different |
| Fluorouracil | 50 mg/ml (50,000 ppm)> 240 minutes | 50 mg/ml (50,000 ppm)> 240 minutes | Same |
| Gemcitabine(Gemzar) | Not tested | 38.0 mg/ml (38,000 ppm)> 240 minutes | Different |
| Idarubicin | Not tested | 1.0 mg/ml (1,000 ppm)> 240 minutes | Different |
| Ifosfamide | 50.0 mg/ml (50,000 ppm)> 240 minutes | 50.0 mg/ml (50,000 ppm)> 240 minutes | Same |
| Irinotecan | Not tested | 20.0 mg/ml (20,000 ppm)> 240 minutes | Different |
| MechlorethamineHCI | 1.0 mg/ml (1,000 ppm)> 240 minutes | 1.0 mg/ml (1,000 ppm)> 240 minutes | Same |
| Melphalan | Not tested | 5.0 mg/ml (5,000 ppm)> 240 minutes | Different |
| Methotrexate | 25 mg/ml (25,000 ppm)> 240 minutes | 25 mg/ml (25,000 ppm)> 240 minutes | Same |
| Mitomycin C | 0.5 mg/ml (500 ppm)> 240 minutes | 0.5 mg/ml (500 ppm)> 240 minutes | Same |
| Mitoxantrone | 2.0 mg/ml (2,000 ppm)> 240 minutes | 2.0 mg/ml (2,000 ppm)> 240 minutes | Same |
| Oxaliplatin | Not tested | 2.0 mg/ml (2,000 ppm)> 240 minutes | Different |
| Paclitaxel | 6 mg/ml (6,000 ppm)> 240 minutes | 6 mg/ml (6,000 ppm)> 240 minutes | Same |
| Paraplatin | Not tested | 10.0 mg/ml (10,000 ppm)> 240 minutes | Different |
| Retrovir | Not tested | 10.0 mg/ml (10,000 ppm)> 240 minutes | Different |
| Rituximab | Not tested | 10.0 mg/ml (10,000 ppm)> 240 minutes | Different |
| Thiotepa | 10 mg/ml (10,000 ppm)47.4 minutes | 10 mg/ml (10,000 ppm)28.8 minutes | Same |
| Topotecan HCL | Not tested | 1.0 mg/ml (1,000 ppm)> 240 minutes | Different |
| Characteristic | Proposed Device | Predicate Device | ComparisonAnalysis |
| Trisonex | Not tested | 1.0 mg/ml (1,000 ppm)> 240 minutes | Different |
| Velcade(Bortezomib) | Not tested | 1.0 mg/ml (1,000 ppm)> 240 minutes | Different |
| Vincristine Sulfate | 1.0 mg/ml (1,000 ppm)> 240 minutes | 1.0 mg/ml (1,000 ppm)> 240 minutes | Same |
Table 2: Comparison of Proposed and Predicate Devices
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Summary of Non-Clinical Testing
The biocompatibility evaluation for the Harbour Health Powder Free Nitrile Examination Glove, Blue (Tested for Use with Chemotherapy Drugs) was conducted in accordance with ANSI/AAMI/ISO 10993-1:2018, Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing Within a Risk Management Process, as recognized by the FDA: and ISO 10993-12:2012, Biological evaluation of medical devices - Part 12: Sample preparation and reference materials, with deviations from Clause 11 without negative impact on testing as documented in Section 018 Performance Testing - Bench.
The following tests were performed to evaluate the biocompatibility of the Harbour Health Powder Free Nitrile Examination Glove, Blue (Tested for Use with Chemotherapy Drugs) to show substantial equivalence to the predicate device:
| • ISO 10993-5:2009 | Cytotoxicity |
|---|---|
| • ISO 10993-10:2010 | Primary Skin Sensitization |
| • ISO 10993-10:2010 | Dermal Sensitization |
| • ISO 10993-11:2017 | Systemic Toxicity |
Summary of Performance Testing (Bench)
Physical performance qualities of the proposed device were evaluated per ASTM D6319-19, Standard Specification for Nitrile Examination Gloves for Medical Application. Permeation testing was conducted to support the addition of the labeling claim: Tested for use with chemotherapy drugs. In addition, the proposed device was tested according to ASTM D6978-05 (Reapproved 2019), Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs, in which minimum breakthrough times were determined for a range of chemotherapy drugs.
In summary, the performance testing of the subject device was conducted to adequately demonstrate the effectiveness of the device in accordance with the relevant test methods cited below:
- . ASTM D5151-19, Standard Test Method for Detection of Holes in Medical Gloves
- . ASTM D6124-06 (2017), Standard Test Method for Residual Powder on Medical Gloves
- ASTM D6319-19, Standard Specification for Nitrile Examination Gloves for Medical ● Application
- ASTM D6978-05 (2019), Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs
Conclusion
In accordance with 21 CFR Part 807 and based on the non-clinical testing and information provided in this premarket notification, Harbour Health LLC concludes that the Harbour Health Powder Free Nitrile Examination Glove, Blue (Tested for Use with Chemotherapy Drugs) is as safe, as effective, and
Harbour Health LLC 4590 MacArthur Boulevard. Suite 500 Newport Beach, CA 92660
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performs as well as the legally marketed predicate device, Powder Free Nitrile Examination Glove, Tested for Use with Chemotherapy Drugs (Blue) (K182600).
Additionally, both the LZA and LZC/OPJ gloves meet the FDA-recognized consensus standards, all labeling claims, and the pinhole acceptable quality level (AQL).
§ 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.