(27 days)
Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue) is a nonsterile disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner. It is also tested to be used against Chemotherapy Drugs and Fentanyl Citrate.
Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue) is a disposable single-use, non- sterile, blue-colored and powder-free examination glove made from nitrile latex. Gloves meet the specification of ASTM D6319-19 and have been tested for resistance to permeation by chemotherapy drugs and fentanyl citrate as per ASTM D6978-05(2019).
The provided text is a 510(k) Premarket Notification from the FDA for a medical device: "Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue)".
This document does not describe the acceptance criteria or a study related to an AI/ML powered device. Instead, it details the testing and comparison of a physical medical device (gloves) against a predicate device, focusing on material properties, performance standards (like resistance to permeation by chemotherapy drugs and fentanyl citrate), and biocompatibility.
Therefore, I cannot extract the requested information regarding AI/ML device acceptance criteria or related studies from this document. The questions about sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth, and training sets are not applicable to the type of device described in this FDA submission.
However, I can extract the acceptance criteria and performance data for the physical device as described:
1. Table of Acceptance Criteria and Reported Device Performance:
The primary performance criterion for the "Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue)" is its resistance to permeation by chemotherapy drugs and fentanyl citrate. The acceptance criterion is a minimum breakthrough detection time for each substance.
| Chemotherapy Drug and Concentration | Acceptance Criteria (Minimum Breakthrough Detection Time in Minutes) | Reported Device Performance (Minimum Breakthrough Detection Time in Minutes) |
|---|---|---|
| Carmustine, 3.3 mg/ml | N/A (Tested to determine time) | 10.2 |
| Cisplatin, 1.0 mg/ml | N/A (Tested to determine time) | >240 |
| Cyclophosphamide, 20.0 mg/ml | N/A (Tested to determine time) | >240 |
| Dacarbazine, 10.0 mg/ml | N/A (Tested to determine time) | >240 |
| Doxorubicin Hydrochloride, 2.0 mg/ml | N/A (Tested to determine time) | >240 |
| Etoposide, 20.0 mg/ml | N/A (Tested to determine time) | >240 |
| Fluorouracil, 50.0 mg/ml | N/A (Tested to determine time) | >240 |
| Methotrexate, 25.0 mg/ml | N/A (Tested to determine time) | >240 |
| Mitomycin C, 0.5 mg/ml | N/A (Tested to determine time) | >240 |
| Paclitaxel, 6.0 mg/ml | N/A (Tested to determine time) | >240 |
| Thiotepa, 10.0 mg/ml | N/A (Tested to determine time) | 30.2 |
| Vincristine Sulfate, 1.0 mg/ml | N/A (Tested to determine time) | >240 |
| Bleomycin Sulfate, 15.0 mg/ml | N/A (Tested to determine time) | >240 |
| Bortezomib, 1.0 mg/ml | N/A (Tested to determine time) | >240 |
| Busulfan, 6.0 mg/ml | N/A (Tested to determine time) | >240 |
| Carboplatin, 10.0 mg/ml | N/A (Tested to determine time) | >240 |
| Chloroquine, 50.0 mg/ml | N/A (Tested to determine time) | >240 |
| Cyclosporin A, 100.0 mg/ml | N/A (Tested to determine time) | >240 |
| Cytarabine, 100.0 mg/ml | N/A (Tested to determine time) | >240 |
| Daunorubicin, 5.0 mg/ml | N/A (Tested to determine time) | >240 |
| Docetaxel, 10.0 mg/ml | N/A (Tested to determine time) | >240 |
| Epirubicin, 2.0 mg/ml | N/A (Tested to determine time) | >240 |
| Fludarabine, 25.0 mg/ml | N/A (Tested to determine time) | >240 |
| Gemcitabine, 38.0 mg/ml | N/A (Tested to determine time) | >240 |
| Idarubicin, 1.0 mg/ml | N/A (Tested to determine time) | >240 |
| Ifosfamide, 50.0 mg/ml | N/A (Tested to determine time) | >240 |
| Irinotecan, 20.0 mg/ml | N/A (Tested to determine time) | >240 |
| Mechlorethamine HCI, 1.0 mg/ml | N/A (Tested to determine time) | >240 |
| Melphalan, 5.0 mg/ml | N/A (Tested to determine time) | >240 |
| Mitoxantrone, 2.0 mg/ml | N/A (Tested to determine time) | >240 |
| Oxaliplatin, 2.0 mg/ml | N/A (Tested to determine time) | >240 |
| Paraplatin, 10.0 mg/ml | N/A (Tested to determine time) | >240 |
| Retrovir, 10.0 mg/ml | N/A (Tested to determine time) | >240 |
| Rituximab, 10.0 mg/ml | N/A (Tested to determine time) | >240 |
| Topotecan, 1.0 mg/ml | N/A (Tested to determine time) | >240 |
| Trisenox, 1.0 mg/ml | N/A (Tested to determine time) | >240 |
| Fentanyl Citrate Injection, 100mcg/2ml | N/A (Tested to determine time) | >240 |
Additional Acceptance Criteria and Performance Data (already met by similar predicate device or physical properties):
| Characteristic | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Freedom from holes | AQL 1.5% (Meets ASTM D5151-19 and ASTM D6319-19) | Pass |
| Residual Powder | Average < 2 mg/glove (Meets ASTM D6319-19 & ASTM D6124-06 (2017)) | Pass |
| Dimensional Conformance | Conforms to ASTM D6319 width, thickness, and length requirements for XS, S, M, L, and XL; AQL 4% | Pass |
| Tensile Performance | Tensile Strength Before Aging: $\ge$ 14 MPa; Ultimate Elongation Before Aging: $\ge$ 500 %; Tensile Strength After Aging: $\ge$ 14 MPa; Ultimate Elongation After Aging: $\ge$ 400 % (Meets ASTM D6319-19); AQL 4% | Pass |
| Biocompatibility: Skin Irritation | Not an irritant (Under the conditions of the study, per ISO 10993-10) | Pass |
| Biocompatibility: Skin Sensitization | Not a sensitizer (Under the conditions of the study, per ISO 10993-10) | Pass |
| Biocompatibility: Acute Toxicity | No acute toxicity (Under the conditions of the study, per ISO 10993-11) | Pass |
2. Sample size used for the test set and the data provenance:
The document mentions that "Fentanyl citrate permeation testing was performed on the subject glove using the ASTM D6978 method." While it confirms the test was done, it does not specify the sample size for the test set used for the permeation testing.
The data provenance is from Malaysia, where the manufacturer (Hartalega NGC Sdn. Bhd.) is located. The study appears to be prospective testing conducted specifically for this 510(k) submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This is not applicable as the "ground truth" for this device is established through physical and chemical testing against industry standards (ASTM D6978, D6319, D5151, D6124, ISO 10993) rather than expert consensus on medical images or diagnoses.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable, as this involves standardized physical and chemical laboratory testing, not human expert 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 medical glove, not an AI/ML-powered device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is a medical glove, not an AI/ML-powered device.
7. The type of ground truth used:
The ground truth is established through standardized laboratory testing protocols (ASTM D6978-05, D6319-19, D5151-19, D6124-06(R17), ISO 10993-10, ISO 10993-11) and the measured chemical permeation times and physical properties of the gloves.
8. The sample size for the training set:
Not applicable. This is a medical glove, not an AI/ML-powered device. There is no concept of a "training set" in this context.
9. How the ground truth for the training set was established:
Not applicable. There is no training set for this type of device.
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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, with the letters "FDA" in a blue square. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
January 8, 2025
Hartalega NGC Sdn. Bhd. Nurul Aisyah Kong General Manager - Quality Assurance No. 1, Persiaran Tanjung, Kawasan Perindustrian Tanjung Sepang, Selangor 43900 Malaysia
Re: K243818
Trade/Device Name: Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue) Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I, reserved Product Code: LZA, LZC, ODO, OPJ Dated: November 29, 2024 Received: December 12, 2024
Dear Nurul Aisyah Kong:
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 (the 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 available 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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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-regulatory
{2}------------------------------------------------
assistance/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,
Image /page/2/Picture/3 description: The image shows the text "Allan Guan -S" in a large, sans-serif font. The text is black and is set against a white background. There is a faint, light blue watermark in the background, but it does not obscure the text. The text is horizontally oriented and centered.
For Bifeng Qian, M.D., Ph.D. Assistant Director DHT4C: Division of Infection Control Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
{3}------------------------------------------------
Indications for Use
510(k) Number (if known) K243818
Device Name
Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue)
Indications for Use (Describe)
Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue) is a nonsterile disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner. It is also tested to be used against Chemotherapy Drugs and Fentanyl Citrate.
These gloves were tested for use with chemotherapy drugs and fentanyl citrate as per ASTM 06978-05 (Reapproved 2019) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.
| Chemotherapy Drug and Concentration | Minimum Breakthrough Detection Time in Minutes |
|---|---|
| Carmustine, 3.3 mg/ml | 10.2 |
| Cisplatin, 1.0 mg/ml | >240 |
| Cyclophosphamide, 20.0 mg/ml | >240 |
| Dacarbazine, 10.0 mg/ml | >240 |
| Doxorubicin Hydrochloride, 2.0 mg/ml | >240 |
| Etoposide, 20.0 mg/ml | >240 |
| Fluorouracil, 50.0 mg/ml | >240 |
| Methotrexate, 25.0 mg/ml | >240 |
| Mitomycin C, 0.5 mg/ml | >240 |
| Paclitaxel, 6.0 mg/ml | >240 |
| Thiotepa, 10.0 mg/ml | 30.2 |
| Vincristine Sulfate, 1.0 mg/ml | >240 |
| Bleomycin Sulfate, 15.0 mg/ml | >240 |
| Bortezomib, 1.0 mg/ml | >240 |
| Busulfan, 6.0 mg/ml | >240 |
| Carboplatin, 10.0 mg/ml | >240 |
| Chloroquine, 50.0 mg/ml | >240 |
| Cyclosporin A, 100.0 mg/ml | >240 |
| Cytarabine, 100.0 mg/ml | >240 |
| Daunorubicin, 5.0 mg/ml | >240 |
| Docetaxel, 10.0 mg/ml | >240 |
| Epirubicin, 2.0 mg/ml | >240 |
| Fludarabine, 25.0 mg/ml | >240 |
| Gemcitabine, 38.0 mg/ml | >240 |
| Idarubicin, 1.0 mg/ml | >240 |
| Ifosfamide, 50.0 mg/ml | >240 |
| Irinotecan, 20.0 mg/ml | >240 |
| Mechlorethamine HCI, 1.0 mg/ml | >240 |
| Melphalan, 5.0 mg/ml | >240 |
| Mitoxantrone, 2.0 mg/ml | >240 |
| Oxaliplatin, 2.0 mg/ml | >240 |
| Paraplatin, 1.0 mg/ml | >240 |
| Retrovir, 10.0 mg/ml | >240 |
| Rituximab, 10.0 mg/ml | >240 |
| Topotecan, 1.0 mg/ml | >240 |
{4}------------------------------------------------
| Trisenox, 1.0 mg/ml | > 240 |
|---|---|
| Fentanyl Citrate and Concentration | Minimum Breakthrough Detection Time in Minutes |
| Fentanyl Citrate Injection, 100mcg/2ml | >240 |
Caution: Testing showed a minimum breakthrough time of 10.2 minutes with Carmustine and 30.2 minutes with Thiotepa.
Warning: Do not use with Carmustine and 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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K243818
SPECIAL 510(k) SUMMARY
FOR
NITRILE POWDER FREE EXAMINATION GLOVE TESTED FOR USE WITH CHEMOTHERAPY DRUGS AND FENTANYL CITRATE (BLUE)
(The information contained herein is being provided in accordance with the requirements of 21 CFR 807.92)
SUBMISSION APPLICANT
| Date Prepared | : January 6, 2025 |
|---|---|
| Name | : Hartalega NGC Sdn. Bhd. |
| Address | : No. 1, Persiaran Tanjung,Kawasan Perindustrian Tanjung43900 Sepang, Selangor,Malaysia |
| Establishment Registration Number | : 3011200663 |
SUBMISSION CORRESPONDENT AND/OR PREPARER
| Contact Name | : | Nurul Aisyah Kong |
|---|---|---|
| Contact Title | : | General Manager – Quality Assurance |
| Phone Number | : | (603) 3280 3888 |
| Fax Number | : | (603) 3271 0135 |
| Contact Email | : | wkkong@hartalega.com.my |
DEVICE IDENTIFICATION
| Common Name of the Device | : | Examination Glove |
|---|---|---|
| Trade Name (Proprietary Name) | : | Nitrile Powder Free Examination Glove Tested for Use withChemotherapy Drugs and Fentanyl Citrate (Blue) |
| Device Class | : | 1 |
| Product Code | : | LZA, LZC, QDO, OPJ |
| Regulation Number | : | 21 CFR 880.6250 |
PREDICATE DEVICE INFORMATION
| 510(k) Number | : | K222225 |
|---|---|---|
| Manufacturer | : | Hartalega NGC Sdn. Bhd. |
| Trade Name (Proprietary Name) | : | Nitrile Powder Free Examination Glove Tested for Use withChemotherapy Drugs (Blue) |
| Device Class | : | 1 |
| Product Code | : | LZA, LZC |
{6}------------------------------------------------
DESCRIPTION OF THE DEVICE:
Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue) is a disposable single-use, non- sterile, blue-colored and powder-free examination glove made from nitrile latex. Gloves meet the specification of ASTM D6319-19 and have been tested for resistance to permeation by chemotherapy drugs and fentanyl citrate as per ASTM D6978-05(2019).
DEVICE MODIFICATION:
The proposed modification to the predicate device is the inclusion of the subject device has been tested for use with fentanyl citrate in addition to its existing claim of use with chemotherapy drugs. The proposed device (physically identical to the predicate device) was tested for use with fentanyl citrate as per ASTM D6978. There are no differences with these two gloves in materials, manufacturing process and compliance with ASTM D6319 performance specifications.
INDICATIONS FOR USE:
Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue) is a nonsterile disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner. It is also tested to be used against Chemotherapy Drugs and Fentanyl Citrate.
The gloves were tested for use with chemotherapy drugs and fentanyl citrate as per ASTM D6978-05 (Reapproved 2019) Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs.
| Chemotherapy Drug and Concentration | Minimum Breakthrough Detection Time in Minutes |
|---|---|
| Carmustine (3.3 mg/ml) | 10.2 |
| Cisplatin (1.0 mg/ml) | > 240 |
| Cyclophosphamide (20.0 mg/ml) | > 240 |
| Dacarbazine (10.0 mg/ml) | > 240 |
| Doxorubicin Hydrochloride (2.0 mg/ml) | > 240 |
| Etoposide (20.0 mg/ml) | > 240 |
| Fluorouracil (50.0 mg/ml) | > 240 |
| Methotrexate (25.0 mg/ml) | > 240 |
| Mitomycin C (0.5 mg/ml) | > 240 |
| Paclitaxel (6.0 mg/ml) | > 240 |
| Thiotepa (10.0 mg/ml) | 30.2 |
| Vincristine Sulfate (1.0 mg/ml) | > 240 |
| Bleomycin Sulfate, 15.0 mg/ml | > 240 |
| Bortezomib, 1.0 mg/ml | > 240 |
| Busulfan, 6.0 mg/ml | > 240 |
| Carboplatin, 10.0 mg/ml | > 240 |
| Chloroquine, 50.0 mg/ml | > 240 |
{7}------------------------------------------------
| Cyclosporin A, 100.0 mg/ml | > 240 |
|---|---|
| Cytarabine, 100.0 mg/ml | > 240 |
| Daunorubicin, 5.0 mg/ml | > 240 |
| Docetaxel, 10.0 mg/ml | > 240 |
| Epirubicin, 2.0 mg/ml | > 240 |
| Fludarabine, 25.0 mg/ml | > 240 |
| Gemcitabine, 38.0 mg/ml | > 240 |
| Idarubicin, 1.0 mg/ml | > 240 |
| Ifosfamide, 50.0 mg/ml | > 240 |
| Irinotecan, 20.0 mg/ml | > 240 |
| Mechlorethamine HCI, 1.0 mg/ml | > 240 |
| Melphalan, 5.0 mg/ml | > 240 |
| Mitoxantrone, 2.0 mg/ml | > 240 |
| Oxaliplatin, 2.0 mg/ml | > 240 |
| Paraplatin, 10.0 mg/ml | > 240 |
| Retrovir, 10.0 mg/ml | > 240 |
| Rituximab, 10.0 mg/ml | > 240 |
| Topotecan, 1.0 mg/ml | > 240 |
| Trisenox, 1.0 mg/ml | > 240 |
Caution: Testing showed a minimum breakthrough time of 10.2 minutes with Carmustine and 30.2 minutes with Thiotepa.
Warning: Do not use with Carmustine and Thiotepa
| Fentanyl Citrate and Concentration | Minimum Breakthrough Detection Time in Minutes |
|---|---|
| Fentanyl Citrate Injection, 100 mcg/2ml | > 240 |
{8}------------------------------------------------
| Characteristicsand Parameters | Subject Device | Predicate Device(K222225) | Discussion |
|---|---|---|---|
| Trade Name | Nitrile Powder Free Examination GloveTested for Use with Chemotherapy Drugsand Fentanyl Citrate (Blue) | Nitrile Powder Free Examination GloveTested for Use with Chemotherapy Drugs(Blue) | Similar |
| Applicant | Hartalega NGC Sdn. Bhd. | Hartalega NGC Sdn. Bhd. | Same |
| Product Code | LZA, LZC, QDO, OPJ | LZA, LZC | Similar |
| Classification | 1 | 1 | Same |
| RegulationNumber | 21 CFR 880.6250 | 21 CFR 880.6250 | Same |
| RegulationName | Patient Examination Glove | Patient Examination Glove | Same |
| Indications forUse | A non-sterile disposable device intended formedical purpose that is worn on theexaminer's hand to prevent contaminationbetween patient and examiner. It is also testedto be used against Chemotherapy Drugs andFentanyl Citrate. | A non-sterile disposable device intended formedical purpose that is worn on theexaminer's hand to prevent contaminationbetween patient and examiner. It is also testedto be used against Chemotherapy Drugs. | Similar |
| The gloves were tested for use withchemotherapy drugs and Fentanyl Citrate asper ASTM D6978-05 (Reapproved 2019)Standard Practice for Assessmentof | The gloves were tested for use withchemotherapy drugs as per ASTM D6978-05(Reapproved 2019) Standard Practice forAssessment of Resistance of Medical Gloves |
TECHNOLOGICAL CHARACTERISTICS COMPARISON TABLE:
| Chemotherapy Drugand Concentration | MinimumBreakthroughDetection Time inMinutes | Chemotherapy Drugand Concentration | MinimumBreakthroughDetection Time inMinutes |
|---|---|---|---|
| Carmustine, 3.3 mg/ml | 10.2 | Carmustine, 3.3 mg/ml | 10.2 |
| Cisplatin, 1.0 mg/ml | > 240 | Cisplatin, 1.0 mg/ml | > 240 |
| Cyclophosphamide(Cytoxan), 20.0 mg/ml | > 240 | Cyclophosphamide(Cytoxan), 20.0 mg/ml | > 240 |
| Dacarbazine, 10.0 mg/ml | > 240 | Dacarbazine, 10.0 mg/ml | > 240 |
| Doxorubicin Hydrochloride,2.0 mg/ml | > 240 | Doxorubicin Hydrochloride,2.0 mg/ml | > 240 |
| Etoposide (Toposar), 20.0mg/ml | > 240 | Etoposide (Toposar), 20.0mg/ml | > 240 |
| Fluorouracil, 50.0 mg/ml | > 240 | Fluorouracil, 50.0 mg/ml | > 240 |
| Methotrexate, 25.0 mg/ml | > 240 | Methotrexate, 25.0 mg/ml | > 240 |
| Mitomycin C, 0.5 mg/ml | > 240 | Mitomycin C, 0.5 mg/ml | > 240 |
| Paclitaxel (Taxol), 6.0 mg/ml | > 240 | Paclitaxel (Taxol), 6.0 mg/ml | > 240 |
| Thiotepa, 10.0 mg/ml | 30.2 | Thiotepa, 10.0 mg/ml | 30.2 |
| Vincristine Sulfate, 1.0mg/ml | > 240 | Vincristine Sulfate, 1.0mg/ml | > 240 |
| Bleomycin Sulfate, 15.0mg/ml | > 240 | Bleomycin Sulfate, 15.0mg/ml | > 240 |
| Bortezomib, 1.0 mg/ml | > 240 | Bortezomib, 1.0 mg/ml | > 240 |
| Busulfan, 6.0 mg/ml | > 240 | Busulfan, 6.0 mg/ml | > 240 |
| Carboplatin, 10.0 mg/ml | > 240 | Carboplatin, 10.0 mg/ml | > 240 |
| Chloroquine, 50.0 mg/ml | > 240 | Chloroquine, 50.0 mg/ml | > 240 |
| Cyclosporin A, 100.0 mg/ml | > 240 | Cyclosporin A, 100.0 mg/ml | > 240 |
| Cytarabine, 100.0 mg/ml | > 240 | Cytarabine, 100.0 mg/ml | > 240 |
| Daunorubicin, 5.0 mg/ml | > 240 | Daunorubicin, 5.0 mg/ml | > 240 |
| Docetaxel, 10.0 mg/ml | > 240 | Docetaxel, 10.0 mg/ml | > 240 |
| Epirubicin, 2.0 mg/ml | > 240 | Epirubicin, 2.0 mg/ml | > 240 |
| Fludarabine, 25.0 mg/ml | > 240 | Fludarabine, 25.0 mg/ml | > 240 |
| Gemcitabine, 38.0 mg/ml | > 240 | Gemcitabine, 38.0 mg/ml | > 240 |
| Idarubicin, 1.0 mg/ml | > 240 | Idarubicin, 1.0 mg/ml | > 240 |
| Ifosfamide, 50.0 mg/ml | > 240 | Ifosfamide, 50.0 mg/ml | > 240 |
| Irinotecan, 20.0 mg/ml | > 240 | Irinotecan, 20.0 mg/ml | > 240 |
| Mechlorethamine HCl, 1.0mg/ml | > 240 | Mechlorethamine HCl, 1.0mg/ml | > 240 |
| Melphalan, 5.0 mg/ml | > 240 | Melphalan, 5.0 mg/ml | > 240 |
| Mitoxantrone, 2.0 mg/ml | > 240 | Mitoxantrone, 2.0 mg/ml | > 240 |
| Oxaliplatin, 2.0 mg/ml | > 240 | Oxaliplatin, 2.0 mg/ml | > 240 |
| Paraplatin, 10.0 mg/ml | > 240 | Paraplatin, 10.0 mg/ml | > 240 |
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| Characteristicsand Parameters | Subject Device | Predicate Device(K222225) | Discussion | ||
|---|---|---|---|---|---|
| Rituximab, 10.0 mg/mlTopotecan, 1.0 mg/mlTrisenox, 1.0 mg/ml | > 240> 240> 240 | Rituximab, 10.0 mg/mlTopotecan, 1.0 mg/mlTrisenox, 1.0 mg/ml | > 240> 240> 240 | ||
| Caution: Testing showed a minimumbreakthrough time of 10.2 minutes withCarmustine and 30.2 minutes with Thiotepa.Warning: Do not use with Carmustine andThiotepa | Caution: Testing showed an averagebreakthrough time of 10.2 minutes withCarmustine and 30.2 minutes with Thiotepa.Warning: Do not use with Carmustine andThiotepa | ||||
| Fentanyl Citrate andConcentrationFentanyl Citrate, 100.0mcg/2ml | MinimumBreakthroughDetection Time inMinutes> 240 | N/A | Fentanyl Citratewas tested onsubject device:Different | ||
| Type of use | Over the counter use | Over the counter use | Same | ||
| Materials | Nitrile | Nitrile | Same | ||
| Color | Blue | Blue | Same | ||
| Design | • Single Use• Non-sterile• Powder-Free• Ambidextrous | • Single Use• Non-sterile• Powder-Free• Ambidextrous | Same | ||
| Sterility | Non-sterile | Non-sterile | Same | ||
| Freedom fromholes | Meets ASTM D5151-19 and ASTM D6319-19:AQL 1.5 | Meets ASTM D5151-19 and ASTM D6319-19:AQL 1.5 | Same | ||
| Length | Meets ASTM D6319-19:$\ge$ 230 mm | Meets ASTM D6319-19:$\ge$ 230 mm | Same | ||
| Dimensions | Meets ASTM D6319-19:XS - 70 ± 10 mmS - 80 ± 10 mmM - 95 ± 10 mmL - 110 ± 10 mmXL - 120 ± 10 mm | Meets ASTM D6319-19:XS - 70 ± 10 mmS - 80 ± 10 mmM - 95 ± 10 mmL - 110 ± 10 mmXL - 120 ± 10 mm | Same | ||
| Thickness | Meets ASTM D6319-19:Palm Thickness: Min 0.05 mmFinger Thickness: Min 0.05 mm | Meets ASTM D6319-19:Palm Thickness: Min 0.05 mmFinger Thickness: Min 0.05 mm | Same | ||
| PhysicalProperties | Meets ASTM D6319-19:Tensile Strength Before Aging: $\ge$ 14 MPaTensile Strength After Aging: $\ge$ 14 MPaUltimate Elongation Before Aging: $\ge$ 500 %Ultimate Elongation After Aging: $\ge$ 400 % | Meets ASTM D6319-19:Tensile Strength Before Aging: $\ge$ 14 MPaTensile Strength After Aging: $\ge$ 14 MPaUltimate Elongation Before Aging: $\ge$ 500 %Ultimate Elongation After Aging: $\ge$ 400 % | Same | ||
| Powder residual | Meets ASTM D6319-19 &ASTM D6124-06 (2017):Residual Powder: $\le$ 2 mg per glove | Meets ASTM D6319-19 &ASTM D6124-06 (2017):Residual Powder: $\le$ 2 mg per glove | Same | ||
| Primary SkinIrritationISO 10993-10 | Under the conditions of the study, the deviceis not an irritant | Under the conditions of the study, the deviceis not an irritant | Same | ||
| DermalSensitizationISO 10993-10 | Under the conditions of the study, the deviceis not a sensitizer | Under the conditions of the study, the deviceis not a sensitizer | Same |
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| Characteristicsand Parameters | Subject Device | Predicate Device(K222225) | Discussion |
|---|---|---|---|
| Acute SystemicToxicity TestISO 10993-11 | Under the conditions of this study, thedevice showed no evidence of acutesystemic toxicity | Under the conditions of this study, thedevice showed no evidence of acutesystemic toxicity | Same |
The subject device and the predicate device are identical. However, the subject device has been tested for use with both chemotherapy drugs and fentanyl citrate, whereas the predicate device has only been tested for use with chemotherapy drugs.
SUMMARY OF NON-CLINICAL TESTING:
The subject device and the predicate device share intended use, identical material and identical manufacturing, and therefore share the same chemotherapy drug permeation testing, biocompatibility characteristics and compliance with ASTM D6319. Fentanyl citrate permeation testing was performed on the subject glove using the ASTM D6978 method
| Testing Performed | Purpose | Criteria | Result |
|---|---|---|---|
| ASTM D6978Standard Practice forAssessment of Resistance ofMedical Gloves toPermeation byChemotherapy Drugs | Demonstrate barrier properties ofgloves to permeation of FentanylCitrate solution | N/A | No breakthrough detected during 240minute test duration |
The following testing was previously performed on the physically-identical predicate device.
| Test | Purpose | Criteria | Result |
|---|---|---|---|
| Standard Test Method forDetection of Holes in MedicalGlovesASTM D5151-19 | To demonstrate glove integrity | Freedom from holesAQL 1.5% | Pass |
| Standard Test Method forResidual Powder on MedicalGlovesASTM D6124-06(R17) | To demonstrate the gloves are 'powderfree' | Average less than 2 mg/glove | Pass |
| Dimensional ConformanceASTM D6319 | To demonstrate appropriate dimensionsfor labeled sizes | Conforms to ASTM D6319width, thickness, and lengthrequirements for XS, S, M, L,and XLAQL 4% | Pass |
| Tensile PerformanceASTM D6319 | To demonstrate adequate tensileproperties | Conforms to ASTM D6319tensile strength of at least14MPa and ultimate elongationof at least 500% requirementsprior to aging, and tensilestrength of at least 14MPa andultimate strength of at least400% after accelerated agingAQL 4% | Pass |
| Biocompatibility: SkinIrritationISO 10993-10 | To demonstrate low potential for skinirritation | Under the conditions of thestudy, not an irritant. | Pass |
| Biocompatibility: SkinSensitizationISO 10993-10 | To demonstrate low potential for skinsensitization | Under the conditions of thestudy, not a sensitizer | Pass |
| Biocompatibility:Acute ToxicityISO 10993-11 | To demonstrate low acute toxicity | Under the conditions of thestudy, no acute toxicity. | Pass |
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CLINICAL PERFORMANCE DATA:
Not applicable.
CONCLUSION:
The conclusions drawn from the non-clinical testing demonstrates that the subject device, Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue), is as safe, as effective, and performs as well as or better than the legally marketed predicate device, Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs (Blue) K222225.
§ 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.