(109 days)
Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs (Blue) is a non-sterile disposable device intended for medical purpose that is worn on the examination between patient and examiner. It is also tested to be used against Chemotherapy Drugs.
These gloves were tested for use with chemotherapy drugs as per ASTM D6978-05 (Reapproved 2019) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.
Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs (Blue) is a disposable singleuse, non-sterile, blue-colored and powder-free examination glove made from nitrile latex.
This document is a 510(k) Premarket Notification for a medical device: "Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs (Blue)". It describes the acceptance criteria and the study that proves the device meets those criteria, specifically for its resistance to chemotherapy drugs.
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Resistance to Permeation by Chemotherapy Drugs (ASTM D6978-05 (Reapproved 2019)) | For most chemotherapy drugs, a minimum breakthrough detection time (e.g., >240 minutes) is desired for adequate protection. Some drugs may have shorter accepted times based on their specific properties and risks. The predicate device (K151997) also established similar benchmark values. | The device reports the following minimum breakthrough detection times: - Carmustine (3.3 mg/ml): 10.2 minutes - Thiotepa (10.0 mg/ml): 30.2 minutes - All other 31 listed chemotherapy drugs (e.g., Cisplatin, Cyclophosphamide, Doxorubicin, Fluorouracil, Methotrexate, Paclitaxel, etc.): >240 minutes Note: A caution explicitly warns against use with Carmustine and Thiotepa due to the shorter breakthrough times. |
| Freedom from holes (ASTM D5151-19 and ASTM D6319-19) | AQL 1.5% | Pass |
| Residual Powder (ASTM D6124-06 (2017)) | Average less than 2 mg/glove | Pass |
| Dimensional Conformance (ASTM D6319-19) | Conforms to ASTM D6319 width, thickness, and length requirements for XS, S, M, L, and XL (AQL 4%) - Length: ≥ 230 mm - Width (XS: 70 ± 10 mm, S: 80 ± 10 mm, M: 95 ± 10 mm, L: 110 ± 10 mm, XL: 120 ± 10 mm) - Palm Thickness: Min 0.05 mm - Finger Thickness: Min 0.05 mm | Pass (Meets specified length, width, palm thickness, and finger thickness requirements. The document specifically states for length "≥ 230 mm" for the subject device and "≥ 240 mm" for the predicate, but both are considered "Same" with a combined ASTM D6319-19 approval) |
| Tensile Performance (ASTM D6319-19) | Conforms to ASTM D6319 tensile strength of at least 14 MPa and ultimate elongation of at least 500% requirements prior to aging, and tensile strength of at least 14 MPa and ultimate strength of at least 400% after accelerated aging (AQL 4%) | Pass |
| Biocompatibility: Skin Irritation (ISO 10993-10) | Under the conditions of the study, not an irritant. | Pass (Under the conditions of the study, the device is not an irritant) |
| Biocompatibility: Skin Sensitization (ISO 10993-10) | Under the conditions of the study, not a sensitizer. | Pass (Under the conditions of the study, the device is not a sensitizer) |
| Biocompatibility: Acute Toxicity (ISO 10993-11) | Under the conditions of the study, no acute systemic toxicity. | Pass (Under the conditions of this study, the device showed no evidence of acute systemic toxicity) |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the specific sample sizes used for each test set within the provided tables (e.g., how many gloves were tested for holes, or how many individual glove samples were exposed to each chemotherapy drug). However, it indicates compliance with recognized standards (ASTM D5151-19, ASTM D6319-19, ASTM D6124-06, ASTM D6978-05). These standards typically specify the minimum sample sizes required for testing.
The data provenance is implied to be prospective testing conducted by the manufacturer (Hartalega NGC Sdn. Bhd.) to meet the requirements for their 510(k) submission. Given the company's address, the testing was likely conducted in Malaysia or an affiliated testing facility.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable as the evaluation of the device's performance against physicochemical and biological standards (like chemical permeation, physical properties, and biocompatibility) does not typically involve human experts establishing ground truth in the way a clinical diagnostic study would. The "ground truth" here is defined by the objective metrics and thresholds established by the ASTM and ISO standards.
4. Adjudication Method for the Test Set
This is not applicable. Adjudication methods (like 2+1, 3+1) are typically used in clinical studies involving human interpretation or subjective assessments to resolve discrepancies. The tests described are objective, standardized laboratory tests.
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 is not applicable. The device is an examination glove, not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is entirely irrelevant to this device.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. The device is a physical medical device (glove), not an algorithm or software. Standalone algorithm performance refers to the assessment of an AI system without human intervention, which does not apply here.
7. The Type of Ground Truth Used
The ground truth used for performance assessment of the Nitrile Powder Free Examination Glove is based on objective, standardized laboratory test results and their comparison against pre-defined acceptance criteria set by international standards:
- Chemotherapy Drug Permeation: Measured breakthrough times (in minutes) as per ASTM D6978-05 (Reapproved 2019). The standard itself establishes the methodology and criteria for evaluating resistance.
- Physical Properties: Measurements against specifications outlined in ASTM D5151-19 (freedom from holes), ASTM D6319-19 (dimensional conformance, tensile performance), and ASTM D6124-06 (R17) (residual powder).
- Biocompatibility: Results of tests performed according to ISO 10993-10 (skin irritation, skin sensitization) and ISO 10993-11 (acute systemic toxicity), which define the methods and expected outcomes for non-toxic materials.
8. The Sample Size for the Training Set
This is not applicable. The device is a manufactured product undergoing standardized testing, not a machine learning model that requires a training set.
9. How the Ground Truth for the Training Set Was Established
This is not applicable for the same reason as point 8.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in a stacked format.
November 11, 2022
Hartalega NGC Sdn. Bhd. Nurul Kong General Manager-Ouality Assurance No. 1, Persiaran Tanjung Kawasan Perindustrian Tanjung Sepang, Selangor Darul Ehsan 43900 Malaysia
Re: K222225
Trade/Device Name: Nitrile Powder Free 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: August 9, 2022 Received: August 17, 2022
Dear Nurul 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 (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.
Bifeng Qian -S
Bifeng Qian, M.D., Ph.D. Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
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Indications for Use
510(k) Number (if known) K22225
Device Name
Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs (Blue)
Indications for Use (Describe)
Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs (Blue) is a non-sterile disposable device intended for medical purpose that is worn on the examination between patient and examiner. It is also tested to be used against Chemotherapy Drugs.
These gloves were tested for use with chemotherapy drugs as per ASTM D6978-05 (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, 10.0 mg/ml | >240 |
| Retrovir, 10.0 mg/ml | >240 |
| Rituximab, 10.0 mg/ml | >240 |
| Topotecan, 1.0 mg/ml | >240 |
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| Trisenox, 1.0 mg/ml |
|---|
| --------------------- |
240
Caution: Testing showed an average 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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510(k) SUMMARY
K222225
NITRILE POWDER FREE EXAMINATION GLOVE TESTED FOR USE WITH CHEMOTHERAPY DRUGS (BLUE)
(The information contained herein is being provided in accordance with the requirements of 21 CFR 807.92)
1. SUBMISSION APPLICANT
1
| Date Prepared | : | November 10, 2022 |
|---|---|---|
| Name | : | Hartalega NGC Sdn. Bhd. |
| Address | : | No. 1, Persiaran Tanjung,Kawasan Perindustrian Tanjung,43900 Sepang, Selangor,Malaysia |
| Establishment RegistrationNumber | : | 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 |
2. DEVICE IDENTIFICATION
| Common Name of the Device | : | Examination Glove |
|---|---|---|
| Trade Name (Proprietary Name) | : | Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs (Blue) |
| Device Class | : | 1 |
| Product Code | : | LZA, LZC, OPJ |
| Regulation Number | : | 21 CFR 880.6250 |
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3. PREDICATE DEVICE INFORMATION
| 510(k)Number | Tradename | ProductCode |
|---|---|---|
| K151997 | Nitrile Powder Free Examination Glove Tested for Use withChemotherapy Drugs - Violet Blue (VBLU) | LZA |
| Regulation Name | Patient Examination Glove | |
| Trade Name (Proprietary Name) | Nitrile Powder Free Examination Glove Tested for Use withChemotherapy Drugs - Violet Blue (VBLU) | |
| Device Class | 1 | |
| Product Code | LZA | |
| Regulation Number | 21 CFR 880.6250 |
4. DESCRIPTION OF THE DEVICE:
Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs (Blue) is a disposable singleuse, non-sterile, blue-colored and powder-free examination glove made from nitrile latex.
5. INDICATIONS FOR USE:
Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs (Blue) is a non-sterile 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.
The gloves were tested for use with chemotherapy drugs 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 inMinutes |
|---|---|
| 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 |
Hartalega NGC Sdn. Bhd.
{6}------------------------------------------------
| 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 HCl, 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 an average breakthrough time of 10.2 minutes with Carmustine and 30.2 minutes with Thiotepa.
Warning: Do not use with Carmustine and Thiotepa
6. TECHNOLOGICAL CHARACTERISTICS COMPARISON TABLE:
| Characteristicsand Parameters | Subject Device | Predicate Device (K151997) | Discussion |
|---|---|---|---|
| Trade Name | Nitrile Powder Free Examination GloveTested for Use with ChemotherapyDrugs (Blue) | Nitrile Powder Free Examination GlovesTested for Use with Chemotherapy Drugs– Violet Blue (VBLU) | - |
| Applicant | Hartalega NGC Sdn. Bhd. | Hartalega NGC Sdn. Bhd. | Same |
| Product Code | LZA, LZC, OPJ | LZA | Similar |
| Classification | 1 | 1 | Same |
| RegulationNumber | 21 CFR 880.6250 | 21 CFR 880.6250 | Same |
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| Regulation Name | Patient Examination Glove | Patient Examination Glove | Same |
|---|---|---|---|
| Indications for Use | A non-sterile disposable device intendedfor medical purpose that is worn on theexaminer's hand to preventcontamination between patient andexaminer. It is also tested to be usedagainst Chemotherapy Drugs.The gloves were tested for use withchemotherapy drugs as per ASTMD6978-05 (Reapproved 2019) StandardPractice for Assessment of Resistance ofMedical Gloves to Permeation byChemotherapy Drugs. | A non-sterile disposable device intendedfor medical purpose that is worn on theexaminer's hand to preventcontamination between patient andexaminer. It is also tested to be usedagainst Chemotherapy Drugs.The gloves were tested for use withchemotherapy drugs as per ASTM D6978-05 (Reapproved 2019) Standard Practicefor Assessment of Resistance of MedicalGloves to Permeation by ChemotherapyDrugs. | Similar |
| Chemotherapy Drugand Concentration | Chemotherapy Drugand Concentration | ||
| Minimum BreakthroughDetection Timein Minutes | Minimum BreakthroughDetection Timein Minutes | ||
| 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, 1.0 mg/ml > 240 | Vincristine Sulfate, 1.0 mg/ml > 240 | ||
| Bleomycin Sulfate, 15.0 mg/ml > 240 | Caution: Testing showed an averagebreakthrough time of 10.2 minutes withCarmustine and 30.2 minutes withThiotepa. | ||
| Bortezomib, 1.0 mg/ml > 240 | Warning: Do not use with Carmustine andThiotepa | ||
| 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 HCl, 1.0 mg/ml > 240 |
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| Melphalan, 5.0 mg/ml > 240Mitoxantrone, 2.0 mg/ml > 240Oxaliplatin, 2.0 mg/ml > 240Paraplatin, 10.0 mg/ml > 240Retrovir, 10.0 mg/ml > 240Rituximab, 10.0 mg/ml > 240Topotecan, 1.0 mg/ml > 240Trisenox, 1.0 mg/ml > 240Caution: Testing showed an averagebreakthrough time of 10.2 minutes withCarmustine and 30.2 minutes withThiotepa.Warning: Do not use with Carmustineand Thiotepa | |||
|---|---|---|---|
| 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:$\geq$ 230 mm | Meets ASTM D6319-19:$\geq$ 240 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 mm FingerThickness: Min 0.05 mm | Meets ASTM D6319-19:Palm Thickness: 0.08 ± 0.01 mm FingerThickness: $\geq$ 0.10 mm | Same |
| PhysicalProperties | Meets ASTM D6319-19:Tensile Strength Before Aging: $\geq$ 14 MPaTensile Strength After Aging: $\geq$ 14 MPaUltimate Elongation Before Aging: $\geq$ 500 %Ultimate Elongation After Aging: $\geq$ 400 % | Meets ASTM D6319-19:Tensile Strength Before Aging: $\geq$ 14 MPaTensile Strength After Aging: $\geq$ 14 MPaUltimate Elongation Before Aging: $\geq$ 500 %Ultimate Elongation After Aging: $\geq$ 400 % | Same |
| Powder residual | Meets ASTM D6319-19 & ASTM D6124-06 (2017):Residual Powder: $\leq$ 2 mg per glove | Meets ASTM D6319-19 & ASTM D6124-06(2017):Residual Powder: $\leq$ 2 mg per glove | Same |
| Primary SkinIrritation ISO10993-10 | Under the conditions of the study, thedevice is not an irritant | Under the conditions of the study, thedevice not an irritant | Same |
| Dermal | Under the conditions of the study, the | Under the conditions of the study, the | Same |
| SensitizationISO 10993-10 | device is not a sensitizer | device not a sensitizer | |
| Acute SystemicToxicity Test ISO10993-11 (2017) | Under the conditions of this study, thedevice showed no evidence of acutesystemic toxicity | Not performed | Different |
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7. SUMMARY OF NON-CLINICAL TESTING:
Non-clinical tests were conducted to verify that the subject device meets all design specifications.
| 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 for ResidualPowder on Medical GlovesASTM D6124-06(R17) | To demonstrate the gloves are'powder free' | Average less than 2mg/glove | Pass |
| Dimensional ConformanceASTM D6319 | To demonstrate appropriatedimensions for labeled sizes | Conforms to ASTM D6319width, thickness, andlength requirements forXS, S, M, L, and XLAQL 4% | Pass |
| Tensile PerformanceASTM D6319 | To demonstrate adequate tensileproperties | Conforms to ASTM D6319tensile strength of at least14MPa and ultimateelongation of at least500% requirements priorto aging, and tensilestrength of at least14MPa and ultimatestrength of at least 400%after accelerated agingAQL 4% | Pass |
| Biocompatibility: Skin IrritationISO 10993-10 | To demonstrate low potential forskin irritation | Under the conditions ofthe study, not an irritant. | Pass |
| Biocompatibility: Skin SensitizationISO 10993-10 | To demonstrate low potential forskin sensitization | Under the conditions ofthe study, not a sensitizer | Pass |
| Biocompatibility:Acute ToxicityISO 10993-11 | To demonstrate low acutetoxicity | Under the conditions ofthe study, no acutetoxicity | Pass |
CLINICAL PERFORMANCE DATA:
Not applicable. No clinical testing was performed in support of this submission.
CONCLUSION:
The conclusions drawn from the non-clinical performance data demonstrate that, the subject device, Nitrile
Powder Free Examination Glove Tested for Use with Chemotherapy Drugs (Blue), is as safe, as effective and performs as well as or better than the legally marketed predicate device K151997.
Hartalega NGC Sdn. Bhd.
§ 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.