(184 days)
Biodegradable Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Fusion Colour) 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 and Fentanyl Citrate.
These 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.
Biodegradable Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentany1 Citrate (Fusion Colour) is a disposable single-use, non-sterile, fusion-colored and powder-free examination glove made from nitrile latex.
The provided text is a 510(k) summary for the Biodegradable Nitrile Powder Free Examination Glove. It details the device's characteristics and compares it to a predicate device, focusing on non-clinical testing to demonstrate substantial equivalence.
Here's an analysis of the provided information regarding acceptance criteria and the study proving the device meets them, presented in the requested format.
1. Table of Acceptance Criteria and Reported Device Performance
The device is a medical glove, and its performance is evaluated against established ASTM and ISO standards for physical characteristics, chemical permeation, and biocompatibility.
| Characteristic/Parameter | Test Methodology/Standard | Acceptance Criteria (Standard) | Reported Device Performance |
|---|---|---|---|
| Dimensions | ASTM D6319-19 | Length (mm): XS, S: Min 220; M, L, XL: Min 230 Width (mm): XS: 70 ± 10; S: 80 ± 10; M: 95 ± 10; L: 110 ± 10; XL: 120 ± 10 | Length (mm): XS: 240; S: 242; M: 239; L: 246; XL: 245 (Meets requirements) Width (mm): XS: 76; S: 86; M: 97; L: 107; XL: 114 (Meets requirements) |
| Thickness | ASTM D6319-19 | Palm: Minimum 0.05 mm Finger: Minimum 0.05 mm | Palm Thickness (mm): XS: 0.05; S: 0.05; M: 0.06; L: 0.06; XL: 0.06 (Meets requirements) Finger Thickness (mm): XS: 0.08; S: 0.08; M: 0.08; L: 0.08; XL: 0.08 (Meets requirements) |
| Physical Properties | ASTM D6319-19 | Tensile Strength: Min 14 MPa (Before & After Aging) Ultimate Elongation: Min 500% (Before Aging); Min 400% (After Aging) | Before Age: Tensile Strength (MPa) Average 35; Elongation at Break (%) Average 565 (Meets requirements) After Age: Tensile Strength (MPa) Average 36; Elongation at Break (%) Average 469 (Meets requirements) |
| Freedom from Holes | ASTM D5151-19, ASTM D6319-19 | AQL 2.5 (Acceptable Quality Level) | Meets ASTM D6319-19 and ASTM D5151-19 requirements of AQL 2.5. Reported as pass at AQL 1.5, which is a tighter quality level. (Meets requirements) |
| Powder Residual | ASTM D6124-06 (2017), ASTM D6319-19 | Powder Free; ≤ 2 mg per glove | Average 0.14 mg/glove (Meets requirements) |
| Chemotherapy Drugs Permeation | ASTM D6978-05 (2019) | Varies per drug; generally, high breakthrough times for most drugs, with specific values for Carmustine and Thiotepa (e.g., >240 minutes for many, as low as 12.1 for Carmustine) | Carmustine (3.3 mg/ml): 12.1 minutes Thiotepa (10.0 mg/ml): 37.8 minutes Other 21 listed drugs: > 240 minutes (Meets specified breakthrough times; noted warnings about Carmustine usability) |
| Fentanyl Citrate Permeation | ASTM D6978-05 (2019) | >240 minutes | >240 minutes (Meets requirements) |
| In Vitro Cytotoxicity | ISO 10993-5:2009 | Not cytotoxic | The neat extract was found to be cytotoxic. (This is a deviation from the acceptance criteria, but the device was still cleared, likely due to overall risk-benefit and other biocompatibility tests. The summary highlights this as a direct finding, not stating it "meets" the non-cytotoxic criterion.) |
| Dermal Sensitization | ISO 10993-10:2021 | Not a sensitizer | Under the conditions of the study, the device is not a sensitizer. (Meets requirements) |
| Primary Skin Irritation | ISO 10993-23:2021 | Not an irritant | Under the conditions of the study, the device is not an irritant. (Meets requirements) |
| Acute Systemic Toxicity | ISO 10993-11:2017 | No systemic toxicity concern | Under the conditions of this study, the device showed no evidence of acute systemic toxicity. (Meets requirements) |
| Shelf-Life Expiry | ASTM D7160-16 | (Not explicitly listed as an acceptance criteria in the table, but reported as a characteristic) | 3 years (Identical to predicate device) |
(Note: The discrepancy for In Vitro Cytotoxicity is explicitly stated in the document as "found to be cytotoxic" while the acceptance criteria is "not cytotoxic." This indicates the device did not meet this specific acceptance criterion, but approval was still granted, implying the FDA found other evidence or risk mitigation sufficient.)
2. Sample Size Used for the Test Set and the Data Provenance
The document does not specify the exact sample sizes (e.g., number of gloves) used for each individual test (test set). It refers to the standards used (ASTM, ISO), which inherently define the testing methodology, including sample sizes for certain evaluations. However, the specific number of units tested for each parameter in this particular study is not provided in the summary.
Data Provenance: The document does not explicitly state the country of origin of the data collectors or the testing laboratories, but the applicant is "Hartalega NGC Sdn. Bhd." located in Malaysia. The tests are non-clinical (laboratory testing of the physical device), not human subject data. The testing appears to be prospective in the sense that the tests were conducted specifically to support this 510(k) submission for this new device.
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 device and study type. The "ground truth" for this medical device (examination glove) is established through standardized, objective laboratory measurements as defined by ASTM and ISO standards for physical properties, chemical resistance, and biocompatibility. There is no human interpretative "ground truth" (e.g., expert consensus on images) involved, as there would be for an AI-based diagnostic device.
4. Adjudication Method for the Test Set
This is Not Applicable. Adjudication methods (e.g., 2+1, 3+1) are typically used in studies involving human interpretation or machine learning models where subjective assessment, diagnostic disagreement, or ground truth establishment based on expert consensus is required. The testing demonstrated here involves objective physical and chemical measurements.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done
This is Not Applicable. An MRMC study assesses the performance of human readers, typically in a diagnostic setting, often with and without AI assistance. This submission describes a physical medical device (examination glove) and its non-clinical performance against established standards, not a diagnostic or AI-assisted product.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
This is Not Applicable. This is not an algorithm or AI product, but a physical examination glove.
7. The Type of Ground Truth Used
The "ground truth" for this device's performance is derived from:
- Standardized Test Methods and Protocols: As defined by ASTM (American Society for Testing and Materials) and ISO (International Organization for Standardization) standards. These standards specify how to objectively measure various properties (e.g., dimensions, tensile strength, permeation time, cytotoxicity).
- Laboratory Measurements: Direct, quantitative measurements of the glove's physical, chemical, and biological interactions according to the established standard methods.
8. The Sample Size for the Training Set
This is Not Applicable. There is no "training set" as this is not an AI/ML device. The testing described is for a physical product, not a statistical model that requires training data.
9. How the Ground Truth for the Training Set was Established
This is Not Applicable as there is no training set for this 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.
May 17, 2023
Hartalega NGC SDN. BHD. Nurul Aisyah Kong General Manager-Ouality Assurance No. 1. Persiaran Tanjung Kawasan Perindustrian Tanjung Sepang. Selangor Darul Ehsan 43900 Malaysia
Re: K223437
Trade/Device Name: Biodegradable Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Fusion Colour) Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I. reserved Product Code: LZA, LZC, QDO, OPJ Dated: March 15, 2023 Received: March 20, 2023
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 (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 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-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 Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K223437
Device Name
Biodegradable Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Fusion Colour)
Indications for Use (Describe)
Biodegradable Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Fusion Colour) 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 and Fentanyl Citrate.
These 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 in Minutes |
|---|---|
| 5-Azacytidine (25.0 mg/ml) | > 240 |
| Carboplatin (10.0 mg/ml) | > 240 |
| Carmustine (3.3 mg/ml) | 12.1 |
| Cisplatin (1.0 mg/ml) | > 240 |
| Cyclophosphamide (Cytoxan) (20.0 mg/ml) | > 240 |
| Dacarbazine (10.0 mg/ml) | > 240 |
| Doxetacel (10.0 mg/ml) | > 240 |
| Doxorubicin HCI (2.0 mg/ml) | > 240 |
| Epirubicin (2.0 mg/ml) | > 240 |
| Etoposide (20.0 mg/ml) | > 240 |
| Fluorouracil (50.0 mg/ml) | > 240 |
| Gemcitabine (38.0 mg/ml) | > 240 |
| Ifosfamide (50.0 mg/ml) | > 240 |
| Irinotecan (20.0 mg/ml) | > 240 |
| Methotrexate (25.0 mg/ml) | > 240 |
| Mitomycin C (0.5 mg/ml) | > 240 |
| Mitoxantrone (2.0 mg/ml) | > 240 |
| Oxalipatin (5.0 mg/ml) | > 240 |
| Paclitaxel (6.0 mg/ml) | > 240 |
| Thiotepa (10.0 mg/ml) | 37.8 |
| Vincristine Sulfate (1.0 mg/ml) | > 240 |
| Oncovin (1.0 mg/ml) | > 240 |
| Vinorelbine (10.0mg/ml) | > 240 |
| Fentanyl Citrate and Concentration | Minimum Breakthrough Detection Time in Minutes |
|---|---|
| Fentanyl Citrate Injection (100mcg/2ml) | >240 |
Caution: Please note that Carmustine and Thiotepa have extremely low permeation times of 12.1 minutes and 37.8 minutes.
Warning: Do not use with Carmustine.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) SUMMARY
K223437
BIODEGRADABLE NITRILE POWDER FREE EXAMINATION GLOVE TESTED FOR USE WITH CHEMOTHERAPY DRUGS AND FENTANYL CITRATE (FUSION COLOUR)
(The information contained herein is being provided in accordance with the requirements of 21 CFR 807.92)
SUBMISSION APPLICANT
| Date Prepared | : | May 15, 2023 |
|---|---|---|
| Name | : | Hartalega NGC Sdn. Bhd. |
| Address | : | No. 1, Persiaran Tanjung,Kawasan Perindustrian Tanjung,Sepang, Selangor Darul Ehsan, 43900Malaysia |
| 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 | : | Non-Powdered Patient Examination Glove |
|---|---|---|
| Trade Name (Proprietary Name) | : | Biodegradable Nitrile Powder Free Examination Glove Tested forUse with Chemotherapy Drugs and Fentanyl Citrate(Fusion Colour) |
| Device Class | : | 1 |
| Product Code | : | LZA, LZC, QDO, OPJ |
| Regulation Number | : | 21 CFR 880.6250 |
| Reason for 510(k) Submission | : | New device |
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PREDICATE DEVICE INFORMATION
| 510(k) Number | Tradename | Product Code | ||
|---|---|---|---|---|
| K200581 | Biodegradable Nitrile Powder Free Examination Glove Tested for Usewith Chemotherapy Drugs and Fentanyl Citrate (Blue) | LZA. LZC, QDO | ||
| Regulation Name | : | Non-Powdered Patient Examination Glove | ||
| Trade Name (Proprietary Name)Biodegradable Nitrile Powder Free Examination Glove Tested for Use: | ||||
| with Chemotherapy Drugs and Fentanyl Citrate (Fusion Colour) | ||||
| Device Class | ||||
| Product Code | : | LZA, LZC, QDO, OPJ | ||
| Regulation Number | : | 21 CFR 880.6250 |
DESCRIPTION OF THE DEVICE:
Biodegradable Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentany1 Citrate (Fusion Colour) is a disposable single-use, non-sterile, fusion-colored and powder-free examination glove made from nitrile latex.
INDICATIONS FOR USE:
Biodegradable Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentary1 Citrate (Fusion Colour) 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 and Fentanyl Citrate.
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.
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| Chemotherapy Drug and Concentration | Minimum Breakthrough Detection Time in Minutes |
|---|---|
| 5- Azacytidine, 25.0 mg/ml | > 240 |
| Carboplatin, 10.0 mg/ml | > 240 |
| Carmustine (3.3 mg/ml) | 12.1 |
| Cisplatin (1.0 mg/ml) | > 240 |
| Cyclophosphamide (20.0 mg/ml) | > 240 |
| Dacarbazine (10.0 mg/ml) | > 240 |
| Docetaxel, 10.0 mg/ml | > 240 |
| Doxorubicin HCL (2.0 mg/ml) | > 240 |
| Epirubicin, 2.0 mg/ml | > 240 |
| Etoposide (20.0 mg/ml) | > 240 |
| Fluorouracil (50.0 mg/ml) | > 240 |
| Gemcitabine, 38.0 mg/ml | > 240 |
| Ifosfamide, 50.0 mg/ml | > 240 |
| Irinotecan, 20.0 mg/ml | > 240 |
| Methotrexate (25.0 mg/ml) | > 240 |
| Mitomycin C (0.5 mg/ml) | > 240 |
| Mitoxantrone, 2.0 mg/ml | > 240 |
| Oxaliplatin, 2.0 mg/ml | > 240 |
| Paclitaxel (6.0 mg/ml) | > 240 |
| Thiotepa (10.0 mg/ml) | 37.8 |
| Vincristine Sulfate (1.0 mg/ml) | > 240 |
| Oncovin (1.0 mg/ml) | > 240 |
| Vinorelbine, 10.0 mg/ml | > 240 |
| Fentanyl Citrate, 100.0 mcg/2ml | > 240 |
Caution: Please note that Carmustine and Thiotepa have extremely low permeation times of 12.1 minutes.
Warning: Do not use with Carmustine.
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TECHNOLOGICAL CHARACTERISTICS COMPARISON TABLE:
| Characteristicsand Parameters | Subject Device | Predicate Device(K200581) | Discussion |
|---|---|---|---|
| Trade Name | Biodegradable Nitrile Powder FreeExamination Glove Tested for Use withChemotherapy Drugs and Fentanyl Citrate(Fusion Colour) | Biodegradable Nitrile Powder FreeExamination Glove Tested for Use withChemotherapy Drugs and Fentanyl Citrate(Blue) | - |
| Applicant | Hartalega NGC Sdn. Bhd. | Hartalega NGC Sdn. Bhd. | Same |
| Product Code | LZA, LZC, QDO, OPJ | LZA, LZC, QDO | Similar |
| Classification | 1 | 1 | Same |
| RegulationNumber | 21 CFR 880.6250 | 21 CFR 880.6250 | Same |
| RegulationName | Non-Powdered Patient Examination Glove | Non-Powdered 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.The gloves were tested for use withchemotherapy drugs as per ASTM D6978-05(Reapproved 2019) Standard Practice forAssessment of Resistance of Medical Glovesto Permeation by Chemotherapy Drugs. | A non-sterile disposable device intended formedical purpose that is worn on the examiner'shand to prevent contamination between patientand examiner. It is also tested to be used againstChemotherapy Drugs and Fentanyl Citrate.The gloves were tested foruse withchemotherapy drugs as per ASTM D6978-05(Reapproved 2013) Standard Practice forAssessment of Resistance of Medical Gloves toPermeation by Chemotherapy Drugs. | Similar |
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| Characteristicsand Parameters | Subject Device | Predicate Device(K200581) | Discussion | ||
|---|---|---|---|---|---|
| Chemotherapy Drug andConcentration | MinimumBreakthroughDetection Timein Minutes | Chemotherapy DrugConcentration | MinimumBreakthroughDetection Timein Minutes | ||
| TestChemotherapyDrugs | 5-Azacytidine, 25.0mg/ml | > 240 | 5-Azacytidine, 25.0mg/ml | > 240 | Similar |
| Carboplatin, 10.0 mg/ml | > 240 | Carboplatin, 10.0 mg/ml | > 240 | ||
| Carmustine (3.3 mg/ml) | 12.1 | Carmustine (3.3 mg/ml) | 21.4 | ||
| Cisplatin (1.0 mg/ml) | > 240 | Cisplatin (1.0 mg/ml) | > 240 | ||
| Cyclophosphamide (20.0 mg/ml) | > 240 | Cyclophosphamide (20.0 mg/ml) | > 240 | ||
| Dacarbazine (10.0 mg/ml) | > 240 | Dacarbazine (10.0 mg/ml) | > 240 | ||
| Docetaxel, 10.0 mg/ml | > 240 | Docetaxel, 10.0 mg/ml | > 240 | ||
| Doxorubicin HCL (2.0 mg/ml) | > 240 | Doxorubicin HCL (2.0 mg/ml) | > 240 | ||
| Epirubicin HCL, 2.0 mg/ml | > 240 | Epirubicin HCL, 2.0 mg/ml | > 240 | ||
| Etoposide (20.0 mg/ml) | > 240 | Etoposide (20.0 mg/ml) | > 240 | ||
| Fluorouracil (50.0 mg/ml) | > 240 | Fluorouracil (50.0 mg/ml) | > 240 | ||
| Gemcitabine, 38.0 mg/ml | > 240 | Gemcitabine, 38.0 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 | ||
| Methotrexate (25.0 mg/ml) | > 240 | Methotrexate (25.0 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 | ||
| Mitoxantrone, 2.0 mg/ml | > 240 | Mitoxantrone, 2.0 mg/ml | > 240 | ||
| Oxaliplatin, 5.0 mg/ml | > 240 | Oxaliplatin, 5.0 mg/ml | > 240 | ||
| Paclitaxel (6.0 mg/ml) | > 240 | Paclitaxel (6.0 mg/ml) | > 240 | ||
| Thiotepa (10.0 mg/ml) | 37.8 | Thiotepa (10.0 mg/ml) | 67.2 | ||
| Vincristine Sulfate (1.0 mg/ml) | > 240 | Vincristine Sulfate (1.0 mg/ml) | > 240 | ||
| Oncovin (1.0 mg/ml) | > 240 | Oncovin (1.0 mg/ml) | > 240 | ||
| Vinorelbine, 10.0 mg/ml | > 240 | Vinorelbine, 10.0 mg/ml | > 240 | ||
| Fentanyl Citrate, 100.0 mcg/2ml | > 240 | Fentanyl Citrate, 100.0 mcg/2ml | > 240 |
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| Characteristicsand Parameters | Subject Device | Predicate Device(K200581) | Discussion |
|---|---|---|---|
| Color | Fusion Colour | Blue | Different |
| Design | • Single Use• Non-sterile• Powder-Free• Ambidextrous | • Single Use• Non-sterile• Powder-Free• Ambidextrous | Similar |
| Sterility | Non-sterile | Non-sterile | Same |
| Freedom fromholes | Meets ASTM D5151-19:AQL 1.5 | Meets ASTM D5151-06(2015):AQL 1.5 | Similar |
| Length | Meets ASTM D6319-19:XS: ≥ 220 mmS: ≥ 220 mmM: ≥ 230 mmL: ≥ 230 mmXL: ≥ 230 mm | Meets ASTM D6319-10(2015):≥ 230 mm | Similar |
| Characteristicsand Parameters | Subject Device | Predicate Device(K200581) | Discussion |
| Width | Meets ASTM D6319-19:XS: 60 - 80 mmS: 70 - 90 mmM: 85 - 105 mmL: 100 - 120 mmXL: 110 - 130 mm | Meets ASTM D6319-10(2015):XS: 60 - 80 mmS: 70 - 90 mmM: 85 - 105 mmL: 100 - 120 mmXL: 110 - 130 mm | Similar |
| Thickness | Meets ASTM D6319-19:Palm Thickness: ≥ 0.05 mmFinger Thickness: ≥ 0.05 mm | Meets ASTM D6319-10(2015):Palm Thickness: ≥ 0.05 mmFinger Thickness: ≥ 0.05 mm | Similar |
| PhysicalProperties | Meets ASTM D6319-19:Tensile Strength Before Aging: ≥ 14 MPaTensile Strength After Aging: ≥ 14 MPaUltimate Elongation Before Aging: ≥ 500 %Ultimate Elongation After Aging: ≥ 400 % | Meets ASTM D6319-10(2015):Tensile Strength Before Aging: ≥ 14 MPaTensile Strength After Aging: ≥ 14 MPaUltimate Elongation Before Aging: ≥ 500 %Ultimate Elongation After Aging: ≥ 400 % | Similar |
| Powder residual | Meets ASTM D6124-06 (2017):Residual Powder: ≤ 2 mg per glove | Meets ASTM D6124-06 (2017):Residual Powder: ≤ 2 mg per glove | Similar |
| In vitroCytotoxicityISO 10993-5 | The neat extract was found to be cytotoxic | NA | Different |
| DermalSensitizationISO 10993-10 | Under the conditions of the study, thedevice is not a sensitizer | Under the conditions of the study, the device isnot a sensitizer | Similar |
| Characteristicsand Parameters | Subject Device | Predicate Device(K200581) | 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, the deviceshowed no evidence of acute systemic toxicity | Similar |
| Primary SkinIrritationISO 10993-23 | Under the conditions of the study, thedevice is not an irritant | Under the conditions of the study, the device isnot an irritant | Similar |
| Shelf-Life ExpiryASTM D7160-16 | 3 years | 3 years | Identical |
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SUMMARY OF NON-CLINICAL TESTING:
Provided are the test methodology used to demonstrate whether the acceptance criteria in each respective standard.
- . Biodegradability is not a medical claim and therefore was not reviewed by FDA.
- . ASTM D6319-19 Standard Specification for Nitrile Examination Gloves for Medical Application
- . ASTM D5151-19 Standard Test Method for Detection of Holes in Medical Gloves
- ASTM D6124-06 (Reapproved 2017) Standard Test Method for Residual Powder on Medical Gloves ●
- ASTM D6978-05 (Reapproved 2019) Standard Practice for Assessment of Resistance of Medical Gloves to . Permeation by Chemotherapy Drugs
- . ISO 10993-5 Biological evaluation of medical devices-Part 5: Tests for in vitro cytotoxicity
- ISO 10993-10 Biological evaluation of medical devices Part 10: Tests for skin sensitization .
- . ISO 10993-11 Biological evaluation of medical devices - Part 11: Tests for systemic toxicity
- . ISO 10993-23 Biological evaluation of medical devices - Part 23: Tests for irritation
- . ASTM D7160-16 Standard Practice for Determination of Expiration Dating for Medical Gloves
Physical Characteristics
| Test Methodology/Standards | Acceptance Criteria of theStandards | Result Summary | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| DimensionsASTM D6319-19Standard Specification forNitrile Examination Gloves forMedical Application | SizeXS | Length(mm)Min 220 | Width(mm)70 ± 10 | Meets ASTM D6319-19 requirements for length, and width. Similar to predicate device.Size | AverageLength (mm) | AverageWidth (mm) | |||||
| S | Min 220 | 80 ± 10 | |||||||||
| M | Min 230 | 95 ± 10 | |||||||||
| L | Min 230 | 110 ± 10 | |||||||||
| XL | Min 230 | 120 ± 10 | |||||||||
| XS | 240 | 76 | |||||||||
| S | 242 | 86 | |||||||||
| M | 239 | 97 | |||||||||
| L | 246 | 107 | |||||||||
| XL | 245 | 114 | |||||||||
| DimensionsASTM D6319-19Standard Specification forNitrile Examination Gloves forMedical Application | Thickness (mm)PalmFinger | Minimum 0.05Minimum 0.05 | Meets ASTM D6319-19 requirements for thickness.Similar to predicate device | Size | AveragePalmThickness(mm) | AverageFingerThickness(mm) | |||||
| XS | 0.05 | 0.08 | |||||||||
| S | 0.05 | 0.08 | |||||||||
| M | 0.06 | 0.08 | |||||||||
| L | 0.06 | 0.08 | |||||||||
| XL | 0.06 | 0.08 |
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| Physical PropertiesASTM D6319-19Standard Specification forNitrile Examination Glovesfor Medical Application | Parameter | BeforeAging | AfterAging | Meets ASTM D6319-19 requirements for tensilestrength and elongation at break before and afteraccelerated aging. Similar to predicate device.Before AgeTensile Strength (MPa)Average 35Elongation at Break (%)Average 565After AgeTensile Strength (MPa)Average 36Elongation at Break (%)Average 469 |
|---|---|---|---|---|
| TensileStrength | Min14 MPa | Min14 MPa | ||
| UltimateElongation | Min500% | Min400% | ||
| Freedom from holesASTM D5151-19Standard Test Method forDetection of Holes in MedicalGlovesASTM D6319-19Standard Specification forNitrile Examination Glovesfor Medical Application | AQL 2.5 | Meets ASTM D6319-19 and ASTM D5151-19requirements of AQL 2.5. Similar to predicatedevice.Inspection Level G1AQL Level 1.5Although pass at AQL 1.5 quality level, it complieswith ASTM D6319-19 and ASTM D5151-19.requirements of AQL 2.5 | ||
| Powder residualASTM D6124-06(2017)Standard Test Method forResidual Powder on MedicalGlovesASTM D6319-19Standard Specification forNitrile Examination Gloves forMedical Application | Powder Free; ≤ 2 mg per glove | Meets ASTM D6319-19 and ASTM D6124-06(2017) requirements for Powder Free; ≤ 2 mg perglove. Similar to predicate device.Average 0.14 mg/glove |
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| Chemotherapy DrugsPermeation | Chemotherapy Drug andConcentration | MinimumBreakthroughDetection Timein Minutes | |
|---|---|---|---|
| ASTM D6978-05(2019)Standard Practice forAssessment of Resistance ofMedical Gloves toPermeation byChemotherapy Drugs | Under the conditions of the study, thepermeation is acceptable. | 5- Azacytidine, 25.0 mg/ml | > 240 |
| Carboplatin, 10.0 mg/ml | > 240 | ||
| Carmustine (3.3 mg/ml) | 12.1 | ||
| Cisplatin (1.0 mg/ml) | > 240 | ||
| Cyclophosphamide (20.0 mg/ml) | > 240 | ||
| Dacarbazine (10.0 mg/ml) | > 240 | ||
| Docetaxel, 10.0 mg/ml | > 240 | ||
| Doxorubicin HCL (2.0 mg/ml) | > 240 | ||
| Epirubicin HCL, 2.0 mg/ml | > 240 | ||
| Etoposide (20.0 mg/ml) | > 240 | ||
| Fluorouracil (50.0 mg/ml) | > 240 | ||
| Gemcitabine, 38.0 mg/ml | > 240 | ||
| Ifosfamide, 50.0 mg/ml | > 240 | ||
| Irinotecan, 20.0 mg/ml | > 240 | ||
| Methotrexate (25.0 mg/ml) | > 240 | ||
| Mitomycin C (0.5 mg/ml) | > 240 | ||
| Mitoxantrone, 2.0 mg/ml | > 240 | ||
| Oxaliplatin, 5.0 mg/ml | > 240 | ||
| Paclitaxel (6.0 mg/ml) | > 240 | ||
| Thiotepa (10.0 mg/ml) | 37.8 | ||
| Vincristine Sulfate (1.0 mg/ml) | > 240 | ||
| Oncovin (1.0 mg/ml) | > 240 | ||
| Vinorelbine, 10.0 mg/ml | > 240 | ||
| Fentanyl Citrate, 100.0 mcg/2ml | > 240 | ||
| Under the conditions of the study, the permeation isacceptable. Similar to predicate devices.Performance level of drugs between subject deviceand predicate devices are comparable |
Biocompatibility
| Test Methodology/Standards | Acceptance Criteria of theStandards | Result Summary |
|---|---|---|
| In Vitro CytotoxicityISO 10993-5:2009Biological evaluation ofmedical devices - Part 5:Tests for in vitrocytotoxicity | Under the conditions of the study, thedevice is not cytotoxic | Under the conditions of the study, the device to befound have cytotoxic effect |
| Dermal SensitizationISO 10993-10:2021Biological evaluation ofmedical devices - Part 10:Tests for skin sensitization | Under the conditions of the study, thedevice is not a sensitizer | Under the conditions of the study, the device is nota sensitizer. |
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| Primary Skin IrritationISO 10993-23:2021Biological evaluation ofmedical devices — Part 10:Tests for irritation and skinsensitization | Under the conditions of the study, thedevice is not an irritant | Under the conditions of the study, the device is notan irritant. |
|---|---|---|
| Acute Systemic ToxicityISO 10993-11:2017Biological evaluation ofmedical devices —Part 11: Tests for systemictoxicity | Under the conditions of the study, thedevice does not pose a toxicityconcern | Under the conditions of the study, there was no signsof toxicity. |
CLINICAL PERFORMANCE DATA:
Not applicable. There was no clinical data required to support the subject device as the indication for use is equivalent to the predicate devices.
CONCLUSION:
The conclusion drawn from the non-clinical tests demonstrates that the subject device herein mentioned is as safe, effective, and performs as well as or better than the legally marketed predicate device (K200581).
§ 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.