(131 days)
A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. These gloves were tested for use with chemotherapy drugs and Fentanyl Citrate as per ASTM D6978-05 (Reapproved 2019) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.
Powder Free Nitrile Patient Examination Glove, Blue Colored, Non-Sterile, Low Dermatitis Potential. Tested for Use with Chemotherapy Drugs and Fentanyl Citrate.
This document describes the acceptance criteria and performance study for the Powder Free Nitrile Patient Examination Glove.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for this device, particularly for its resistance to chemotherapy drugs and Fentanyl Citrate, are defined by the "Minimum Breakthrough Detection Time in Minutes" as specified in the ASTM D6978-05 (Reapproved 2019) standard. The reported device performance is indicated by the measured breakthrough times against various substances.
| Chemotherapy Drug and Concentration | Acceptance Criteria (Minimum Breakthrough Detection Time in Minutes) | Reported Device Performance (Minimum Breakthrough Detection Time in Minutes) |
|---|---|---|
| Bendamustine HCI (Treanda) (5 mg/ml) | Not explicitly stated as a minimum, but tested to ASTM D6978-05. A "pass" would typically be >240 minutes for standard chemotherapy glove claims. | >240 |
| Bleomycin Sulfate (15 mg/ml) | Not explicitly stated as a minimum, but tested to ASTM D6978-05. | >240 |
| Busulfan (6 mg/ml) | Not explicitly stated as a minimum, but tested to ASTM D6978-05. | >240 |
| Carboplatin (10 mg/ml) | Not explicitly stated as a minimum, but tested to ASTM D6978-05. | >240 |
| Carfilzomib (2 mg/ml) | Not explicitly stated as a minimum, but tested to ASTM D6978-05. | >240 |
| Carmustine (BCNU) (3.3 mg/ml) | Not explicitly stated as a minimum, but tested to ASTM D6978-05. | 26.2 |
| Cetuximab (Erbitux) (2 mg/ml) | Not explicitly stated as a minimum, but tested to ASTM D6978-05. | >240 |
| Cisplatin (1 mg/ml) | Not explicitly stated as a minimum, but tested to ASTM D6978-05. | >240 |
| Cladribine (1 mg/ml) | Not explicitly stated as a minimum, but tested to ASTM D6978-05. | >240 |
| Cyclosporin A (100 mg/ml) | Not explicitly stated as a minimum, but tested to ASTM D6978-05. | >240 |
| Cyclophosphamide (Cytoxan) (20 mg/ml) | Not explicitly stated as a minimum, but tested to ASTM D6978-05. | >240 |
| Cytarabine (100 mg/ml) | Not explicitly stated as a minimum, but tested to ASTM D6978-05. | >240 |
| Cytovene (Ganciclovir) (10 mg/ml) | Not explicitly stated as a minimum, but tested to ASTM D6978-05. | >240 |
| Dacarbazine (DTIC) (10 mg/ml) | Not explicitly stated as a minimum, but tested to ASTM D6978-05. | >240 |
| Daunorubicin HCI (5 mg/ml) | Not explicitly stated as a minimum, but tested to ASTM D6978-05. | >240 |
| Decitabine (5 mg/ml) | Not explicitly stated as a minimum, but tested to ASTM D6978-05. | >240 |
| Docetaxel (Taxotere) (20 mg/ml) | Not explicitly stated as a minimum, but tested to ASTM D6978-05. | >240 |
| Doxorubicin Hydrochloride (2 mg/ml) | Not explicitly stated as a minimum, but tested to ASTM D6978-05. | >240 |
| Epirubicin HCI (Ellence) (2 mg/ml) | Not explicitly stated as a minimum, but tested to ASTM D6978-05. | >240 |
| Etoposide (20 mg/ml) | Not explicitly stated as a minimum, but tested to ASTM D6978-05. | >240 |
| Fludarabine (25 mg/ml) | Not explicitly stated as a minimum, but tested to ASTM D6978-05. | >240 |
| Fluorouracil (50 mg/ml) | Not explicitly stated as a minimum, but tested to ASTM D6978-05. | >240 |
| Gemcitabine (38 mg/ml) | Not explicitly stated as a minimum, but tested to ASTM D6978-05. | >240 |
| Idarubicin HCI (1 mg/ml) | Not explicitly stated as a minimum, but tested to ASTM D6978-05. | >240 |
| Ifosfamide (50 mg/ml) | Not explicitly stated as a minimum, but tested to ASTM D6978-05. | >240 |
| Irinotecan (20 mg/ml) | Not explicitly stated as a minimum, but tested to ASTM D6978-05. | >240 |
| Mechlorethamine HCI (1 mg/ml) | Not explicitly stated as a minimum, but tested to ASTM D6978-05. | >240 |
| Melphalan (5 mg/ml) | Not explicitly stated as a minimum, but tested to ASTM D6978-05. | >240 |
| Methotrexate (25 mg/ml) | Not explicitly stated as a minimum, but tested to ASTM D6978-05. | >240 |
| Mitomycin C (0.5 mg/ml) | Not explicitly stated as a minimum, but tested to ASTM D6978-05. | >240 |
| Mitoxantrone (2 mg/ml) | Not explicitly stated as a minimum, but tested to ASTM D6978-05. | >240 |
| Oxaliplatin (5 mg/ml) | Not explicitly stated as a minimum, but tested to ASTM D6978-05. | >240 |
| Paclitaxel (Taxol) (6 mg/ml) | Not explicitly stated as a minimum, but tested to ASTM D6978-05. | >240 |
| Pemetrexed (25 mg/ml) | Not explicitly stated as a minimum, but tested to ASTM D6978-05. | >240 |
| Raltitrexed (0.5 mg/ml) | Not explicitly stated as a minimum, but tested to ASTM D6978-05. | >240 |
| Retrovir (Zidovudine) (10 mg/ml) | Not explicitly stated as a minimum, but tested to ASTM D6978-05. | >240 |
| Rituximab (10 mg/ml) | Not explicitly stated as a minimum, but tested to ASTM D6978-05. | >240 |
| Thiotepa (10 mg/ml) | Not explicitly stated as a minimum, but tested to ASTM D6978-05. | 59.1 |
| Topotecan (1 mg/ml) | Not explicitly stated as a minimum, but tested to ASTM D6978-05. | >240 |
| Trisenox (Arsenic Trioxide) (1 mg/ml) | Not explicitly stated as a minimum, but tested to ASTM D6978-05. | >240 |
| Velcade (Bortezomib) (1 mg/ml) | Not explicitly stated as a minimum, but tested to ASTM D6978-05. | >240 |
| Vidaza (Azacytidine) (25 mg/ml) | Not explicitly stated as a minimum, but tested to ASTM D6978-05. | >240 |
| Vinblastine (1 mg/ml) | Not explicitly stated as a minimum, but tested to ASTM D6978-05. | >240 |
| Vincristine Sulfate (1 mg/ml) | Not explicitly stated as a minimum, but tested to ASTM D6978-05. | >240 |
| Vinorelbine (10 mg/ml) | Not explicitly stated as a minimum, but tested to ASTM D6978-05. | >240 |
| Zoledronic Acid (1 mg/25ml) | Not explicitly stated as a minimum, but tested to ASTM D6978-05. | >240 |
| Fentanyl Citrate Injection (100 mcg/2ml) | Not explicitly stated as a minimum, but tested to ASTM D6978-05. | >240 |
| Simulated Gastric Acid Fluid | Not explicitly stated as a minimum, but tested to ASTM D6978-05. | >240 |
Note: For Carmustine (BCNU) and Thiotepa, the reported times (26.2 and 59.1 minutes respectively) are below the ">240" observed for most other drugs. This results in explicit warnings not to use with Carmustine (BCNU) and caution when using with Thiotepa due to low permeation times.
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size (number of gloves or individual tests) used for the permeation test for each chemical. It only provides the resulting "Minimum Breakthrough Detection Time in Minutes."
The data provenance is not specified in terms of country of origin. The study appears to be a prospective test specifically designed to evaluate the performance of these gloves against the listed chemicals, rather than a retrospective analysis of existing data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This type of study (chemical permeation test as per ASTM D6978-05) does not involve human experts establishing "ground truth" in the way that image interpretation or diagnostic studies do. The "ground truth" is the objective measurement of chemical breakthrough time, determined in a laboratory setting according to a standardized protocol (ASTM D6978-05). Therefore, there are no medical experts (e.g., radiologists) involved in establishing this particular ground truth.
4. Adjudication Method for the Test Set
Not applicable. As noted above, this is a laboratory-based chemical permeation test, not a subjective assessment requiring adjudication among experts. The results are objective measurements based on the ASTM D6978-05 standard.
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 not a study involving human readers or AI. It is a chemical resistance test for a medical device (gloves).
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This is not an algorithm or AI study. It is a physical performance test of a medical device.
7. The Type of Ground Truth Used
The ground truth used is objective laboratory measurement based on a standardized protocol, specifically "Assessment of Medical Gloves to Permeation by Chemotherapy Drugs" as per ASTM D6978-05 (Reapproved 2019). The outcome is a quantified "Minimum Breakthrough Detection Time in Minutes."
8. The Sample Size for the Training Set
Not applicable. This is not an AI/machine learning study, so there is no concept of a "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable. As there is no training set for this type of physical performance study, no ground truth was established for it.
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March 15, 2023
Kossan International Sdn Bhd3 Cho Sow Fong Senior Manager Regulatory Affairs Wisma Kossan, Lot 782, Jalan Sungai Putus Off Batu 3 3/4, Jalan Kapar Klang, Selangor 42100 Malaysia
Re: K223375
Trade/Device Name: Powder Free Nitrile Patient Examination Glove, Blue Colored, Non-sterile, Low Dermatitis Potential. Tested for Use with Chemotherapy Drugs and Fentanyl Citrate Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I, reserved Product Code: LZA, LZC, OPJ, QDO Dated: January 31, 2023 Received: February 2, 2023
Dear Cho Sow Fong:
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) K223375
Device Name
Powder Free Nitrile Patient Examination Glove, Blue Colored, Non-Sterile, Low Dermatitis Potential. Tested for Use with Chemotherapy Drugs and Fentanyl Citrate.
Indications for Use (Describe)
A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.
These gloves were tested for use with chemotherapy drugs and Fentanyl Citrate 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 |
|---|---|
| Bendamustine HCI (Treanda) (5 mg/ml) | >240 |
| Bleomycin Sulfate (15 mg/ml) | >240 |
| Busulfan (6 mg/ml) | >240 |
| Carboplatin (10 mg/ml) | >240 |
| Carfilzomib (2 mg/ml) | >240 |
| Carmustine (BCNU) (3.3 mg/ml) | 26.2 |
| Cetuximab (Erbitux) (2 mg/ml) | >240 |
| Cisplatin (1 mg/ml) | >240 |
| Cladribine (1 mg/ml) | >240 |
| Cyclosporin A (100 mg/ml) | >240 |
| Cyclophosphamide (Cytoxan) (20 mg/ml) | >240 |
| Cytarabine (100 mg/ml) | >240 |
| Cytovene (Ganciclovir) (10 mg/ml) | >240 |
| Dacarbazine (DTIC) (10 mg/ml) | >240 |
| Daunorubicin HCI (5 mg/ml) | >240 |
| Decitabine (5 mg/ml) | >240 |
| Docetaxel (Taxotere) (20 mg/ml) | >240 |
| Doxorubicin Hydrochloride (2 mg/ml) | >240 |
| Epirubicin HCI (Ellence) (2 mg/ml) | >240 |
| Etoposide (20 mg/ml) | >240 |
| Fludarabine (25 mg/ml) | >240 |
| Fluorouracil (50 mg/ml) | >240 |
| Gemcitabine (38 mg/ml) | >240 |
| Idarubicin HCI (1 mg/ml) | >240 |
| Ifosfamide (50 mg/ml) | >240 |
| Irinotecan (20 mg/ml) | >240 |
| Mechlorethamine HCI (1 mg/ml) | >240 |
| Melphalan (5 mg/ml) | >240 |
| Methotrexate (25 mg/ml) | >240 |
| Mitomycin C (0.5 mg/ml) | >240 |
| Mitoxantrone (2 mg/ml) | >240 |
| Oxaliplatin (5 mg/ml) | >240 |
| Paclitaxel (Taxol) (6 mg/ml) | >240 |
| Pemetrexed (25 mg/ml) | >240 |
| Raltitrexed (0.5 mg/ml) | >240 |
| Retrovir (Zidovudine) (10 mg/ml) | >240 |
| Rituximab (10 mg/ml) | >240 |
| Thiotepa (10 mg/ml) | 59.1 |
| Topotecan (1 mg/ml) | >240 |
| Trisenox (Arsenic Trioxide) (1 mg/ml) | >240 |
| Velcade (Bortezomib) (1 mg/ml) | >240 |
| Vidaza (Azacytidine) (25 mg/ml) | >240 |
| Vinblastine (1 mg/ml) | >240 |
| Vincristine Sulfate (1 mg/ml) | >240 |
| Vinorelbine (10 mg/ml) | >240 |
| Zoledronic Acid (1 mg/25ml) | >240 |
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Please note that Carmustine (BCNU) and Thiotepa has low permeation times of 26.2 and 59.1 minutes respectively. Warning: Do Not Use with Carmustine (BCNU)
Caution: Thiotepa has low permeation times of 59.1 minutes
| Opioid and Concentration | Minimum Breakthrough Detection Time in Minutes |
|---|---|
| Fentanyl Citrate Injection (100 mcg/2ml) | >240 |
| Simulated Gastric Acid Fluid | Minimum Breakthrough Detection Time in Minutes |
Simulated Gastric Acid Fluid
240
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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§ 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.