(51 days)
A powder-free 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.
In addition, these chemotherapy gloves were tested for use with the following drug concentrations per ASTM D6978-05:
The following drugs had NO breakthrough detected up to 240 minutes:
Bleomycin sulfate (15.0mg/ml), Busulfan (6.0mg/ml), Carboplatin (10.0mg/ml), Cisplatin (1 mg/ml), Cyclophosphamide (20 mg/ml), Cytarabine HCl (100.0mg/ml), Dacarbazine (10 mg/ml), Daunorubicin Hcl (5.0mg/ml), Docetaxel (10.0mg/ml), Doxorubicin HCl (Adriamycin) (2 mg/ml), Ellence (Epirubicin) (2.0mg/ml), Etoposide (20 mg/ml), Fludarabine (25.0mg/ml), Fluorouracil (adrucil) (50 mg/ml), Gemcitabine (38.0mg/ml), Idarubicin (1.0mg/ml), Ifosfamide (50mg/ml), Irinotecan (20.0mg/ml), Mechlorethamine HCl (1.0mg/ml), Melphalan (5.0mg/ml), Methotrexate (25.0mg/ml), Mitomycin (0.5mg/ml), Mitoxantrone (2 mg/ml), Paclitaxel (Taxol) (6 mg/ml), Paraplatin (10.0mg/ml), Rituximab (10.0mg/ml), ThioTEPA (10.0mg/ml), Trisenox (0.1mg/ml), Vincristine Sulfate (1 mg/ml)
Please note that the following drug has extremely low permeation times of less than 60 minutes: Carmustine (3.3 mg/ml) 48.6 minutes
Kimberly-Clark PURPLE NITRILE-XTRA* Sterile Powder-Free Exam Gloves are 12-inch long, sterile, purple-colored nitrile, powder-free, ambidextrous patient examination glove that meets all of the requirements of ASTM D 6319-00a, Standard Specification for Nitrile Examination Gloves for Medical Application. The gloves are packaged as two gloves per sterile pouch.
Kimberly-Clark PURPLE NITRILE* Sterile Powder-Free Exam Gloves are 9.5-inch long, sterile, purplecolored nitrile, powder-free, ambidextrous patient examination glove that meets all of the requirements of ASTM D 6319-00a, Standard Specification for Nitrile Examination Gloves for Medical Application. The gloves are packaged as two gloves per sterile pouch.
Kimberly-Clark PURPLE NITRILE* Sterile Powder-Free Exam Gloves are 9.5-inch long, sterile, purplecolored nitrile, powder-free, ambidextrous patient examination glove that meets all of the requirements of ASTM D 6319-00a, Standard Specification for Nitrile Examination Gloves for Medical Application. The gloves are packaged as one glove per sterile bouch.
Kimberly-Clark PURPLE NITRILE-XTRA* Sterile Powder-Free Exam Gloves (Chemotherapy Glove) are 12-inch long, sterile, purple-colored nitrile, powder-free, ambidextrous patient examination glove that meets all of the requirements of ASTM D 6319-00a, Standard Specification for Nitrile Examination Gloves for Medical Application. In addition these gloves were tested for use with the Intended Use(s) section below, per ASTM D6978-05 "Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs." The gloves are packaged as two gloves per sterile pouch.
Kimberly-Clark PURPLE NITRILE* Sterile Powder-Free Exam Gloves (Chemotherapy Glove) are 9.5-inch long, sterile, purple-colored nitrile, powder-free, ambidextrous patient examination glove that meets all of the requirements of ASTM D 6319-00a, Standard Specification for Nitrile Examination Gloves for Medical Application. In addition these gloves were tested for use with the drugs listed in the Intended Use(s) section below, per ASTM D6978-05 "Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs." The gloves are packaged as two gloves per sterile pouch.
Kimberly-Clark PURPLE NITRILE* Sterile Powder-Free Exam Gloves (Chemotherapy Glove) are 9.5-inch long, sterile, purple-colored nitrile, powder-free, ambidextrous patient examination glove that meets all of the requirements of ASTM D 6319-00a, Standard Specification for Nitrile Examination Gloves for Medical Application. In addition these gloves were tested for use with the Intended Use(s) section below, per ASTM D6978-05 "Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs." The gloves are packaged as one glove per sterile pouch.
The provided document K102032 describes several types of Kimberly-Clark PURPLE NITRILE Sterile Powder-Free Exam Gloves. The acceptance criteria and the study proving the device meets these criteria are detailed in the "Non-Clinical Testing" sections for each bundled device.
Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance:
The devices are patient examination gloves, and their acceptance criteria are based on recognized consensus standards, primarily ASTM D 6319-00a (Standard Specification for Nitrile Examination Gloves for Medical Applications), ASTM D 5151-06 (Standard Test Method for Detection of Holes in Medical Gloves), ASTM D 6124-06 (Standard Test Method for Residual Powder on Medical Gloves), ISO 10993 Part 10 (Biological evaluation of medical devices – Part 10: Tests for irritation and skin sensitization), ISO 10993 Part 5 (Biological evaluation of medical devices – Part 5: Tests for in vitro cytotoxicity), and for chemotherapy gloves, ASTM D6978-05 (Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs) and/or ASTM F 739-07 (Standard Test Method for Permeation of Liquids and Gases through Protective Clothing Materials under Conditions of Continuous Contact).
All listed devices report that their performance "Meets ASTM Requirements" or "Meets ASTM Requirements - See Intended Use Section" for "Resistance to Permeation".
| Characteristics | Applicable Recognized Standards | Reported Device Performance |
|---|---|---|
| Dimensions | ASTM D 6319-00a | Meets ASTM Requirements |
| Physical Properties | ASTM D 6319-00a | Meets ASTM Requirements |
| Freedom from pinholes | ASTM D 6319-00a, ASTM D 5151-06 | Meets ASTM Requirements |
| Powder Free (Powder Content) | ASTM D 6319-00a, ASTM D 6124-06 | Meets ASTM Requirements |
| ISO Skin Irritation Study and Sensitization | ISO 10993, Part 10 | Meets ASTM Requirements |
| ISO Cytotoxicity Study | ISO 10993, Part 5 | Meets ASTM Requirements |
| Resistance to Permeation (for Chemotherapy Gloves only) | ASTM D 6978-05 and/or ASTM F 739-07 | Meets ASTM Requirements (and specific drug permeation data are detailed in the Intended Use sections) |
2. Sample size used for the test set and the data provenance:
The documents do not specify the exact sample sizes used for each test. The results are reported as meeting the requirements of the standards, implying that the sample sizes used for testing adhered to the specifications of the referenced ASTM and ISO standards.
The data provenance is not explicitly stated in terms of country of origin or whether it was retrospective or prospective. However, given that these are non-clinical laboratory tests performed to meet recognized international (ISO) and American (ASTM) standards, it's implied that these tests were conducted under controlled laboratory conditions.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
These are non-clinical, performance-based tests against established standards (ASTM, ISO). There is no "ground truth" established by human experts in the way it would be for a diagnostic device. The "ground truth" is defined by the objective metrics and methodologies specified within the standards themselves. Therefore, human experts are involved in conducting and interpreting these standardized tests according to the established protocols, not in establishing subjective ground truth.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
Not applicable. As noted above, these are non-clinical, objective performance tests against established standards. There is no subjective interpretation or adjudication by multiple human readers.
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 an AI-assisted diagnostic device, but a physical medical device (examination gloves). Therefore, no MRMC study or AI assistance evaluation was performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is not an algorithm-based device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The "ground truth" for these tests is the quantitative and qualitative criteria defined within the applicable ASTM and ISO standards. For example, for "Freedom from pinholes," the ground truth is whether or not a glove exhibits pinholes when tested according to ASTM D 5151-06. For "Resistance to Permeation," the ground truth is the measured breakthrough time of specific chemotherapy drugs as per ASTM D6978-05.
8. The sample size for the training set:
Not applicable. This is a physical medical device, not a machine learning model, so there is no concept of a "training set."
9. How the ground truth for the training set was established:
Not applicable. As stated above, there is no training set for this type of device.
§ 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.