(83 days)
Powder-Free Frost Nitrile Examination Gloves (Blue) (Tested for use with Chemotherapy Drugs and Fentany) Citrate) is a disposable device intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner.
In addition, these gloves were tested for use with Chemotherapy drugs and Fentanyl Citrate in accordance with ASTM D6978-05 Standard Practice for Assessment of Medical Gloves to permeation by Chemotherapy Drugs.
Powder-Free Frost Nitrile Examination Gloves (Blue) (Tested for use with Chemotherapy Drugs and Fentanyl Citrate) is a Powder Free Nitrile Examination Glove. The subject device is a patient examination glove manufactured 100% nitrile-Butadiene Copolymer dispersion), Per 21 CFR 880.6250, Product codes LZA, LZC, OPJ, QDO and Class 1, Blue Color, Powder Free and Non-Sterile. The device meets the specifications in ASTM D6319-19. Standard specifications for Nitrile Examination Gloves. The glove sizes provided are Small, Medium, Large, and X-Large. The gloves design features include ambidextrous and textured fingers. The subject device complies with requirements for standard practice for assessment of resistance of medical glove to permeation by chemotherapy drugs as per ASTM D6978-05 (2019).
It appears there's a misunderstanding regarding the provided document. The request asks for details about the acceptance criteria and study proving a device meets these criteria, specifically in the context of an AI/ML medical device.
However, the provided text is an FDA 510(k) clearance letter and related documentation for Powder-Free Frost Nitrile Examination Gloves. This document focuses on demonstrating substantial equivalence to a predicate device, primarily through physical and chemical performance tests, and biocompatibility, as applicable to examination gloves.
This document does NOT describe an AI/ML medical device. Therefore, the questions related to AI/ML specific aspects (e.g., sample size for test set, number of experts, MRMC studies, ground truth establishment, training set size) are not applicable to the content provided.
Instead, the document details the acceptance criteria and study results for the nitrile examination gloves. Here's a breakdown based on the provided text, focusing on the relevant criteria for gloves:
Acceptance Criteria and Reported Device Performance (Non-AI Device)
| Acceptance Criteria (for Nitrile Examination Gloves) | Reported Device Performance |
|---|---|
| Physical Dimensions | |
| Length: Min 220 mm (Small), Min 230 mm (others) | Met Standard |
| Width: S: 80+/-10 mm, M: 95+/-10 mm, L: 110+/-10 mm, XL: 115+/-10 mm | Met Standard |
| Palm Thickness: 0.05 mm min (all sizes) | Met Standard |
| Finger Thickness: 0.05 mm min (all sizes) | Met Standard |
| Physical Properties (ASTM D412) | |
| Tensile Strength (Before Aging): 14 MPa, min | $\ge$ 14 MPa (Reported 19.0 min MPa) |
| Ultimate Elongation (Before Aging): 500 % min | 500% (Reported 610 min %) |
| Tensile Strength (After Aging): 14 MPa, min | $\ge$ 14 MPa (Reported 22.6 min MPa) |
| Ultimate Elongation (After Aging): 400 % min | 400% (Reported 486 min %) |
| Integrity | |
| Detection of Holes (ASTM D5151-2019): AQL 2.5 | Meets requirement (AQL = 2.5) |
| Residual Powder (ASTM D6124-06): $\le$ 2.0 mg/glove | 0.54 mg/Glove |
| Chemotherapy Drug Permeation (ASTM D6978-05) | |
| Carmustine (3.3 mg/ml): Breakthrough Detection Time | 16.2 min (Note: Lower than predicate, addressed by labeling warning) |
| Cisplatin (1 mg/ml): Breakthrough Detection Time | >240 min. |
| Cyclophosphamide (20 mg/ml): Breakthrough Detection Time | >240 min. |
| Dacarbazine (10 mg/ml): Breakthrough Detection Time | >240 min. |
| Doxorubicin HCL (2 mg/ml): Breakthrough Detection Time | >240 min. |
| Etoposide (20 mg/ml): Breakthrough Detection Time | >240 min. |
| Fluorouracil (50 mg/ml): Breakthrough Detection Time | >240 min. |
| Mitomycin C (0.5 mg/ml): Breakthrough Detection Time | >240 min. |
| Paclitaxel (60 mg/ml): Breakthrough Detection Time | >240 min. |
| Thiotepa (10 mg/ml): Breakthrough Detection Time | 40.6 min (Note: Lower than predicate, addressed by labeling warning) |
| Vincristine Sulfate (1 mg/ml): Breakthrough Detection Time | >240 min. |
| Fentanyl/Citrate Injection (100mcg/2mL): Breakthrough Detection Time | >240 min. |
| Biocompatibility | |
| Skin Sensitization (ISO 10993-10:2010) | Pass (Non-Sensitizer) |
| Intracutaneous Reactivity (ISO 10993-23:2021) | Pass (Non-Irritant) |
| In vitro Cytotoxicity (ISO 10993-5:2009) | Considered Cytotoxic (Note: This is an observation, not necessarily a failure from a regulatory standpoint if mitigated or typical for the material) |
| Acute Systemic Toxicity (ISO 10993-11:2017) | Pass |
Study Details (for Nitrile Examination Gloves - as provided by the document):
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Sample sizes used for the test set and the data provenance: The document does not explicitly state the sample sizes for each specific test (e.g., how many gloves were tested for length, how many for elongation, etc.), nor does it specify the country of origin of the data. The tests are bench tests performed on the product itself. The data provenance is implied to be laboratory testing conducted to support the 510(k) submission. It's retrospective in the sense that the tests were completed before the submission.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This is not applicable. For physical and chemical tests of medical examination gloves, "ground truth" is established by the standardized test methods themselves (e.g., ASTM standards) and objective measurements by trained laboratory personnel, not by human expert interpretation in the way it would be for an AI device.
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Adjudication method for the test set: Not applicable. Results are objective measurements against defined standards.
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If a multi reader multi case (MRMC) comparative effectiveness study was done: Not applicable. This type of study is for evaluating human reader performance, typically in diagnostic imaging, with and without AI assistance. The submitted device is a physical product (gloves).
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is not an algorithm/AI device. The "standalone" performance here refers to the glove's inherent physical and chemical properties as tested against standards.
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The type of ground truth used:
- For physical and performance characteristics (length, width, thickness, tensile strength, elongation, hole detection, residual powder), the ground truth is established by objective measurements and performance against predefined industry standards (e.g., ASTM D6319-19, ASTM D412, ASTM D5151, ASTM D6124).
- For chemotherapy drug permeation, the ground truth is the measured breakthrough time according to ASTM D6978-05.
- For biocompatibility, the ground truth is determined by standardized biological assays (e.g., ISO 10993 series) with specified endpoints (e.g., non-sensitizer, non-irritant, non-cytotoxic, no systemic toxicity concern).
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The sample size for the training set: Not applicable. This device is not an AI/ML model, so there is no "training set."
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How the ground truth for the training set was established: Not applicable.
§ 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.