(386 days)
A Nittile powder free exam glove is a disposable device, worn on the hand or finger to prevent contamination between examiner and patient. This glove has also been tested for use with Chemotherapy Drugs.
Non-sterile, Powder Free, ambidextrous, textured, beaded cuff, single use, Doffy® Nitrile Examination Glove, Tested for use with Chemotherapy Drugs
This document is a 510(k) premarket notification for a medical device: "Non-sterile, Powder Free, ambidextrous, textured, beaded cuff, single use, Doffy® Nitrile Examination Glove, Tested for use with Chemotherapy Drugs".
The main acceptance criteria for this device, beyond its primary function as an examination glove, is its resistance to permeation by various chemotherapy drugs. This is evaluated by the "Minimum Breakthrough Detection Time (minutes)" for each tested drug.
Here's the breakdown of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Chemotherapy Drug and Concentration) | Reported Device Performance (Min Breakthrough Detection Time - minutes) |
|---|---|
| Carboplatin, 10 mg/ml | >240 |
| Carmustine, 3.3 mg/ml | 15.0 |
| Cisplatin (BCNU), 1.0 mg/ml | >240 |
| Cyclophosphamide (Cytoxan), 20.0 mg/ml | >240 |
| Dacarbazine (DTIC), 10.0 mg/ml | >240 |
| Doxorubicin Hydrochloride, 2.0 m/ml | >240 |
| Etoposide (Toposar), 20.0 mg/ml | >240 |
| Fluorouracil, 5.0 mg/ml | >240 |
| Ifosfamide, 50.0 mg/ml | >240 |
| Methotrexate, 25 mg/ml | >240 |
| MitomycinC, 0.5mg/ml | >240 |
| Mitoxantrone, 2 mg/ml | >240 |
| Paclitaxel (Taxol), 6.0 mg/ml | >240 |
| ThioTEPA, 10.0 mg/ml | 30.1 |
| Vincristine Sulfate, 1.0 mg/ml | >240 |
Note: The document itself specifies a warning based on these results: "WARNING: NOT TO BE USED WITH CARMUSTINE OR THIOTEPA" due to their extremely low permeation times (15.0 minutes and 30.1 minutes respectively). While the provided table states the reported performance, the implied acceptance criteria for safe use would be a breakthrough time considered acceptable for handling (likely much higher than 15 or 30 minutes, commonly 240 minutes per ASTM D6978). The device meets the criteria by reporting its performance, allowing users to make informed decisions and the FDA to determine substantial equivalence.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not explicitly state the sample size for the test set (number of gloves tested or repetitions per drug). It also does not explicitly state the country of origin of the data or whether the study was retrospective or prospective. We only know the applicant is YTY Industry (Manjung) Sdn Bhd from Malaysia.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This device is a physical product (nitrile examination glove) and not an AI or diagnostic tool requiring expert interpretation of images or data. Therefore, the concept of "experts establishing ground truth" in the typical sense for test sets of AI models is not applicable here. The ground truth (breakthrough time) is established through standardized laboratory testing protocols (likely ASTM D6978 for chemotherapy drug permeation), not human expert consensus.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable for a physical product performance test. This concept is relevant for studies involving human interpretation or subjective assessment where consensus among multiple reviewers is needed to establish ground truth.
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 device is a physical product (glove), not an AI or assistive diagnostic technology.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a physical product (glove), not an algorithm or software.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The ground truth for the chemotherapy drug permeation is established through laboratory testing using standardized methods, likely following a standard like ASTM D6978 "Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs". This involves precise measurement of the time it takes for a detectable amount of a chemotherapy drug to pass through the glove material.
8. The sample size for the training set
Not applicable. This device is a physical product. The concept of a "training set" is relevant for machine learning models, not for traditional manufacturing and testing of physical goods.
9. How the ground truth for the training set was established
Not applicable, as there is no "training set" in the context of this 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.