(30 days)
The glove is disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner. In addition, gloves were tested for use with Chemotherapy drugs and Fentanyl citrate in accordance with ASTM D6978.
Powder Free Nitrile Examination Gloves (Blue, Purple-Blue), Tested for Use with Chemotherapy Drugs and Fentanyl Citrate Are Class I Patient Examination Gloves and Specialty Chemotherapy Gloves. They are ambidextrous and come in different sizes-Extra Small, Small, Medium, Large, Extra Large and XXL. Gloves meet the specification of ASTM D6319-19 and have been tested for resistance to permeation by chemotherapy drugs and fentanyl citrate as per ASTM D6978-05(2019).
The provided document describes the acceptance criteria and results of non-clinical testing for "Powder Free Nitrile Examination Gloves (Blue, Purple-Blue), Tested For Use With Chemotherapy Drugs and Fentanyl Citrate" (K240072). This is a physical medical device (gloves), not an AI/ML powered device. Therefore, questions related to AI/ML specific criteria (such as effect size of human readers with AI assistance, sample size for training sets, number of experts for ground truth, adjudication methods) are not applicable.
Here's the relevant information from the document:
1. A table of acceptance criteria and the reported device performance
| Referenced Standards | Test Performed/Purpose | Acceptance Criteria | Reported Device Performance (Results) |
|---|---|---|---|
| ASTM D6319-19 | Physical Dimensions Length | Minimum 220mm for size XS and S, 230mm for size M, L, XL, XXL | Pass |
| ASTM D6319-19 | Physical Dimensions Palm Width | XS: 70±10mm, S: 80±10mm, M: 95±10mm, L:110±10mm, XL: 120±10mm, XXL: 130±10mm | Pass |
| ASTM D6319-19 | Physical Dimensions Thickness | Finger: 0.05mm (min), Palm: 0.05mm (min) | Pass |
| ASTM D6319-19, ASTM D412-16 (2021) | Physical Properties | Tensile Strength (Min 14 MPa), Elongation (Before Aging 500% and after aging 400% min) | Pass |
| ASTM D6319-19, ASTM D5151-19 | Freedom from holes | G-I, AQL 2.5 | Pass |
| ASTM D6319-19, ASTM D6124-06 (2017) | Powder Residue | Max 2mg/glove | Pass |
| ASTM D6978-05 (2019) | Chemotherapy Drugs, Opioid Drug Permeation | Refer the tables for specific Minimum BDT (Breakthrough Detection Time) for each drug (e.g., >240 minutes for most, with specific lower times for Carmustine and Thiotepa) | Pass (Specific BDTs are listed in the document for each drug) |
| ISO 10993-10:2010 | Irritation and Skin Sensitization | No Skin sensitization and Skin irritation | Is non-sensitization and Non-irritation |
| ISO 10993-5:2009 | Cytotoxicity Test | Under the conditions of this study, no cytotoxic potential | Under the conditions of this study, the test article extract showed potential toxicity |
| ISO 10993-11:2017 | Acute systemic toxicity study | Subject showed no adverse biological reaction | Under the conditions of this study, there was no evidence of acute systemic toxicity. |
Breakthrough Detection Time (BDT) for Chemotherapy Drugs and Fentanyl Citrate:
Please refer to the tables provided in pages 3, 4, 7, and 8 of the document for the detailed BDT for each specific chemotherapy drug and Fentanyl Citrate for both Blue and Purple-Blue gloves. The general acceptance criterion implied is that the gloves provide a certain level of protection (BDT), and the performance reports these measured BDTs. Notably, for Carmustine and Thiotepa, the BDTs are explicitly called out as "extremely low permeation times" with a warning not to use them with these drugs.
2. Sample sized 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 sizes for each specific non-clinical test (e.g., number of gloves tested for physical dimensions, chemotherapy permeation, etc.). However, these tests are generally conducted by manufacturers according to standardized protocols (e.g., ASTM standards) which define the required sample sizes for each test. The provenance specific to the data (e.g., country of origin, retrospective/prospective) is not detailed for these non-clinical bench tests. These are laboratory tests on the product itself.
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)
Not applicable. This is a physical device submission (nitrile examination gloves) and not an AI/ML-powered device that would require expert-established ground truth from medical imaging or similar data. The acceptance criteria are based on defined physical and chemical properties measured through standardized bench tests.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. Adjudication methods are typically associated with human review of data, especially in clinical or AI/ML studies, to establish ground truth. This document pertains to non-clinical bench testing of a physical product.
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/ML device, and no MRMC study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is not an AI/ML device.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
The "ground truth" for this device is established through performance against recognized industry standards (e.g., ASTM D6319-19, ASTM D6978-05 (2019), ISO 10993 series). These standards define objective, measurable physical, chemical, and biological properties of the gloves. For example, breakthrough detection time for chemotherapy drugs is a direct measurement based on established laboratory procedures.
8. The sample size for the training set
Not applicable. This is a physical device; there is no "training set" in the context of AI/ML.
9. How the ground truth for the training set was established
Not applicable. There is no training set for this physical 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.