(245 days)
A Patient examination glove is a disposable device intended for medical purposes that worn on the examiner's hand or finger to prevent contamination between patient and examiner. Tested for use with chemotherapy drugs as listed below.
PowderFree White Blue Sterilized Nitrile Copolymer Examination Gloves Tested for Use with Chemotherapy Drugs.
This document is an FDA 510(k) clearance letter for "PowderFree White Blue Sterilized Nitrile Copolymer Examination Gloves Tested for use with chemotherapy drugs." It outlines the device name, indications for use, and a table detailing the breakthrough detection times for various chemotherapy drugs when used with white and blue versions of these gloves.
The primary "acceptance criterion" for these gloves, beyond their general use as patient examination gloves, relates to their performance against chemotherapy drugs. The study aims to demonstrate that the gloves provide a sufficient barrier to these hazardous substances.
Here's a breakdown of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state pre-defined acceptance criteria for "Breakthrough Detection Time" in terms of what would be considered "acceptable." Instead, it presents the results of testing against these drugs. The implicit acceptance is that the gloves demonstrably offer a barrier, especially for drugs with breakthrough times greater than 240 minutes, which is often a standard benchmark for extended protection in such contexts. The warning about Carmustine and Thio-Tepa highlights drugs that do not meet a high standard of protection (implicitly, a breakthrough time significantly less than 240 minutes).
However, based on the provided data, we can infer a performance comparison:
| Chemotherapy Drugs | Implicit Acceptance Criteria (Inferred from common safety standards/other drugs' performance) | White Glove Performance (Breakthrough Detection Time in Minutes) | Blue Glove Performance (Breakthrough Detection Time in Minutes) |
|---|---|---|---|
| Carmustine (BCNU) 3.3 mg/ml | Ideally >240 min (or a clearly stated acceptable minimum for safe handling) | 7.1 min | 23.4 min |
| Cisplatin 1.0 mg/ml | Ideally >240 min | >240 min | >240 min |
| Cyclophosphamide 20mg/ml | Ideally >240 min | >240 min | >240 min |
| Dacarbazine (DTIC) 10.0 mg/ml | Ideally >240 min | >240 min | >240 min |
| Doxorubicin HCl 2.0 mg/ml | Ideally >240 min | >240 min | >240 min |
| Etoposide 20.0 mg/ml | Ideally >240 min | >240 min | >240 min |
| Fluorouracil 50.0 mg/ml | Ideally >240 min | >240 min | >240 min |
| Ifosfamide 50.0 mg/ml | Ideally >240 min | >240 min | >240 min |
| Methotrexate 25 mg/ml | Ideally >240 min | >240 min | >240 min |
| Mitomycin C 0.5 mg/ml | Ideally >240 min | >240 min | >240 min |
| Mitoxantrone 2.0 mg/ml | Ideally >240 min | >240 min | >240 min |
| Paclitaxel (Taxol) 6.0 mg/ml | Ideally >240 min | >240 min | >240 min |
| Thio-Tepa 10.0 mg/ml | Ideally >240 min (or a clearly stated acceptable minimum for safe handling) | 78.6 min | 39.3 min |
| Vincristine Sulfate 1.0 mg/ml | Ideally >240 min | >240 min | >240 min |
Note: The "Implicit Acceptance Criteria" column is an inference based on the reported ">240 min" for most drugs, and the explicit warning for those below this threshold. A formal acceptance criterion would typically be a pre-defined quantifiable value.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: The document does not specify the sample size (number of gloves or repetitions per drug) used for the permeation testing.
- Data Provenance: The document does not explicitly state the country of origin of the data or whether the study was retrospective or prospective. It is a submission by "Smart Glove Corporation Sdn. Bhd." from Malaysia, suggesting the testing likely originates from or was commissioned by this Malaysian company.
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 point is not applicable to the document. The "ground truth" here is the chemical permeation performance measured through standardized laboratory testing, not medical expert opinion or consensus.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This point is not applicable. Adjudication methods like 2+1 or 3+1 typically refer to the process of resolving discrepancies in expert interpretations of data (e.g., medical images). Here, the testing involves objective chemical analysis, not subjective human interpretation requiring adjudication.
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
This point is not applicable. An MRMC study is relevant for evaluating the impact of AI on human performance in diagnostic tasks. This document concerns the physical barrier properties of gloves against chemical permeation, which does not involve "human readers" or "AI assistance."
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This point is not applicable. "Standalone performance" refers to the performance of an algorithm without human intervention, usually in the context of AI/ML devices. This document refers to the physical testing of gloves.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth used is objective laboratory measurement of chemical permeation/breakthrough time as determined by a standardized testing method (likely ASTM F739 or similar, although not explicitly stated). This is a direct measurement of the glove's barrier integrity against specific chemotherapy drugs.
8. The sample size for the training set
This point is not applicable. There is no "training set" in the context of physical product testing like glove permeation. Training sets are relevant for machine learning models.
9. How the ground truth for the training set was established
This point is not applicable as there is no training set involved in this type of device submission.
§ 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.