(362 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.
Powder Free Blue Nitrite Examination Gloves- Tested for Use with Chemotherapy Drugs.
This document describes the FDA's 510(k) clearance for "Powder Free Blue Nitrile Examination Gloves - Tested for Use with Chemotherapy Drugs" (K182089). The primary focus of the performance data in this document relates to the gloves' resistance to permeation by chemotherapy drugs.
Here's an analysis based on your request, using the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
The "acceptance criteria" for gloves used with chemotherapy drugs are typically defined by regulatory bodies or consensus standards (like ASTM D6978, which is often referenced for chemotherapy glove testing) as a minimum breakthrough time. While explicit "acceptance criteria" values are not stated in this document as a separate column, the reported device performance clearly indicates whether the gloves meet the implied standard of extended protection (often >240 minutes for many drugs).
| Chemotherapy Drug | Concentration | Acceptance Criteria (Implied by standard practice, e.g., ASTM D6978) | Reported Device Performance (Breakthrough Detection Time) | Meets Implied Criteria? |
|---|---|---|---|---|
| Carmustine (BCNU) | 3.3 mg/ml | Typically >240 min desired | 9.0 min | No (specifically cautioned against) |
| Cisplatin | 1.0 mg/ml | Typically >240 min desired | >240 min | Yes |
| Cyclophosphamide (Cytoxan) | 20mg/ml | Typically >240 min desired | >240 min | Yes |
| Dacarbazine (DTIC) | 10.0 mg/ml | Typically >240 min desired | >240 min | Yes |
| Doxorubicin Hydrochloride | 2.0mg/ml | Typically >240 min desired | >240 min | Yes |
| Etoposide (Toposar) | 20.0 mg/ml | Typically >240 min desired | >240 min | Yes |
| Fluorouracil | 50.0 mg/ml | Typically >240 min desired | >240 min | Yes |
| Ifosfamide | 50.0 mg/ml | Typically >240 min desired | >240 min | Yes |
| Methotrexate | 25 mg/ml | Typically >240 min desired | >240 min | Yes |
| Mitomycin C | 0.5 mg/ml | Typically >240 min desired | >240 min | Yes |
| Mitoxantrone | 2.0 mg/ml | Typically >240 min desired | >240 min | Yes |
| Paclitaxel (Taxol) | 6.0 mg/ml | Typically >240 min desired | >240 min | Yes |
| Thio-Tepa | 10.0 mg/ml | Typically >240 min desired | 16.2 min | No (specifically cautioned against) |
| Vincristine Sulfate | 1.0 mg/ml | Typically >240 min desired | >240 min | Yes |
Note: The document explicitly states: "Please Note that Carmustine and Thio-Tepa have low permeation time of less than 240 minutes. Do not use with Carmustine and Thio-Tepa." This indicates that for these two drugs, the gloves did not meet the standard expectation for chemotherapy glove use, and this limitation is clearly communicated.
The subsequent questions (2-9) are primarily relevant to clinical studies involving AI or diagnostics that interpret medical data. This document describes the clearance of a medical device (gloves) based on laboratory testing for chemical permeation, not a clinical study involving human patients, expert readers, or AI algorithms. Therefore, most of these questions are not applicable to the provided information.
However, I will address those that can be inferred or directly commented on:
2. Sample size used for the test set and the data provenance:
- Sample Size for Test Set: Not explicitly stated in terms of number of gloves tested, but it would involve multiple samples of the glove material subjected to permeation testing according to a standard like ASTM D6978. For each chemotherapy drug listed, a sample of the glove material would be exposed, and the time until breakthrough is detected would be measured.
- Data Provenance: The document implies laboratory testing conducted by the manufacturer or a certified lab. The country of origin of the data is not specified beyond the manufacturer being "Platinum Glove Industries Sdn Bhd" from "Malaysia." This is retrospective testing of the glove material properties.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. This is not a study involving human interpretation of medical data where "ground truth" is established by experts. The "ground truth" in this context is the physical property of the glove's resistance to chemical permeation, measured by laboratory instrumentation and protocols (e.g., using a permeation cell and analytical detection methods).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Applicable. See point 3.
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 a clinical or AI-based diagnostic study.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not Applicable. This is not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- The "ground truth" in this context is the measured chemical permeation time of specific chemotherapy drugs through the glove material, determined through standardized laboratory testing (e.g., in accordance with ASTM D6978 or an equivalent standard).
8. The sample size for the training set:
- Not Applicable. This is not an AI or machine learning study, so there is no "training set."
9. How the ground truth for the training set was established:
- Not Applicable. See point 8.
§ 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.