(98 days)
The Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs (White); Dark Violet Blue (DVBU); Dark Blue (DKBU) is a non - sterile disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner. It is also tested to be used against Chemotherapy Drugs. The list of Chemotherapy Drugs (tested with breakthrough times) is as per below table.
Nitrile Powder Free Examination Gloves Tested For Use With Chemotherapy Drugs (White); Dark Violet Blue (DVBU); Dark Blue (DKBU)
This document describes the Surgical Gloves produced by Hartalega Sdn. Bhd. and their testing against chemotherapy drugs. The information provided exclusively focuses on the performance of the gloves when exposed to various chemotherapy drugs, specifically their "breakthrough times," which is the time it takes for a chemotherapy drug to penetrate the glove material.
I. Acceptance Criteria and Reported Device Performance
The acceptance criteria for each glove type would implicitly be a resistance (breakthrough time) to specific chemotherapy agents. There is no explicit "acceptance criteria" stated as a minimum breakthrough time for all drugs in the general sense; rather, the measured breakthrough times are reported for each drug. The "acceptance" is that the gloves have been tested for use with these drugs and the breakthrough times are provided for the user to determine suitability.
Here's a combined table of the reported device performance for each glove type:
Table 1: Acceptance Criteria (Breakthrough Time) for Nitrile Powder Free Examination Gloves Tested with Chemotherapy Drugs
| Chemotherapy Drug (Concentration) | White Gloves Reported Performance (Breakthrough Time) | Dark Violet Blue Gloves Reported Performance (Breakthrough Time) | Dark Blue Gloves Reported Performance (Breakthrough Time) |
|---|---|---|---|
| Carmustine (BCNU) (3.3 mg/ml) | 15.1 minutes | 15.1 minutes | 1.7 minutes |
| Cisplatin (1.0 mg/ml) | > 240 minutes | > 240 minutes | > 240 minutes |
| Cyclophosphamide (Cytoxan) (20 mg/ml) | > 240 minutes | > 240 minutes | > 240 minutes |
| Dacarbazine (DTIC) (10.0 mg/ml) | > 240 minutes | > 240 minutes | > 240 minutes |
| Doxorubicin Hydrochloride (2.0 mg/ml) | > 240 minutes | > 240 minutes | > 240 minutes |
| Etoposide (Toposar) (20.0 mg/ml) | > 240 minutes | > 240 minutes | > 240 minutes |
| Fluorouracil (50.0 mg/ml) | > 240 minutes | > 240 minutes | > 240 minutes |
| Methotrexate (25 mg/ml) | > 240 minutes | > 240 minutes | > 240 minutes |
| Mitomycin C (0.5 mg/ml) | > 240 minutes | > 240 minutes | > 240 minutes |
| Paclitaxel (Taxol) (6.0 mg/ml) | > 240 minutes | > 240 minutes | > 240 minutes |
| Thiotepa (10.0 mg/ml) | 15.4 minutes | 46.4 minutes | 10.8 minutes |
| Vincristine Sulfate (1.0 mg/ml) | > 240 minutes | > 240 minutes | > 240 minutes |
Note: The manufacturer highlights specific drugs with "extremely low permeation times":
- White Gloves: Carmustine (15.1 min), Thiotepa (15.4 min)
- Dark Violet Blue Gloves: Carmustine (15.1 min), Thiotepa (46.4 min)
- Dark Blue Gloves: Carmustine (1.7 min), Thiotepa (10.8 min)
II. Sample Sized used for the test set and the data provenance
The document does not specify the sample size used for the test set (number of gloves or repetitions of each test).
The data provenance (e.g., country of origin, retrospective or prospective) is not explicitly stated in the provided text. However, the manufacturer is Hartalega Sdn. Bhd. which is a Malaysian company. The testing procedures would typically follow recognized international standards for protective equipment, though the specific standard is not listed here.
III. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This section is not applicable to this type of device testing. The "ground truth" for glove performance against chemotherapy drugs is established through laboratory testing according to standardized protocols (e.g., ASTM F739 - Standard Test Method for Permeation of Liquids and Gases through Protective Clothing Materials under Conditions of Continuous Contact). It does not involve human expert consensus or clinical evaluation in the same way an AI diagnostic device would.
IV. Adjudication method for the test set
This section is not applicable. As stated above, the "ground truth" is determined by objective laboratory measurements of chemical permeation, not by human interpretation or adjudication.
V. 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 section is not applicable. This document describes physical product performance testing (gloves resisting chemical permeation), not an AI diagnostic or assistance system. Therefore, no MRMC study, human readers, or AI assistance is involved.
VI. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This section is not applicable. This document describes physical product performance testing, not an algorithm or AI system.
VII. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for this device is based on objective laboratory measurements of breakthrough time, which quantifies the time it takes for specific chemotherapy drugs to permeate the glove material. This is a direct physical measurement.
VIII. The sample size for the training set
This section is not applicable. There is no "training set" as this is not an AI/ML or modeling application. The product performance is determined by physical testing.
IX. How the ground truth for the training set was established
This section is not applicable for the same reason as VIII. No training set or ground truth for a training set is established for physical performance testing of medical gloves.
§ 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.