Search Results

A powder free nitrile examination glove is a disposable device intended for medical purposes that is worn on the examiner's hands and finger to prevent contamination between patient and examiner. In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTMD6978-05 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs:

These patient examination gloves are formulated using nitrile, non-sterile, powder free, meet all the requirements of ASTM D6319 and tested for use with chemotherapy drugs.

The provided text describes the acceptance criteria and performance of "Non-Sterile Powder Free Blue Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs." This is a medical device, and the data presented relates to its physical and chemical properties, not an AI/ML powered device. Therefore, many of the requested fields are not applicable.

Here's the information extracted from the document based on the prompt:

1. A table of acceptance criteria and the reported device performance

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 tests conducted to determine the breakthrough detection times or other physical properties. It generally refers to conducting tests "in accordance with ASTMD6978-05 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs," and other ASTM and ISO standards. These standards typically specify sample sizes for their respective tests. The provenance of the data is implied to be from the manufacturer's testing (Maxter Glove Manufacturing Sdn Bhd) in Malaysia, as they are the submitter of the 510(k). The tests are prospective in nature, as they are performed to demonstrate compliance with standards for the device being submitted.

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 (gloves) and the "ground truth" is established through standardized laboratory testing against chemical permeation and physical properties, not through expert consensus on medical images or diagnoses.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. This is a physical device.

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 a physical device, not an AI/ML powered medical device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is a physical device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for this device is based on objective measurements conducted according to established international and national standards (e.g., ASTM D6319-10, ASTM D5151, ASTM D6124, ASTM D6978-05, ISO 10993). This involves laboratory measurements for physical dimensions, tensile strength, elongation, freedom from holes, powder residue levels, breakthrough time for chemotherapy drugs, and biocompatibility endpoints (irritation, sensitization, cytotoxicity).

8. The sample size for the training set

Not applicable. This is a physical device, not an AI/ML-powered device that requires a training set.

9. How the ground truth for the training set was established

Not applicable. This is a physical device.

Ask a specific question about this device