(401 days)
A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. These gloves were tested for use with chemotherapy drugs as per ASTM D6978-05 (Reapproved 2013) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.
Powder Free Nitrile Patient Examination Glove, Blue Colored, Non-Sterile, Tested for Use with Chemotherapy Drugs; and Powder Free Nitrile Patient Examination Glove, White Colored, Non-Sterile, Tested for Use with Chemotherapy Drugs, is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. The gloves are made of Nitrile Butadiene Rubber, powder free, ambidextrous with beaded-cuff, blue or white colored, single-use disposable devices that come in six sizes (XS, S, M, L, XL, XXL), and supplied in Non-Sterile state. These gloves were designed and manufactured per ASTM D6319-10 standard, and tested for use with chemotherapy drugs per ASTM D6978-05 (Reapproved 2013) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.
The provided document describes the acceptance criteria and performance data for two types of Powder Free Nitrile Patient Examination Gloves (blue and white colored) tested for use with chemotherapy drugs.
Here's the breakdown of the information requested:
1. A table of acceptance criteria and the reported device performance
The acceptance criteria are established by various ASTM standards. The reported device performance is presented as a "Results Summary" or direct values.
| Characteristic | Standard Requirements | Reported Device Performance (Summary / Blue Glove) | Reported Device Performance (Summary / White Glove) |
|---|---|---|---|
| Dimensions | ASTM D6319-10: Length ≥ 230mm, Palm Thickness ≥ 0.05mm, Finger Thickness ≥ 0.05mm, Widths for XS-XXL | Meets Standard Requirements (Specific ranges for Length, Palm/Finger Thickness, and Width are provided in the source for each size, all falling within or exceeding the standard requirements) | Meets Standard Requirements (Specific ranges for Length, Palm/Finger Thickness, and Width are provided in the source for each size, all falling within or exceeding the standard requirements) |
| Physical Properties | ASTM D6319-10: Before Aging: Tensile Strength ≥ 14 MPA, Elongation ≥ 500%; After Aging: Tensile Strength ≥ 14 MPA, Elongation ≥ 400% | Meets Standard Requirements (Table states values met) | Meets Standard Requirements (Table states values met) |
| Freedom from Pinholes | ASTM D5151-11, ASTM D6319-10: Pass quality level at G1 AQL 1.5 | Tested in accordance with ASTM D5151 test method. Pass quality level at G1 AQL 1.5. | Tested in accordance with ASTM D5151 test method. Pass quality level at G1 AQL 1.5. |
| Powder Free Residue | ASTM D6124-11, ASTM D6319-10: ≤ 2 mg of residual powder per glove | Result generated values ≤ 2 mg of residual powder per glove. | Result generated values ≤ 2 mg of residual powder per glove. |
| Biocompatibility | Dermal Sensitization (ISO 10993-10:2010), Primary Skin Irritation Test (ISO 10993-10:2010) | Magnusson & Kligman Scale is '0' (not a sensitizer). Primary Irritation Index for Erythema and Edema is '0' (not an irritant). | Magnusson & Kligman Scale is '0' (not a sensitizer). Primary Irritation Index for Erythema and Edema is '0' (not an irritant). |
| Chemotherapy Drugs Permeation Test (ASTM D6978-05) | No explicit general "acceptance criteria" is listed beyond the standard itself. Performance is measured by Minimum Breakthrough Detection Time. | Carmustine (BCNU) (3.3 mg/ml): 10.1 min | |
| Cisplatin (1.0 mg/ml): >240 min | |||
| Cyclophosphamide (Cytoxan) (20.0 mg/ml): >240 min | |||
| Cytarabine (100 mg/ml): >240 min | |||
| Dacarbazine (DTIC) (10.0 mg/ml): >240 min | |||
| Doxorubicin Hydrochloride (2.0 mg/ml): >240 min | |||
| Etoposide (20.0 mg/ml): >240 min | |||
| Fluorouracil (50.0 mg/ml): >240 min | |||
| Ifosfamide (50.0 mg/ml): >240 min | |||
| Methotrexate (25.0 mg/ml): >240 min | |||
| Mitomycin C (0.5 mg/ml): >240 min | |||
| Mitoxantrone (2.0 mg/ml): >240 min | |||
| Paclitaxel (Taxol) (6.0 mg/ml): >240 min | |||
| Thiotepa (10.0 mg/ml): 30.2 min | |||
| Vincristine Sulfate (1.0 mg/ml): >240 min | Carmustine (BCNU) (3.3 mg/ml): 10.1 min | ||
| Cisplatin (1.0 mg/ml): >240 min | |||
| Cyclophosphamide (Cytoxan) (20.0 mg/ml): >240 min | |||
| Cytarabine (100 mg/ml): >240 min | |||
| Dacarbazine (DTIC) (1.0 mg/ml): >240 min | |||
| Doxorubicin Hydrochloride (2.0 mg/ml): >240 min | |||
| Etoposide (20.0 mg/ml): >240 min | |||
| Fluorouracil (50.0 mg/ml): >240 min | |||
| Ifosfamide (50.0 mg/ml): >240 min | |||
| Methotrexate (25.0 mg/ml): >240 min | |||
| Mitomycin C (0.5 mg/ml): >240 min | |||
| Mitoxantrone (2.0 mg/ml): >240 min | |||
| Paclitaxel (Taxol) (6.0 mg/ml): >240 min | |||
| Thiotepa (10.0 mg/ml): 10.4 min | |||
| Vincristine Sulfate (1.0 mg/ml): >240 min |
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 extensively refers to testing according to specific ASTM and ISO standards for various characteristics. While these standards implicitly define sample sizes and testing methodologies, the exact sample sizes used for each specific test (e.g., number of gloves for pinhole test, number of samples for chemotherapy drug permeation) are not explicitly stated in the provided text.
- Data Provenance: The manufacturer is Kossan International Sdn. Bhd., located in Malaysia. It is highly probable the testing and data originate from Malaysia or laboratories contracted by the Malaysian manufacturer. The data appears to be prospective as it involves the performance testing of new devices against established standards prior to market approval.
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 question is not applicable to this type of device and study. The "ground truth" here is not established by human experts interpreting data. Instead, it is defined by objective, quantifiable physical and chemical properties measured according to standardized methods (ASTM, ISO). For example, the breakthrough time for chemotherapy drugs is a direct measurement, not an expert assessment.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This question is not applicable. Adjudication methods like 2+1 or 3+1 typically refer to expert consensus processes for ambiguous cases in diagnostic studies. The performance testing for these gloves relies on direct, objective measurements against pre-defined physical and chemical standards, not on subjective interpretations 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 question is not applicable. This document describes the performance of a patient examination glove, a physical medical device. It does not involve any imaging, diagnostic algorithms, or human reader interpretation, nor does it concern AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This question is not applicable. As stated above, this is a physical medical device (gloves) and does not involve an algorithm or AI.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" in this context refers to the objective performance metrics and thresholds established by recognized national and international standards. For example:
- ASTM D6319-10 (Standard Specification for Nitrile Examination Gloves for Medical Application)
- ASTM D5151-11 (Standard Test Method for Detection of Holes in Medical Gloves)
- ASTM D6124-11 (Standard Test Method for Residual Powder on Medical Gloves)
- ASTM D6978-05 (Reapproved 2013) (Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs)
- ISO 10993-10:2010 (Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization)
The "ground truth" is therefore based on standardized test methods and predetermined quantitative criteria.
8. The sample size for the training set
This question is not applicable. This device is a physical product and does not involve AI/ML models that require a "training set." The testing described evaluates the manufactured product's inherent physical and chemical properties.
9. How the ground truth for the training set was established
This question is not applicable for the same reasons as #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.