(87 days)
A 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. These gloves were tested for use with Chemotherapy Drugs and Fentanyl Citrate as per ASTM D6978-05 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.
Dual Color Nitrile Examination Gloves, Powder Free, Non-Sterile, Tested For Use With Chemotherapy Drugs And Fentanyl meets all requirements of ASTM standard D6319-19. The powder free examination glove is manufactured from synthetic rubber nitrile. Inner surface of gloves undergoes surface treatment process to produce a smooth surface that assists the user in donning the gloves with ease without using any lubricant such as powder on the glove surface. The glove is ambidextrous, i.e. can be worn on right hand or left hand. The physical properties of glove i.e. tensile strength meet ASTM standard D6319. Device is intended for single use and nonsterile. The powder free examination glove, non-sterile is supplied in the following sizes: S, M, L, XL and XXL. This glove is green (inner) and white (outer) in color and powder free.
The provided text describes the acceptance criteria and performance of "Dual Color Nitrile Examination Gloves, Powder Free, Non-Sterile, Tested For Use With Chemotherapy Drugs And Fentanyl". This is a medical device, specifically examination gloves, and therefore the "study" concerns non-clinical performance testing rather than studies involving human participants or AI algorithms.
Here's a breakdown of the requested information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance:
| Test Method | Standard | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Physical Properties | |||
| Tensile Strength (Before aging) | ASTM D412 | Min 14.0 MPa | Pass |
| Ultimate Elongation (Before aging) | ASTM D412 | Min 500% | Pass |
| Tensile Strength (After aging) | ASTM D412 | Min 14.0 MPa | Pass |
| Ultimate Elongation (After aging) | ASTM D412 | Min 400% | Pass |
| Dimension | |||
| Length (Small) | ASTM D3767 | Min 220 mm | Pass |
| Length (Medium) | ASTM D3767 | Min 230 mm | Pass |
| Length (Large) | ASTM D3767 | Min 230 mm | Pass |
| Length (Extra Large) | ASTM D3767 | Min 230 mm | Pass |
| Length (Double Extra Large) | ASTM D3767 | Min 230 mm | Pass |
| Width (Small) | ASTM D3767 | 80 ± 10 mm | Pass |
| Width (Medium) | ASTM D3767 | 95 ± 10 mm | Pass |
| Width (Large) | ASTM D3767 | 110 ± 10 mm | Pass |
| Width (Extra Large) | ASTM D3767 | 120 ± 10 mm | Pass |
| Width (Double Extra Large) | ASTM D3767 | 130 ± 10 mm | Pass |
| Thickness (Finger) | ASTM D3767 | Min 0.05 mm | Pass |
| Thickness (Palm) | ASTM D3767 | Min 0.05 mm | Pass |
| Watertight | |||
| Hole Detection (All sizes listed) | ASTM D5151 | AQL: 1.5 | Found 0 (Pass) for all sizes |
| Residual Powder | ASTM D6124 | Less than 2.0 mg per glove | Pass |
| Biocompatibility | |||
| Primary Skin Irritation | ISO 10993-10 (E) | Not an irritant | Pass |
| Dermal Sensitization | ISO 10993-10 (E) | Not a sensitizer | Pass |
| Acute Systemic Toxicity | ISO 10993-11 (E) | No acute systemic toxicity | Pass |
| Chemotherapy Drug Permeation | ASTM D6978-05 | ||
| Carmustine (BCNU) (3.3 mg/ml) | Minimum breakthrough time >240 min (general criteria listed) | 44.5 min (explicitly stated in the table, with warning that it is low) | |
| Cisplatin (1.0 mg/ml) | Minimum breakthrough time >240 min | >240 min | |
| Cyclophosphamide (20.0 mg/ml) | Minimum breakthrough time >240 min | >240 min | |
| Dacarbazine (10.0 mg/ml) | Minimum breakthrough time >240 min | >240 min | |
| Doxorubicin HCl (2.0 mg/ml) | Minimum breakthrough time >240 min | >240 min | |
| Etoposide (20.0 mg/ml) | Minimum breakthrough time >240 min | >240 min | |
| Fluorouracil (50.0 mg/ml) | Minimum breakthrough time >240 min | >240 min | |
| Ifosfamide (50.0 mg/ml) | Minimum breakthrough time >240 min | >240 min | |
| Methotrexate (25.0 mg/ml) | Minimum breakthrough time >240 min | >240 min | |
| Mitoxantrone HCl (2.0 mg/ml) | Minimum breakthrough time >240 min | >240 min | |
| Paclitaxel (6.0 mg/ml) | Minimum breakthrough time >240 min | >240 min | |
| ThioTepa (10.0 mg/ml) | Minimum breakthrough time >240 min (general criteria listed) | 79.1 min (explicitly stated in the table, with warning that it is low) | |
| Vincristine Sulfate (1.0 mg/ml) | Minimum breakthrough time >240 min | >240 min | |
| Fentanyl Citrate (50 mcg/ml) | Minimum breakthrough time >240 min | >240 min | |
| Shelf Life | ASTM D7160 | 3 years (based on accelerated aging) | Established 3 years |
2. Sample size used for the test set and the data provenance:
- For Watertightness (ASTM D5151):
- Small: 200 pcs
- Medium: 315 pcs
- Large: 315 pcs
- Extra Large: 315 pcs
- Double Extra Large: 200 pcs
- For other tests (Physical Properties, Dimension, Residual Powder, Biocompatibility, Chemotherapy Drug and Fentanyl Citrate Permeation): The specific sample sizes are not explicitly stated in the provided text. However, for these types of non-clinical tests, samples are typically drawn from manufacturing lots according to the requirements of the respective ASTM or ISO standards.
- Data Provenance: The document does not specify the country of origin of the data or whether the tests were retrospective or prospective. It is a report of completed non-clinical performance and safety testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not applicable. The document describes the performance of a physical medical device (gloves) through standardized non-clinical laboratory testing (e.g., tensile strength, chemical permeation) to establish its physical and chemical properties and safety. There is no "ground truth" to be established by human experts in the context of diagnostic performance or clinical outcomes for this type of device.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This information is not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies, particularly for diagnostic devices or AI algorithms, to resolve discrepancies in human expert interpretations or to establish a consensus ground truth. This document pertains to non-clinical laboratory testing of a tangible product.
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 is not applicable. The device is a physical examination glove, not an AI-powered diagnostic tool. Therefore, no MRMC comparative effectiveness study was done, and there is no AI assistance involved.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This is not applicable. The device is a physical examination glove, not an algorithm, so there is no standalone algorithm performance to evaluate.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The "ground truth" for this device's performance is established by the accepted methodologies and metrics defined in the referenced ASTM and ISO standards for physical, chemical, and biocompatibility testing. For example:
- Physical properties (tensile strength, elongation) are measured objectively using a Tensile Testing Machine.
- Dimension (length, width, thickness) is measured using appropriate measurement tools.
- Watertightness is determined objectively by inspecting for holes after filling with water.
- Chemical permeation is physically measured based on the detection time of breakthrough.
- Biocompatibility is assessed through standardized in-vitro or in-vivo (animal) tests specified by ISO 10993 standards.
There is no "expert consensus," "pathology," or "outcomes data" ground truth in the traditional sense of a diagnostic or therapeutic device for this type of product.
8. The sample size for the training set:
This is not applicable. The device is a physical product, not a machine learning model, so there is no training set.
9. How the ground truth for the training set was established:
This is not applicable as there is no training set for a physical product.
§ 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.