(30 days)
This device is an ambidextrous patient examination glove that is a non-sterile, single use, disposable device intended for medical purposes, worn on the examiner's hand or finger to prevent contamination between patient and examiner. The tested chemotherapy drugs are: Carmustine (BCNU) (3.3 mg/ml). Permeation time: Carmustine (BCNU) has extremely low permeation times of 14.7 minutes. Cisplatin (1.0 mg/ml). Permeation time: no breakthrough up to 240 minutes Cyclophosphamide (Cytoxan) (20.0 mg/ml). Permeation time: no breakthrough up to 240 minutes Cytarabine (100 mg/ml). Permeation time: no breakthrough up to 240 minutes Dacarbazine (DTIC) (10.0 mg/ml). Permeation time: no breakthrough up to 240 minutes Doxorubicin Hydrochloride (2.0 mg/ml). Permeation time: no breakthrough up to 240 minutes Etoposide (20.0 mg/ml). Permeation time: no breakthrough up to 240 minutes Fluorouracil (50.0 mg/ml). Permeation time: no breakthrough up to 240 minutes lfosfamide (50.0 mg/ml). Permeation time: no breakthrough up to 240 minutes Methotrexate (25.0 mg/ml). Permeation time: no breakthrough up to 240 minutes Mitomycin C (0.5 mg/ml). Permeation time: no breakthrough up to 240 minutes Mitoxantrone (2.0 mg/ml). Permeation time: no breakthrough up to 240 minutes Paclitaxel (Taxol) (6.0 mg/ml). Permeation time: no breakthrough up to 240 minutes Thiotepa (10.0 mg/ml). Permeation time: Thiotepa has extremely low permeation times of 13.6 minutes Vincristine Sulfate (1.0 mg/ml). Permeation time: no breakthrough up to 240 minutes The tested Opioid is: Fentanyl Citrate Injection (100mcg/2mL). Permeation: no breakthrough up to 240 minutes Please note that the following drugs have extremely low permeation times: Carmustine: 14.7 minutes Thiotepa: 13.6 minutes Warning: DO NOT USE WITH CARMUSTINE OR THIOTEPA
The Non-Sterile, Single use, Powder-free Examination glove, Blue, tested for use with Chemotherapy Drugs and fentanyl is provided in blue. It meets all the requirements of ASTM D6319. It is a medical glove which is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between examiner and patient. In addition, these gloves were tested for use with chemotherapy drugs as well as Fentanyl, per ASTM D6978 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drug. It can be available in 4 specifications: S, M, L and XL.
The provided text is a 510(k) summary for a Nitrile Examination Glove. It details the device's characteristics, indications for use, and non-clinical testing conducted to support its substantial equivalence to a predicate device.
Here's an analysis of the acceptance criteria and the study performed, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
| Test Method | Purpose | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| ASTM D6319 | Dimensions | Length: ≥220mm (XS, S), ≥230mm (M, L, XL) | |
| Width: 70±10mm (XS), 80±10mm (S), 95±10mm (M), 110±10mm (L), 120±10mm (XL) | |||
| Thickness (mm): Finger: ≥0.05, Palm: ≥0.05 | Pass | ||
| ASTM D6319 | Physical Properties | Before Aging: Tensile Strength ≥14MPa, Ultimate Elongation ≥500% | |
| After Aging: Tensile Strength ≥14MPa, Ultimate Elongation ≥400% | Pass | ||
| ASTM D5151 | Freedom from Holes | Shall comply with freedom from holes (AQL = 2.5) | Pass |
| ASTM D6124 | Powder-free Residue | Powder residue limit of 2.0 mg | Pass |
| ISO 10993-10 | To determine if the finished device material is an irritant. | Non-irritating | Pass (Not an irritant) |
| ISO 10993-10 | To determine if the finished device material is a sensitizer. | Non-sensitizing | Pass (Not a sensitizer) |
| ASTM D6978 | Resistance to permeation by Fentanyl | No breakthrough when tested for permeation with Fentanyl | Pass |
| ASTM D6978 | Resistance to Permeation by Chemotherapy Drugs | No breakthrough (up to 240 minutes) for most listed drugs. Carmustine (BCNU) and Thiotepa had extremely low permeation times (14.7 and 13.6 minutes, respectively), leading to a warning not to use with these drugs. | Pass (based on specified permeation times) |
2. Sample Size Used for the Test Set and the Data Provenance:
The document does not explicitly state the sample sizes used for each specific test in the test set. However, it indicates tests were conducted according to ASTM and ISO standards, which typically specify sampling plans. The data provenance is not mentioned, so we cannot determine the country of origin of the data or whether it was retrospective or prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts:
This information is typically not applicable to studies for medical gloves, as the "ground truth" is established by direct physical, chemical, and biological testing against predefined scientific standards, not by expert consensus or review of diagnostic images.
4. Adjudication Method for the Test Set:
Not applicable, as the tests involve objective measurements against established standards, not interpretation by experts 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:
Not applicable. This is a medical glove, not an AI-powered diagnostic or assistive device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Not applicable. This is a medical glove, not an algorithm. The device performance is assessed through laboratory testing.
7. The Type of Ground Truth Used:
The ground truth for the device's performance is based on objective measurements and chemical/physical assessments against established industry standards (ASTM and ISO). For example:
- Dimensional measurements: Direct physical measurement.
- Physical properties (Tensile strength, Elongation): Mechanical testing.
- Freedom from holes: Water leak test as per ASTM D5151.
- Powder-free residue: Gravimetric analysis as per ASTM D6124.
- Biocompatibility (Irritation and Sensitization): Biological testing on animal models (typically as per ISO 10993-10).
- Permeation by Fentanyl and Chemotherapy Drugs: Chemical permeation testing as per ASTM D6978, measuring breakthrough time.
8. The Sample Size for the Training Set:
Not applicable. This is a physical medical device, not an AI model, so there is no "training set."
9. How the Ground Truth for the Training Set was Established:
Not applicable, as there is no training set for this device.
§ 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.