(38 days)
A patient examination gloves is a disposable device intended for medical purpose that is worn on the examiner's hand or fingers to prevent contamination between patient and examiner. In addition, these gloves were tested for use with chemotherapy drugs, fentanyl citrate, and xylazine in accordance with ASTM D6978-05 Standard Practice for Assessment of Resistance of Medical gloves to Permeation by Chemotherapy Drugs.
"Disposable Powder Free Nitrile Examination Glove, Blue Color, Tested For Use With Chemotherapy Drugs And Fentanyl Citrate And Xylazine" is a patient examination glove made from nitrile compound, non-sterile (as per 21 CFR 880.6250, Class I). The principle operation of this medical device is to provide single use barrier protection for the wearer and the device meets the specifications for Barrier Protection and tensile properties as defined in ASTM D6319-19, Standard specification for Nitrile Examination Gloves.
The provided document is a 510(k) Premarket Notification for a Disposable Powder Free Nitrile Examination Glove, Blue Color, Tested For Use With Chemotherapy Drugs and Fentanyl Citrate and Xylazine.
This device is a Class I medical device (non-powered patient examination glove). For devices in this class, the FDA typically does not require a clinical performance study with human subjects. Instead, evidence of substantial equivalence to a predicate device is primarily demonstrated through non-clinical performance data (bench testing).
Therefore, the requested information regarding AI device acceptance criteria, MRMC studies, ground truth establishment, training sets, and expert adjudication are not applicable to this particular device submission. This document describes the performance of a physical examination glove, not an AI or imaging device.
However, I can extract the acceptance criteria and reported device performance from the non-clinical testing:
Acceptance Criteria and Reported Device Performance
The study aims to demonstrate that the subject device (Disposable Powder Free Nitrile Examination Glove, Blue Color, Tested For Use With Chemotherapy Drugs and Fentanyl Citrate and Xylazine) meets the acceptance criteria for various physical and chemical resistance properties, establishing its substantial equivalence to a predicate device (K193555).
Here is a table summarizing the acceptance criteria and the device's reported performance:
| Test | Test Method | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Dimension | ASTM D6319-19 | Length: | |
| Short cuff: ≥230mm | |||
| Long cuff: ≥300mm | |||
| Thickness: | |||
| Palm: ≥ 0.05 mm | |||
| Finger: ≥ 0.05 mm | |||
| Cuff: ≥ 0.05 mm | |||
| Palm Width: | |||
| XS: 70 ± 10 mm; | |||
| S: 80 ± 10 mm; | |||
| M: 95 ± 10 mm; | |||
| L: 110 ± 10 mm; | |||
| XL: 120 ± 10 mm | Pass | ||
| Freedom from holes (Water leak) | 21 CFR 800.20 & ASTM D5151-19 | G-I/ AQL 2.5 | Pass |
| Tensile strength (Before aging/ After aging) | ASTM D6319-19 | Before Aging: ≥14MPa | |
| After Aging: ≥14MPa | Pass | ||
| Elongation (Before aging/ After aging) | ASTM D6319-19 | Before Aging: ≥500% | |
| After Aging: ≥400% | Pass | ||
| Powder Residual | ASTM D6319-19 | 240 minutes minimum breakthrough detection time. For Carmustine (BCNU) and Thiotepa, specific lower breakthrough times were accepted (21.5 minutes and 13.6 minutes, respectively), with warnings provided. For Xylazine, no breakthrough was detected for up to 240 minutes. | Pass (as detailed in the tables for each drug) |
Regarding the specific questions about AI/imaging studies:
- 2. Sample size used for the test set and the data provenance: Not applicable. This refers to physical tests on glove samples.
- 3. Number of experts used to establish the ground truth... and their qualifications: Not applicable. Ground truth for physical properties is established by standardized testing methods.
- 4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. Results are quantitative measurements from lab tests.
- 5. If a multi reader multi case (MRMC) comparative effectiveness study was done...: Not applicable. This is not an AI or imaging device.
- 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm.
- 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" for this device's performance is established through adherence to recognized international/national standards for medical glove testing (e.g., ASTM D6319-19, ASTM D5151-19, ASTM D6978-05, AAMI/ANSI/ISO 10993-5, AAMI/ANSI/ISO 10993-10). These standards define the test methods and performance requirements.
- 8. The sample size for the training set: Not applicable. This is a manufactured product, not an AI model.
- 9. How the ground truth for the training set was established: Not applicable. Manufacturing controls and quality assurance ensure consistency, not a "training set" in the context of AI.
§ 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.