(103 days)
The nitrile powder free patient examination glove is a non-sterile disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.
In addition to routine examination glove's intended use, the gloves are Tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate, Simulated Gastric Acid and Fentanyl in Simulated Gastric Acid.
KIMTECH™ Polaris™ Xtra Nitrile Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate, Simulated Gastric Acid and Fentanyl in Simulated Gastric Acid are dark magenta in color, and are single use only, non-sterile, disposable gloves. The powder-free gloves are made of synthetic copolymers of acrylonitrile and butadiene. The product will be sold as a disposable and non-sterile product in extrasmall, small, medium, large, and extra-large sizes.
The provided text describes the acceptance criteria and study results for "KIMTECH™ Polaris™ Xtra Nitrile Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate, Simulated Gastric Acid and Fentanyl in Simulated Gastric Acid." This is a medical device, specifically examination gloves, and the acceptance criteria and studies are related to its physical properties, biocompatibility, and resistance to permeation by certain chemicals.
Here's an analysis based on your request:
1. Table of acceptance criteria and the reported device performance:
| Acceptance Criteria (Standard Where Limits Test Limits Set) | Reported Device Performance (Results) |
|---|---|
| Dimensions (ASTM D 6319) | Meets Requirements |
| Length: 220 mm minimum (XS, S), 230 mm minimum (M, L, XL) | All sizes comply with length dimensions |
| Width (mean): 70 mm minimum (XS), 80 mm minimum (S), 95 mm minimum (M), 110 mm minimum (L), 120 mm minimum (XL) | All sizes comply with width dimensions |
| Finger Thickness: 0.05 mm minimum | All sizes comply with Finger Thickness dimensions |
| Palm Thickness: 0.05 mm minimum | All sizes comply with Palm Thickness dimensions |
| Physical Properties (ASTM D 6319) | Meets Requirements |
| Before Aging: Tensile Strength: ≥ 14 MPa, Ultimate elongation: ≥ 500% | Complies both before and after accelerated aging |
| After Aging: Tensile Strength: ≥ 14 MPa, Ultimate elongation: 400% | Complies both before and after accelerated aging |
| Freedom from Pinholes (ASTM D 5151) | Meets Requirements |
| AQL 2.5, No leakage | Pass (AQL 0.65) - Note: Subject device has a tighter AQL than the predicate |
| Powder-Free (ASTM D 6124) | Meets Requirements |
| ≤ 2 mg / glove | Passed at 240 min) |
2. Sample size used for the test set and the data provenance:
The document does not explicitly state the exact sample sizes used for each specific test (e.g., how many gloves were tested for pinholes, or how many individual permeation tests were conducted for each chemical). However, it references recognized standards like ASTM D6319 (for dimensions and physical properties, which dictates sampling plans), ASTM D5151 (for holes, which specifies AQLs), and ISO 2859-1:1999 (Sampling Procedures and Tables for Inspection by Attributes). Meeting these AQLs (Acceptable Quality Levels) implies specific sample sizes would have been drawn and tested in accordance with the standards.
The data provenance is not explicitly stated as "country of origin" or "retrospective/prospective." However, given it's an FDA 510(k) submission, the studies would have been conducted by the manufacturer (Kimberly-Clark Corporation) or their designated testing facilities, likely in a controlled, prospective manner to generate data for the submission. The testing standards are international (ASTM, ISO), suggesting globally recognized methods.
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 to this type of device and study. The testing described involves objective, quantitative measurements of physical and chemical resistance properties according to established engineering and material science standards (ASTM, ISO). "Ground truth" in this context is defined by the objective measurement procedures and acceptance criteria outlined in these standards, not by expert consensus or interpretation of images/clinical data.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
This is not applicable. Adjudication methods like 2+1 or 3+1 refer to processes for resolving disagreements among multiple human readers in diagnostic imaging or clinical studies. The studies presented here are laboratory-based, objective material property tests.
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. This submission is for a physical medical device (examination gloves), not an AI-powered diagnostic tool. Therefore, MRMC studies and the concept of "human readers improving with AI assistance" are irrelevant.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
This is not applicable. As stated above, this is not an AI algorithm. The performance described is inherent to the physical glove material and construction.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The "ground truth" for this device's performance is established by objective, quantitative measurements conducted in a laboratory setting according to internationally recognized standards and test methods. For example:
- Dimensions: Measured directly using calibrated instruments.
- Tensile Strength & Elongation: Measured using universal testing machines as per ASTM standards.
- Freedom from Pinholes: Determined by water leak tests following ASTM D5151.
- Powder Content: Measured gravimetrically as per ASTM D6124.
- Biocompatibility: Determined by laboratory animal studies (e.g., skin irritation, sensitization, systemic toxicity) following ISO 10993 guidelines, which define the biological response.
- Permeation Resistance: Measured by quantifying breakthrough time of specific chemicals using analytical techniques (e.g., chromatography) as per ASTM D6978-05.
8. The sample size for the training set:
This is not applicable. These studies are for a physical product validation, not for training an AI or machine learning model. There is no "training set" in this context.
9. How the ground truth for the training set was established:
This is not applicable as there is no training set for this type of device validation.
§ 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.