(217 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 and Fentanyl Citrate as per ASTM D6978-05 (Reapproved 2019) Standard Practice for Assessment of Medical Gloves of Permeation by Chemotherapy Drugs
The Medline Powder-Free Blue Nitrile Examination Gloves (Tested for use with Chemotherapy Drugs and Fentanyl) – Regular Cuff and the Medline Powder-Free Blue Nitrile Examination Gloves (Tested for use with Chemotherapy Drugs and Fentany)) - Extended Cuff are non-sterile, single use, disposable gloves intended for medical purposes to be worn on the hands of examiners to prevent contamination between a patient and an examiner. The gloves are nitrile, powder-free, ambidextrous, and blue-colored with a beaded cuff. The proposed device is offered in two versions: Regular cuff (VS311) and Extended cuff (VS711).
The provided document is a 510(k) Premarket Notification from Medline Industries, Inc. for their Powder-Free Blue Nitrile Examination Gloves. This document focuses on demonstrating the substantial equivalence of their new device to a legally marketed predicate device.
It is NOT a study about a device employing an Artificial Intelligence (AI) algorithm. Therefore, the requested information regarding acceptance criteria and study proving device meets acceptance criteria for an AI device cannot be extracted directly from this document. The document describes traditional performance testing for physical attributes and chemical permeation resistance of medical gloves, not AI algorithm performance.
However, I can extract and present analogous information from the document as if it were a "device" in a general sense, focusing on the acceptance criteria and performance data for the gloves as described. I will make a note where the requested information is not applicable (N/A) due to the nature of the device (medical gloves vs. AI algorithm).
Acceptance Criteria and Device Performance for Medline Powder-Free Blue Nitrile Examination Gloves
This document pertains to the performance testing of Medline Powder-Free Blue Nitrile Examination Gloves (Regular Cuff and Extended Cuff versions) for medical uses, specifically their resistance to chemotherapy drugs and Fentanyl permeation, as well as general physical characteristics. This is not an AI-powered device, so typical AI/ML study components like training/test sets, expert adjudication, or MRMC studies are not applicable.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the gloves are based on various ASTM standards.
Regular Cuff (VS311) - Summarized Performance
| Characteristic | Acceptance Criteria (Standard) | Reported Device Performance (Average) | Complies with Standard (Y/N) |
|---|---|---|---|
| Biocompatibility | |||
| Irritation Testing | Pass/Fail (Not a primary skin irritant) | Pass | Y |
| Sensitization Testing | Pass/Fail (Not a primary skin sensitizer) | Pass | Y |
| Cytotoxicity Testing | Pass/Fail (Not cytotoxic) | Failed* (Device is cytotoxic) | N* |
| Systemic Toxicity Testing | Pass/Fail (Not toxic) | Pass | Y |
| Physical Dimensions (per ASTM D6319-10) | |||
| Glove Length (XS-XL) | 220mm min. (XS-S), 230mm min. (M-XL) | 247-251mm | Y |
| Palm Width (XS-XL) | Ranges from 70 ± 10mm (XS) to 120 ± 10mm (XL) | 78-119mm (within specified ranges) | Y |
| Finger Thickness (XS-XL) | 0.05mm min. | 0.15-0.16mm | Y |
| Palm Thickness (XS-XL) | 0.05mm min. | 0.11mm | Y |
| Freedom from Holes (per ASTM D5151-06 & ASTM D6319-10, G-1) | AQL 1.5 | XS/Small/Medium – 1/200; Large – 4/400; X-Large -2/200 | Y |
| Powder Content (per ASTM D6124-06) | Less Than 2mg/glove | 0.16-0.20 mg/glove | Y |
| Chemotherapy Drug Permeation (per ASTM D6978-05) | N/A (Breakthrough time specific to each drug) | Varies per drug (>240 min for most, 33.1 min for Carmustine, 69.2 min for Thiotepa) | Y (within stated limitations) |
| Fentanyl Permeation (per ASTM D6978-05) | N/A (Breakthrough time specific to Fentanyl) | >240 min | Y |
*Note: The cytotoxicity testing failed, indicating the device is cytotoxic under the conditions of the study. However, the FDA has still cleared the device. This implies that the cytotoxicity is either not considered clinically significant for the intended use (external, short-term contact) or that the benefits outweigh this particular risk, likely due to a robust biocompatibility assessment involving multiple tests. This document itself doesn't elaborate further on the implications of the "Failed" cytotoxicity result beyond reporting it.
Extended Cuff (VS711) - Summarized Performance (Only differences from Regular Cuff noted, otherwise assumed to be the same)
| Characteristic | Acceptance Criteria (Standard) | Reported Device Performance (Average) | Complies with Standard (Y/N) |
|---|---|---|---|
| Physical Dimensions (per ASTM D6319-10) | |||
| Glove Length (XS-XL) | 220mm min. (XS-S), 230mm min. (M-XL) | 298-302mm (Extended cuff, so longer than regular cuff) | Y |
| Palm Width (XS-XL) | Ranges from 70 ± 10mm (XS) to 120 ± 10mm (XL) | 78-115mm (within specified ranges) | Y |
| Finger Thickness (XS-XL) | 0.05mm min. | 0.16-0.18mm | Y |
| Palm Thickness (XS-XL) | 0.05mm min. | 0.12-0.23mm | Y |
| Chemotherapy Drug Permeation (per ASTM D6978-05) | N/A | Varies per drug (>240 min for most, 59.4 min for Carmustine, 68.2 min for Thiotepa) | Y (within stated limitations) |
| Fentanyl Permeation (per ASTM D6978-05) | N/A | >240 min | Y |
2. Sample size used for the test set and the data provenance
- Sample Size for Physical Dimensions and Powder Content: 13 glove samples of each size (extra-small, small, medium, large, and extra-large) were tested for physical dimensions. For powder content, the average results across all five sizes are summarized, implying individual testing for each size.
- Sample Size for Freedom from Holes: Varies based on total number inspected:
- Regular Cuff: XS/Small/Medium – 200 gloves each; Large – 400 gloves; X-Large -200 gloves.
- Extended Cuff: XS/Small/Medium, Large, X-Large - 200 gloves each.
- Sample Size for Permeation Testing: The document does not specify the exact number of samples tested for each chemotherapy drug or Fentanyl. The test method cited is ASTM D6978, which typically involves multiple replicates per drug.
- Data Provenance: The tests were conducted to support a 510(k) premarket notification for a disposable medical device. This is regulatory testing to demonstrate compliance with recognized standards. The country of origin of the data is not explicitly stated beyond being part of an FDA submission. The nature of this engineering testing is retrospective, as it's data collected to support a product already manufactured or designed.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This is not an AI/ML device where expert human annotation typically establishes ground truth. The "ground truth" for glove performance is established by adherence to physical and chemical testing standards (e.g., ASTM D6319, ASTM D5151, ASTM D6124, ASTM D6978). The qualification of personnel conducting these lab tests would typically be laboratory technicians and engineers with expertise in the relevant standards and equipment, but this is not specified in the document.
4. Adjudication method for the test set
Not applicable. There is no human interpretative "test set" requiring adjudication in the context of this device. Performance is determined by objective physical and chemical measurements against defined standards.
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 not an AI-assisted device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI algorithm.
7. The type of ground truth used
The "ground truth" for the device's performance is objective measurement against established industry standards (ASTM standards for physical properties, hole detection, powder content, and chemical permeation). These standards define the acceptable range or threshold for each characteristic.
8. The sample size for the training set
Not applicable. This is not an AI/ML device and therefore does not have a "training set" in the context of machine learning.
9. How the ground truth for the training set was established
Not applicable. See point 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.