(177 days)
A disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner. This device is single use only. Tested for use with chemotherapy drugs. Tested chemotherapy drugs are as follows (Fluorouracil, Etoposide, Cyclophosphamide, Carmustine, Thio-Tepa, Paclitaxel, Doxorubicin Hydrochloride, Dacarbazine, Cisplatin)
Blue and Red with Pearlescent® Pigment. Powder Free Nitrile Examination Gloves with Aloe Vera, Tested for use with Chemotherapy Drugs meets all the requirements of ASTM D 6978-05, ASTM D6319-00a(2005) and FDA 21 CFT 880.6250.
The provided text describes the acceptance criteria and performance for "Blue and Red with Pearlescent® Pigment, Powder Free Nitrile Examination Gloves with Aloe Vera, Tested for use with Chemotherapy Drugs" (K101436). It focuses on the physical properties and, most significantly, the resistance to permeation by chemotherapy drugs.
Here's an analysis based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
| Characteristic | Acceptance Criteria (Standard) | Device Performance (Red Gloves) | Device Performance (Blue Gloves) |
|---|---|---|---|
| Dimensions | ASTM D 6319-00a05 | Meets | Meets (Implied to be same as Red, as general statement applies to both) |
| Physical Properties | ASTM D 6319-00a05 | Meets | Meets (Implied to be same as Red, as general statement applies to both) |
| Freedom from pinholes | ASTM D 5151-06 | Meets (AQL 2.5) | Meets (AQL 2.5) (Implied to be same as Red, as general statement applies to both) |
| Powder Residual | ASTM D 6124-06 | Meets (240 min | >240 min |
| Doxorubicin HCl (Adriamycin) | Breakthrough Detection Time per ASTM D6978-05 | >240 min | >240 min |
| Carmustine | Breakthrough Detection Time per ASTM D6978-05 | 0.68 min | 2.10 min |
| Etoposide | Breakthrough Detection Time per ASTM D6978-05 | >240 min | >240 min |
| Fluorouracil (Adrucil) | Breakthrough Detection Time per ASTM D6978-05 | >240 min | >240 min |
| Paclitaxel (Taxol) | Breakthrough Detection Time per ASTM D6978-05 | >240 min | >240 min |
| ThioTEPA | Breakthrough Detection Time per ASTM D6978-05 | 34.21 min | 27.17 min |
| Dacarbazine | Breakthrough Detection Time per ASTM D6978-05 | >240 min | >240 min |
| Cisplatin | Breakthrough Detection Time per ASTM D6978-05 | >240 min | >240 min |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size used for the test set for each specific characteristic. It refers to compliance with ASTM standards. For instance, for Resistance to permeation by Chemotherapy Drugs, it refers to ASTM D6978-05. This standard would specify the number of samples required for testing. For Freedom from pinholes, it mentions "AQL 2.5," which is an Acceptance Quality Limit and implies a specific sampling plan, but the exact number of gloves tested isn't stated.
Data Provenance: The data appears to be prospective, generated specifically for this 510(k) submission to demonstrate compliance with the referenced ASTM standards. The country of origin of the data is not specified beyond being submitted by Shen Wei (USA) Inc.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This type of medical device (nitrile examination gloves) does not typically involve human experts to establish "ground truth" in the way a diagnostic imaging AI algorithm would. The "ground truth" for the performance characteristics (e.g., tensile strength, pinholes, chemical permeation) is established through standardized laboratory testing procedures as defined by the relevant ASTM (American Society for Testing and Materials) standards. The results are objective measurements rather than subjective expert interpretations. Therefore, no information on "number of experts" or their "qualifications" for ground truth establishment is provided or relevant in this context.
4. Adjudication Method for the Test Set
Not applicable. As noted above, the ground truth is established by objective measurements based on standardized testing, not by expert consensus requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is typically performed for diagnostic devices where human readers (e.g., radiologists) interpret images or data, and AI assistance can impact their performance. Nitrile examination gloves are a physical barrier device, and their performance is evaluated through material science and chemical permeation tests, not through human interpretation tasks.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, the performance reported for the gloves for all characteristics (dimensions, physical properties, pinholes, powder residual, biocompatibility, and chemotherapy drug permeation) represents the standalone performance of the device without human-in-the-loop. The tests are designed to measure the inherent properties of the glove material.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
The ground truth used for the device's performance claims is based on objective measurements derived from standardized laboratory tests defined by ASTM (American Society for Testing and Materials) standards. This is often referred to as analytical performance or technical performance data.
- For physical properties, it's measurements against ASTM D 6319-00a05.
- For freedom from pinholes, it's a test against ASTM D 5151-06.
- For powder residual, it's a test against ASTM D 6124-06.
- For biocompatibility, it's a test for primary skin irritation and dermal sensitization.
- For resistance to chemotherapy drugs, it's permeation testing according to ASTM D6978-05.
8. The Sample Size for the Training Set
Not applicable. This device is a physical product (nitrile gloves), not an algorithm or an AI system that requires a "training set." The concept of a training set is relevant for machine learning models, which are not involved in the development or testing of these gloves.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this type of 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.