(150 days)
A 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.
These gloves were tested for use with Chemotherapy Drugs as per ASTM D6978-05 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs:
Powder Free Blue Nitrile Patient Examination Glove, Non-Sterile the meets all requirements of ASTM standard D6319-10, D6978-05 and FDA 21 CFR 880.6250.
The powder free nitrile examination qlove is manufactured from synthetic rubber latex. Inner surface of gloves undergoes surface treatment process to produce a smooth surface that assists the user in donning the gloves without using any lubricant such as powder on the glove surface. The glove is ambidextrous, i.e. can be worn on right hand or left hand. The physical properties of glove i.e. tensile strength meet ASTM standard D6319-10.
The provided text describes the acceptance criteria and performance of "Dermagrip Powder Free Blue Nitrile Patient Examination Gloves, Non-sterile, Tested For Use With Chemotherapy Drugs." This document is a 510(k) premarket notification to the FDA, asserting substantial equivalence to an existing predicate device (K141982).
Here's an analysis of the provided information:
1. Table of Acceptance Criteria and Reported Device Performance
The device performance is compared to relevant ASTM standards. The table below summarizes the acceptance criteria and the device's reported performance:
| Characteristic | Standard/Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Dimensions | ASTM D6319-10 (Min 240mm length) | Min 240mm (Meets) |
| Physical Properties | ASTM D6319-10 | Meets |
| Thickness - Finger | ASTM D6319-10 (0.07 - 0.10mm) | 0.07 - 0.10mm (Meets) |
| Thickness - Palm | ASTM D6319-10 (0.07 - 0.09mm) | 0.07 - 0.09mm (Meets) |
| Thickness - Cuff | ASTM D6319-10 (0.06 - 0.08mm) | 0.06 - 0.08mm (Meets) |
| Powder Free | ASTM D6124-06 (≤ 2 mg/glove) | Meets |
| Chemotherapy Drug Permeation Test (ASTM D6978-05) | Minimum Breakthrough Detection Time (varies by drug) | |
| Flourouracil (Adrucil) | > 240 minutes | > 240 minutes (Meets) |
| Etopside (Toposar) | > 240 minutes | > 240 minutes (Meets) |
| Cyclophosphamide (Cytoxan) | > 240 minutes | > 240 minutes (Meets) |
| *Carmustine (BCNU) | 15.0 minutes | 15.0 minutes (Meets) |
| *Thiotepa | 2.0 minutes | 2.0 minutes (Meets) |
| Paclitaxel (Taxol) | > 240 minutes | > 240 minutes (Meets) |
| Doxorubicin Hydrochloride (Adriamycin) | > 240 minutes | > 240 minutes (Meets) |
| Dacarbazine | > 240 minutes | > 240 minutes (Meets) |
| Cisplatin | > 240 minutes | > 240 minutes (Meets) |
| Ifosfamide | > 240 minutes | > 240 minutes (Meets) |
| Mitoxantrone | > 240 minutes | > 240 minutes (Meets) |
| Vincristine Sulfate | > 240 minutes | > 240 minutes (Meets) |
| Methotrexate | > 240 minutes | > 240 minutes (Meets) |
| Mitomycin C | > 240 minutes | > 240 minutes (Meets) |
| Biocompatibility - Primary Skin Irritation | ISO 10993-10:2010(E) (Passes, Not a primary skin irritant) | Passes, Not a primary skin irritant under the conditions of the study. (Meets) |
| Biocompatibility - Dermal Sensitization | ISO 10993-10:2010(E) (Passes, Not a contact sensitizer) | Passes, Not a contact sensitizer under the conditions of the study. (Meets) |
| Watertight (1000ml) | ASTM D5151-06 (Passes) | Passes (Meets) |
| Intended Use | A disposable device for medical purposes, worn on hand/finger to prevent contamination. | Matches. |
| Material | ASTM D6319-10 (Nitrile) | Nitrile (Meets) |
| Color | - | Blue |
| Texture | - | Finger textured |
| Size | ASTM D6319-10 (Extra Small, Small, Medium, Large, Extra Large) | Extra Small, Small, Medium, Large, Extra Large (Meets) |
| Single Use | Medical Glove Guidance Manual - Labeling | Single use (Meets) |
Note: The acceptance criteria for Carmustine (BCNU) and Thiotepa are highlighted with a warning due to their extremely low permeation times, which the device matches.
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the specific sample sizes used for each test (e.g., number of gloves tested for permeation, physical properties, etc.). However, the tests were conducted according to established ASTM standards (D6319-10, D6978-05, D6124-06, D5151-06) and ISO 10993-10:2010(E). These standards typically specify the minimum sample sizes required for such testing.
The provenance of the data is from WRP Asia Pacific Sdn Bhd, located in Sepang, Selangor Darul Ehsan, Malaysia (based on the submitter's address). The study is non-clinical performance data, indicating it's laboratory testing rather than data collected from patients. It is implicitly retrospective as it reports the results of tests already conducted.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not applicable to this document. The "ground truth" here is based on objective, standardized laboratory measurements and performance against established ASTM and ISO standards, not on subjective expert consensus. No individual experts were used to establish ground truth in the way one would for diagnostic AI.
4. Adjudication Method for the Test Set
This is not applicable. The data presented are based on direct physical and chemical testing, adhering to specific methodologies outlined in the referenced standards. There is no ambiguous interpretation that would require an adjudication process.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size of human readers improve with AI vs without AI assistance
This is not applicable. This document concerns a physical medical device (examination gloves) and its material properties, not an AI or imaging diagnostic tool. Therefore, no MRMC study or AI assistance evaluation was performed.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) study was done
This is not applicable. This document describes the performance of a physical product and does not involve any algorithms or AI.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the device's performance is established by objective measurements and adherence to recognized international standards. Specifically:
- ASTM D6319-10: Standard Specification for Nitrile Examination Gloves for Medical Application (for dimensions, physical properties, material).
- ASTM D6978-05: Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs (for chemotherapy drug permeation).
- ASTM D6124-06: Standard Test Method for Residual Powder on Medical Gloves (for powder freedom).
- ISO 10993-10:2010(E): Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization (for biocompatibility).
- ASTM D5151-06: Standard Test Method for Detection of Holes in Medical Gloves (for watertightness).
8. The Sample Size for the Training Set
This is not applicable. This document describes the testing of a physical medical device, not a machine learning model. Therefore, there is no "training set."
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 submission.
§ 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.