(212 days)
A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or fingers to prevent contamination between patient an examiner.
Non-Sterile, Powder-Free Nitrile Examination Gloves (Original Blue, Cobalt Blue) Tested for use with Chemotherapy Drugs, meets all the current specifications listed under ASTM Specifications D6319-05 , Standard Specification for Nitrile Examination Gloves for Medical Application and D6978-05, Standard Practice for Assessment of Resistance to Permeation by Chemotherapy Drugs.
The provided document describes the acceptance criteria and performance of "Non-Sterile, Powder-Free Nitrile Examination Gloves (Original Blue, Cobalt Blue) Tested for use with Chemotherapy Drugs" by YTY INDUSTRY (MANJUNG) SDN. BHD. This is a 510(k) premarket notification summary, demonstrating substantial equivalence to a predicate device (K101822).
The study primarily focuses on demonstrating that the gloves meet established industry standards and FDA requirements for patient examination gloves and resistance to chemotherapy drugs.
Here's an analysis based on your requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are generally based on ASTM D6319-10 (for examination gloves) and ASTM D6978-05 (for chemotherapy drug permeation), along with FDA 1000ml watertight test and powder content requirements. The reported device performance is for two colors: "Original Blue" and "Cobalt Blue."
| Test / Characteristic | Acceptance Criteria (Standard) | Original Blue Performance | Cobalt Blue Performance |
|---|---|---|---|
| Pinhole/Watertight | FDA 1000ml Water Leak Test, AQL = 2.5 (GI Multiple Normal) | Pass | Pass |
| Length (mm) | Min 230 (chemo claim min 270) | 273 - 278 (for M, L, XL sizes) | 276 - 278 (for M, L, XL sizes) |
| Palm Width (mm) | 95 ± 10 (for size M) | 97 - 99 (for size M) | 98 - 99 (for size M) |
| Thickness (mm) Single Layer | |||
| - Finger | Min 0.05 (chemo claim min 0.10) | 0.15 - 0.21 | 0.16 - 0.20 |
| - Palm | Min 0.05 (chemo claim min 0.10) | 0.11 - 0.12 | 0.11 - 0.12 |
| Physical Properties | |||
| - Before Aging: Tensile Strength (MPa) | Min 14 | 20.3 - 25.9 | 19.6 - 25.3 |
| - Before Aging: Ultimate Elongation (%) | Min 500 | 580 - 620 | 560 - 580 |
| - After Aging: Tensile Strength (MPa) | Min 14 | 26.5 - 35.6 | 25.0 - 28.4 |
| - After Aging: Ultimate Elongation (%) | Min 400 | 500 - 520 | 460 - 520 |
| Powder Content | Max 2.0 mg/glove | 0.34 mg/glove | 0.39 mg/glove |
| Moisture Content | Max 2.0% | 0.92% | 0.84% |
| Biocompatibility | Pass Primary Skin Irritation in Rabbits; Pass Guinea Pig Maximization | Yes (Pass) | Yes (Pass) |
| Chemotherapy Breakthrough (min) | (Breakthrough time varies by drug; generally >240 min desired for most drugs) | (See detailed table below) | (See detailed table below) |
Chemotherapy Breakthrough Detection Time (in minutes):
| TESTED CHEMOTHERAPY DRUG | Original Blue Average Breakthrough Detection Time (min) | Cobalt Blue Average Breakthrough Detection Time (min) |
|---|---|---|
| Carboplatin, 10 mg/ml | >240 | >240 |
| Carmustine (BCNU), 3.3 mg/ml | 1.84 | 1.82 |
| Cisplatin, 1.0 mg/ml | >240 | >240 |
| Cyclophosphamide (Cytoxan), 20.0 mg/ml | >240 | >240 |
| Dacarbazine (DTIC), 10.0 mg/ml | >240 | >240 |
| Doxorubicin Hydrochloride, 2.0 mg/ml | >240 | >240 |
| Etoposide (Toposar), 20.0 mg/ml | >240 | >240 |
| Fluorouracil, 50.0 mg/ml | >240 | >240 |
| Ifosfamide, 50.0 mgs/ml | >240 | >240 |
| Methotrexate, 25 mg/ml | >240 | >240 |
| Mitomycin C, 0.5 mg/ml | >240 | >240 |
| Mitoxantrone, 2 mg/ml | >240 | >240 |
| Paclitaxel (Taxol), 6.0 mg/ml | >240 | >240 |
| Thiotepa, 10.0 mg/ml | 0.76 | 0.93 |
| Vincristine Sulfate, 1.0 mg/ml | >240 | >240 |
Note: Carmustine and Thiotepa show very low breakthrough times, and a warning is included in the labeling that these chemicals are not recommended for use with these gloves.
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 for watertight test, number of gloves for physical properties, amount of chemotherapy testing). However, it implies testing according to ASTM standards, which would define appropriate sample sizes.
The data provenance is not explicitly stated as "retrospective" or "prospective" but represents testing conducted by the manufacturer (YTY INDUSTRY (MANJUNG) SDN. BHD.) for the purpose of this 510(k) submission. The company is located in Malaysia, suggesting the data originates from testing facilities associated with the manufacturer or their designated testing laboratories. Chemotherapy testing was performed by "ARDL CHEMICAL ANALYTICAL SERVICES."
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This type of submission (for examination gloves) does not typically involve human experts establishing ground truth in the way it would for AI-driven diagnostic devices. The acceptance criteria are based on established industrial standards (ASTM) and regulatory requirements (FDA). The "ground truth" here is the pass/fail criteria defined by these standards for physical properties, barrier integrity, and chemical resistance. Expert involvement would be in interpreting these standards and overseeing the testing, rather than reaching a consensus on individual test outcomes.
4. Adjudication Method for the Test Set
Not applicable. As noted above, the "ground truth" is determined by adherence to established, objective test methods and performance specifications from ASTM standards and FDA requirements. There isn't a subjective assessment that requires adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
Not applicable. This device is a physical product (examination gloves), not an AI-driven diagnostic or interpretative system. Therefore, an MRMC study or assessment of human reader improvement with AI assistance is irrelevant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This is a physical medical device, not an algorithm or AI system.
7. The Type of Ground Truth Used
The ground truth used is based on:
- Industry Standards: ASTM D6319-10 (Standard Specification for Nitrile Examination Gloves for Medical Application) and ASTM D6978-05 (Standard Practice for Assessment of Resistance to Permeation by Chemotherapy Drugs).
- Regulatory Requirements: FDA 1000ml watertight test criteria and specific powder content limits.
- Biocompatibility Testing: Standards for primary skin irritation and sensitization tests.
These standards provide objective, measurable criteria for the performance of the gloves.
8. The Sample Size for the Training Set
Not applicable. There is no "training set" in the context of this device. The physical properties and chemical resistance are inherent to the product's design and manufacturing process, and performance is evaluated against defined standards, not through machine learning.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this type of device. The "ground truth" for the performance evaluation is established by the accepted and universally applied methods and specifications outlined in the ASTM standards and FDA guidelines.
§ 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.