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510(k) Data Aggregation
(267 days)
A patient examination gloves is a disposable device intended for medical purpose that is worn on the examiner's hand or fingers to prevent contamination between patient and examiner. In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978-05 Standard Practice for Assessment of Medical gloves to Permeation by Chemotherapy Drugs.
The subject device is single use, disposable gloves intended for medical purposes to be worn on the examiner's hands to prevent contamination between patient and examiner. The gloves are powder-free, ambidextrous with beaded cuff, blue/purple colored, nitrile, and tested for use with chemotherapy drugs. The gloves are offered in four sizes: S, M, L, XL. The subject device is non-sterile.
The provided document describes the acceptance criteria and the results of a study for "Disposable Nitrile Inspection Gloves (Tested for Use with Chemotherapy Drugs)".
Here's the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
| Test Method | Purpose | Acceptance Criteria | Reported Device Performance (Blue Gloves) | Reported Device Performance (Purple Gloves) |
|---|---|---|---|---|
| ASTM D6319 | Physical Dimensions Test | Length(mm): S: ≥220; M/L/XL: ≥230. | (S: ≥220; M/L/XL: ≥230) - Pass | (S: ≥220; M/L/XL: ≥230) - Pass |
| Width(mm): S: 80±10; M: 95±10; L: 110±10; XL: 120±10. | S: 84-86/Pass; M: 96-98/Pass; L: 104-106/Pass; XL: 114-116/Pass | S: 88-90/Pass; M: 99-100/Pass; L: 102-104/Pass; XL: 115-117/Pass | ||
| Finger Thickness: ≥0.05 mm | 0.10-0.13 mm / Pass | 0.12-0.15 mm / Pass | ||
| Palm Thickness: ≥0.05 mm | 0.06-0.09 mm / Pass | 0.07-0.09 mm / Pass | ||
| ASTM D5151 | Watertightness Test for Detection of Holes | AQL 2.5 | 0/125 / Pass | 0/125 / Pass |
| ASTM D6124 | Powder Content | 0, ideally >240 for most drugs) | Reported Device Performance (>240 is generally considered passing for clinical relevance) | |
| ------------------- | --------------- | ------------------------------------------------------------------------------------------------- | ------------------------------------------------------------------------------------------ | |
| Carboplatin | 10.0 mg/ml | > 240 Minutes | > 240 Minutes / Pass | |
| Carmustine | 3.3 mg/ml | > 240 Minutes (implicit desired) | 18.4 Minutes / Caution (Low permeation time) | |
| Cisplatin | 1.0 mg/ml | > 240 Minutes | > 240 Minutes / Pass | |
| Cyclophosphamide | 20.0 mg/ml | > 240 Minutes | > 240 Minutes / Pass | |
| Doxorubicin HCI | 2.0 mg/ml | > 240 Minutes | > 240 Minutes / Pass | |
| Etoposide | 20.0 mg/ml | > 240 Minutes (implicit desired) | 202.7 Minutes / Caution (Low permeation time) | |
| Fluorouracil | 50.0 mg/ml | > 240 Minutes | > 240 Minutes / Pass | |
| Paclitaxel | 6.0 mg/ml | > 240 Minutes | > 240 Minutes / Pass | |
| ThioTepa | 10.0 mg/ml | > 240 Minutes (implicit desired) | 26.6 Minutes / Caution (Low permeation time) |
Chemotherapy Drug Permeation (Purple Gloves):
| Chemotherapy Drug | Concentration | Breakthrough Detection Time in Minutes (Acceptance implicitly >0, ideally >240 for most drugs) | Reported Device Performance (>240 is generally considered passing for clinical relevance) |
|---|---|---|---|
| Carboplatin | 10.0 mg/ml | > 240 Minutes | > 240 Minutes / Pass |
| Carmustine | 3.3 mg/ml | > 240 Minutes (implicit desired) | 20.9 Minutes / Caution (Low permeation time) |
| Cisplatin | 1.0 mg/ml | > 240 Minutes | > 240 Minutes / Pass |
| Cyclophosphamide | 20.0 mg/ml | > 240 Minutes | > 240 Minutes / Pass |
| Doxorubicin HCI | 2.0 mg/ml | > 240 Minutes | > 240 Minutes / Pass |
| Etoposide | 20.0 mg/ml | > 240 Minutes | > 240 Minutes / Pass |
| Fluorouracil | 50.0 mg/ml | > 240 Minutes | > 240 Minutes / Pass |
| Paclitaxel | 6.0 mg/ml | > 240 Minutes | > 240 Minutes / Pass |
| ThioTepa | 10.0 mg/ml | > 240 Minutes (implicit desired) | 33.5 Minutes / Caution (Low permeation time) |
2. Sample size used for the test set and the data provenance
The document provides details of the tests conducted but does not explicitly state the exact sample sizes for each test (e.g., number of gloves tested for physical dimensions, biocompatibility, or chemotherapy permeation). It mentions quantities like "0/125/Pass" for the watertightness test, implying 125 units were tested.
The data provenance is not specified regarding the country of origin. The study appears to be bench testing (non-clinical), meaning it was performed in a lab setting rather than with human subjects, making it akin to a controlled experimental study rather than retrospective or prospective clinical data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This section is not applicable as the document describes bench testing for physical properties, chemical permeation, and biocompatibility of gloves. These tests rely on established scientific methods and instrumental measurements, not on expert human interpretation or consensus to establish ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable as the study did not involve human interpretation or subjective assessments that would require adjudication. The performance is determined by objective measurements against predefined criteria in the 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
This is not applicable. The device is an examination glove, not an AI-assisted diagnostic or therapeutic tool. Therefore, MRMC studies and AI-related effectiveness metrics are irrelevant.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This is not applicable. The device is a physical product (gloves) 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 these tests is defined by industry standards and their specified acceptance criteria. For example:
- Physical Properties: ASTM D6319, ASTM D412 specify acceptable ranges for length, width, thickness, tensile strength, and elongation.
- Freedom from Holes: ASTM D5151 sets the Acceptable Quality Level (AQL) for watertightness.
- Powder Content: ASTM D6124 defines the maximum allowable powder.
- Biocompatibility: ISO 10993 standards define methods and acceptable responses for cytotoxicity, irritation, sensitization, and systemic toxicity.
- Chemotherapy Permeation: ASTM D6978-05 provides the standard practice for assessing breakthrough times. The "ground truth" here is the measured time until breakthrough, compared against a desired clinical threshold (e.g., >240 minutes for safe handling).
8. The sample size for the training set
This is not applicable. There is no "training set" as the device is a physical product and the study involves direct measurements and testing against specified standards, not machine learning model training.
9. How the ground truth for the training set was established
This is not applicable for the same reason as point 8.
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