(198 days)
A device made of natural rubber intended to be worn by operating room personnel to protect a surgical wound from contamination. The device has been tested for use with chemotherapy drugs.
The Encore Acclaim Sterile Powder-Free Latex Surgical Gloves, Tested for Use with Chemotherapy Drugs with a Protein Content Label Claim
The document is a 510(k) summary for the Encore® Acclaim® Sterile Powder-Free Latex Surgical Gloves. It describes the device, its intended use, and the studies conducted to demonstrate its safety and effectiveness.
Here’s a breakdown of the information requested:
1. Table of Acceptance Criteria and Reported Device Performance
| Characteristics | Standard (Acceptance Criteria) | Device Performance |
|---|---|---|
| Dimensions | ASTM D3577-09e1 | Meets |
| Physical Properties | ASTM D3577-09e1 | Meets |
| Freedom from Holes | ASTM D3577-09e1, ASTM D 5151-06 | Meets |
| Powder-Free | ASTM D 6124-06 (≤ 2 mg per glove) | ≤ 2 mg per glove |
| Protein Content | ASTM D3577-09e1, ASTM D 5712 (Maximum 50 µg/dm²) | Maximum 50 µg/dm² |
| Biocompatibility: Dermal Sensitization | (No specific standard number mentioned, but implies passing criteria) | Passes |
| Biocompatibility: Primary Skin Irritation Study | (No specific standard number mentioned, but implies passing criteria) | Passes |
| Chemotherapy Drug Permeation | ASTM D6978-05 (Breakthrough detection time in minutes) | Reported Time (minutes) |
| Vincristine Sulfate (1.0mg/mL) | (Implied >0, but no explicit minimum) | >240 |
| Carmustine (BiCNU) (3.3mg/mL) | (Implied >0, but no explicit minimum) | 1.5 |
| Cyclophosphamide (Cytoxan) (20.0mg/mL) | (Implied >0, but no explicit minimum) | >240 |
| Doxorubicin Hydrochloride (2.0mg/mL) | (Implied >0, but no explicit minimum) | >240 |
| 5-Fluorouracil (50.0mg/mL) | (Implied >0, but no explicit minimum) | >240 |
| Methotrexate (25.0mg/mL) | (Implied >0, but no explicit minimum) | >240 |
| Etoposide (Toposar) (20.0mg/mL) | (Implied >0, but no explicit minimum) | >240 |
| Paclitaxel (Taxol) (6.0mg/mL) | (Implied >0, but no explicit minimum) | >240 |
| ThioTEPA (10.0mg/mL) | (Implied >0, but no explicit minimum) | 15.26 |
2. Sample size used for the test set and the data provenance
The document does not specify the exact sample sizes used for each test (e.g., dimensions, physical properties, freedom from holes, powder-free, protein content, biocompatibility, or chemotherapy drug permeation). It mentions that the device was "tested against the ASTM standards," which would implicitly define sample size requirements within those standards, but the specific numbers are not provided in this summary.
The data provenance is from non-clinical performance data conducted by Ansell Healthcare Products LLC. There is no information provided about the country of origin of the data or whether it was retrospective or prospective, though performance testing is typically prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This type of information is generally not applicable to the performance testing of medical devices like surgical gloves. The "ground truth" for these tests is established by adhering to widely accepted, standardized testing protocols (e.g., ASTM standards) rather than expert consensus on individual cases. The results are objective measurements.
4. Adjudication method for the test set
Not applicable. The tests performed are objective, measurable outcomes based on ASTM standards. There is no subjective interpretation requiring an adjudication method.
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 a medical device for personal protection, not an AI-assisted diagnostic or interpretive tool. Therefore, MRMC studies and AI improvement effect sizes are not relevant.
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 software.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth used for demonstrating device performance consists of established, objective measurements specified by recognized industry standards (ASTM standards). For example, the ground truth for protein content is "Maximum 50 µg/dm²" as specified in ASTM D3577-09e1 and ASTM D5712. For chemotherapy drug permeation, the ground truth is the measured breakthrough time according to ASTM D6978-05.
8. The sample size for the training set
Not applicable. This device is a physical product, not a machine learning model. Therefore, there is no "training set."
9. How the ground truth for the training set was established
Not applicable. As there is no training set, this question is not relevant.
§ 878.4460 Non-powdered surgeon's glove.
(a)
Identification. A non-powdered surgeon's glove is a device intended to be worn on the hands of operating room personnel to protect a surgical wound from contamination. A non-powdered surgeon's 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).