(43 days)
These gloves are intended to be worn by operating room personnel to protect a surgical wound from contamination in environments within hospitals and other healthcare facilities. The gloves are appropriate for use during invasive as well as non-invasive medical procedures requiring sterility. These gloves contain 50 micrograms or less of water extractable protein per gram.
Protegrity Blue Latex / Nitrile Surgical Gloves with Neu-Thera are formulated using Natural Rubber Latex. These are offered powder-free and sterile.
Here's a breakdown of the acceptance criteria and study information for the Protegrity Blue Latex / Nitrile Surgical Gloves with Neu-Thera, based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria (from predicate/standard) | Reported Device Performance |
|---|---|---|
| Primary Skin Irritation | Not explicitly stated as a numerical criterion, but implies non-irritating. | Gloves are non-irritating. |
| Guinea Pig Maximization | Not explicitly stated as a numerical criterion, but implies no sensitization potential. | Gloves do not display any potential for sensitization. |
| Ultimate Elongation & Tensile Strength | Requirements for rubber surgical gloves per ASTM D3577-01ae2. | Gloves exceed requirements for rubber surgical gloves per ASTM D3577-01ae2. |
| Barrier Defects (AQL) | Requirements per 21 CFR §800.20 and ASTM D3577-01ae2, AQL = 1.5. | Gloves exceed requirements per 21 CFR §800.20 and ASTM D3577-01ae2, AQL = 1.5. |
| Powder Level (for "Powder Free" designation) | Below 2 mg of residual powder per glove (ASTM Standard D6124-01). | Results generated values below 2 mg of residual powder per glove, meeting powder level requirements for "Powder Free" designation using ASTM Standard D6124-01. |
| Water Extractable Protein | 50 micrograms or less of water extractable protein per gram. | These latex gloves contain 50 micrograms or less of water extractable protein per gram. (Stated in intended use and claims). No specific "reported performance" value given, but claimed to meet the limit. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a distinct "test set" in the context of device performance in a clinical study as one would expect for an AI/diagnostic device. The testing described is primarily for material properties and biological reactivity.
- For physical and biological testing (Primary Skin Irritation, Guinea Pig Maximization, Ultimate Elongation & Tensile Strength, Barrier Defects, Powder Level), the sample sizes are not explicitly stated in the provided text. These tests are typically performed on representative batches of gloves according to relevant ASTM or ISO standards.
- The data provenance is from the manufacturer's internal testing (Cardinal Health), related to the manufacturing and design of the surgical gloves. It is retrospective in the sense that the data supports the premarket notification for a device that is about to be marketed, rather than being part of a prospective clinical trial.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable to the type of device and testing described. Surgical gloves do not typically involve expert interpretation of results to establish "ground truth" in the way a diagnostic imaging device would. The "ground truth" for the performance criteria (e.g., tensile strength, protein levels, barrier integrity) is established by the standardized test methods themselves and their quantitative outputs, rather than by expert consensus.
4. Adjudication Method for the Test Set
Not applicable for this type of device and testing. Adjudication methods (like 2+1, 3+1) are used for resolving discrepancies in expert interpretations, which is not relevant here.
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 surgical glove, not an AI-assisted diagnostic device. Therefore, no MRMC study with human readers and AI assistance was performed.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This is a physical medical device (surgical glove), not an algorithm or AI system.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
The ground truth for the device's performance is based on:
- Standardized Test Methods: Adherence to established ASTM (American Society for Testing and Materials) standards (e.g., D3577-01ae2 for rubber surgical gloves, D6124-01 for residual powder).
- Regulatory Requirements: Compliance with regulations outlined in 21 CFR (e.g., §800.20 for barrier defects) and the general requirements for medical devices.
- Quantitative Measurements: Direct measurements of physical properties (tensile strength, elongation), chemical properties (protein levels), and biological responses (irritation, sensitization potential) as defined by the test methods.
8. The Sample Size for the Training Set
Not applicable. This is a physical device, not a machine learning model, so there is no concept of a "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this device.
§ 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).