(65 days)
A device made of synthetic rubber intended to be worn by operating room personnel to protect a surgical wound from contamination and for use handling chemotherapy drugs.
Elite™ Powder Free Polyurethane Synthetic Surgical Gloves (Chemotherapy Use), meet all of the requirements of ASTM D 3577, Type 2.
Elite™ Powder Free Polyurethane Synthetic Surgical Gloves (Chemotherapy Use) meet all the current specifications for ASTM D 3577 Rubber Surgical Gloves.
Elite™ Powder Free Polyurethane Synthetic Surgical Gloves (Chemotherapy Use) are sterile disposable devices intended to be worn by operating room personnel to protect a surgical wound from contamination and for use handling chemotherapy drugs.
Here's a breakdown of the acceptance criteria and study information for the Elite™ Powder Free Polyurethane Synthetic Surgical Gloves:
1. Table of Acceptance Criteria and Reported Device Performance
| Characteristics | Acceptance Criteria (Standard) | Reported Device Performance |
|---|---|---|
| Dimensions | Meets ASTM D 3577 | Meets ASTM D 3577 |
| Physical Properties | Meets ASTM D 3577, Type 2 | Meets ASTM D 3577, Type 2 |
| Freedom from holes | Meets ASTM D 3577 | Meets ASTM D 3577 |
| Freedom from holes | Meets ASTM D 5151 | Meets ASTM D 5151 |
| Powder-Free | Meets described test in Attachment VI of K973461 | Not more than 2 mg residue by mass. |
| Biocompatibility: Primary Skin Irritation in Rabbits | Pass | Passes |
| Biocompatibility: Guinea Pig Sensitization | Pass | Passes |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the exact sample size used for the test set during the performance evaluations. It generally states that the "performance test data of the non clinical tests are the same as mentioned immediately above," referring to the ASTM standards.
The data provenance is not explicitly stated in terms of country of origin, but the testing refers to ASTM (American Society for Testing and Materials) standards, suggesting testing was conducted against these established specifications, likely in the US or by labs adhering to these standards. The testing appears to be retrospective in the sense that the results are presented as already achieved, rather than for a future study.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the document. The "ground truth" for these types of device performance tests (e.g., dimensions, physical properties, freedom from holes, biocompatibility) is typically established by objective measurements and standardized procedures, not by human expert consensus in the way clinical diagnostic products might be. The ASTM standards themselves define the methods and criteria.
4. Adjudication Method for the Test Set
This information is not applicable and therefore not provided. Adjudication methods like "2+1" or "3+1" are relevant for subjective interpretations, often in clinical studies where multiple human readers assess cases. For objective device performance tests against ASTM standards, there isn't typically a panel of adjudicators. The tests are designed to yield objective results.
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
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for AI-powered diagnostic or assistive devices where human readers (e.g., radiologists) are involved in interpreting results. The Elite™ gloves are a medical device without an AI component for interpretation.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
No, a standalone study was not done. This question is also relevant for AI-powered diagnostic or assistive devices. The Elite™ gloves are a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth used for these performance tests is based on objective measurements defined by the specific ASTM standards referenced. For example:
- Dimensions: Measured against specified tolerances in ASTM D 3577.
- Physical Properties: Determined through standardized tests (e.g., tensile strength, elongation) described in ASTM D 3577.
- Freedom from Holes: Assessed using methods outlined in ASTM D 3577 and ASTM D 5151 (e.g., water leak test).
- Powder-Free: Quantified by residue mass as per the described test in Attachment VI of K973461.
- Biocompatibility: Evaluated through standardized animal tests (rabbits for skin irritation, guinea pigs for sensitization), where "Passes" indicates compliance with established toxicity criteria.
8. The Sample Size for the Training Set
This information is not applicable and therefore not provided. The concept of a "training set" refers to data used to train machine learning models. The Elite™ gloves are a manufactured product, not an AI system.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the same reason as above.
§ 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).