(70 days)
A device made of natural rubber intended to be worn by operating room personnel to protect a surgical wound from contamination.
Encore Mark IV Powder Free Surgical Gloves (Protein Labeling Claim) are sterile disposable devices intended to be worn by operating room personnel to protect a surgical wound from contamination. Encore Mark IV Powder Free Surgical Gloves (Protein Labeling Claim), meet all of the requirements of ASTM D 3577, Type 1. Encore Mark IV Powder Free Surgical Gloves (Protein Labeling Claim) meet all the current specifications for ASTM D 3577 Rubber Surgical Gloves.
Acceptance Criteria and Device Performance Study for Encore Mark IV Powder Free Surgical Gloves
This document details the acceptance criteria and the study that demonstrates the Encore Mark IV Powder Free Surgical Gloves (Protein Labeling Claim) meet these criteria, as described in the provided 510(k) summary.
1. Table of Acceptance Criteria and Reported Device Performance
| Characteristic | Acceptance Criteria (Standard) | Reported Device Performance |
|---|---|---|
| Dimensions | Meets ASTM D 3577 | Meets ASTM D 3577 |
| Physical Properties | Meets ASTM D 3577, Type 1 | Meets ASTM D 3577, Type 1 |
| Freedom from holes | Meets ASTM D 3577 & Meets ASTM D 5151 | Meets ASTM D 3577 & Meets ASTM D 5151 |
| Powder-Free | Meets ASTM D 6124 (Not more than 2 mg residue by mass) | Meets ASTM D 6124 (Not more than 2 mg residue by mass) |
| Protein Label Claim | Not more than 50 micrograms of total water extractable protein per gram | Not more than 50 micrograms of total water extractable protein per gram |
| Biocompatibility: Primary Skin Irritation in Rabbits | Passes | Passes |
| Biocompatibility: Guinea Pig Sensitization | Passes | Passes |
2. Sample Size Used for the Test Set and Data Provenance
The provided document does not specify explict sample sizes for the test sets for each characteristic. The testing appears to be conducted on the product described, which are "Encore Mark IV Powder Free Surgical Gloves (Protein Labeling Claim)".
The data provenance is retrospective, as the submission is a 510(k) premarket notification, indicating that the product has been developed and tested. The country of origin of the data is not explicitly stated, but the submission is to the US FDA, implying testing conducted to US standards.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
Not applicable. For medical gloves, the "ground truth" is established by adherence to recognized industry standards (e.g., ASTM standards) and regulatory requirements (e.g., FDA hole requirements). These standards define objective, measurable criteria, and their application typically involves laboratory testing and interpretation of results by qualified technicians or engineers, rather than a panel of clinical experts establishing a "ground truth" through consensus in the way it would be for diagnostic imaging.
4. Adjudication Method for the Test Set
Not applicable. Adjudication methods like 2+1 or 3+1 are typically used in studies where human interpretation or subjective assessment is involved to resolve discrepancies. For the objective performance characteristics of surgical gloves, such as dimensions, physical properties, or protein content, the results are typically determined by laboratory measurements and adherence to pre-defined thresholds within the specified ASTM standards.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. Such studies are relevant for devices that aid human readers in making diagnoses or interpretations (e.g., AI for radiology). Surgical gloves are a direct-use medical device; their effectiveness is measured by their inherent physical and biological properties.
6. Standalone Performance Study
Yes, a standalone performance study was done in the sense that the device's performance was evaluated against the specified standards independent of human intervention in its "reading" or "interpretation." The tests described (e.g., for dimensions, physical properties, freedom from holes, powder-free, protein content, biocompatibility) are all evaluations of the intrinsic characteristics of the glove itself.
7. Type of Ground Truth Used
The ground truth used is objective, measurable criteria defined by recognized industry standards and regulatory requirements. Specifically:
- ASTM Standards: ASTM D 3577 (for dimensions and physical properties), ASTM D 5151 (for freedom from holes), ASTM D 6124 (for powder-free residue).
- Protein Label Claim: A defined threshold of "50 micrograms or less of total water extractable protein per gram."
- Biocompatibility Testing: "Passes" criteria for Primary Skin Irritation in Rabbits and Guinea Pig Sensitization, which are also based on established testing protocols and acceptance thresholds.
8. Sample Size for the Training Set
Not applicable. The Encore Mark IV Powder Free Surgical Gloves are a physical medical device, not an AI/machine learning algorithm. Therefore, there is no "training set" in the context of data used to train an algorithm. The manufacturing process of such gloves involves quality control and process validation, but this is distinct from training an AI model.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As stated above, 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).