(124 days)
Ultrafree Sterile Latex Powder-Free Surgical Gloves are intended for use in sterile environments within hospitals and other healthcare facilities. The gloves are appropriate for use during invasive surgical procedures and non-invasive medical procedures requiring sterility. They are intended to be worn by operating room personnel to protect a surgical wound from contamination
The Ultrafree Surgical gloves are formulated using natural rubber latex and offered sterile.
Here's an analysis of the provided text regarding the Ultrafree Sterile Latex Powder-Free Surgical Gloves, focusing on acceptance criteria and study details. It's important to note that the document describes a 510(k) submission for a medical device (surgical gloves), which has different types of "acceptance criteria" and "studies" compared to AI/software-as-a-medical-device (SaMD) clearances. Therefore, the questions designed for SaMDs will be addressed in the context of this traditional medical device.
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Requirement) | Reported Device Performance |
|---|---|
| Biocompatibility: | |
| Primary Skin Irritation: No potential for irritation | Glove does not display any potential for irritation. |
| Systemic Toxicity: No toxic reactions to acute application | Glove does not elicit any toxic reactions to acute application. |
| Intracutaneous Reactivity: No reactivity | No reactivity was observed. |
| Hemocompatibility: Hemocompatible, no lysis | Gloves are hemocompatible exhibiting no lysis. |
| Guinea Pig Maximization: No potential for irritation | Glove does not display any potential for irritation. |
| Physical Properties: | |
| Ultimate Elongation & Tensile Strength: Meets or exceeds ASTM D3577-91 requirements for rubber surgical gloves | Glove meets or exceeds requirements for rubber surgical gloves per ASTM D3577-91. |
| Barrier Defects: Meets or exceeds 21 CFR §800.20, AQL = 2.5 | Glove meets or exceeds requirements per 21 CFR §800.20, AQL = 2.5. |
| Powder Level: Meets "Powder Free" designation (below 2 mg/glove cornstarch, negative iodine test) | Glove meets powder level requirements for "Powder Free" designation using the vacuum filtration method plus a negative iodine test. Results generated values below the 2 mg/glove cornstarch level including negative iodine test. |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not explicitly state the sample sizes for each specific test (e.g., number of gloves tested for tensile strength, number of animals for biocompatibility tests). However, these types of tests are typically conducted with standardized sample sizes as dictated by the relevant ASTM standards or regulatory guidelines for biocompatibility.
- Data Provenance: The tests would have been conducted by or for Allegiance Healthcare Sdn. Bhd. (located in Penang, West Malaysia) and/or its parent company, Allegiance Healthcare Corporation (USA). The data would be prospective, as these are tests conducted specifically to support the 510(k) submission for this device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts:
This question is not applicable in the context of this device. Surgical gloves are physical products, and their performance is evaluated through standardized physical, chemical, and biological tests, not through expert consensus on interpretations like medical images. The "ground truth" is defined by the objective measurement or observation against a predefined standard (e.g., ASTM D3577-91 for tensile strength, or observed biological reactions in animal models for biocompatibility).
4. Adjudication Method for the Test Set:
Not applicable. As described above, the evaluation of surgical gloves is based on objective measurements and observations against established standards, not on subjective interpretations requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done:
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic imaging devices or AI systems where human readers interpret medical cases. Surgical gloves do not involve human interpretation of "cases." The "comparative effectiveness" for these gloves is established by demonstrating substantial equivalence to a predicate device (Triflex® Sterile Latex Powder-Free Surgical Gloves) based on their physical and biological properties.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Not applicable. This device is a physical product (surgical gloves), not an algorithm or AI system.
7. The Type of Ground Truth Used:
The "ground truth" for this device's performance is based on:
- Standardized Test Methods and Criteria: For physical properties, this includes meeting or exceeding requirements of standards like ASTM D3577-91 and 21 CFR §800.20.
- Biological Endpoints: For biocompatibility, it involves observable biological reactions (or lack thereof) in animal models or in vitro tests (e.g., no irritation, no toxicity, no lysis).
- Chemical Analysis: For powder levels, it involves quantitative chemical analysis (vacuum filtration method and negative iodine test).
8. The Sample Size for the Training Set:
Not applicable. This device is not an AI/ML algorithm that requires a "training set."
9. How the Ground Truth for the Training Set Was Established:
Not applicable. As this is not an AI/ML device, there is no "training set" or establishment of ground truth for such a set.
§ 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).