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510(k) Data Aggregation
(63 days)
These gloves are intended for use 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. They are intended to be worn by operating room personnel to protect a surgical wound from contamination.
The Ultrafree Textured Surgical gloves are formulated using natural rubber latex and offered powder-free and sterile.
The provided document describes the Ultrafree Textured Sterile Latex Powder-Free Surgical Gloves (K983962). Here's a breakdown of the acceptance criteria and the study information:
1. Table of Acceptance Criteria and Reported Device Performance
| Test/Acceptance Criteria | Reported Device Performance |
|---|---|
| Biocompatibility: | Biocompatibility tests successfully performed on Ultrafree Surgical Gloves were considered applicable to Ultrafree Textured Surgical Glove since they are made using the same latex formulation and manufacturing process. |
| Primary Skin Irritation: | Gloves do not display any potential for irritation. |
| Systemic Toxicity: | Gloves do not elicit any toxic reactions to acute application. |
| Intracutaneous Reactivity: | Gloves show no reactivity. |
| Hemocompatibility: | Gloves are hemocompatible exhibiting no lysis. |
| Guinea Pig Maximization (for potential sensitization): | Gloves do not display any potential for irritation. (Note: "irritation" is stated here, but guinea pig maximization test typically assesses sensitization. It's possible the document uses "irritation" broadly or has a slight imprecision in language for this specific test.) |
| Physical Properties: | |
| Ultimate Elongation & Tensile Strength: | Gloves meet or exceed requirements for rubber surgical gloves per ASTM D3577-91. |
| Barrier Defects (Water Leak Test): | Gloves meet or exceed requirements per 21 CFR §800.20, AQL = 2.5. |
| Powder Level (for "Powder Free" designation): | Gloves meet powder level requirements for "Powder Free" designation using ASTM Standard D6124-97-Standard test method for residual powder on medical gloves. Results generated values below 2 mg of residual powder per glove. (Acceptance criteria is implicitly < 2mg/glove as per ASTM D6124-97 for "powder-free" designation, or at least that the device met this standard). |
2. Sample size used for the test set and the data provenance
The document specifies test method standards (e.g., ASTM D3577-91, 21 CFR §800.20, ASTM D6124-97) but does not provide explicit sample sizes for the test sets used for each of these performance criteria.
Data Provenance: Not explicitly stated, but given the manufacturer is Allegiance Healthcare Sdn. Bhd. (Penang, West Malaysia) and the regulatory affairs contact is based in McGaw Park, IL, USA, the testing was likely conducted by or for the manufacturer, potentially in West Malaysia or the US. The results are presented for a 510(k) submission to the US FDA. The studies are retrospective as they were conducted to obtain regulatory clearance for an existing product design.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This device is a physical medical device (surgical gloves), not an AI/imaging device requiring expert interpretation of images. Therefore, the concept of "experts establishing ground truth for the test set" (as in clinical or radiological diagnosis) is not applicable. The "ground truth" for these tests is defined by the physical, chemical, and biological standards and their associated methodologies (e.g., ASTM standards, biocompatibility testing protocols).
4. Adjudication method for the test set
Not applicable. As this is a physical device tested against defined standards, there is no human adjudication process involved in assessing the primary performance metrics, unlike image interpretation or clinical trial endpoints. The results are quantitative measurements or qualitative observations based on laboratory assays and physical tests.
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 not an AI-powered diagnostic or assistive device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is not an AI algorithm.
7. The type of ground truth used
The ground truth used for this device's performance evaluation is based on established industry standards and regulatory requirements for medical gloves. This includes:
- ASTM (American Society for Testing and Materials) Standards:
- ASTM D3577-91 for rubber surgical gloves (for ultimate elongation and tensile strength).
- ASTM D6124-97 for residual powder on medical gloves.
- Regulatory Standards:
- 21 CFR §800.20 for barrier defects (AQL = 2.5).
- Biocompatibility Standards: Implicitly, recognized International Organization for Standardization (ISO) standards for biocompatibility (e.g., ISO 10993 series) would guide these tests, though specific ISO standards are not cited in the summary. These tests ensure the material is not cytotoxic, irritating, sensitizing, or acutely toxic.
8. The sample size for the training set
Not applicable. This is a physical medical device that does not use a "training set" in the context of machine learning or AI.
9. How the ground truth for the training set was established
Not applicable. As above, there is no "training set" for this type of device. The "ground truth" for the device's design and manufacturing is derived from established engineering principles, material science, and prior regulatory and industry best practices for similar devices.
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