(245 days)
The Biogel® PI UltraTouch S Surgical Glove with a Low Dermatitis Potential Claim is a disposable device made of polyisoprene, that is intended to be worn on the hands, usually in a surgical setting, to provide a barrier against potentially infectious material and other contaminants.
The Biogel® PI UltraTouch S Indicator Underglove with a Low Dermatitis Potential Claim is a disposable device made of polyisoprene, blue in color, that is intended to be worn on the hands, usually in a surgical setting, to provide a barrier against potentially infectious material and other contaminants.
Subject of this submission are two surgical gloves: a single-use, sterile, straw-colored overglove which is a disposable, powder-free surgical glove made from synthetic polyisoprene, and a single-use, sterile, blue underglove which is a disposable, powder-free surgical glove made from synthetic polyisoprene. The overglove, and underglove may be used independently or worn as a double-gloving pair if desired.
This document is a 510(k) summary for a medical device (surgical gloves) and not a study describing the validation of an AI/ML device. Therefore, the requested information regarding acceptance criteria, study design, sample sizes, expert involvement, and ground truth for an AI/ML device is not applicable and cannot be extracted from the provided text.
The document discusses the substantial equivalence of the subject devices (Biogel® PI UltraTouch S Surgical Glove and Indicator Underglove with a Low Dermatitis Potential Claim) to predicate devices already on the market. The low dermatitis potential claim is supported by non-clinical testing.
Here's what can be extracted, although it pertains to non-AI/ML device testing:
1. Acceptance Criteria and Reported Device Performance (for the non-AI/ML medical device):
The acceptance criteria for the surgical gloves are primarily defined by adherence to recognized standards and the demonstration of "Low Dermatitis Potential."
| Test/Characteristic | Acceptance Criteria (Standard/Requirement) | Reported Device Performance (Subject Device) |
|---|---|---|
| Biocompatibility | ||
| Primary Skin Irritation | ISO 10993-10:2010 (Tests for irritation and skin sensitization) | Not an irritant |
| ISO Closed Patch Sensitization | ISO 10993-10:2010 (Tests for irritation and skin sensitization) | Not a sensitizer |
| Acute Systemic Toxicity | ISO 10993-11:2010 (Tests for systemic toxicity) | No mortality or evidence of systemic toxicity from the extracts |
| Performance Test | ||
| Low Dermatitis Potential | Modified Draize-95 Test (demonstrate reduced potential for sensitizing users to chemical additives) | Demonstrated Low dermatitis potential: reduced potential for sensitizing users to chemical additives |
| Physical Characteristics | ||
| Dimensions | ASTM D3577-09(2015) requirements for length, width, and thickness | Meets ASTM D3577-09(2015) requirements for length, width, and thickness. Identical to predicate. |
| Physical Properties | ASTM D3577-09(2015) requirements for tensile strength and elongation at break before and after accelerated aging | Meets ASTM D3577-09(2015) requirements for tensile strength and elongation at break before and after accelerated aging. Identical to Predicate. |
| Freedom from holes | 21 CFR 800.20 and ASTM D3577-09(2015) requirements of AQL 1.5; ASTM D5151-06(2015) (Detection of Holes in Medical Gloves) | Exceeds 21 CFR 800.20 and ASTM D3577-09(2015) requirements of AQL 1.5. Identical to predicate. |
| Powder residual | ≤ 2.0 mg/glove for Powder-free designation per ASTM D3577-09(2015); ASTM D6124-06(2017) (Residual Powder on Medical Gloves) | Meets powder level requirements for "Powder-free" designation per ASTM D3577-09(2015). Identical to predicate. |
2. Sample size used for the test set and the data provenance:
The document refers to "studies" for biocompatibility and performance, but does not specify sample sizes for these tests. The data provenance is implied to be from testing conducted by or for the manufacturer, Mölnlycke Health Care US, LLC. The testing is described as "non-clinical," meaning it does not involve human subjects in a clinical setting when assessing device performance characteristics.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not applicable as the document describes the testing of a physical medical device (surgical gloves), not an AI/ML device requiring expert ground truth establishment for algorithm performance.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This information is not applicable as the document describes the testing of a physical medical device (surgical gloves), not an AI/ML device requiring adjudication of expert interpretations.
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:
This information is not applicable as the document describes the testing of a physical medical device (surgical gloves), not an AI/ML device. "Clinical data was not required" for this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This information is not applicable as the document describes the testing of a physical medical device (surgical gloves), not an AI/ML device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The "ground truth" for the surgical gloves is established by their adherence to defined physical, chemical, and biological performance characteristics measured against industry standards (e.g., ASTM, ISO) and specific test methodologies (e.g., Modified Draize-95 Test).
8. The sample size for the training set:
This information is not applicable as the document describes the testing of a physical medical device (surgical gloves), not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established:
This information is not applicable as the document describes the testing of a physical medical device (surgical gloves), not an AI/ML device that requires a training set and corresponding ground truth.
In summary, the provided FDA 510(k) summary is for a traditional Class I medical device (surgical gloves) and therefore does not contain the information typically associated with the validation of an AI/ML-driven 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).