(210 days)
BarrierPlus® Gold Powder-free Synthetic Polyisoprene Surgical Gloves are intended to be worn by operating room personnel to protect a surgical wound from contamination.
Not Found
This document is a 510(k) clearance letter for the BarrierPlus® Gold Powder-free Synthetic Polyisoprene Surgical Glove, not a study report. Therefore, it does not contain the detailed information required to describe the acceptance criteria and the study that proves the device meets those criteria in the way a clinical study report would.
However, based on the information provided, I can infer some aspects and highlight what is missing:
Missing Information:
- Acceptance Criteria/Reported Performance: The document provides the device name and its intended use, but it does not list specific performance metrics or acceptance criteria (e.g., tensile strength, puncture resistance, barrier integrity, biocompatibility data, etc.) that would typically be required for a surgical glove. It also does not report any device performance against such criteria.
- Study Details: There is no mention of any specific study that proves the device meets acceptance criteria. The 510(k) process relies on demonstrating "substantial equivalence" to a legally marketed predicate device, rather than requiring new clinical efficacy or performance studies in all cases. The letter indicates that the FDA "reviewed your Section 510(k) premarket notification" and deemed the device substantially equivalent. This suggests that the submission included data (likely non-clinical, mechanical, and perhaps biocompatibility testing) to support this equivalence, but those specific data points and the studies that generated them are not detailed here.
Inferences based on the document:
- Device Type: Surgical Glove (Product Code: KGO, Regulation Number: 21 CFR 878.4460)
- Intended Use: "BarrierPlus® Gold Powder-free Synthetic Polyisoprene Surgical Gloves are intended to be worn by operating room personnel to protect a surgical wound from contamination."
Summary of Missing and Inferable Information:
-
Table of Acceptance Criteria and Reported Device Performance: This information is not provided in the document. Surgical gloves typically have acceptance criteria related to:
- Barrier integrity (e.g., AQL for pinholes)
- Physical properties (e.g., tensile strength, elongation, force at break)
- Dimensions (e.g., length, palm width, thickness)
- Biocompatibility (e.g., cytotoxicity, irritation, sensitization)
- Powder content (since it's powder-free)
- Sterility (if applicable)
The document only states that the device was found substantially equivalent to a predicate device, implying it met certain undisclosed performance standards.
-
Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): This information is not provided. Any testing supporting the 510(k) submission would have involved sample sizes for specific tests (e.g., AQL testing for pinholes, mechanical property testing), but these details are absent.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience): This is not applicable to a submission for a surgical glove. "Ground truth" and expert reviews are typically associated with diagnostic or image-analysis AI devices, not physical medical devices like gloves. Performance data for gloves is obtained through objective laboratory testing.
-
Adjudication method (e.g. 2+1, 3+1, none) for the test set: This is not applicable for the same reasons as point 3.
-
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 is not applicable as this is a physical medical device (surgical glove), not an AI-assisted diagnostic tool.
-
If a standalone (i.e. algorithm only without human-in-the loop performance) was done: This is not applicable as this is a physical medical device, not an algorithm.
-
The type of ground truth used (expert concensus, pathology, outcomes data, etc): This is not applicable for a surgical glove. Performance is measured against established international standards (e.g., ASTM, ISO) for glove properties.
-
The sample size for the training set: This is not applicable as there is no "training set" for a physical medical device. This term applies to machine learning/AI models.
-
How the ground truth for the training set was established: This is not applicable for the same reasons as point 8.
In summary, this document is an FDA clearance letter based on substantial equivalence, not a detailed technical report of device performance studies. The types of questions asked (e.g., ground truth, experts, training sets, MRMC studies) are characteristic of AI/diagnostic device evaluations, which do not apply to the BarrierPlus® Gold Powder-free Synthetic Polyisoprene Surgical Glove.
§ 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).