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BarrierPlus® Gold Powder-free Synthetic Polyisoprene Surgical Gloves are intended to be worn by operating room personnel to protect a surgical wound from contamination.

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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:

1. 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.

2. 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.

3. 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.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: This is not applicable for the same reasons as point 3.

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 is not applicable as this is a physical medical device (surgical glove), not an AI-assisted diagnostic tool.

6. 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.

7. 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.

8. 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.

9. 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.

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BarrierPlus® Platinum Powder-free Synthetic Polychloroprene Surgical Gloves are intended to be worn by operating room personnel to protect a surgical wound from contamination.

BarrierPlus® Platinum Powder-free Synthetic Polychloroprene Surgical Gloves

This is a 510(k) premarket notification for "BarrierPlus® Platinum Powder-Free Synthetic Polychloroprene Surgical Gloves." This type of submission relies on demonstrating substantial equivalence to a predicate device rather than providing extensive clinical study data with acceptance criteria for device performance. Therefore, the traditional elements of a study proving a device meets acceptance criteria as typically found in clinical trials or AI/software validation studies are largely absent in this document.

However, I can extract information related to what would be considered "performance" in the context of a surgical glove and the regulatory process.

Based on the provided document, here's what can be inferred and what information is missing:

1. A table of acceptance criteria and the reported device performance:

Since this is a 510(k) for a surgical glove, the "performance" is primarily assessed against established standards for barrier integrity and biocompatibility, typically demonstrated through bench testing rather than clinical "performance" metrics in the way one might evaluate a diagnostic algorithm. The document doesn't explicitly state the acceptance criteria values or the reported device performance in a table, but surgical gloves are subject to specific ASTM or ISO standards for testing.

Inferred Performance Criteria (based on general surgical glove requirements):

2. Sample size used for the test set and the data provenance:

• Sample Size: Not specified in this document. For physical properties, sample sizes would be defined by the relevant ASTM or ISO standards (e.g., for AQL testing).
• Data Provenance: Not specified. Testing would typically be conducted by the manufacturer or a third-party lab.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not Applicable in the context of this 510(k) summary. This type of information is relevant for clinical studies involving expert interpretation (e.g., reading medical images). For a surgical glove, "ground truth" is established by adherence to physical and chemical standards, not expert adjudication.

4. Adjudication method for the test set:

• Not Applicable. Adjudication methods (like 2+1, 3+1) are used for resolving disagreements among human readers in a clinical setting. This is a bench-tested device.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, or an effect size of how much human readers improve with AI vs without AI assistance:

• Not Applicable. This is a physical medical device (surgical glove), not an AI/software device or a diagnostic tool that involves human readers interpreting data.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

• Not Applicable. This is a physical medical device.

7. The type of ground truth used:

• For the performance characteristics of a surgical glove, the "ground truth" is defined by established international and national standards (e.g., ASTM International, ISO standards) for physical properties (tensile strength, elongation, freedom from holes) and biocompatibility testing (e.g., ISO 10993 series). The device's performance is compared against these normative standards, often by comparison to a legally marketed predicate device that already meets these standards.

8. The sample size for the training set:

• Not Applicable. This device is not an AI/machine learning algorithm requiring a "training set."

9. How the ground truth for the training set was established:

• Not Applicable. This device is not an AI/machine learning algorithm.

Summary of what the document does provide:

• Device Name: BarrierPlus® Platinum Powder-free Synthetic Polychloroprene Surgical Gloves
• Intended Use: To be worn by operating room personnel to protect a surgical wound from contamination.
• Regulatory Classification: Class I, Product Code KGO
• Predicate Device: The substantial equivalence determination is based on a comparison to a legally marketed predicate device (not named in this snippet, but would be detailed in the full 510(k) submission). The assumption is that the new device performs as safely and effectively as the predicate by meeting relevant recognized standards.
• Regulatory Pathway: 510(k) premarket notification, indicating no new safety or effectiveness concerns compared to a predicate.

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BarrierPlus® Gold Ortho Powder-free Synthetic Polyisoprene Orthopedic Surgical Gloves are intended to be worn by operating room personnel to protect a surgical wound from contamination.

BarrierPlus® Gold Ortho Powder-free Synthetic Polyisoprene Orthopedic Surgical Glove

The provided text is a 510(k) premarket notification letter from the FDA regarding a surgical glove, not a study report for a diagnostic device or AI algorithm. Therefore, it does not contain the information required to answer your prompt. The document is an approval letter for a medical device (surgical gloves) and discusses regulatory compliance rather than performance studies or acceptance criteria in the context of device accuracy or effectiveness for diagnostic purposes.

Specifically, the document does not provide:

• A table of acceptance criteria and reported device performance.
• Sample sizes for test sets, data provenance, or details about the ground truth.
• Information on expert adjudication, MRMC studies, or standalone algorithm performance.
• Details about training sets or how ground truth for training was established.

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The Synthalon® PC Plus Powder-free Polychloroprene Examination Glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

Synthalon® PC Plus Powder-free Polychloroprene Examination Glove

This document is a 510(k) premarket notification letter from the FDA regarding a medical glove. It does not contain information about acceptance criteria or a study proving device performance in the way typically expected for an AI/ML medical device.

Therefore, I cannot provide the requested table and study details. The document is a regulatory approval for a physical medical device (examination glove) based on substantial equivalence to a predicate device, not on clinical performance metrics or AI algorithm evaluation.

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These gloves are intended for use in sterile environments within hospitals and other healthcare facilities. The gloves are appropriate for use during invasive surgical procedures as well as noninvasive activities requiring sterility. They are designed to be worn by operating room personnel to protect a surgical wound from contamination and to protect the user from blood-borne pathogens.

Synthetic Powder-Free Surgical Gloves

Unfortunately, based on the provided text, I cannot extract the specific information requested about acceptance criteria and a study proving device performance. The document is an FDA 510(k) clearance letter for "BarrierPlus™ Synthetic Powder-Free Surgical Gloves."

Here's why the requested information is not available in the provided text:

• Nature of the Document: This is a regulatory clearance letter, not a detailed technical report or study summary. It states that the device is "substantially equivalent" to previously marketed devices, meaning it doesn't need to undergo new, extensive efficacy studies if it's demonstrated to be as safe and effective as a predicate device.
• Focus of the Document: The letter confirms market clearance, lists the product code and classification, and outlines general regulatory obligations. It does not contain clinical trial data, performance metrics, or details about ground truth establishment.
• Missing Information: All the specific points you asked for (acceptance criteria table, sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, type of ground truth, training set size, training ground truth establishment) are typical components of a study report, which is not this document.

What the document does tell us about performance (indirectly):

• Indications for Use (Page 2): "These gloves are intended for use in sterile environments within hospitals and other healthcare facilities. The gloves are appropriate for use during invasive surgical procedures as well as noninvasive activities requiring sterility. They are designed to be worn by operating room personnel to protect a surgical wound from contamination and to protect the user from blood-borne pathogens."
• Substantial Equivalence: The FDA's determination of "substantial equivalence" implies that the device performs comparably to a predicate device already on the market for these indications. This process relies on comparing the new device's technological characteristics and performance data (which would have been submitted in the 510(k) application but is not in this letter) to the predicate device.

To get the information you're looking for, you would need access to the full 510(k) submission (K990710) submitted by BarrierMed Glove Company, which would contain the performance data and comparisons to predicate devices. This letter only summarizes the FDA's decision based on that submission.

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