(70 days)
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):
| Performance Criterion (Inferred) | Acceptance Criteria (Typical for Surgical Gloves) | Reported Device Performance (Not explicitly stated in this document, but implied to meet predicate standards) |
|---|---|---|
| Freedom from Holes | AQL (Acceptable Quality Limit) of 1.5 or 2.5 | Implied to meet AQL for surgical gloves |
| Tensile Strength | Meets or exceeds specified standards (e.g., ASTM D412) | Implied to meet predicate device's performance |
| Elongation at Break | Meets or exceeds specified standards (e.g., ASTM D412) | Implied to meet predicate device's performance |
| Puncture Resistance | Meets or exceeds specified standards | Implied to meet predicate device's performance |
| Biocompatibility (Dermal Sensitivity) | Non-irritating, non-sensitizing | Implied to be non-irritating/non-sensitizing |
| Powder-Free Status | Meets powder residue limits (if applicable) | Stated as "Powder-Free" |
| Sterility (if applicable) | Sterility Assurance Level (SAL) | Not explicitly mentioned but surgical gloves are typically sterile |
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.
§ 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).