(80 days)
A surgeon's glove is a device made of natural or synthetic rubber intended to be worn by operating room personnel to protect a surgical wound from contamination.
Sterile Powdered Latex Surgical Gloves with Protein Labeling Claim ( 200 Micrograms or Less )
This document is a letter from the FDA regarding a 510(k) premarket notification for "Sterile Powdered Latex Surgical Gloves with Protein Labeling Claim (200 Micrograms or Less)."
It is important to understand that a 510(k) notification is for demonstrating substantial equivalence to a legally marketed predicate device, not for proving a device meets specific acceptance criteria through a study with the detail you've requested for AI/software devices.
Therefore, most of the requested information regarding acceptance criteria, study design, sample sizes, expert involvement, and ground truth establishment will not be found in this document. This document focuses on the regulatory clearance process for a physical medical device (gloves), not a software or AI-driven diagnostic tool.
Information that CANNOT be Extracted from the Provided Document:
- A table of acceptance criteria and the reported device performance: This document does not detail specific performance metrics beyond the protein labeling claim.
- Sample size used for the test set and the data provenance: Not applicable to this type of device clearance.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
- Adjudication method: Not applicable.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not applicable.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is a physical device, not an algorithm.
- The type of ground truth used: Not applicable in the context of AI/software ground truth.
- The sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
Information that CAN be Extracted (and interpreted in the context of a 510(k) physical device):
1. A table of (implied) acceptance criteria and the reported device performance
While not structured as a typical "acceptance criteria" table for an AI study, the core claim being reviewed for this device is the "Protein Labeling Claim (200 micrograms or less)." The FDA's issuance of the 510(k) implies that the manufacturer provided sufficient data (likely through testing following recognized standards for surgical gloves) to substantiate this claim and demonstrate substantial equivalence to a predicate device.
| Implied "Acceptance Criteria" Category | Device Performance as per FDA Clearance |
|---|---|
| Protein Content Claim | "200 Micrograms or Less" |
| Device Type | Sterile Powdered Latex Surgical Gloves |
| Intended Use | Worn by operating room personnel to protect a surgical wound from contamination. |
| Premarket Review Outcome | Substantially Equivalent to legally marketed predicate devices. |
Summary of "Study" (as implied by a 510(k) for this device):
The "study" for a 510(k) for a physical device like surgical gloves typically involves:
- Material Characterization: Demonstrating the material properties of the gloves meet relevant standards (e.g., ASTM, ISO) for strength, elasticity, freedom from holes, etc.
- Sterility Testing: Validating the sterilization process to ensure the gloves are sterile.
- Biocompatibility Testing: Ensuring the materials are safe for skin contact, often through tests like cytotoxicity, sensitization, and irritation.
- Protein Content Testing: Specific analytical testing methods (e.g., modified Lowry method, ELISA) to quantify the amount of extractable protein to substantiate the "200 micrograms or less" claim.
- Shelf-life Testing: Stability studies to ensure the device maintains its properties over its declared shelf life.
The 510(k) process primarily relies on demonstrating that the new device is as safe and effective as a legally marketed predicate device, often by showing it meets recognized consensus standards (like ASTM D3577 for surgical gloves) and has the same technological characteristics and intended use, or that any differences do not raise new questions of safety or effectiveness. The document states a "protein labeling claim" of 200 micrograms or less, which would have been substantiated by specific testing.
§ 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).