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510(k) Data Aggregation
(106 days)
These gloves are intended to be worn by operating room personnel to protect a surgical wound from contamination in environments within hospitals and other healthcare facilities. The gloves are appropriate for use during invasive as well as non-invasive medical procedures requiring sterility.
Latex Surgical Gloves are formulated using Natural Rubber Latex. These are offered powder-free and sterile. Protein Labeling Claim of 50 mcg or less of total water extractable protein
This document describes the safety and effectiveness of Cardinal Health's Polymer Coated Sterile Powder-Free Latex Surgical Gloves (Trade Name: Triflex Select), which received 510(k) clearance (K070647) by demonstrating substantial equivalence to a predicate device.
Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria (from referenced standards) | Reported Device Performance |
|---|---|---|
| Primary Skin Irritation | Not explicitly stated, but implied as "non-irritating" | Gloves are non-irritating. |
| Guinea Pig Maximization (Sensitization) | Not explicitly stated, but implied as "no potential for sensitization" | Gloves do not display any potential for sensitization. |
| Ultimate Elongation & Tensile Strength | Exceed requirements per ASTM D3577-01 (Standard Specification for Rubber Surgical Gloves) | Gloves exceed requirements for rubber surgical gloves per ASTM D3577-01. |
| Barrier Defects (Watertightness) | Exceed requirements per 21 CFR §800.20, AQL 2.5 and ASTM D3577-01, AQL = 1.5 | Gloves meet AQL of 1.0 (indicating better performance than the required AQLs of 1.5 and 2.5, where lower AQL is better). |
| Powder Level | Meet "Powder Free" designation using ASTM D6124-01 (residual powder below 2 mg per glove) | Gloves meet powder level requirements for "Powder Free" designation using ASTM D6124-01-Standard test method for residual powder on medical gloves. Results generated values below 2 mg of residual powder per glove. |
| Protein Labeling Claim | 50 mcg or less of total water extractable protein | 50 mcg or less of total water extractable protein (explicitly stated in the device name and description, implying it met this claim). |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample sizes used for each specific test (e.g., number of gloves tested for barrier defects, number of animals for irritation/sensitization). The data provenance is not specified beyond the tests being conducted to meet established ASTM and CFR standards, which are general US regulatory and industry standards. It is implied these are results from device testing, likely conducted retrospectively for the purpose of the 510(k) submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not applicable to this submission. This device is a surgical glove, and its performance is evaluated against objective, standardized physical, chemical, and biological tests (e.g., ASTM standards, FDA regulations for barrier defects, irritation/sensitization studies). The "ground truth" for these tests is defined by the objective pass/fail criteria of the specified standards and methods, not by expert consensus or interpretation of images/data as would be the case for diagnostic AI devices.
4. Adjudication Method for the Test Set
This is not applicable as the evaluation relies on objective measurements against pre-defined criteria, not subjective interpretation requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. These studies are typically conducted for interpretive diagnostic devices where human readers' performance is compared with and without AI assistance. This device is a surgical glove, and its effectiveness is determined by its physical and biological properties.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
N/A. This device is a physical product (surgical glove), not an algorithm or software. Therefore, the concept of "standalone performance" for an algorithm is not applicable. The device's "standalone" performance is its intrinsic ability to meet the physical and biological specifications when tested directly.
7. The Type of Ground Truth Used
The "ground truth" for this device is based on:
- Performance Standards: Compliance with established industry standards (e.g., ASTM D3577-01 for physical properties, ASTM D6124-01 for powder level) and FDA regulations (e.g., 21 CFR §800.20 for barrier defects).
- Biological Testing Results: Outcomes from standardized primary skin irritation and guinea pig maximization tests.
- Chemical Analysis: Measurement of total water extractable protein.
These are objective, measurable criteria, not expert consensus or pathology in the context of medical images or diagnoses.
8. The Sample Size for the Training Set
This is not applicable. This device is a physical product, not an AI/ML algorithm that requires a training set. The performance data presented are from testing carried out on the manufactured product.
9. How the Ground Truth for the Training Set Was Established
This is not applicable as there is no training set for a physical device like a surgical glove.
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