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510(k) Data Aggregation
(28 days)
A powder-free sterile surgeon's glove is a disposable device made of natural rubber intended to be worn by operating room personnel to protect a surgical wound from contamination.
The proposed device is a disposable device intended for over the counter use and is provided powder-free and sterile. The glove is made with natural rubber latex and is cream in color. The glove is manufactured using molds that feature independent thumb and tapered mechanically locking cuffs to help reduce cuff roll down.
Here's a summary of the acceptance criteria and study information for the Protexis™ Latex Basic, Sterile Latex Powder-Free Surgical Gloves (Cream), based on the provided text:
Acceptance Criteria and Device Performance
The device is a modified version of an already cleared predicate device (K120934). The primary modification is the removal of colorant from the glove formulation. The acceptance criteria and performance are based on meeting established industry standards for surgical gloves and demonstrating substantial equivalence to the predicate device.
1. Table of Acceptance Criteria and Reported Device Performance
| Characteristic / Acceptance Criteria | Standard/Test/FDA Guidance | Reported Device Performance (Modified Device) |
|---|---|---|
| Material Composition | N/A (Comparative Characteristic) | Sterile Latex Powder-Free Surgical Gloves with Protein Content Label Claim of 50 µg/dm² or less (Cream) |
| Design | N/A (Comparative Characteristic) | Single Use, Sterile, Powder-free, Hand Specific, Independent Thumb, Beaded Cuff, Lubricated |
| Intended Use/Indications for Use | N/A (Comparative Characteristic) | Powder-Free Surgeon's Glove |
| Dimensions & Physical Properties | ASTM D3577 | Meet requirements |
| Freedom from Holes (AQL) | 21 CFR 800.20 & ASTM D3577 (Tested per ASTM D5151) | Meets requirements (acceptable results) |
| Powder Residual | ASTM D3577 (Tested per ASTM D6124) | Meets requirements of ≤2.0 mg/glove for "Powder-Free" designation. Results generated values < 2mg of residual powder per glove. |
| Protein Content | ASTM D5712, FDA Medical Glove Guidance Manual | Contains less than 50 µg/dm² of total water extractable protein per glove |
| Biocompatibility: Primary Skin Irritation | ISO 10993-10 | Meets requirements |
| Biocompatibility: Guinea Pig Maximization (Sensitization) | ISO 10993-10 | Meets requirements |
| Biocompatibility (General) | ISO 10993-1 | Meets requirements |
2. Sample size used for the test set and the data provenance:
The provided document does not explicitly state the specific sample sizes used for each individual test (e.g., number of gloves tested for dimensions, holes, protein content). It refers to compliance with established ASTM and ISO standards, which would typically specify sampling plans.
The data provenance is non-clinical performance testing, conducted by the manufacturer, Cardinal Health, in the context of a 510(k) submission to demonstrate substantial equivalence to a predicate device. The document does not provide details on country of origin of the data beyond "Cardinal Health" as the applicant.
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 information is not applicable as the device is a medical glove, and the "ground truth" is established by adherence to recognized performance standards (ASTM, ISO) and laboratory testing methodologies, not by expert interpretation of images or clinical data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This information is not applicable. Adjudication methods are typically relevant for studies involving subjective human interpretation (e.g., clinical trials or diagnostic accuracy studies) to resolve disagreements among observers. For physical and chemical testing of a medical device like a glove, the results are typically quantitative measurements against defined criteria.
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 information is not applicable. An MRMC study is relevant for evaluating diagnostic imaging or AI-assisted diagnostic tools. This submission pertains to surgical gloves, which do not involve human readers interpreting cases or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
This information is not applicable. This is not an AI-based device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
The "ground truth" for the device's performance is based on objective measurements and results from standardized laboratory tests that demonstrate compliance with national and international standards (ASTM D3577, 21 CFR 800.20, ASTM D5151, ASTM D6124, ASTM D5712, ISO 10993-1, ISO 10993-10). The predicate device's prior clearance serves as the benchmark for substantial equivalence.
8. The sample size for the training set:
This information is not applicable. This is not a machine learning or AI-driven device, so there is no "training set." The device is manufactured according to specifications and tested against standards.
9. How the ground truth for the training set was established:
This information is not applicable as there is no training set for this device.
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