(76 days)
NEUTRALON* PF* Powder Free Brown Latex Surgical Gloves are intended to protect the wearer from liquids such as body fluids and blood, as well as to protect surgical wounds or sterile fields from microbiological contamination from the wearer.
NEUTRALON* PF Powder Free Brown Latex Surgical Gloves meet the description of Rubber Surgical Gloves as described in American Society for Testing Materials (ASTM D 3577-91) as Type 1 gloves compounded primarily from natural rubber latex. They are brown in color and are powder free. They are packaged sterile in pairs in size 5-1/2 through size 9.
The provided text describes a 510(k) submission for NEUTRALON* PF POWDER FREE BROWN LATEX SURGICAL GLOVES. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, not for proving a new device meets specific, novel acceptance criteria through extensive clinical studies. Therefore, many of the requested details about acceptance criteria, clinical study design, and AI performance will not be applicable or available in this document.
However, I can extract the information that is present:
1. Table of Acceptance Criteria and Reported Device Performance
The device is evaluated against existing standards for rubber surgical gloves. The "acceptance criteria" are implicitly the requirements of these standards.
| Acceptance Criteria (Standard) | Reported Device Performance |
|---|---|
| ASTM D-3577-91 requirements | Product meets the requirements of this standard. |
| 21 CFR 800.20 requirements | Product meets the requirements of this standard. |
| Primary skin irritation (rabbit) | No irritation. |
| Delayed contact sensitization (guinea pig) | No sensitization. |
| Surface extractable particulates (per glove) | Not more than 2 mg. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not specified in the provided text.
- Data Provenance: Not specified, but generally, testing for compliance with ASTM and CFR standards would be conducted in a laboratory setting. This would be considered non-clinical, controlled testing, not human-patient data from a specific country.
- Retrospective or Prospective: N/A for this type of non-clinical testing.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
N/A. Ground truth for these types of non-clinical, performance-based tests is established by objective measurements against a standard, not by expert consensus on clinical findings.
4. Adjudication Method for the Test Set
N/A. This is not applicable to the non-clinical testing described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
No. This is a non-clinical device (surgical glove) and does not involve human readers interpreting images or data, nor does it have an AI component.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No. This is a physical medical device (surgical glove), not an algorithm or AI.
7. The Type of Ground Truth Used
The "ground truth" for the non-clinical tests is the established specifications and limits defined by ASTM D-3577-91 and 21 CFR 800.20 for surgical gloves, as well as the results of standard animal safety tests (skin irritation, sensitization).
8. The Sample Size for the Training Set
N/A. There is no "training set" as this device does not involve machine learning or AI.
9. How the Ground Truth for the Training Set Was Established
N/A. There is no training set for this device.
§ 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).