(78 days)
ULTRALON* Powder Free 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.
ULTRALON* Powder Free 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 unpigmented and are powder free. They are packaged sterile in pairs in size 5-1/2 through size 9.
This document is a 510(k) summary for ULTRALON* Powder Free Latex Surgical Gloves, which are surgical gloves, not an AI/ML device. Therefore, the requested information regarding acceptance criteria and studies related to AI/ML device performance (such as sample sizes for test/training sets, expert involvement, MRMC studies, or standalone algorithm performance) is not applicable to this submission.
The acceptance criteria provided here are for traditional medical device testing as per ASTM and FDA regulations for surgical gloves.
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria (Standard) | Reported Device Performance (Compliance) |
|---|---|---|
| Physical Properties | ||
| ASTM D-3577-91 (Rubber Surgical Gloves Standard) | Meets requirements of the standard | Product meets the requirements of the standard |
| 21 CFR 800.20 (Surgical Glove Requirements) | Meets requirements of the standard | Product meets the requirements of the standard |
| Biocompatibility | ||
| Primary Skin Irritation (in rabbit) | No irritation | No irritation |
| Delayed Contact Sensitization (in guinea pig) | No sensitization | No sensitization |
| Excipient-Related Test | ||
| USP Iodine Test (for starch) | Negative for starch | Negative for the presence of starch |
2. Sample Size Used for the Test Set and Data Provenance
Not applicable to this type of medical device which relies on laboratory testing against established standards rather than data sets for performance evaluation. The "test set" here refers to the actual manufactured gloves subjected to various physical and biological tests.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not applicable. Ground truth for these physical and biological tests is established by the specifications defined in the ASTM, CFR, and USP standards themselves, which are developed by expert committees and regulatory bodies. The evaluation is against these predefined objective criteria, not through expert consensus on individual "cases."
4. Adjudication Method for the Test Set
Not applicable. Testing involves objective measurements and observations against pre-established pass/fail criteria from recognized standards.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC study was not done as this is a surgical glove, not an AI/ML diagnostic or assistive device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable, as this is a physical medical device (surgical glove), not an algorithm.
7. The Type of Ground Truth Used
The ground truth is based on:
- Established Industry Standards: ASTM D-3577-91 for Rubber Surgical Gloves.
- Federal Regulations: 21 CFR 800.20 for Surgical Glove Requirements.
- Pharmacopoeia Standards: USP (United States Pharmacopeia) iodine test for starch.
- Biocompatibility Guidelines: Standard animal testing protocols for primary skin irritation and delayed contact sensitization.
8. The Sample Size for the Training Set
Not applicable. This is not an AI/ML device requiring a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as this is not an AI/ML 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).