(77 days)
This Surgeon's Glove is a device made of natural rubber latex intended to be worn by operating room personnel to protect a surgical wound from contamination
CLINCARE Latex Surgical Gloves are class I powdered surgeon's gloves, powdered with absorbable dusting powder, and meet all the requirements of ASTM D 3577.
The provided text describes the acceptance criteria and performance data for the "CLINCARE Latex Surgical Gloves." This document is a 510(k) summary, which is a premarket notification to the FDA to demonstrate that a device is substantially equivalent to a legally marketed predicate device.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Characteristics | Acceptance Criteria (Standard) | Reported Device Performance |
|---|---|---|
| Dimensions | Meets ASTM D 3577-00 | Meets ASTM D 3577-00 |
| Physical Properties | Meets ASTM D 3577-00, Type I | Meets ASTM D 3577-00, Type I |
| Freedom From Holes | Meets ASTM D 3577-00 | Meets ASTM D 3577-00 |
| Biocompatibility (Primary Skin Irritation in Rabbits) | Passes | Passes |
| Biocompatibility (Guinea Pig Sensitization) | Passes | Passes |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify sample sizes for the tests conducted to meet the ASTM standards or biocompatibility. It only states that the device "meets all the requirements of ASTM D 3577." The data provenance is not explicitly mentioned (e.g., country of origin), but it's related to the manufacturing company, TTK Healthcare, Ltd., which is based in India. The studies appear to be retrospective in the sense that they are validations against established standards, not necessarily new prospective clinical trials.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the document. The acceptance criteria are based on established ASTM standards, which are developed by expert consensus within the field, but the specific experts involved in the testing of this particular device are not stated.
4. Adjudication Method for the Test Set
This information is not provided. The assessment appears to be a direct comparison against predefined quantitative and qualitative criteria within the ASTM standards and biocompatibility tests.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. This type of study is typically used for diagnostic devices involving human interpretation of images, which is not applicable to surgical gloves.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, the performance evaluation for the surgical gloves described is inherently standalone. The device (surgical glove) is tested directly against physical, mechanical, and biological standards without human interpretation in the loop. There is no "algorithm" involved, but the criteria are objective and assessed against the device's inherent properties.
7. The Type of Ground Truth Used
The ground truth used is based on established industry standards (ASTM D 3577-00) and recognized biocompatibility testing protocols. These standards define the acceptable range or pass/fail criteria for various characteristics of surgical gloves.
8. The Sample Size for the Training Set
This information is not applicable and therefore not provided. Surgical gloves are physical devices, not machine learning algorithms, so there is no "training set" in the context of AI.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable as there is no training set for a device like surgical gloves in this context.
§ 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).