(187 days)
These gloves are intended for use 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. They are intended to be worn by operating room personnel to protect a surgical wound from contamination.
Ultraderm Surgical gloves are formulated using natural rubber latex and contain 50 micrograms or less of total water extractable protein per gram
Here's a breakdown of the acceptance criteria and study information for the Ultraderm Sterile Latex Surgical Gloves with Protein Content Labeling Claim, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Primary Skin Irritation | No potential for irritation | Biocompatibility tests were successfully performed on Ultraderm Surgical Gloves with Protein Content Labeling Claim. Gloves do not display any potential for irritation. |
| Systemic Toxicity | No toxic reactions to acute application | Gloves do not elicit any toxic reactions to acute application. |
| Intracutaneous Reactivity | No reactivity | Gloves show no reactivity. |
| Hemocompatibility | No lysis | Gloves are hemocompatible exhibiting no lysis. |
| Guinea Pig Maximization | No potential for irritation | Gloves do not display any potential for irritation. |
| Ultimate Elongation & Tensile Strength | Meet or exceed requirements for rubber surgical gloves per ASTM D3577-98 | Gloves meet or exceed requirements for rubber surgical gloves per ASTM D3577-98. |
| Barrier Defects | Meet or exceed requirements per 21 CFR §800.20, AQL = 2.5 | Gloves meet or exceed requirements per 21 CFR §800.20, AQL = 2.5. |
| Protein Content Labeling Claim | 50 micrograms or less of total water extractable protein per gram | Gloves meet requirements for protein claim of 50 micrograms or less of water extractable protein per gram. |
Missing Information (Not Available in the Provided Text):
The provided text does not contain information regarding the following aspects, as it pertains to a medical device and not an AI/software-based device performance study:
- Sample size used for the test set and the data provenance
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Adjudication method for the test set
- If a multi reader multi case (MRMC) comparative effectiveness study was done, and the effect size
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The sample size for the training set
- How the ground truth for the training set was established
This is expected as the document describes the substantial equivalence of a physical medical device (surgical gloves) and not a software algorithm or AI-powered system, which would typically involve such detailed study designs. The "studies" described are biocompatibility and physical property tests for the gloves themselves.
§ 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).