(77 days)
These gloves are intended to be worn by operating room personnel to protect a surgical wound from contamination in environments within hospitals and other healthcare facilities. These gloves are appropriate for use during invasive as well as non-invasive medical procedures requiring sterility.
Esteem Blue Polyisoprene Surgical Gloves with coating are formulated using Synthetic Rubber Latex. These are offered powder-free and sterile.
This document describes acceptance criteria and testing for the Esteem Blue Polyisoprene Surgical Gloves with Coating.
1. Table of Acceptance Criteria and Reported Device Performance:
| Test/Characteristic | Acceptance Criteria (Set by Regulations/Standards) | Reported Device Performance |
|---|---|---|
| Primary Skin Irritation | Not explicitly stated in the provided text, but implied as "non-irritating" for safe use. | Gloves are non-irritating. |
| Guinea Pig Maximization | Not explicitly stated in the provided text, but implied as not causing sensitization for safe use. | Gloves do not display any potential for sensitization. |
| Ultimate Elongation & Tensile Strength | Exceed requirements for rubber surgical gloves per ASTM D3577-01a2. | Gloves exceed requirements for rubber surgical gloves per ASTM D3577-01a2. |
| Barrier Defects | Exceed requirements per 21 CFR §800.20 and ASTM D3577-01a2, with an Acceptance Quality Limit (AQL) of 1.5. | Gloves exceed requirements per 21 CFR §800.20 and ASTM D3577-01a2, AQL = 1.5. |
| Powder Level | Meet powder level requirements for "Powder Free" designation using ASTM Standard D6124-01 (implied |
§ 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).