(63 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.
The Ultrafree Textured Surgical gloves are formulated using natural rubber latex and offered powder-free and sterile.
The provided document describes the Ultrafree Textured Sterile Latex Powder-Free Surgical Gloves (K983962). Here's a breakdown of the acceptance criteria and the study information:
1. Table of Acceptance Criteria and Reported Device Performance
| Test/Acceptance Criteria | Reported Device Performance |
|---|---|
| Biocompatibility: | Biocompatibility tests successfully performed on Ultrafree Surgical Gloves were considered applicable to Ultrafree Textured Surgical Glove since they are made using the same latex formulation and manufacturing process. |
| Primary Skin Irritation: | Gloves do not display any potential for irritation. |
| Systemic Toxicity: | Gloves do not elicit any toxic reactions to acute application. |
| Intracutaneous Reactivity: | Gloves show no reactivity. |
| Hemocompatibility: | Gloves are hemocompatible exhibiting no lysis. |
| Guinea Pig Maximization (for potential sensitization): | Gloves do not display any potential for irritation. (Note: "irritation" is stated here, but guinea pig maximization test typically assesses sensitization. It's possible the document uses "irritation" broadly or has a slight imprecision in language for this specific test.) |
| Physical Properties: | |
| Ultimate Elongation & Tensile Strength: | Gloves meet or exceed requirements for rubber surgical gloves per ASTM D3577-91. |
| Barrier Defects (Water Leak Test): | Gloves meet or exceed requirements per 21 CFR §800.20, AQL = 2.5. |
| Powder Level (for "Powder Free" designation): | Gloves meet powder level requirements for "Powder Free" designation using ASTM Standard D6124-97-Standard test method for residual powder on medical gloves. Results generated values below 2 mg of residual powder per glove. (Acceptance criteria is implicitly |
§ 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).