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510(k) Data Aggregation
K Number
K983962Manufacturer
Date Cleared
1999-01-08
(63 days)
Product Code
Regulation Number
878.4460Type
SpecialPanel
General HospitalReference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
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.
Device Description
The Ultrafree Textured Surgical gloves are formulated using natural rubber latex and offered powder-free and sterile.
AI/ML Overview
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 |
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