Summit Glove Inc 2025

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The document is a 510(k) summary for the NitriTech® Non-Sterile Powdered Nitrile Examination Gloves submitted by Summit Glove Inc. It outlines the device's classification, intended use, performance data, and biocompatibility testing results. The gloves are intended for medical purposes to prevent contamination between patients and examiners and have been determined to be substantially equivalent to a predicate device. The summary includes details on compliance with ASTM standards and FDA regulations.

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What is the process of manufacturing gloves?

During glove manufacturing, a ceramic hand-shaped mold called a former is conveyed through a dipping series at 60 C. First, the formers are put through an acid and alkali wash followed by rinsing to remove dirt and residues. Then, they go through dipping, in which the first coat of a coagulant solution is applied.

What are the components of surgical gloves?

Medical gloves are made of different polymers including latex, nitrile rubber, polyvinyl chloride and neoprene; they come unpowdered, or powdered with corn starch to lubricate the gloves, making them easier to put on the hands.

How are surgical gloves manufactured?

Producing the gloves The manufacturing equipment first runs ceramic, hand-shaped formers through water and bleach to clean them and remove any residue. The formers then dry and are dipped in a mixture of calcium carbonate and calcium nitrate, which helps the synthetic materials coagulate around the formers.

Are there any nitrile glove manufacturers in the USA?

Made in America As the FIRST woman-owned and one of the largest manufacturers of AMERICAN-MADE NITRILE GLOVES, Nephron Nitrile has built a Best-In-Class, 434,000 square-foot facility on 36 acres that can produce over 3 billon gloves annually.

Who is the largest manufacturer of surgical gloves?

Kanam Latex is Indias Largest Manufacturer and Exporter of Latex Surgical gloves and Examination gloves.

What are the raw materials for surgical gloves?

The most commonly used raw materials for the production of gloves are natural rubber latex (generally referred to as latex), nitrile butadiene rubber (or simply, nitrile) and polyvinylchloride (commonly called vinyl or PVC gloves). We also use synthetic polyisoprene to manufacture certain products.

Who makes quality gloves?

Ansell is among the highly-rated glove manufacturers in the world that strive to create advanced solutions that solve healthcare specialists worries about the spread of diseases and contaminants.

Who makes rubber gloves?

Latex Glove Manufacturer Ranking RankCompanyClick Share 1 Ocelco 12.8% 2 SAE Manufacturing Specialties Corp 8.3% 3 Glove America 7.5% 4 The Safety Zone 7.5%6 more rows

Summit Glove Inc 2025

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