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PubMed · 8088905

Disposable polyethylene wiremesh capsules for histopathological tissue processing.

Abstract

An attempt was made to find a suitable alternative material for tissue carriers other than gauze and stainless steel capsules. Since polyethylene (high density) wire mesh is resistant to all acids, alkalis and inorganic chemicals and has no known solvent at room temperature, it is a suitable alternative disposable material for histopathological tissue processing purposes.

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BibTeXRIS

A V Kumari, S Sandhyamani, A V Ramani. 1994. Disposable polyethylene wiremesh capsules for histopathological tissue processing.. https://pubmed.ncbi.nlm.nih.gov/8088905/

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Medical devices; reprocessed single-use devices; requirement for submission of validation data. Direct final rule.

The Food and Drug Administration (FDA or we) is amending certain classification regulations for reprocessed single-use devices (SUDs) whose exemption from premarket notification (510(k)) requirements have been terminated and other reprocessed SUDs already subject to premarket notification for which validation data, as specified under the Medical Device User Fee and Modernization Act of 2002 (MDUFMA), are necessary in a 510(k). Elsewhere in this issue of the Federal Register, we are publishing a companion proposed rule, under FDA's usual procedures for notice and comment, to provide a procedural framework to finalize the rule in the event we receive any significant adverse comment and withdraw the direct final rule. This action codifies actions taken in previous Federal Register notices in accordance with MDUFMA.

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