FDA 510(k) Search - By Innolitics (SaMD and AI Experts)

The sterilization wrap (pouch) is a device intended to be used to enclose another medical device that is to be sterilized using ethylene oxide or steam by a health care provider. It is intended to allow sterilization via ethylene oxide or steam of the enclosed medical device and also to maintain sterility of the enclosed device until used.

Device Description

Sterilization Wrap (pouch)

AI/ML Overview

I am sorry, but based on the provided FDA letter and accompanying documents, there is no information available regarding the acceptance criteria, study details, or performance of the "Global Healthcare Self-Sealing Sterilization Pouch."

The documents primarily consist of:

An FDA 510(k) clearance letter for the device, confirming its substantial equivalence to a predicate device.
An "Indications for Use" statement for the sterilization wrap (pouch).

These documents do not contain the type of technical study data, performance metrics, or statistical analysis typically found in a clinical or validation study report. Therefore, I cannot provide the requested information.

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K Number

K954549

Device Name

SURGICAL APPAREL

Manufacturer

GLOBAL HEALTHCARE, INC.

Date Cleared

1996-04-18

(199 days)

Product Code