(86 days)
The Hinson and Hale Medical Technologies, Inc. Infused(R) Polyester Wrappers. Models PJ2020 and SP3158, are devices intended to be used to enclose another medical device that is to be sterilized by a health care provider. It is intended to allow sterilization of the enclosed medical device and also to maintain sterility of the enclosed device up until 30 days. The Hinson and Hale Medical Technologies, Inc. Infused(R) Polyester Wrappers. Models PJ2020 and SP3158. are provided non-sterile and must be processed before use. These wrappers may be reprocessed for a total of 100 uses when laundered and sterilized according to the label and instructions provided with the product. Reprocessing instructions are based on industrial laundering procedures and steam sterilization (pre-vacuum, 270oF, 4 minutes with 20 minutes drying time).
Not Found
This is a letter from the FDA regarding the 510(k) premarket notification for "Hinson and Hale Medical Technologies, Inc. Infused® Polyester Wrappers". This document is a regulatory approval letter and an indications for use statement. It does not contain information about acceptance criteria or a study proving the device meets those criteria. Therefore, I cannot generate the requested information based on the provided text.
§ 880.6850 Sterilization wrap.
(a)
Identification. A sterilization wrap (pack, sterilization wrapper, bag, or accessories, is a device intended to be used to enclose another medical device that is to be sterilized by a health care provider. It is intended to allow sterilization of the enclosed medical device and also to maintain sterility of the enclosed device until used.(b)
Classification. Class II (performance standards).