# K102864: 84E Series Single Ply Wrapper

- Pathway: 510(k) (Traditional)
- Applicant: Lac Mac, Ltd.
- Decided: Jan 14, 2011 after 106 days
- Product code: FRG (Wrap, Sterilization)
- Device class: 2
- Regulation: 21 CFR 880.6850
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Indications for use
The Lac-Mac Ltd. 84E Series Single Ply Wrappers are devices intended to be used to enclose another medical device that is to be sterilized by a health care provider. They are intended to allow sterilization of the enclosed medical device and also to maintain sterility of the enclosed medical device for at least 30 days. The Lac-Mac Ltd. 84E Series Single Ply Wrappers 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 (prevacuum, 270TF, 4 minutes with 40 minutes drying time).

Source page: https://510kreport.com/device/K102864
Methodology: https://510kreport.com/methodology