# K964364: Disposable Apron

- Pathway: 510(k) (Traditional)
- Applicant: Instrument Makar, Inc.
- Decided: Feb 25, 1997 after 116 days
- Product code: LYU (Accessory, Surgical Apparel)
- Device class: 1
- Regulation: 21 CFR 878.4040
- 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 summary cites one number, which could not be confirmed as its predicate (listed below).
- (no number) Sloan Medical, Disposable Surgical Jumpsuit: named in the summary without a submission number

## Cited in the summary but kept off the family tree
- K960264: Conmed Ekg Stripper, Conmedcorp (1996). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Indications for use
The Disposable Apron will be used in indications which are the same for that of other aprons. Specifically, the Disposable Apron is intended to be used in the hospital environment to protect the healthcare worker from the transfer of micro-organisms, blood, body fluids and particulate material between the worker and the patient. The Disposable Apron is a disposable product intended for single use only.

Source page: https://510kreport.com/device/K964364
Methodology: https://510kreport.com/methodology