# K971920: Gown Poly Reinforced Large (Product NO.900-522)/(Reorder NO. 0522)

- Pathway: 510(k) (Traditional)
- Applicant: Customed, Inc.
- Decided: Dec 4, 1997 after 195 days
- Product code: FYA (Gown, Surgical)
- Device class: 2
- Regulation: 21 CFR 878.4040
- Recalls of this device: 10 (0 Class I)
- 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. FDA’s file for it is a 510(k) statement, which names no predicate.

## Recalls of this device
- Jan 7, 2016 · Class II · Z-1475-2016: Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
- Jan 7, 2016 · Class II · Z-1465-2016: Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
- Jan 7, 2016 · Class II · Z-1474-2016: Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
- Jul 10, 2015 · Class II · Z-2684-2015: Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
- Jul 10, 2015 · Class II · Z-2683-2015: Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
- Jul 10, 2015 · Class II · Z-2668-2015: Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
- Jul 10, 2015 · Class II · Z-2595-2015: Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
- Jul 10, 2015 · Class II · Z-2642-2015: Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
- Jul 10, 2015 · Class II · Z-2644-2015: Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
- Jul 10, 2015 · Class II · Z-2643-2015: Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.

## Indications for use
Surgical apparel that are intended to be worn by operating room personnel during surgical procedures to protect both the patient and personnel from transfer of microorganisms, body fluids and particulate material.

Source page: https://510kreport.com/device/K971920
Methodology: https://510kreport.com/methodology