# K041501: Guangzhou Fortunique Drapes, Bags and Covers

- Pathway: 510(k) (Traditional)
- Applicant: Guangzhou Fortunique, Ltd.
- Decided: Nov 30, 2004 after 176 days
- Product code: MMP (Cover, Barrier, Protective)
- Device class: 2
- Regulation: 21 CFR 878.4370
- Recalls of this device: 6 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K931417 (1995). 11 ancestors in all.
No later device cites it as a predicate yet.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K032065: Medline Band Bags and Equipment Covers, Medline Industries, Inc. (2003) Summary page 1.
- K022868: Primagard Surgical Equipment Drapes, Primeline Medical Products, Inc. (2002) Summary page 1.
- K023540: Snap Kover, Model 01-2020; Snap Kaps, Model 03-KP09, Valumed (2003) Summary page 1.
- K014239: Medsurg Equipment Covers, International Medsurg Connection (2002) Summary page 1.
- K961699: Equipment Covers, United States Surgical, A Division of Tyco Healthc (1996) Summary page 1.
- K962288: Cover-All, Drape-IT-All, Chair Sleve, X-Ray Sleeve, Headrest Cover, Pinnacle Products, Inc. (1997) Summary page 1.

## Recalls of this device
- Jan 7, 2020 · Class II · Z-1926-2020: Sterile drapes packaged in an unsealed pouch.
- Jun 27, 2017 · Class II · Z-3234-2017: The sterile drape material may contain a pinhole compromising its integrity resulting in a breach of the sterile barrier.
- Jun 27, 2017 · Class II · Z-3236-2017: The sterile drape material may contain a pinhole compromising its integrity resulting in a breach of the sterile barrier.
- Jun 27, 2017 · Class II · Z-3235-2017: The sterile drape material may contain a pinhole compromising its integrity resulting in a breach of the sterile barrier.
- Jan 23, 2017 · Class II · Z-1409-2017: Sterility compromised due to breach in sterile barrier
- Jan 23, 2017 · Class II · Z-1408-2017: Sterility compromised due to breach in sterile barrier

## Indications for use
Guangzhou Fortunique's Drapes, Bags and Covers are intended to cover equipment, to maintain a sterile field and as an aid in the clean up of equipment after surgery or other medical procedures. These drapes, bags and covers are not intended to be used as patient drapes and they have no patient contact. Fortunique intends to manufacture and market Drapes, Bags and Covers sterile in ready to use form and will also provide them in non-sterile form to other companies for inclusion in convenience packages which they will then sterilize.

Source page: https://510kreport.com/device/K041501
Methodology: https://510kreport.com/methodology