# K052668: OR Specific Big Case Back Table Cover

- Pathway: 510(k) (Traditional)
- Applicant: Or Specific, Inc.
- Decided: Jul 24, 2006 after 300 days
- Product code: KKX (Drape, Surgical, Antimicrobial)
- Device class: 2
- Regulation: 21 CFR 878.4370
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K931417 (1995). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K050322: Microtek Equipment Drapes, Microtek Medical, Inc. (2005) Summary page 2.
- K931417: Sterile Equipment Covers, Custom Medical Products, Ltd. (1995) Summary page 2.

## Cited in the summary but kept off the family tree
- K030206: APEX 90, We Dong Myung Dental Industrial Co., Ltd. (2003). Our reading of the summary gave K030206, FDA’s number for APEX 90 (We Dong Myung Dental Industrial Co., Ltd.). Its FDA name has none of the distinctive words the summary uses for the device it names, “Medline Band Bags and Equipment Drapes”. Kept off the family tree. Summary page 2.

## Indications for use
The OR Specific, Inc. Big Case Back Table Cover is a single use, sterile packaged operating room equipment drape that is intended to provide and maintain a barrier against contamination between the OR Specific dual adjustable shelf operating room equipment tables and a variety of surgical and non surgical equipment during various procedures in the clinical and hospital operating room environment. In normal use as directed this product will not make direct contact with a patient. The drape is available 4 models to meet user requirements. Part Number Description 420HD-S Big Case Back Table Cover (Heavy Duty) for 6' long Table (Sterile) 420-S Big Case Back Table Cover (Standard) for 6' Long Table (Sterile) 419HD-S Big Case Back Table Cover (Heavy Duty) for 5' Long Table (Sterile) 419-S Big Case Back Table Cover (Standard) for 5' Long Table (Sterile) Drapes are available in two lengths to fit 5 foot long and 6 foot long OR Specific dual adjustable shelf operating room equipment tables and each length of Drape is available in a Standard and Heavy Duty version differing in the thickness and composition of the poly film fluid barrier material used in the construction of the drape.

Source page: https://510kreport.com/device/K052668
Methodology: https://510kreport.com/methodology