TPLC - Total Product Life Cycle

• Device: drape, surgical
• Regulation Description: Surgical drape and drape accessories.
• Product Code: KKX
• Regulation Number: 878.4370
• Device Class: 2

Premarket Reviews
Manufacturer	Decision
	SUBSTANTIALLY EQUIVALENT	2
3M COMPANY
	SUBSTANTIALLY EQUIVALENT	5
A PLUS INTERNATIONAL, INC
	SUBSTANTIALLY EQUIVALENT	1
ABCO DEALERS, INC.
	SUBSTANTIALLY EQUIVALENT	3
ADVANCE MEDICAL DESIGNS, INC.
	SUBSTANTIALLY EQUIVALENT	5
APPLIED MEDICAL RESOURCES CORP.
	SUBSTANTIALLY EQUIVALENT	5
ARROW INTL., INC.
	SUBSTANTIALLY EQUIVALENT	1
AUSTIN MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	1
BAXTER HEALTHCARE CORP.
	SUBSTANTIALLY EQUIVALENT	5
BD
	SUBSTANTIALLY EQUIVALENT	1
BUSSE HOSPITAL DISPOSABLES, INC.
	SUBSTANTIALLY EQUIVALENT	4
C.R. BARD, INC.
	SUBSTANTIALLY EQUIVALENT	1
CARDINAL HEALTH
	SUBSTANTIALLY EQUIVALENT	10
CARL ZEISS MEDITEC INC
	SUBSTANTIALLY EQUIVALENT	1
CIVCO
	SUBSTANTIALLY EQUIVALENT	1
CONTOUR FABRICATORS, INC.
	SUBSTANTIALLY EQUIVALENT	1
CURRIE MEDICAL SPECIALTIES, INC.
	SUBSTANTIALLY EQUIVALENT	2
DEPUY INTL., LTD.
	SUBSTANTIALLY EQUIVALENT	1
DEROYAL
	SUBSTANTIALLY EQUIVALENT	12
DUKAL CORP.
	SUBSTANTIALLY EQUIVALENT	1
DYNAREX
	SUBSTANTIALLY EQUIVALENT	1
Eagle
	SUBSTANTIALLY EQUIVALENT	1
FERRIS MFG. CORP.
	SUBSTANTIALLY EQUIVALENT	1
INVOTEC INTERNATIONAL, INC.
	SUBSTANTIALLY EQUIVALENT	1
JOHNSON & JOHNSON
	SUBSTANTIALLY EQUIVALENT	3
JOYKEY INDUSTRIAL LTD.
	SUBSTANTIALLY EQUIVALENT	1
KENDALL
	SUBSTANTIALLY EQUIVALENT	1
KIMBERLY-CLARK CORP.
	SUBSTANTIALLY EQUIVALENT	8
LAC MAC, LTD.
	SUBSTANTIALLY EQUIVALENT	1
LIFESTREAM INT'L, INC.
	SUBSTANTIALLY EQUIVALENT	1
MEDICAL ACTION INDUSTRIES, INC.
	SUBSTANTIALLY EQUIVALENT	1
MEDIKMARK, INC.
	SUBSTANTIALLY EQUIVALENT	1
	SUBSTANTIALLY EQUIVALENT - KIT WITH DRUGS	2
MEDLINE
	SUBSTANTIALLY EQUIVALENT	6
MICROTEK MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	2
MOLNLYCKE HEALTH CARE
	SUBSTANTIALLY EQUIVALENT	3
OR SOLUTIONS
	SUBSTANTIALLY EQUIVALENT	1
PROMEDICAL PRODUCTS CO., LTD.
	SUBSTANTIALLY EQUIVALENT	3
Remington Medical, Inc.
	SUBSTANTIALLY EQUIVALENT	1
SMITH & NEPHEW, INC.
	SUBSTANTIALLY EQUIVALENT	1
STERILMED
	SUBSTANTIALLY EQUIVALENT	1
TAUT
	SUBSTANTIALLY EQUIVALENT	2
THE ANSPACH EFFORT, INC.
	SUBSTANTIALLY EQUIVALENT	1
TRINITY
	SUBSTANTIALLY EQUIVALENT	3
	SUBSTANTIALLY EQUIVALENT - KIT	2
	SUBSTANTIALLY EQUIVALENT - KIT WITH DRUGS	3
VANGUARD MEDICAL CONCEPTS, INC.
	SUBSTANTIALLY EQUIVALENT	1
VOLCANO CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
W.L. GORE & ASSOCIATES,INC
	SUBSTANTIALLY EQUIVALENT	1
WELMED INC.
	SUBSTANTIALLY EQUIVALENT	1

Device Problems
Device, or device fragments remain in patient	1
Tear, rip or hole in device packaging	1
Total Device Problems	2

Recalls
	2007	2008	2009	2010	2011	2012	2013
Class I	0	0	0	0	0	0	0
Class II	0	1	0	1	1	1	0
Class III	0	0	0	0	0	1	0

Recalls
Manufacturer		Recall Class	Date Posted
1	Kimberly-Clark Corporation	II	Nov-07-2012
2	Kimberly-Clark Corporation	III	Sep-20-2012
3	Kimberly-Clark Corporation	II	Jul-21-2011
4	Microtek Medical, Inc.	II	Dec-10-2010
5	OEC Medical Systems, Inc	II	Jul-23-2008