Far-East Shoe Covers

FDA 510(k) K971191 · Far East Science & Technology Development Co., Ltd.

Substantially Equivalent

510(k) numberK971191

Submission

Device name
Far-East Shoe Covers
Applicant
Far East Science & Technology Development Co., Ltd.
Garden Grove, CA, US
Received
March 31, 1997
Decision date
July 10, 1997
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
FXP – Cover, Shoe, Operating-Room
Device class
Class I (low risk)
Regulation
21 CFR 878.4040
Specialty
General, Plastic Surgery

Other 510(k)s with product code FXP

510(k)DeviceApplicantDecision
K971076Primed Shoe Covers, Primed Head CoversFXP · Traditional Primeline Medical Products, Inc.01/13/1998SE
K970815Convertors Impervious Shoe CoversFXP · Traditional Allegiance Healthcare Corp.03/27/1997SE
K961342Shoe Cover, Non-SterileFXP · Traditional Copioumed Intl., Inc.12/30/1996SE
K955835Fluid Barrier Boot Knee & Ankle-HighFXP · Traditional Instrument Makar, Inc.11/19/1996SE
K952937Niomed Non-Skid Shoe CoversFXP · Traditional Amerasia Corp.10/23/1995SE
K952897Niomed Shoe CoversFXP · Traditional Amerasia Corp.10/23/1995SE
K943034Orex Shoe CoversFXP · Traditional Thantex Specialties, Inc.01/02/1995SE
K932738Kappler Pro/Vent BootFXP · Traditional Kappler, Inc.03/29/1994SE
K925815Reusable Liquidproof BootieFXP · Traditional Amsco Sterile Recoveries, Inc.07/09/1993SE
K914702Sterile View(Tm) Knee-High Boots/Depuy Shoe BootsFXP · Traditional Depuy, Inc.01/29/1993SE

More from Depuy, Inc.

510(k)DeviceDecision
K970988Far-East Bouffant CapsLYU · Traditional 07/10/1997SE
K971702Far-East Barrier GownsFYC · Traditional 07/08/1997SE

Questions and answers

When was Far-East Shoe Covers cleared by the FDA?

Far-East Shoe Covers (K971191) received a 510(k) decision of Substantially Equivalent on July 10, 1997, 101 days after the submission was received.

What is the product code of K971191?

The FDA product code is FXP – Cover, Shoe, Operating-Room, a Class I (low risk) device regulated under 21 CFR 878.4040.