Cover, Shoe, Operating-room
General, Plastic Surgery · 21 CFR 878.4040
Recent MDR events
114 adverse event reports on file
- RegardJul 27, 2026MalfunctionResource Optimization & Innovation, Llc3004513970-2026-00002
- RegardJul 27, 2026MalfunctionResource Optimization & Innovation, Llc3004513970-2026-00003
- HALYARD HI GUARD ULTRA FULL COVERAGE BOOT UNIVERSALJul 2, 2026MalfunctionO&m Halyard, Inc.3014421917-2026-00015
- HALYARD HI GUARD ULTRA FULL COVERAGE BOOTJun 4, 2026MalfunctionO&m Halyard, Inc3014421917-2026-00012
- UNKNOWN SHOE COVERJun 3, 2026MalfunctionO&m Halyard, Inc.3014421917-2026-00014
- HALYARD HI GUARD ULTRA FULL COVERAGE BOOT XLMay 5, 2026InjuryO&m Halyard, Inc.3014421917-2026-00009
- HALYARD HI GUARD ULTRA FULL COVERAGE BOOT, UNIVERSALMay 5, 2026InjuryO&m Halyard, Inc.3014421917-2026-00008
- HALYARD HI GUARD ULTRA FULL COVERAGE BOOT UNIVERSALApr 22, 2026MalfunctionO&m Halyard, Inc3014421917-2026-00007
- HALYARD HI GUARD ULTRA FULL COVERAGE BOOT UNIVERSALApr 7, 2026MalfunctionO&m Halyard, Inc.3014421917-2026-00006
- HALYARD HI GUARD ULTRA FULL COVERAGE BOOT UNIVERSALJan 15, 2026MalfunctionO&m Halyard, Inc.3014421917-2026-00001
Event type breakdown
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
291 firms currently registered for this product code
Hilo Healthcare China Co.,ltd
Lu'An Anhui, CN
Xiantao Generalcare Protection Products Co.,ltd
Xiantao City Hubei, CN
Suzhou Suning Underpad Co., Ltd.
SUZHOU, JIANGSU PROVINCE, CN
Hubei Kangning Protective Products Co., Ltd
XIanTao Hubei, CN
Tien Jiang Enterprise Co., Ltd.
TAINAN CITY, TW
Debo Medical Technology (shijiazhuang) Co., Ltd.
Shijiazhuang Hebei, CN
Yadu Medical (henan) Co., Ltd
Changyuan Henan, CN
Wuhan Zonsen Medical Products Co., Ltd
Wuhan Hubei, CN
Qing Dao Tong Hui Clothing Co., Ltd.
QING DAO, SHAN DONG Shandong, CN
Evereast Medical Products Group Co., Ltd
Changyuan City Henan, CN
Jingmen Huasheng Asia Dynamics Sanitary Products Co., Ltd.
Jingmen City Hubei, CN
Suzhou Acmed Import & Export Co., Ltd.
SUZHOU Jiangsu, CN
Copioumed International, Inc.
TAIPEI Taiwan, CN
Suzhou Hengxiang Imp. & Exp. Co., Ltd
SUZHOU Jiangsu, CN
Anhui Kangfu Industrial Foreign Trade Co.,ltd
Tianchang Anhui, CN
Hubei Yiye Plastics Co. Ltd
Tianmen Hubei, CN
Narang Medical, Ltd.
New Delhi, IN
Ningjin Runboda Medical Protective Products Co., Ltd.
Xingtai Hebei, CN
Grupo Alyger, S.a. De C.v.
Guadalupe Nuevo Leon, MX
Boen Healthcare Co., Ltd.
Suzhou Jiangsu, CN
Yearstar Healthcare Technology Co.,ltd
JIANGYIN Jiangsu, CN
Dukal Llc
Ronkonkoma, NY, US
Shanghai Alwings Medical Instrument Co.,ltd.
Shanghai, CN
Okia Vietnam Optical Co Ltd.
Tay Ninh, VN
Unisource Shanghai Ltd.
SHANGHAI, CN
510(k) clearances
36 clearances for this product code
- Primeline Medical Products, Inc.Jan 13, 1998
K971076 · PRIMED SHOE COVERS, PRIMED HEAD COVERS
- Far East Science & Technology Development Co., Ltd.Jul 10, 1997
K971191 · FAR-EAST SHOE COVERS
- Allegiance Healthcare Corp.Mar 27, 1997
K970815 · CONVERTORS IMPERVIOUS SHOE COVERS
- Copioumed Intl., Inc.Dec 30, 1996
K961342 · SHOE COVER, NON-STERILE
- Instrument Makar, Inc.Nov 19, 1996
K955835 · FLUID BARRIER BOOT KNEE & ANKLE-HIGH
- Amerasia Corp.Oct 23, 1995
K952937 · NIOMED NON-SKID SHOE COVERS
- Amerasia Corp.Oct 23, 1995
K952897 · NIOMED SHOE COVERS
- Thantex Specialties, Inc.Jan 2, 1995
K943034 · OREX SHOE COVERS