Personal Protection Kit
General Hospital · 21 CFR 880.6250
This product code has been established in accordance with the May 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.
Recent MDR events
1 adverse event reports on file
Event type breakdown
Most-reported manufacturers
Recalls
1 recall events for this product code
Registered firms
23 firms currently registered for this product code
Shaoxing Songqiao Textile Co, Ltd
Shaoxing Zhejiang, CN
Dongguan Luda Industrial Co., Ltd
Dongguan Guangdong, CN
Hynaut Health Technology Co., Ltd.
Qingdao Shandong, CN
Productos Medline S.a. De C.v.
NUEVO LAREDO Tamaulipas, MX
Sterigenics U.s., Llc
Charlotte, NC, US
An Lanh Investment And Trading Company Limited
Thanh Nam Ward Ninh Binh, VN
Jiangsu New Pentastar Medical Products Co. Ltd.
Changzhou Jiangsu, CN
Isomedix Operations Inc
El Paso, TX, US
Cardinal Health 200, Llc
El Paso, TX, US
Cardinal Health 200, Llc
Waukegan, IL, US
Hefei Juniushangmao Co.,ltd
Hefei Anhui, CN
North American Rescue, Llc.
Greer, SC, US
Acme United Corp.
Rocky Mount, NC, US
Ming Fai Enterprise International Co., Ltd
Kowloon, Hong Kong, CN
Isomedix Operations Inc
EL PASO, TX, US
Midwest Sterilization Corp.
JACKSON, MO, US
Convertors De Mexico S. De R.l. De C.v
CD.JUAREZ Chihuahua, MX
Medsource Labs, Llc
Chanhassen, MN, US
Minlong Pharmaceutical Biotechnology (shenzhen) Co., Ltd.
shenzhen Guangdong, CN
Sterigenics Us Llc
Grand Prairie, TX, US
Hubei Qianjiang Kingphar Medical Material Co., Ltd
QIANJIANG, HUBEI, CN
Medline Industries, Lp - Northfield
Northfield, IL, US
Nar Medical Depot, Llc
Greer, SC, US
510(k) clearances
0 clearances for this product code
No 510(k) clearances on file for this product code.