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U.S. Department of Health and Human Services

Import Refusal Report

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Refusal Actions by FDA as Recorded in OASIS

for 80-General Hospital/Personal Use


Entry/doc/line/sfx Refusal Date Product
Code
Manufacturer
FEI
Manufacturer
Name
Manufacturer
Country/Area
112-9822389-5/1/1 07-Jan-2010 80FLL 3007392403 AMPEROR ELECTRONIC (SZ) CO., LTD China
 
336-3803114-9/2/1 14-Jan-2010 80FMF 3008019977 Jays Close United Kingdom
 
MH9-0079672-2/1/1 25-Jan-2010 80FMT 3003307657 Ningbo David Medical Device Co.,Ltd China
 
336-3803114-9/9/1 14-Jan-2010 80FPA 3008019977 Jays Close United Kingdom
 
336-3803114-9/2/2 14-Jan-2010 80FPA 3008019977 Jays Close United Kingdom
 
W16-5019429-5/1/1 14-Jan-2010 80FRF 1924066 Allied Healthcare Products Inc United States
 
FR1-0013040-5/1/1 14-Jan-2010 80FRN 3007363456 Tianjin Hanaco Xingda Medical Co., Ltd. China
 
MH9-0079672-2/1/2 25-Jan-2010 80KMI 3003307657 Ningbo David Medical Device Co.,Ltd China
 
EQ6-0010496-0/1/1 14-Jan-2010 80LDQ 5833 EPPENDORF AG Germany
 
BDF-0012156-0/3/1 13-Jan-2010 80LYY 1000254914 Zhangjiagang Dayu Rubber Products Co., Ltd. China
 
W69-3129672-8/1/1 20-Jan-2010 80LYY 3005907586 High Momentum Sdn Bhd Malaysia
 
ARE-4106048-9/2/1 23-Jan-2010 80LYY 3007697912 Happy Hands Gloves Co Thailand
 
ARE-4106048-9/1/1 23-Jan-2010 80LYY 3007697912 Happy Hands Gloves Co Thailand
 
112-5547929-1/1/1 28-Jan-2010 80LYY 1000154564 Shun Thai Rubber Gloves Industry Co., Ltd. (Factory) Thailand
 
BJV-0719729-7/1/1 28-Jan-2010 80LYY 3003256709 Latexx Manufacturing Sdn Bhd Malaysia
 
BJV-0719729-7/1/2 28-Jan-2010 80LYY 3003256709 Latexx Manufacturing Sdn Bhd Malaysia
 
BJV-0719729-7/1/4 28-Jan-2010 80LYY 3003256709 Latexx Manufacturing Sdn Bhd Malaysia
 
BJV-0719729-7/1/3 28-Jan-2010 80LYY 3003256709 Latexx Manufacturing Sdn Bhd Malaysia
 
595-4633021-4/1/1 15-Jan-2010 80LYZ 3004026632 Shen Wei (Yangzhong) Hygienical Products Co., Ltd. China
 
AEK-9647502-1/1/1 12-Jan-2010 80LZA 1000153953 Laglove Sdn Bhd (M) aka LA Glove Malaysia
 
AEK-9647502-1/1/2 12-Jan-2010 80LZA 1000153953 Laglove Sdn Bhd (M) aka LA Glove Malaysia
 
BJV-0719698-4/1/1 28-Jan-2010 80LZA 3003256709 Latexx Manufacturing Sdn Bhd Malaysia
 
BJV-0719698-4/1/4 28-Jan-2010 80LZA 3003256709 Latexx Manufacturing Sdn Bhd Malaysia
 
BJV-0719698-4/1/3 28-Jan-2010 80LZA 3003256709 Latexx Manufacturing Sdn Bhd Malaysia
 
BJV-0719698-4/1/2 28-Jan-2010 80LZA 3003256709 Latexx Manufacturing Sdn Bhd Malaysia
 
BJV-0719716-4/1/1 28-Jan-2010 80LZA 3003256709 Latexx Manufacturing Sdn Bhd Malaysia
 
BJV-0719716-4/1/2 28-Jan-2010 80LZA 3003256709 Latexx Manufacturing Sdn Bhd Malaysia
 
BJV-0719716-4/1/3 28-Jan-2010 80LZA 3003256709 Latexx Manufacturing Sdn Bhd Malaysia
 
BJV-0719760-2/1/1 28-Jan-2010 80LZA 3003256709 Latexx Manufacturing Sdn Bhd Malaysia
 
BJV-0719760-2/1/2 28-Jan-2010 80LZA 3003256709 Latexx Manufacturing Sdn Bhd Malaysia
 
BJV-0719761-0/1/2 28-Jan-2010 80LZA 3003256709 Latexx Manufacturing Sdn Bhd Malaysia
 
BJV-0719761-0/1/1 28-Jan-2010 80LZA 3003256709 Latexx Manufacturing Sdn Bhd Malaysia
 
427-7310523-6/1/1 04-Jan-2010 80MSN 3007527397 Shenzhen Technology Co Ltd China
 
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