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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
K51-0061923-5/1/1 31-May-2007 80DWL 3006264798 I-Ming Sanitary Materials Co Ltd Taiwan
 
112-5799203-4/1/1 01-May-2007 80FMH 3005982847 Hangzhou Changtian Co Ltd China
 
JF7-0055112-6/1/1 15-May-2007 80FOZ 3004184613 Smiths Medical Ind United Kingdom
 
112-6014528-1/2/1 01-May-2007 80FPK 3003895248 Sar-Med Inc Canada
 
K51-0061923-5/2/1 31-May-2007 80FQM 3006264798 I-Ming Sanitary Materials Co Ltd Taiwan
 
112-6014528-1/1/1 01-May-2007 80JOL 3003895248 Sar-Med Inc Canada
 
112-6014528-1/3/1 01-May-2007 80KYZ 3003895248 Sar-Med Inc Canada
 
110-8222631-1/1/3 21-May-2007 80KZH 3006164886 Adolfo Fermin Mercado Rubio Mexico
 
112-5891342-7/1/1 01-May-2007 80LDQ 3007005431 MED&CARE (SHENZHEN) CO., LTD. China
 
EQ6-0006131-9/1/1 02-May-2007 80LDQ 5833 EPPENDORF AG Germany
 
D68-0048785-5/1/1 07-May-2007 80LDQ 3002619595 Brainlab AG Germany
 
EQ6-0006312-5/1/1 21-May-2007 80LDQ 5833 EPPENDORF AG Germany
 
112-6014528-1/4/1 01-May-2007 80LKB 3003895248 Sar-Med Inc Canada
 
112-9025965-6/1/1 07-May-2007 80LYY 1000153304 Brightway Holdings SDN BHD Malaysia
 
112-9025965-6/2/1 07-May-2007 80LYY 1000153304 Brightway Holdings SDN BHD Malaysia
 
KQ6-0012731-1/1/1 07-May-2007 80LYY 3001441743 Glovco (M) Sdn Bhd Malaysia
 
413-2790442-5/1/2 11-May-2007 80LYY 1000296579 Kossan Latex Industries (M) Sdn Bhd Malaysia
 
413-2790187-6/1/2 23-May-2007 80LYY 1000296579 Kossan Latex Industries (M) Sdn Bhd Malaysia
 
349-0887161-8/1/1 25-May-2007 80LYY 3004040517 Pt Haloni Jane Indonesia
 
349-0887161-8/1/2 25-May-2007 80LYY 3004040517 Pt Haloni Jane Indonesia
 
349-0887161-8/1/3 25-May-2007 80LYY 3004040517 Pt Haloni Jane Indonesia
 
349-0887161-8/1/4 25-May-2007 80LYY 3004040517 Pt Haloni Jane Indonesia
 
525-0730182-9/1/1 03-May-2007 80LYZ 3005060582 Zibo Sinocare Plastic Products Co., Ltd. China
 
525-0733231-1/1/1 08-May-2007 80LYZ 3003994600 Top Glove (Zhangjigang) Co., Ltd. China
 
112-5691223-1/1/1 22-May-2007 80LZA 1043622 Showa Best Glove Inc. United States
 
FR1-0011774-1/1/1 04-May-2007 80MEB 3000247873 Nipro Corporation Japan
 
FR1-0011803-8/2/1 29-May-2007 80MEB 3000247873 Nipro Corporation Japan
 
110-8222672-5/1/5 23-May-2007 80MEG 1000232458 Becton Dickinson De Mexico Mexico
 
FR1-0011803-8/1/1 29-May-2007 80MIA 3000247873 Nipro Corporation Japan
 
110-8329258-5/2/1 24-May-2007 80MXI 3006246457 Katherine Ortiz Colombia
 
ES3-2008645-8/1/1 17-May-2007 80NPD 3006041298 Guangdong Guangzhou Lingjiao Gloves Factory China
 
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