On October 26, the Food and Drug Administration announced that 44 companies had withdrawn their 130 medical device registration application projects. The announcement showed that from August 26, 2016 to October 19, 2016, a total of 44 companies withdrew 130 medical treatments. Device registration application. Among them, the State Food and Drug Administration's "Notice on the Relevant Situations of Clinical Trial Supervision and Spot Checking of Four Medical Device Registration Applications" (No. 147 of 2016) has withdrawn 13 enterprises (see Annex 1); in Liaoning Province The registration application for medical device clinical trials by the Three People's Hospital, the Third Affiliated Hospital of Liaoning University of Traditional Chinese Medicine and the Third People's Hospital of Jilin Province has been withdrawn by 85 (see Annex 2); other applications for medical device registration have been withdrawn by themselves 32 (See Annex 3), the specific list is as follows: attachment1: Serial number Acceptance number product name applicant 1 CSX1600004 Alpha-fetoprotein assay kit (chemiluminescence method) Sichuan Mike Biotechnology Co., Ltd. 2 CSZ1600047 Schistosomiasis Antibody Detection Kit (Colloidal Gold Method) Sichuan Mike Biotechnology Co., Ltd. 3 CSZ1600165 ABO , RhD blood type test card (microcolumn gel method) Sichuan Mike Biotechnology Co., Ltd. 4 CSX1600002 Hepatitis C virus antibody assay kit (Chemiluminescence method) Sichuan Mike Biotechnology Co., Ltd. 5 CSZ1600166 Anti-human globulin (anti- IgG + C3d ) test card (microcolumn gel method) Sichuan Mike Biotechnology Co., Ltd. 6 Standard 15-2796 Hepatitis B virus e antigen calibrator (Chemiluminescence method) Sichuan Mike Biotechnology Co., Ltd. 7 Standard 15-2795 Hepatitis B virus e antigen control (Chemiluminescence method) Sichuan Mike Biotechnology Co., Ltd. 8 Enter  15-1886 Rheumatoid factor IgA antibody assay kit (enzyme immunoassay) ORGENTEC Diagnostika GmbH 9 Enter  15-1889 Rheumatoid factor antibody screening kit (law) ORGENTEC Diagnostika GmbH 10 Enter  15-1884 Anti-centromere B antibody assay kit (enzyme immunoassay) ORGENTEC Diagnostika GmbH 11 Enter  15-1885 Rheumatoid factor IgG antibody assay kit (enzyme immunoassay) ORGENTEC Diagnostika GmbH 12 Enter  15-1681 Anti-cyclic citrullinated peptide antibody assay kit (law) ORGENTEC Diagnostika GmbH 13 Enter  15-1683 Anti-cyclic citrullinated peptide antibody assay kit (enzyme immunoassay) ORGENTEC Diagnostika GmbH We, Jiangsu YanFang Medical Technology Co., Ltd, commenced our medical gloves manufacturing in 2020. Currently, we possess a total of 12 high-capacity NBR Glove Dipping Production Lines. Medical Exam Nitrile Gloves,Blue Disposable Nitrile Gloves,Medical Gloves,Examination Nitrile Gloves Jiangsu Yanfang Medical Technology Co.,Ltd. , https://www.yanfangchina.com
Likewise, we are not only certified with ISO9001, ISO13485 but also fully complied with the essential USFDA, CE Compliances, as well as obtaining relevant accreditation of FDA510K, EN455, and EN374.
Nonetheless, our NBR Examination, Chemotherapy, and Food Grade products are being well established in both US and Europe markets.
We look forward to cooperating and working closely with our valuable customers and stakeholders, who are seeking long-term business relationships in high-quality NBR glove supplies.