FDA 药品与器械查询
实时对接美国 FDA 官方开放数据（openFDA），可查询美国上市药品 NDC 目录、医疗器械管理类别与 21 CFR 法规号、以及已获许可的 510(k) 清单，用于出海美国的准入判断、注册路径选择与同类竞品调研。支持中文关键词自动转英文检索。
数据源：美国 FDA 官方开放数据平台 openFDA，实时查询美国上市药品 NDC 目录、器械分类与 510(k) 许可，用于出海美国的准入与合规自查。
支持中文关键词自动转英文检索；此为美国监管口径，与中国 NMPA 批准情况相互独立。
查询器械在 FDA 的管理类别（I/II/III 类）、产品代码与 21 CFR 法规号，是判断注册路径（豁免 / 510(k) / PMA）的第一步。
已将中文关键词转为英文「glove」检索 FDA 数据库。
共找到 11 条与「glove」匹配的结果
当前展示 11 条FDA 器械分类记录； 海关数据库提供全球买卖明细与竞争对手出货记录咨询完整数据 ›
| 器械名称 | 管理类别 | 产品代码 | 法规号（21 CFR） | 所属科室 | 定义 / 用途 |
|---|---|---|---|---|---|
| Polymer Patient Examination Glove | I 类 | LZA | 21 CFR 880.6250 | General Hospital | A nitrile (or polymer) patient examination glove is a disposable device made of nitrile rubber or synthetic polymers that may or may not bear a trace amount of residual powder, and is intended to be worn on the hand for medical purposes to provide a barrier against potentially infectious materials and other contaminants. |
| Powder-Free Polychloroprene Patient Examination Glove | I 类 | OPC | 21 CFR 880.6250 | General Hospital | A powder free polychloroprene patient examination glove is a disposable device made of polychloroprene rubber tthat bears powder to facilitate donning, and is intended to be worn on the hand for medical purposes to provide a barrier against potentially infectious materials and other contaminants. |
| Latex Patient Examination Glove | I 类 | LYY | 21 CFR 880.6250 | General Hospital | A latex patient examination glove is a disposable device made of natural rubber latex that may or may not bear a trace amount of residual powder, and is intended to be worn on the hand for medical purposes to provide a barrier against potentially infectious materials and other contaminants. |
| Radiation Attenuating Medical Glove | I 类 | OPH | 21 CFR 880.6250 | General Hospital | Radiations attenuating medical gloves are medical gloves that are used during medical or surgical procedures involving radiation to shield the hands of the wearer from scattered radiation exposure. The gloves offer some degree of protection to the hand from radiation exposure as well as protection from transmission of infectious agents. The use of these gloves includes procedures that require the use of fluoroscopy or radiography. In addition to meeting the requirements for examination or surgeon¿s gloves, manufacturers should have technical data to show that their attenuation claims meet the energy range of x-rays normally used in medical procedures. |
| Patient Examination Glove | I 类 | FMC | 21 CFR 880.6250 | General Hospital | |
| Anaerobic Box Glove | I 类 | JTM | 21 CFR 866.2120 | Microbiology | |
| Vinyl Patient Examination Glove | I 类 | LYZ | 21 CFR 880.6250 | General Hospital | A vinyl patient examination glove is a disposable device made of poly(vinyl chloride) that may or may not bear a trace amount of residual powder, and is intended to be worn on the hand for medical purposes to provide a barrier against potentially infectious materials and other contaminants. |
| Medical Glove, Specialty | I 类 | LZC | 21 CFR 880.6250 | General Hospital | A disposable medical glove (examination or surgeons) is a device that may or may not bear a trace amount of residual powder and is intended to be worn on the hand or finger(s) for medical purposes to prevent contamination. In addition, these gloves may have specialty claims such as chemotherapy, etc. |
| Powder-Free Guayle Rubber Examination Glove | I 类 | OIG | 21 CFR 880.6250 | General Hospital | A disposable patient examination glove made from guayule natural rubber latex. This alternative source of natural rubber latex (guayale) does not contain the same protein associated with allergic reactions to latex products from the hevea rubber tree. This device is intended to be worn on the hand for medical purposes to provide a barrier against potentially infectious materials and other contaminants. |
| Radiographic Protective Glove | I 类 | IWP | 21 CFR 892.6500 | Radiology | A protective radiographic glove is a "personnel protective shield." The gloves are intended to protect the operator, patient, or other person from unnecessary exposure to radiation during radiological procedures by providing an attenuating barrier to radiation. Note: These devices are not patient examination gloves or surgeon's gloves. - |
| Fentanyl And Other Opioid Protection Glove | I 类 | QDO | 21 CFR 880.6250 | General Hospital | A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. Fentanyl and other opioid protection gloves are tested for use with chemotherapy drugs, Fentanyl Citrate, and possibly other opioids per ASTM D6978-05 (Reapproved 2013) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs. |
数据随 FDA 官方库更新，仅供参考，不构成医学或法律建议；正式注册与报关请以 FDA 官方文件及最新法规为准。