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。
检索已获 FDA 上市前通告许可的器械清单，可查看同类产品的申请人、K 号与许可日期，用于竞品与等效器械调研。
已将中文关键词转为英文「glove」检索 FDA 数据库。
共找到 1131 条与「glove」匹配的结果
当前展示 50 条FDA 510(k) 许可记录； 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 ›
| K 号 | 器械名称 | 申请人 | 许可日期 | 结论 | 产品代码 | 审查科室 |
|---|---|---|---|---|---|---|
| K000745 | SENSI GRIP LATEX EXAMINATION GLOVE, POWDERED CONTAINS 200 MCGM OR LESS OF TOTAL WATER EXTRACTABLE PROTEIN PER GRAM | Tillotson Healthcare Corp. | 2000-05-03 | Substantially Equivalent | LYY | General Hospital |
| K190860 | Disposable Powder Free Nitrile Examination Glove, Tested For Use With Chemotherapy Drugs, White color, Disposable Powder Free Nitrile Examination Glove, Tested For Use With Chemotherapy Drugs, Orange color | Ever Growth (Vietnam) Co. , Ltd. | 2019-12-23 | Substantially Equivalent | LZA | General Hospital |
| K891646 | TOPLAS VINYL PATIENT EXAMINATION GLOVE | Toplas Industrial Co., Ltd. | 1989-04-25 | Substantially Equivalent | LYZ | General Hospital |
| K890651 | LATEX EXAMINATION GLOVE | Tianjin Tang GU Latex Factory | 1989-05-31 | Substantially Equivalent | LYY | General Hospital |
| K984020 | POWDERED LATEX EXAMINATION GLOVE WITH PROTEIN CONTENT LABELING CLAIM (150 MICROGRAMS OR LESS) | Kossan Latex Industries(M)Sdn Bhd | 1998-12-23 | Substantially Equivalent | LYY | General Hospital |
| K180646 | Halyard Lavender Nitrile Powder-Free Exam Glove Tested for Use with Chemotherapy Drugs | Halyard Health | 2018-06-27 | Substantially Equivalent | LZC | General Hospital |
| K024025 | POWDER-FREE NITRILE PATIENT EXAMINATION GLOVE, VIOLET COLOR | Kossan Latex Industries(M)Sdn Bhd | 2002-12-18 | Substantially Equivalent | LZA | General Hospital |
| K001375 | ULTIMATE N-DEX POWER FREE NITRILE EXMINATION GLOVE (TESTED FOR USE WITH CHEMOTHERAPY DRUGS) | Best Manufacturing Company | 2000-07-25 | Substantially Equivalent | LZA | General Hospital |
| K021598 | ELASTYLITE SYNTHETIC POWDERED SURGICAL GLOVE | Eci Medical Technologies, Inc. | 2002-06-10 | Substantially Equivalent | KGO | General, Plastic Surgery |
| K091427 | VINYL POWDERED EXAMINATION GLOVE | Shun DA (Xinghua) Co., Ltd. | 2009-06-23 | Substantially Equivalent | LYZ | General Hospital |
| K170152 | POLYCHLOROPRENE POWDER FREE SURGICAL GLOVE (GREEN) | Hartalega Sdn Bhd | 2017-05-05 | Substantially Equivalent | KGO | General, Plastic Surgery |
| K990752 | DERMAGRIP POWDER FREE NITRILE EXAMINATION GLOVE, NON STERILE | Wrp Specialty Products Sdn. Bhd. | 1999-10-18 | Substantially Equivalent | LZA | General Hospital |
| K935658 | MEROCEL(R) TURBINATE GLOVE AND SEPTAL SPLINT | Merocel Corp. | 1994-03-04 | Substantially Equivalent | LYA | Ear, Nose, Throat |
| K142992 | TULIP Natural Rubber Latex Surgeon's Glove (Powdered) | Shanghai Jinxiang Latex Products Co., Ltd. | 2015-03-18 | Substantially Equivalent | KGO | General, Plastic Surgery |
| K221667 | Non Sterile Powder Free Latex Examination Glove | New Era Medicare Sdn. Bhd. | 2022-10-28 | Substantially Equivalent | LYY | General Hospital |
| K922407 | WELLS LAMONT CUT RESISTANT SURGICAL GLOVE LINERS | Wells Lamont Corp. | 1993-06-15 | Substantially Equivalent | LYU | General, Plastic Surgery |
| K042378 | NON-STERILE POWDER FREE BLUE NITRILE PATIENT EXAMINATION GLOVE | Shijiazhuang Tillotson Rubber Products Co., Ltd. | 2004-09-20 | Substantially Equivalent | LZA | General Hospital |
| K142862 | POWDER FREE NITRILE EXAMINATION GLOVE, BLUE (Colored). | Careplus (M) Sdn Bhd | 2015-01-16 | Substantially Equivalent | LZA | General Hospital |
| K223250 | Disposable Nitrile Examination Glove | Yangzhou Saraguard Medical Supplies Co., Ltd. | 2023-01-19 | Substantially Equivalent | LZA | General Hospital |
| K212182 | Iconic Nitrile Glove | Iconic Medicare Sdn Bhd | 2021-12-11 | Substantially Equivalent | LZA | General Hospital |
| K021452 | STERILE SENSICARE ADVANTIX POWDER FREE POLYURETHANE MEDICAL/DENTAL EXAMINATION GLOVE | Maxxim Medical | 2002-08-01 | Substantially Equivalent | LZA | General Hospital |
| K151208 | Powder Free Nitrile Examination Glove | Vrg Khai Hoan Joint Stock Company | 2015-09-14 | Substantially Equivalent | LZA | General Hospital |
| K070030 | POWDER FREE VINYL PATIENT EXAMINATION GLOVE | Super Safe Plastic Products Co., Ltd. | 2007-02-16 | Substantially Equivalent | LYZ | General Hospital |
| K230662 | Nitrile Exam Glove, Extended cuff, Tested For Use With Chemotherapy Drugs, Fentanyl Citrate, And Select Other Drugs | Zhonghong Pulin Medical Products Co., Ltd. | 2023-10-26 | Substantially Equivalent | LZA | General Hospital |
| K190736 | Disposable Powder Free Nitrile Examination Glove,Blue Color, Tested For Use With Chemotherapy Drugs | Ever Growth (Vietnam) Co. , Ltd. | 2019-12-23 | Substantially Equivalent | LZA | General Hospital |
| K901237 | GLOVE LEAK DETECTOR | Utah Medical Products, Inc. | 1990-08-21 | Substantially Equivalent | LDQ | General Hospital |
| K951908 | REGENT BIOGEL LATEX-FREE SURGEON'S GLOVE | Regent Hospital Products | 1995-09-01 | Substantially Equivalent | KGO | General, Plastic Surgery |
| K897048 | CLEAN HAND-VCL GLOVE DISPENSER | Safety Today, Inc. | 1990-01-25 | Substantially Equivalent | LYY | General Hospital |
| K060726 | POWDER FREE NITRILE EXAMINATION GLOVE COATED WITH CUCUMBER WITH GLYCERINE (BLUE COLOR) | Smart Glove Corp. Sdn Bhd | 2006-05-25 | Substantially Equivalent | LZA | General Hospital |
| K121925 | POWDERED LATEX SURGEON'S GLOVE | Suzhou Colour-Way Enterprise Development Co., Ltd. | 2013-08-28 | Substantially Equivalent | KGO | General, Plastic Surgery |
| K244034 | Disposable Powder Free Nitrile Examination Glove, Blue Color, Tested For Use With Chemotherapy Drugs and Fentanyl Citrate and Xylazine | Ever Global (Vietnam) Enterprise Corporation | 2025-02-06 | Substantially Equivalent | LZA | General Hospital |
| K193555 | Disposable Powder Free Nitrile Examination Glove, Blue Color, Tested For Use With Chemotherapy Drugs and Fentanyl Citrate | Ever Global (Vietnam) Enterprise Corp | 2020-06-04 | Substantially Equivalent | LZC | General Hospital |
| K093696 | SR GLOVE, NU GLOVE, HIGHSTRESS MODEL 801, MODEL 802, MODEL 803 | Central Medicare Sdn Bhd | 2010-02-12 | Substantially Equivalent | LZA | General Hospital |
| K891978 | PATIENT EXAMINATION GLOVE (LATEX) | Latex Supply Products (Hp), Inc. | 1989-05-02 | Substantially Equivalent | LYY | General Hospital |
| K990696 | OMNI FLEX NITRILE EXAMINATION GLOVE, POWDER-FREE,WHITE | Omnigrace (Thailand) , Ltd. | 1999-05-13 | Substantially Equivalent | LZA | General Hospital |
| K890987 | VINYL PATIENT EXAMINATION GLOVE | Jm Gloves Co., Ltd. | 1989-04-06 | Substantially Equivalent | LYZ | General Hospital |
| K992223 | HEALTH-PLUS, SANITEX, RELIANCE POWDER-FREE NITRILE EXAMINATION GLOVE | Pamitex Industries Sdn Bhd | 1999-08-30 | Substantially Equivalent | LZA | General Hospital |
| K072223 | VINYL EXAMINATION GLOVE, POWDERED | Pinnacle Co., Ltd. | 2008-02-21 | Substantially Equivalent | LYZ | General Hospital |
| K013303 | CLEANTEXX POWDERFREE SYNTHETIC LATEX EXAMINATION GLOVE MADE WITH BARRIER-PRO BUTADIENE CO-POLMER | Latexx Manufacturing Sdn.Bhd. | 2002-01-23 | Substantially Equivalent | LZA | General Hospital |
| K170575 | Disposable Powder Free Vinyl Exam Glove, Clear/Yellow | Ever Global (Vietnam) Enterprise Corp | 2017-05-16 | Substantially Equivalent | LYZ | General Hospital |
| K123628 | STERILE LATEX SURGICAL GLOVE | Lucenxia Prescience AG | 2013-03-18 | Substantially Equivalent | KGO | General, Plastic Surgery |
| K111134 | NON-STERILE, POWDER-FREE NITRILE EXAMINATION GLOVE, BLUE, TESTED FOR USE WITH CHEMOTHERAPY DRUGS | Siem Aempemed Corp., Ltd. | 2012-01-26 | Substantially Equivalent | LZA | General Hospital |
| K990750 | DERMAGRIP POWDER FREE BLUE NITRILE EXAMINATION GLOVE, NON STERILE | Wrp Specialty Products Sdn. Bhd. | 1999-10-15 | Substantially Equivalent | LZA | General Hospital |
| K082370 | POWDER FREE NITRILE EXAMINATION GLOVE (BLUE) | Smart Glove Corp. Sdn Bhd | 2008-10-17 | Substantially Equivalent | LZA | General Hospital |
| K874099 | REGENT DISPO STERILE BIOGEL STARCH FREE SURG GLOVE | Biopro, Inc. | 1987-12-14 | Substantially Equivalent | KGO | General, Plastic Surgery |
| K052956 | NITRILE BLUE POWDER FREE EXAMINATION GLOVE | Great Glove Sdn Bhd | 2005-12-21 | Substantially Equivalent | LZA | General Hospital |
| K070035 | POWDERED VINYL PATIENT EXAMINATION GLOVE | Super Safe Plastic Products Co., Ltd. | 2007-01-23 | Substantially Equivalent | LYZ | General Hospital |
| K913893 | RESIST(TM) ORTHOPAEDIC SURGICAL GLOVE | Depuy, Inc. | 1992-10-23 | Substantially Equivalent | KGO | General, Plastic Surgery |
| K905527 | NEEDLESTICK PROTECTIVE GLOVE | Medev Corp. | 1991-03-22 | Substantially Equivalent | LZC | General Hospital |
| K901855 | LATEX PATIENT EXAMINATION GLOVE | Tower Marketing Sdn. Bhd. | 1990-05-18 | Substantially Equivalent | LYY | General Hospital |
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。