First Aid Kit With Drug
Which Manufacturers in China Make This?
Chinese manufacturers registered for this device type are concentrated in Zhejiang, Jiangsu and Guangdong, and 9 other provinces: 57 hold an FDA registration. 7 are contract manufacturers.
- Allmed Medical Products Co., Ltd. Hubei, contract manufacturer
- Allwin First AID Supplies Taizhou Co., Ltd. Jiangsu
- Anertai Industrial Limited Guangdong
- Anji Hongde Medical Products Co., Ltd. Zhejiang, contract manufacturer
- Allmed Industrial Limited Guangdong
- Beijing Zksk Technology Co., Ltd. Beijing, contract manufacturer
- Bestreat Safety & First AID Solution Co., Ltd. Hubei
- Caremax Co., Ltd. contract manufacturer
- Changzhou Hualian Health Dressing Co., Ltd. Jiangsu
- Cosmuses Cosmetics (Ningbo) Co., Ltd. Zhejiang, contract manufacturer
- Dawn Breeze Int'l Trading Limited Hong Kong
- DC Safety Manufacturing (Guangzhou) Ltd Guangdong
- Dong Guan Shenglian Tins Products Co., Ltd. Guangdong
- Dongguan City Risen Medical Products Co., Ltd. Guangdong
- Dongyang City Yonoel Outdoor Products Co., Ltd. Zhejiang, contract manufacturer
- Dongguan City Ruimi Gift Products Co Ltd Guangdong
- Emsrun Group Jiangsu
- Firstar Healthcare Company Limited (Guangzhou) Guangdong, contract manufacturer
- Gauke (Hubei) Healthcare Co., Ltd. Hubei, contract manufacturer
- Gauke International Trading Co., Ltd. Hubei
- GFA Production Xiamen Co., Ltd. Fujian
- Guangdong Comfort Medical Products Co., Ltd. Guangdong
- H&K International Trade Limited (China) Zhejiang, contract manufacturer
- Hangzhou Yoniner Pharmaceutical Co., Ltd. Zhejiang, contract manufacturer
- Heaven Healthcare Co., Ltd. Zhejiang
- Hynaut Health Technology Co., Ltd. Shandong, contract manufacturer
- Jcmed Tianjin Import AND Export Co., Ltd. Tianjin
- Jiangsu NEW Pentastar Medical Products Co., Ltd. Jiangsu
- Jiangsu WLD Medical Co., Ltd. Jiangsu, contract manufacturer
- Jiangsu Yizheng Carepro Medical Instruments Co., Ltd. Jiangsu, contract manufacturer
- JSL CAR Accessories Co., Ltd. Shanghai
- Jiangsu Nanfang Medical Co., Ltd. Jiangsu, contract manufacturer
- Kingstar Medical (Xianning) Co., Ltd. Hubei, contract manufacturer
- Medical Distribution Industries, Ltd.
- Nanning Tecbod Biological Technology Co., Ltd. Guangxi, contract manufacturer
- Ningbo First Import & Export Co., Ltd. Zhejiang
- Ningbo Hanyue Medical Technology Co., Ltd. Zhejiang, contract manufacturer
- Ningbo Risenmed Technology Co., Ltd. Zhejiang, contract manufacturer
- Ningbo Tianbo First AID Product Co., Ltd. Zhejiang
- Planet (Anhui) Medical Products Co., Ltd. Anhui, contract manufacturer
- Planet(Shanghai) International Co., Ltd. Shanghai
- Rfx+care Manufacturing Co., Ltd. Zhejiang
- Shenzhen Intra Industry DBA SBI Smart Brands International [america] Guangdong
- Suzhou Hengxiang IMP. & EXP. Co., Ltd. Jiangsu
- Suzhou Pulikang Medical Device Co Ltd Jiangsu
- Shanghai Care Us Medical Product Co., Ltd. Shanghai, contract manufacturer
- Taizhou Xinkang Medical Materials Co., Ltd. Jiangsu, contract manufacturer
- Wenzhou Zhusi Medical Supplies Co., Ltd. Zhejiang, contract manufacturer
- Wuhan Jinshengyuan Textile Manufacturing Co Ltd. Hubei
- Wuhan Zonsen Medical Products Co., Ltd. Hubei, contract manufacturer
- Yiwu Haoding Medical Co., Ltd. Zhejiang, contract manufacturer
- Yiwu Kebon Healthcare Co., Ltd. Zhejiang
- Yiwu Ori-Power Medtech Co., Ltd. Zhejiang, contract manufacturer
- Zhejiang Excellent United Medical Technology Co., Ltd. Zhejiang, contract manufacturer
- Zhejiang Hongyu Medical Commodity Co., Ltd. Zhejiang, contract manufacturer
- Zhejiang Changdi Medical Co., Ltd. Zhejiang, contract manufacturer
- Zhejiang Safemate Automotive Safety & Emergency Technology Co Ltd Zhejiang
What Is This Device?
Note: In addition to compliance with our convenience kit guidance, in regards to any drug products contained in this kit compliance with the Center for Drug Evaluation is required as well. www.fda.gov/cder/index.html – This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.
How Is LRR Classified?
First Aid Kit With Drug is FDA product code LRR, not classified.
How Does It Reach the US Market?
The FDA exercises enforcement discretion for this code and does not currently require a premarket submission for devices that meet the conditions it has set for it.
What Do the Recalls Say?
The FDA has recorded 30 recalls under this product code since 2006. None was by a company in China. 1 is Class I, the most serious grade.
The root causes the FDA records most often are Labeling False and Misleading (8), Material/Component Contamination (6) and Process change control (5). A recall is a fact about one product and its maker, not a grade for every manufacturer of the type.