Medical Grade Adhesive Tapes 10×5 Cm for Fixing Sheaths and Drapes
Catalogue number 12.U0014.00, listed by Omnia Medical, United States, under Drape, Adhesive, Aerosol. 12 manufacturers in China are registered for this product code.
Drape, Adhesive, Aerosol
Which Manufacturers in China Make This?
Chinese manufacturers registered for this device type are concentrated in Jiangsu, Guangdong and Hubei, and 1 other province: 12 hold an FDA registration. 1 is a contract manufacturer.
- Boen Healthcare Co., Ltd. Jiangsu
- Guangzhou Fuzelong Hygiene Material Co., Ltd. Guangdong, contract manufacturer
- Hony Medical Co., Ltd. Guangdong, contract manufacturer
- Hospital & Homecare IMP. & EXP. Co., Ltd. Jiangsu, contract manufacturer
- Hubei Hendry Medical Appliance Co., Ltd. Hubei
- Jiangsu Classic NEW-Type Medical Products Co., Ltd. Jiangsu, contract manufacturer
- Jiangsu Medplus NON-Woven Manufacturer Co., Ltd. Jiangsu
- Jiangsu NEW Pentastar Medical Products Co., Ltd. Jiangsu
- Ningbo Hysent Medical Technology Co., Ltd. Zhejiang
- Wuhan Hangu Technology Co., Ltd. Hubei, contract manufacturer
- Wuhan Huawei Technology Co., Ltd. Hubei, contract manufacturer
- Yafho BIO-Technology Co., Ltd. Guangdong
How Is KGT Classified?
Drape, Adhesive, Aerosol is FDA product code KGT, Class 1, 21 CFR 878.4380.
How Does It Reach the US Market?
It is exempt from premarket notification: the manufacturer registers its establishment and lists the device, and no 510(k) is needed before it is sold in the United States.
What Do the Recalls Say?
The FDA has recorded 1 recall under this product code since 2008. None was by a company in China. The root cause the FDA records most often is Incorrect or no expiration date (1).
A recall is a fact about one product and its maker, not a grade for every manufacturer of the type.
Name
Record
Adhesive Films
10 Sterile Blisters of 5 Adhesive Films (20x20 cm) – 2 CROSS20 – Light Blue
3m™ Steri-Drape™
3M™ Steri-Drape™ Operation Tape Bulk 9099NS, 3 IN x 21 IN, 1050/CS