Pad, Menstrual, Intralabial
Who Makes This Device Type in China?
2 manufacturers in China hold an FDA registration for this device type, based in Guangdong and Shandong.
- Hynaut Health Technology Co., Ltd. Shandong, contract manufacturer
- Shantou City Chuangrong Apparel Industrial Co., Ltd. Guangdong, contract manufacturer
What Is It?
An unscented menstrual pad intended as an intralabial pad, which is placed over the vaginal introitus to absorb menstrual fluid or other vaginal discharge and is made of common cellulosic or synthetic material with an established safety profile.
How Is NUR Classified?
Pad, Menstrual, Intralabial is FDA product code NUR, Class 1, 21 CFR 884.5435.
What Does It Take to Sell It in the United States?
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.
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