Product code OIG— General Hospital
YULEX LATEX POWDER-FREE EXAM GLOVES
- Classification name
- Powder-Free Guayle Rubber Examination Glove
- Device class
- Class 1
- Regulation
- 21 CFR 880.6250
- Advisory panel
- General Hospital
- Total cleared
- 1
- First cleared
- Most recent
FDA classification definition
“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.”
Market context for product code OIG
FDA has cleared device under product code OIG, all in 2008, filed by 1 applicant company. No FDA device recalls reference this product code. Class I devices are low-risk and subject to FDA general controls; many Class I device types are exempt from 510(k) premarket notification.
Top applicants under product code OIG
Recent clearances under product code OIG
Data sourced from openFDA. This site is unofficial and independent of the FDA.