510(k) K063810
K063810 is an FDA 510(k) premarket notification submitted by Yulex Corporation for the device "YULEX LATEX POWDER-FREE EXAM GLOVES". The FDA issued a decision of Substantially Equivalent on April 18, 2008. The device falls under product code OIG (Powder-Free Guayle Rubber Examination Glove), a Class I device regulated under 21 CFR 880.6250.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 18, 2008
- Date Received
- December 22, 2006
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Powder-Free Guayle Rubber Examination Glove
- Device Class
- Class I
- Regulation Number
- 880.6250
- Review Panel
- HO
- Submission Type
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.