OIG — Powder-Free Guayle Rubber Examination Glove Class I
FDA product code OIG covers "Powder-Free Guayle Rubber Examination Glove", a Class I medical device regulated under 21 CFR 880.6250. Submissions are reviewed by the General Hospital panel. At least 1 recent 510(k) clearance has been granted under this product code.
Classification Details
- Product Code
- OIG
- Device Class
- Class I
- Regulation Number
- 880.6250
- Submission Type
- Review Panel
- HO
- Medical Specialty
- General Hospital
- Implant
- No
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.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K063810 | yulex corporation | YULEX LATEX POWDER-FREE EXAM GLOVES | April 18, 2008 |