OIG · Class I · 21 CFR 880.6250

FDA Product Code OIG: Powder-free Guayle Rubber Examination Glove

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.

1
Total
1
Cleared
483d
Avg days
2008
Since

FDA 510(k) Cleared Powder-free Guayle Rubber Examination Glove Devices (Product Code OIG)

1 devices
1–1 of 1
No devices found for this product code.

About Product Code OIG - Regulatory Context