Powder-Free Guayle Rubber Examination Glove
OIG is the FDA product code for Powder-Free Guayle Rubber Examination Glove, a class I device type, regulated under 21 CFR 880.6250. FDA's definition for this code reads: "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...". As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and 2 recalls.
Classification record
- Product code
- OIG
- Device name
- Powder-Free Guayle Rubber Examination Glove
- FDA 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.
- Regulation
- 21 CFR 880.6250
- Device class
- Class I
- Review panel
- General Hospital
- Submission type
- 510(k)
- Implant
- No
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- Yes
- Ingested clearances
- 1
- Ingested recalls
- 2
Clearances, product code OIG
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 2008 | 1 |
Applicants with the most clearances
Product code OIG| Applicant | Clearances |
|---|---|
| Yulex Corporation | 1 |
Companies listing this code with FDA
Companies whose registered establishments list this codeNo registered establishment in MDM’s records lists product code OIG.
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