FDA product code OIG: Powder-Free Guayle Rubber Examination Glove
OIG is the FDA product code for powder-free guayle rubber examination glove. It is a Class I device, regulated under 21 CFR 880.6250 and reviewed by the General Hospital panel. FDA has cleared 1 510(k) submission under OIG. The average 510(k) review took 483 days (median 483). FDA has posted 2 recalls for OIG devices.
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.
Classification
| Field | Value |
|---|---|
| Device name | Powder-Free Guayle Rubber Examination Glove |
| Device class | Class I |
| Regulation | 21 CFR 880.6250 |
| Review panel | HO — General Hospital |
| Medical specialty | General Hospital |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Compare with all 510(k) review times · Search every OIG clearance
Top OIG applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Yulex Corporation | 1 | 2008-04-18 |
Most recent OIG clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K063810 | Yulex Corporation | YULEX LATEX POWDER-FREE EXAM GLOVES | 2008-04-18 | 483 |
Recalls for OIG devices
2 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2011-02-03.
Frequently asked questions
What is FDA product code OIG?
OIG is the FDA product code for powder-free guayle rubber examination glove. It is a Class I device, regulated under 21 CFR 880.6250 and reviewed by the General Hospital panel.
What device class is OIG?
Class I, regulation 21 CFR 880.6250. Typical premarket route: 510(k).
How long does a 510(k) take for product code OIG?
Across 1 cleared submissions the average was 483 days from receipt to decision (median 483).
Which companies have the most OIG clearances?
Yulex Corporation (1).
Have OIG devices been recalled?
Yes: 2 product recalls across 1 recall events; the most recent began 2011-02-03.
Next steps
- Run an FDA pathway report with predicate devices for product code OIG
- Run a recall and safety report across every OIG manufacturer
- Watch product code OIG for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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