FDA product code OPC: Powder-Free Polychloroprene Patient Examination Glove
OPC is the FDA product code for powder-free polychloroprene patient 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 OPC. The average 510(k) review took 57 days (median 57).
Definition
A powder free polychloroprene patient examination glove is a disposable device made of polychloroprene rubber tthat bears powder to facilitate donning, and 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 Polychloroprene Patient 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 |
510(k) clearances per year for OPC
| Year | Clearances | Avg. review days |
|---|---|---|
| 2021 | 1 | 57 |
Compare with all 510(k) review times · Search every OPC clearance
Top OPC applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Hartalega NGC Sdn. Bhd. | 1 | 2021-08-03 |
Most recent OPC clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K211758 | Hartalega NGC Sdn. Bhd. | Polychloroprene Powder Free Examination Glove Tested for Use with Chemotherapy Drugs (Fusion Colour) | 2021-08-03 | 57 |
Recalls for OPC devices
openFDA lists no recalls for product code OPC.
Frequently asked questions
What is FDA product code OPC?
OPC is the FDA product code for powder-free polychloroprene patient 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 OPC?
Class I, regulation 21 CFR 880.6250. Typical premarket route: 510(k).
How long does a 510(k) take for product code OPC?
Across 1 cleared submissions the average was 57 days from receipt to decision (median 57).
Which companies have the most OPC clearances?
Hartalega NGC Sdn. Bhd. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code OPC
- Run a recall and safety report across every OPC manufacturer
- Watch product code OPC 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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