Data / Medical devices / Powder-Free Polychloroprene Patient Examination Glove
Powder-Free Polychloroprene Patient Examination Glove (OPC): 4 FDA-registered makers in 2 countries
4 establishments in 2 countries are registered with the FDA to make Powder-Free Polychloroprene Patient Examination Glove (product code OPC, Class 1, 21 CFR 880.6250). 3 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 1 510(k) clearance under this code, the latest on August 3, 2021, and lists 0 recall events (0 Class I). FDA data exported November 3, 2026.
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- Product code
- OPC
- Device class
- 1
- Regulation
- 880.6250
- Medical specialty
- General Hospital
Makers by country
| Country | Makers |
|---|---|
| Malaysia | 3 |
| Canada | 1 |
Makers of Powder-Free Polychloroprene Patient Examination Glove
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| AMD Medicom Inc. | Pointe-Claire, Montreal Quebec, Canada | Complaint file establishment, Exporter to the US, Specification developer | 1 | August 3, 2021 | 0 | 0 | 0 | api.fda.gov |
| Hartalega NGC Sdn Bhd | Sepang Selangor, Malaysia | Manufacturer | 1 | August 3, 2021 | 0 | 0 | 0 | api.fda.gov |
| Hartalega NGC Sdn. Bhd. (lot 39496) | Sepang Selangor, Malaysia | Manufacturer | 1 | August 3, 2021 | 0 | 0 | 0 | api.fda.gov |
| Encompass Industries Sdn. Bhd. | KEMAMAN Terengganu, Malaysia | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated August 3, 2021. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.