Ultrawin Sdn Bhd
Teluk Intan, MY
Ultrawin Sdn Bhd appears in FDA device records in Teluk Intan, MY. FDA records list 5 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 5
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 5 510(k) clearances for Ultrawin Sdn Bhd between 1992 and 2009. The busiest year on record is 1992, with 1. The most recent is 2009, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1992 | 1 |
| 1998 | 1 |
| 1999 | 1 |
| 2008 | 1 |
| 2009 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K090828 | NON-STERILE, POWDER FREE NITRILE EXAMINATION GLOVES | LZA | Substantially Equivalent | |
| K072802 | SINGLE USE, DISPOSABLE, BLUE COLOR, POWDER FREE LATEX PATIENT EXAMINATION GLOVE | LYY | Substantially Equivalent | |
| K992175 | EXTRA-CARE LATEX PATIENT EXAMINATION GLOVE, POWDER-FREE, POLYMER COATED | LYY | Substantially Equivalent | |
| K983175 | EXTRA-CARE POWDER-FREE EXAMINATION GLOVE | LYY | Substantially Equivalent | |
| K920059 | ULTRASAFE | LYY | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain