Prestige Ameritech
North Richland Hills, TX, US
PRESTIGE AMERITECH appears in FDA device records in North Richland Hills, TX. FDA records list 6 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 6 510(k) clearances for Prestige Ameritech between 2006 and 2024. The busiest year on record is 2016, with 2. The most recent is 2024, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2006 | 1 |
| 2010 | 1 |
| 2016 | 2 |
| 2017 | 1 |
| 2024 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K231741 | ProGear® Surgical Mask with Oxafence®, Model AV82030 | OUK | Substantially Equivalent | |
| K171162 | Surgical Earloop Face Mask with Bottom Gap Shield and Surgical Tie-On Face Mask with Bottom Gap Shield | FXX | Substantially Equivalent | |
| K160100 | Prestige Ameritech Pediatric/Child’s Face mask | OXZ | Substantially Equivalent | |
| K152561 | Communicator Surgical Facemask with Clear Window | FXX | Substantially Equivalent | |
| K102092 | PRO GEAR N95 PARTICULATE FILTER RESPIRATOR & SURGICAL MASK, REGULAR SIZE MODEL RP CERIES | MSH | Substantially Equivalent | |
| K061716 | PRESTIGE AMERITECH FACE MASK | FXX | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3005022483 | 3005022483 | PRESTIGE AMERITECH | 7201 Iron Horse Blvd., North Richland Hills, TX 76180 US | 2026 | and 3 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- LYUAccessory, Surgical Apparel
- FMEGown, Examination
- EYJHolder, Ureteral Catheter
- FXXMask, Surgical
- LZCMedical Glove, Specialty
- OXZPediatric/Child Facemask
- LZAPolymer Patient Examination Glove
- MSHRespirator, Surgical
- HOYShield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)
- KPYShield, Protective, Personnel
- KGOSurgeon'S Gloves
- OUKSurgical Mask With Antimicrobial/Antiviral Agent
- KGXTape And Bandage, Adhesive
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