Data / Medical devices / United States / Prestige Ameritech
Prestige Ameritech: FDA-registered device maker in North Richland Hills, TX, United States, 18 510(k) clearances
Prestige Ameritech is registered with the FDA (registration 3005022483) in North Richland Hills, TX, United States. It lists 13 device types. The FDA files 18 510(k) clearances under its listings, the newest dated September 5, 2024. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3005022483
- Address
- 7201 Iron Horse Blvd., North Richland Hills, TX, United States, 76180
- Owner or operator
- PRESTIGE AMERITECH (9070341)
- Roles
- Complaint file establishment, Contract manufacturer, Manufacturer, Specification developer
- First device listed
- November 7, 2006
- Registered through
- 2026
- Brand names listed
- Dry Shield Fluid Resistant Personal Protection Gown, PRESTIGE AMERITECH FACE MASK, Prestige Ameritech Pediatric/Child's Face Mask, Pro Gear Face Mask, Pro Gear Face Shields, Pro Gear N95 Particulate Filter Respirator and Surgical Mask, ProGear, SafeSecure
Devices it lists
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| September 5, 2024 | K231741 | ProGear® Surgical Mask with Oxafence®, Model AV82030 | OUK | Substantially Equivalent | Prestige Ameritech | accessdata.fda.gov |
| November 11, 2022 | K222225 | Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs (Blue) | LZA | Substantially Equivalent | Hartalega NGC Sdn. Bhd. | accessdata.fda.gov |
| May 12, 2022 | K220118 | Nitrile Powder Free Examination Gloves, Chemotherapy Nitrile Powder Free Examination Gloves | LZA | Substantially Equivalent | Kl-Kepong Rubber Products Sdn. Bhd. | accessdata.fda.gov |
| November 30, 2018 | K182600 | Powder Free Nitrile Examination Glove, Tested for Use with Chemotherapy Drugs (Blue) | LZA | Substantially Equivalent | Better Care Plastic Technology Co., Ltd. | accessdata.fda.gov |
| November 15, 2017 | K171873 | Powder Free Nitrile Patient Examination Glove, Blue Colored, Non Sterile, Tested for Use with Chemotherapy Drugs | LZA | Substantially Equivalent | Zhonghong Pulin Medical Products Co., Ltd. | accessdata.fda.gov |
| August 25, 2017 | K170136 | Synthetic Nitrile Patient Examination Gloves, Powder Free, Blue Color, and Tested for Use with Chemotherapy Drugs | LZA | Substantially Equivalent | Shandong Feiyang Professional Gloves Co., Ltd. | accessdata.fda.gov |
| August 15, 2017 | K171162 | Surgical Earloop Face Mask with Bottom Gap Shield and Surgical Tie-On Face Mask with Bottom Gap Shield | FXX | Substantially Equivalent | Prestige Ameritech | accessdata.fda.gov |
| October 7, 2016 | K160100 | Prestige Ameritech Pediatric/Childs Face mask | OXZ | Substantially Equivalent | Prestige Ameritech | accessdata.fda.gov |
| June 3, 2016 | K152561 | Communicator Surgical Facemask with Clear Window | FXX | Substantially Equivalent | Prestige Ameritech , Ltd. | accessdata.fda.gov |
| March 9, 2016 | K151694 | Gammex PI Hybrid Surgical Gloves | KGO | Substantially Equivalent | Ansell Healthcare Products, LLC | accessdata.fda.gov |
| July 7, 2011 | K103714 | ENCORE ACCLAIM STERILE POWDER-FREE LATEX SURGICAL GLOVES, TESTED FOR USE WITH CHEMOTHERA | KGO | Substantially Equivalent | Ansell Healthcare Products, LLC | accessdata.fda.gov |
| October 6, 2010 | K102092 | PRO GEAR N95 PARTICULATE FILTER RESPIRATOR & SURGICAL MASK, REGULAR SIZE MODEL RP CERIES | MSH | Substantially Equivalent | Prestige Ameritech | accessdata.fda.gov |
| October 4, 2010 | K102096 | POWDER FREE NITRILE EXAMINATION GLOVES, BLUE | LZA | Substantially Equivalent | Syntex Healthcare Products Co., Ltd. | accessdata.fda.gov |
| December 13, 2007 | K071746 | DERMA PRENE PI OR ISOTOUCH GREEN STERILE POWDER-FREE SYNTHETIC POLYISOPRENE SURGICAL GLOVES | KGO | Substantially Equivalent | Ansell Healthcare Products, LLC | accessdata.fda.gov |
| August 14, 2006 | K061716 | PRESTIGE AMERITECH FACE MASK | FXX | Substantially Equivalent | Prestige Ameritech | accessdata.fda.gov |
| August 17, 2005 | K051793 | ENCORE STERILE POWDER-FREE LATEX SURGICAL GLOVE WITH PROPRIETARY COATING (CONTAINING GLYCERINE) | KGO | Substantially Equivalent | Ansell Healthcare Products, LLC | accessdata.fda.gov |
| February 16, 2000 | K000295 | ENCORE MICROPTIC POWDER FREE LATEX SURGICAL GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS) | KGO | Substantially Equivalent | Ansell Perry | accessdata.fda.gov |
| February 26, 1999 | K984558 | DERMA PRENE POWDER-FREE SYNTHETIC SURGICAL GLOVES (CHEMOTHERAPY USE) | KGO | Substantially Equivalent | Ansell Perry | accessdata.fda.gov |
Compare with other makers
- All makers of Surgeon'S Gloves
- All makers of Medical Glove, Specialty
- All makers of Pediatric/Child Facemask
- All makers of Mask, Surgical
- All makers of Tape And Bandage, Adhesive
- All makers of Polymer Patient Examination Glove
Updated September 5, 2024. 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.