The following data is part of a premarket notification filed by Onetexx Sdn Bhd with the FDA for Blue Nitrile Powder Free Patient Examination Glove, Non-sterile, Tested For Use With The Opioid Fentanyl Citrate, Simulated Gastric Acid, And Fentanyl In Gastric Acid.
| Device ID | K221773 |
| 510k Number | K221773 |
| Device Name: | Blue Nitrile Powder Free Patient Examination Glove, Non-Sterile, Tested For Use With The Opioid Fentanyl Citrate, Simulated Gastric Acid, And Fentanyl In Gastric Acid |
| Classification | Polymer Patient Examination Glove |
| Applicant | ONETEXX SDN BHD No 73-86, JLN Logam 5, Perindustrian KMNTG 3 KMNTG Raya Ind Estate Kamunting, MY 34600 |
| Contact | Freddy Low |
| Correspondent | Wava Truscott Truscott MedSci Associates, LLC. 180 Burkemeade Ct. Roswell, GA 30075 |
| Product Code | LZA |
| Subsequent Product Code | LZC |
| Subsequent Product Code | QDO |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-06-21 |
| Decision Date | 2022-07-30 |