The following data is part of a premarket notification filed by Onetexx Sdn Bhd with the FDA for Black Nitrile Powder Free Patient Examination Glove, Non Sterile.
| Device ID | K210588 |
| 510k Number | K210588 |
| Device Name: | Black Nitrile Powder Free Patient Examination Glove, Non Sterile |
| Classification | Polymer Patient Examination Glove |
| Applicant | Onetexx SDN BHD No 73-86, Jalan Logam 5, Perindustrian Kamunting 3, Kamunting Raya Industrial Estate Kamunting, MY 34600 |
| Contact | Freddy Low |
| Correspondent | Wava Truscott Onetexx Sdn Bhd 189 Burkemeade Ct. Roswell, GA 30075 |
| Product Code | LZA |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-02-26 |
| Decision Date | 2021-10-31 |