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 |