The following data is part of a premarket notification filed by Latexx Partners Bhd. with the FDA for Qtexx Pre-powdered Nitrile Examination Gloves.
| Device ID | K992671 |
| 510k Number | K992671 |
| Device Name: | QTEXX PRE-POWDERED NITRILE EXAMINATION GLOVES |
| Classification | Polymer Patient Examination Glove |
| Applicant | LATEXX PARTNERS BHD. PT. 5054, KAMUNTING IND ESTATE P.O. BOX 9 Kamunting, Perak, MY 34600 |
| Contact | Chong Eng |
| Correspondent | Chong Eng LATEXX PARTNERS BHD. PT. 5054, KAMUNTING IND ESTATE P.O. BOX 9 Kamunting, Perak, MY 34600 |
| Product Code | LZA |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-08-10 |
| Decision Date | 1999-09-24 |
| Summary: | summary |