The following data is part of a premarket notification filed by Latexx Partners Bhd. with the FDA for Qtexx Powderfree Latex Examination Gloves.
| Device ID | K981767 |
| 510k Number | K981767 |
| Device Name: | QTEXX POWDERFREE LATEX EXAMINATION GLOVES |
| Classification | Latex Patient Examination Glove |
| Applicant | LATEXX PARTNERS BHD. PO BOX 9 Taiping Perak, MY 34600 |
| Contact | Goh S Khek |
| Correspondent | Goh S Khek LATEXX PARTNERS BHD. PO BOX 9 Taiping Perak, MY 34600 |
| Product Code | LYY |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-05-19 |
| Decision Date | 1998-06-11 |
| Summary: | summary |