The following data is part of a premarket notification filed by Latexx Partners Bhd. with the FDA for Proflex Powder Free Nitrile Examination Gloves.
| Device ID | K981159 |
| 510k Number | K981159 |
| Device Name: | PROFLEX POWDER FREE NITRILE EXAMINATION GLOVES |
| Classification | Polymer Patient Examination Glove |
| Applicant | LATEXX PARTNERS BHD. PO BOX 9 Taiping Perak, MY 34600 |
| Contact | Goh See Khek |
| Correspondent | Goh See Khek LATEXX PARTNERS BHD. PO BOX 9 Taiping 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 | 1998-03-31 |
| Decision Date | 1998-06-01 |
| Summary: | summary |