The following data is part of a premarket notification filed by Latexx Partners Bhd. with the FDA for Qtexx Powder Free Latex Examination Gloves, Polymer Coated.
| Device ID | K991462 |
| 510k Number | K991462 |
| Device Name: | QTEXX POWDER FREE LATEX EXAMINATION GLOVES, POLYMER COATED |
| Classification | Latex Patient Examination Glove |
| Applicant | LATEXX PARTNERS BHD. PT. 5054, KAMUNTING IND ESTATE P.O. BOX 9 Kamunting, Perak, MY 34600 |
| Contact | Chong Eng Lim |
| Correspondent | Chong Eng Lim LATEXX PARTNERS BHD. PT. 5054, KAMUNTING IND ESTATE P.O. BOX 9 Kamunting, 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 | 1999-04-27 |
| Decision Date | 1999-05-28 |
| Summary: | summary |