The following data is part of a premarket notification filed by Medtexx Manufacturing Sdn. Bhd. with the FDA for Powder Free Natural Rubber Latex Examination Gloves.
| Device ID | K120963 |
| 510k Number | K120963 |
| Device Name: | POWDER FREE NATURAL RUBBER LATEX EXAMINATION GLOVES |
| Classification | Latex Patient Examination Glove |
| Applicant | MEDTEXX MANUFACTURING SDN. BHD. PT 4004 JALAN PERUSAHAAN 3 KAMUNTING INDUSTRIAL ESTATE Kamunting, MY 34600 |
| Contact | Ooi Loon Seng |
| Correspondent | Ooi Loon Seng MEDTEXX MANUFACTURING SDN. BHD. PT 4004 JALAN PERUSAHAAN 3 KAMUNTING INDUSTRIAL ESTATE Kamunting, 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 | 2012-03-30 |
| Decision Date | 2012-06-29 |