The following data is part of a premarket notification filed by Medtexx Manufacturing Sdn. Bhd. with the FDA for Non-chlorinated Polymer Coated Powder-free Natural Latex Examination Gloves.
| Device ID | K070072 |
| 510k Number | K070072 |
| Device Name: | NON-CHLORINATED POLYMER COATED POWDER-FREE NATURAL LATEX EXAMINATION GLOVES |
| Classification | Latex Patient Examination Glove |
| Applicant | MEDTEXX MANUFACTURING SDN. BHD. PT 4004 KAMUNTING INDU. ESTATE Kamunting, Taiping, Perak, MY 34600 |
| Contact | Ooi Loon Seng (mdm) |
| Correspondent | Ooi Loon Seng (mdm) MEDTEXX MANUFACTURING SDN. BHD. PT 4004 KAMUNTING INDU. ESTATE Kamunting, 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 | 2007-01-08 |
| Decision Date | 2007-03-15 |
| Summary: | summary |