The following data is part of a premarket notification filed by Latexx Manufacturing Sdn.bhd. with the FDA for Medtexx Green Colour Powdered Nitrile Rubber Examination Gloves.
| Device ID | K022347 |
| 510k Number | K022347 |
| Device Name: | MEDTEXX GREEN COLOUR POWDERED NITRILE RUBBER EXAMINATION GLOVES |
| Classification | Polymer Patient Examination Glove |
| Applicant | LATEXX MANUFACTURING SDN.BHD. PT. 5054, P.O. BOX 9 KAMUNTING INDUSTRIAL ESTATE Taiping, Perak, MY 34600 |
| Contact | Teoh Choh Shee |
| Correspondent | Teoh Choh Shee LATEXX MANUFACTURING SDN.BHD. PT. 5054, P.O. BOX 9 KAMUNTING INDUSTRIAL ESTATE 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 | 2002-07-19 |
| Decision Date | 2002-08-15 |
| Summary: | summary |