The following data is part of a premarket notification filed by Medtexx Manufacturing Sdn. Bhd. with the FDA for Chlorinated Powder Free Nitrile Latex Examination Gloves.
| Device ID | K071740 |
| 510k Number | K071740 |
| Device Name: | CHLORINATED POWDER FREE NITRILE LATEX EXAMINATION GLOVES |
| Classification | Polymer Patient Examination Glove |
| Applicant | MEDTEXX MANUFACTURING SDN. BHD. PT 4004 KAMUNTING INDU. ESTATE Kamunting, Taiping, Perak, MY 34600 |
| Contact | Ooi Loon Seng |
| Correspondent | Ooi Loon Seng MEDTEXX MANUFACTURING SDN. BHD. PT 4004 KAMUNTING INDU. ESTATE Kamunting, 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 | 2007-06-27 |
| Decision Date | 2007-10-04 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10859140003429 | K071740 | 000 |
| 00817415021229 | K071740 | 000 |
| 00817415021243 | K071740 | 000 |
| 00817415021267 | K071740 | 000 |
| 10817415021271 | K071740 | 000 |
| 10859140003313 | K071740 | 000 |
| 10859140003320 | K071740 | 000 |
| 10859140003337 | K071740 | 000 |
| 10859140003344 | K071740 | 000 |
| 10859140003399 | K071740 | 000 |
| 10859140003405 | K071740 | 000 |
| 10859140003412 | K071740 | 000 |
| 00817415021205 | K071740 | 000 |