The following data is part of a premarket notification filed by Latexx Manufacturing Sdn.bhd. with the FDA for Black Colour Powder-free Nitrile Rubber Examination Gloves.
| Device ID | K034052 |
| 510k Number | K034052 |
| Device Name: | BLACK COLOUR POWDER-FREE NITRILE RUBBER EXAMINATION GLOVES |
| Classification | Polymer Patient Examination Glove |
| Applicant | LATEXX MANUFACTURING SDN.BHD. 216 CHARLES ST. Hackensack, NJ 07601 |
| Contact | Law Siau Woei (terry Law) |
| Correspondent | Law Siau Woei (terry Law) LATEXX MANUFACTURING SDN.BHD. 216 CHARLES ST. Hackensack, NJ 07601 |
| Product Code | LZA |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-12-30 |
| Decision Date | 2004-03-15 |
| Summary: | summary |