The following data is part of a premarket notification filed by Wrp Rubber Products Sdn Bhd with the FDA for Powder Free Blue Nitrile Patient Examination Gloves, Non-sterile.
| Device ID | K140418 |
| 510k Number | K140418 |
| Device Name: | POWDER FREE BLUE NITRILE PATIENT EXAMINATION GLOVES, NON-STERILE |
| Classification | Polymer Patient Examination Glove |
| Applicant | WRP RUBBER PRODUCTS SDN BHD LOT 3, JALAN 3, KAWASAN PERUSAHAAN BANDER BARU SALAK TINGGI Sepang ,selangor Darul Ehsan, MY 43900 |
| Contact | Lim Chin Yit |
| Correspondent | Lim Chin Yit WRP RUBBER PRODUCTS SDN BHD LOT 3, JALAN 3, KAWASAN PERUSAHAAN BANDER BARU SALAK TINGGI Sepang ,selangor Darul Ehsan, MY 43900 |
| Product Code | LZA |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-02-18 |
| Decision Date | 2014-09-03 |
| Summary: | summary |