The following data is part of a premarket notification filed by Wrp Asia Pacific Sdn Bhd with the FDA for Powder Free Nitrile Patient Examination Gloves, Non-sterile (orange).
| Device ID | K192635 |
| 510k Number | K192635 |
| Device Name: | Powder Free Nitrile Patient Examination Gloves, Non-Sterile (Orange) |
| Classification | Polymer Patient Examination Glove |
| Applicant | WRP ASIA PACIFIC SDN BHD Lot 1, Jalan 3, Kawasan Perusahaan Bandar Baru Salak Tinggi Sepang, MY 43900 |
| Contact | Hasnah Abdul Hamid |
| Correspondent | Hasnah Abdul Hamid WRP ASIA PACIFIC SDN BHD Lot 1, Jalan 3, Kawasan Perusahaan Bandar Baru Salak Tinggi Sepang, 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 | 2019-09-23 |
| Decision Date | 2020-01-17 |