The following data is part of a premarket notification filed by Wrp Asia Pacific Sdn. Bhd. with the FDA for Comfit Chemo Plus Plus Powder Free Nitrile Examination Gloves (tested For Use With Chemotherapy Drugs).
| Device ID | K001613 |
| 510k Number | K001613 |
| Device Name: | COMFIT CHEMO PLUS PLUS POWDER FREE NITRILE EXAMINATION GLOVES (TESTED FOR USE WITH CHEMOTHERAPY DRUGS) |
| Classification | Polymer Patient Examination Glove |
| Applicant | WRP ASIA PACIFIC SDN. BHD. LOT 1, JALAN 3, KAWASAN PERUSAHAAN BANDAR BARU Salak Tinggi, Sepang Selangor, MY 43900 |
| Contact | Yue Wha Chow |
| Correspondent | Yue Wha Chow WRP ASIA PACIFIC SDN. BHD. LOT 1, JALAN 3, KAWASAN PERUSAHAAN BANDAR BARU Salak Tinggi, Sepang Selangor, 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 | 2000-05-25 |
| Decision Date | 2000-11-22 |