The following data is part of a premarket notification filed by Wrp Asia Pacific Sdn. Bhd. with the FDA for Comfit Powder Free Blue Nitrile Examination Glove, Sterile.
| Device ID | K993313 |
| 510k Number | K993313 |
| Device Name: | COMFIT POWDER FREE BLUE NITRILE EXAMINATION GLOVE, STERILE |
| 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 Wah Chow |
| Correspondent | Yue Wah 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 | 1999-10-04 |
| Decision Date | 1999-11-23 |
| Summary: | summary |