The following data is part of a premarket notification filed by Wrp Asia Pacific Sdn. Bhd. with the FDA for Profeel Powder Free Polymer Coated Neoprene Surgical Gloves Sterile.
| Device ID | K003019 |
| 510k Number | K003019 |
| Device Name: | PROFEEL POWDER FREE POLYMER COATED NEOPRENE SURGICAL GLOVES STERILE |
| Classification | Surgeon's Gloves |
| 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 | KGO |
| CFR Regulation Number | 878.4460 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-09-27 |
| Decision Date | 2000-11-03 |