The following data is part of a premarket notification filed by Wrp Asia Pacific Sdn. Bhd. with the FDA for Powder Free Polymer Coated Latex Surgical Gloves, Sterile (protein Labeling Claim).
| Device ID | K020019 |
| 510k Number | K020019 |
| Device Name: | POWDER FREE POLYMER COATED LATEX SURGICAL GLOVES, STERILE (PROTEIN LABELING CLAIM) |
| 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 W Chow |
| Correspondent | Yue W 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 | 2002-01-03 |
| Decision Date | 2002-01-23 |
| Summary: | summary |