The following data is part of a premarket notification filed by Wrp Asia Pacific Sdn. Bhd. with the FDA for Powder Free Polymer Coated Brown Latex Surgical Gloves, Sterile, Coated With Aloe Vera And With Protein Content Labeling.
| Device ID | K070619 |
| 510k Number | K070619 |
| Device Name: | POWDER FREE POLYMER COATED BROWN LATEX SURGICAL GLOVES, STERILE, COATED WITH ALOE VERA AND WITH PROTEIN CONTENT LABELING |
| Classification | Surgeon's Gloves |
| Applicant | WRP ASIA PACIFIC SDN. BHD. LOT1,JALAN3,KAWASAN PERUSAHAAN BANDAR BARU SALAK TINGGI Sepang,selangor Darul Ehsan, MY 43900 |
| Contact | Kirk Penner |
| Correspondent | Kirk Penner WRP ASIA PACIFIC SDN. BHD. LOT1,JALAN3,KAWASAN PERUSAHAAN BANDAR BARU SALAK TINGGI Sepang,selangor Darul Ehsan, MY 43900 |
| Product Code | KGO |
| CFR Regulation Number | 878.4460 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-03-05 |
| Decision Date | 2007-06-27 |
| Summary: | summary |