The following data is part of a premarket notification filed by Wrp Asia Pacific Sdn. Bhd. with the FDA for Powder Free Blue Latex Patient Examination Gloves, Tested For Use With Chemotherapy Drugs With A Protein Content Label.
| Device ID | K083409 |
| 510k Number | K083409 |
| Device Name: | POWDER FREE BLUE LATEX PATIENT EXAMINATION GLOVES, TESTED FOR USE WITH CHEMOTHERAPY DRUGS WITH A PROTEIN CONTENT LABEL |
| Classification | Patient Examination Glove, Specialty |
| Applicant | WRP ASIA PACIFIC SDN. BHD. LOT 1, JALAN 3, KAWASAN PERUSAHAAN BANDAR BARU Salak Tinggi, Sepang Selangor, MY 43900 |
| Contact | Kirk Penner |
| Correspondent | Kirk Penner WRP ASIA PACIFIC SDN. BHD. LOT 1, JALAN 3, KAWASAN PERUSAHAAN BANDAR BARU Salak Tinggi, Sepang Selangor, MY 43900 |
| Product Code | LZC |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-11-18 |
| Decision Date | 2009-07-29 |
| Summary: | summary |