The following data is part of a premarket notification filed by Wrp Specialty Products Sdn. Bhd. with the FDA for Dermagrip-x Powder Free Latex Examination Gloves Coated With Alpha Lipoic Acid And Vitamin E, And With Protein Content.
| Device ID | K032016 |
| 510k Number | K032016 |
| Device Name: | DERMAGRIP-X POWDER FREE LATEX EXAMINATION GLOVES COATED WITH ALPHA LIPOIC ACID AND VITAMIN E, AND WITH PROTEIN CONTENT |
| Classification | Latex Patient Examination Glove |
| Applicant | WRP SPECIALTY PRODUCTS SDN. BHD. LOT 11, JALAN 2, KAWASAN PERUSAHAAN BANDAR BARU SALAK Tinggi, Sepang, Selangor, MY 43900 |
| Contact | V. Nadarajan |
| Correspondent | V. Nadarajan WRP SPECIALTY PRODUCTS SDN. BHD. LOT 11, JALAN 2, KAWASAN PERUSAHAAN BANDAR BARU SALAK Tinggi, Sepang, Selangor, MY 43900 |
| Product Code | LYY |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-06-30 |
| Decision Date | 2004-05-11 |
| Summary: | summary |