The following data is part of a premarket notification filed by Wrp Specialty Products Sdn. Bhd. with the FDA for Dermagrip Powder Free Polymer Coated Latex Examination Glove Sterile, Contains 50 Micrograms Or Less Of Total Extractabl.
| Device ID | K002975 |
| 510k Number | K002975 |
| Device Name: | DERMAGRIP POWDER FREE POLYMER COATED LATEX EXAMINATION GLOVE STERILE, CONTAINS 50 MICROGRAMS OR LESS OF TOTAL EXTRACTABL |
| Classification | Latex Patient Examination Glove |
| Applicant | WRP SPECIALTY PRODUCTS SDN. BHD. LOT11, JL.2,KAWASAN PERUSAHAAN BANDAR BARU SLAK TINGGI Selangor Daurl Ehsan, Sepang, MY 43900 |
| Contact | Mohd Haizan Hussein |
| Correspondent | Mohd Haizan Hussein WRP SPECIALTY PRODUCTS SDN. BHD. LOT11, JL.2,KAWASAN PERUSAHAAN BANDAR BARU SLAK TINGGI Selangor Daurl Ehsan, Sepang, 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 | 2000-09-22 |
| Decision Date | 2000-10-24 |