The following data is part of a premarket notification filed by Wrp Specialty Products Sdn. Bhd. with the FDA for Dermagrip Powder Free Latex Examination Gloves With Aloe Vera Protein Content Labeling Claim (50 Micrograms Or Less).
| Device ID | K012876 |
| 510k Number | K012876 |
| Device Name: | DERMAGRIP POWDER FREE LATEX EXAMINATION GLOVES WITH ALOE VERA PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS) |
| 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 | Mohd Haizan Hussein |
| Correspondent | Mohd Haizan Hussein 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 | 2001-08-27 |
| Decision Date | 2001-10-01 |
| Summary: | summary |