The following data is part of a premarket notification filed by Wrp Specialty Products Sdn. Bhd. with the FDA for Dermgrip Powder Free Polymer Coated Latex Surgeon's Gloves,sterile With Protein Content Labeling Claim (50 Microgram Ors.
| Device ID | K014288 |
| 510k Number | K014288 |
| Device Name: | DERMGRIP POWDER FREE POLYMER COATED LATEX SURGEON'S GLOVES,STERILE WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAM ORS |
| Classification | Surgeon's Gloves |
| Applicant | WRP SPECIALTY PRODUCTS SDN. BHD. LOT11 JALAN2 PERUSAHAAN BANDAR KAWASAN BARU SALAK TINGGI Sepang, Selangor, MY 43900 |
| Contact | Mohd H Hussein |
| Correspondent | Mohd H Hussein WRP SPECIALTY PRODUCTS SDN. BHD. LOT11 JALAN2 PERUSAHAAN BANDAR KAWASAN BARU SALAK TINGGI Sepang, Selangor, MY 43900 |
| Product Code | KGO |
| CFR Regulation Number | 878.4460 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-12-28 |
| Decision Date | 2002-02-13 |
| Summary: | summary |