The following data is part of a premarket notification filed by Wrp Specialty Products Sdn. Bhd. with the FDA for Powder Free Blue Latex Examination Glove, Non-sterile (protein Content Labeling).
| Device ID | K013942 |
| 510k Number | K013942 |
| Device Name: | POWDER FREE BLUE LATEX EXAMINATION GLOVE, NON-STERILE (PROTEIN CONTENT LABELING) |
| Classification | Latex Patient Examination Glove |
| 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 | LYY |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-11-29 |
| Decision Date | 2001-12-31 |
| Summary: | summary |