The following data is part of a premarket notification filed by Wrp Specialty Products Sdn. Bhd. with the FDA for Dermagrip And Multiple Powder Free Purple Nitrile Examination Gloves, Non-sterile.
| Device ID | K021396 |
| 510k Number | K021396 |
| Device Name: | DERMAGRIP AND MULTIPLE POWDER FREE PURPLE NITRILE EXAMINATION GLOVES, NON-STERILE |
| Classification | Polymer Patient Examination Glove |
| Applicant | WRP SPECIALTY PRODUCTS SDN. BHD. LOT11 JALAN2 PERUSAHAAN BANDAR KAWASAN BARU SALAK TINGGI Sepang, Selangor, MY 43900 |
| Contact | V. Nadarajan |
| Correspondent | V. Nadarajan WRP SPECIALTY PRODUCTS SDN. BHD. LOT11 JALAN2 PERUSAHAAN BANDAR KAWASAN BARU SALAK TINGGI Sepang, Selangor, MY 43900 |
| Product Code | LZA |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-05-02 |
| Decision Date | 2002-05-16 |
| Summary: | summary |