The following data is part of a premarket notification filed by Wrp Specialty Products Sdn. Bhd. with the FDA for Dermagrip Powdered Latex Surgical Glove, Sterile.
| Device ID | K993215 |
| 510k Number | K993215 |
| Device Name: | DERMAGRIP POWDERED LATEX SURGICAL GLOVE, STERILE |
| Classification | Surgeon's Gloves |
| Applicant | WRP SPECIALTY PRODUCTS SDN. BHD. LOT11, JL.2,KAWASAN PERUSAHAAN BANDAR BARU SLAK TINGGI Selangor Daurl Ehsan, Sepang, MY 43900 |
| Contact | Ooi Soo Kang |
| Correspondent | Ooi Soo Kang WRP SPECIALTY PRODUCTS SDN. BHD. LOT11, JL.2,KAWASAN PERUSAHAAN BANDAR BARU SLAK TINGGI Selangor Daurl Ehsan, Sepang, 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 | 1999-09-24 |
| Decision Date | 1999-12-02 |
| Summary: | summary |