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 Glove, Non Sterile (protein Content Labeling).
| Device ID | K991044 |
| 510k Number | K991044 |
| Device Name: | DERMAGRIP POWDER FREE LATEX EXAMINATION GLOVE, NON STERILE (PROTEIN CONTENT LABELING) |
| Classification | Latex Patient Examination Glove |
| Applicant | WRP SPECIALTY PRODUCTS SDN. BHD. LOT11, JL.2,KAWASAN PERUSAHAAN BANDAR BARU SLAK TINGGI Selangor Daurl Ehsan, Sepang, MY 43900 |
| Contact | Cheng Hean Khoo |
| Correspondent | Cheng Hean Khoo WRP SPECIALTY PRODUCTS SDN. BHD. LOT11, JL.2,KAWASAN PERUSAHAAN BANDAR BARU SLAK TINGGI Selangor Daurl Ehsan, Sepang, 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 | 1999-03-30 |
| Decision Date | 1999-04-23 |
| Summary: | summary |