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 Gloves, Non-sterile With Protein Content Labeling Claim (50 Ug Or Less).
| Device ID | K022808 |
| 510k Number | K022808 |
| Device Name: | DERMAGRIP POWDER FREE LATEX EXAMINATION GLOVES, NON-STERILE WITH PROTEIN CONTENT LABELING CLAIM (50 UG OR LESS) |
| Classification | Latex Patient Examination Glove |
| Applicant | WRP SPECIALTY PRODUCTS SDN. BHD. KAWASAN PERUSAHAAN BANDAR BARU SALAK TINGGI Sepang Selangor Darul Ehsan, MY 43900 |
| Contact | V. Nadarajan |
| Correspondent | V. Nadarajan WRP SPECIALTY PRODUCTS SDN. BHD. KAWASAN PERUSAHAAN BANDAR BARU SALAK TINGGI Sepang Selangor Darul Ehsan, 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 | 2002-08-23 |
| Decision Date | 2002-10-03 |
| Summary: | summary |