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 Latex Examination Gloves, Sterile With Protein Content Labeling Claim (50 Microgram O.
| Device ID | K021561 |
| 510k Number | K021561 |
| Device Name: | DERMAGRIP AND MULTIPLE POWDER FREE LATEX EXAMINATION GLOVES, STERILE WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAM O |
| Classification | Latex Patient Examination Glove |
| Applicant | WRP SPECIALTY PRODUCTS SDN. BHD. BARU SALAK TINGGI 43900 SEPANG Selangor Darul Ehsan, MY |
| Contact | V. Nadarajan |
| Correspondent | V. Nadarajan WRP SPECIALTY PRODUCTS SDN. BHD. BARU SALAK TINGGI 43900 SEPANG Selangor Darul Ehsan, MY |
| Product Code | LYY |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-05-13 |
| Decision Date | 2002-06-11 |
| Summary: | summary |