The following data is part of a premarket notification filed by Dash Medical Gloves Sdn Bhd with the FDA for Dash, Sullivan, Vital Gard Hypoallergenic With Protein Content Labeling Claim.
| Device ID | K955425 |
| 510k Number | K955425 |
| Device Name: | DASH, SULLIVAN, VITAL GARD HYPOALLERGENIC WITH PROTEIN CONTENT LABELING CLAIM |
| Classification | Latex Patient Examination Glove |
| Applicant | DASH MEDICAL GLOVES SDN BHD LOT 16, LENGKONGAN HISHAMUDDIN KAWASAN 20, SELAT KLANG UTARA, Pelabuhan Klang, Selangor, MY 42000 |
| Contact | Khoo Seang Hoe |
| Correspondent | Khoo Seang Hoe DASH MEDICAL GLOVES SDN BHD LOT 16, LENGKONGAN HISHAMUDDIN KAWASAN 20, SELAT KLANG UTARA, Pelabuhan Klang, Selangor, MY 42000 |
| Product Code | LYY |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-11-28 |
| Decision Date | 1996-12-30 |