The following data is part of a premarket notification filed by Dash Medical Gloves Sdn Bhd with the FDA for Dash Siliconized Polymer Coated Powder Free Latex Examination Gloves With Protein Content Labeling Claim (50 Micrograms.
| Device ID | K992128 |
| 510k Number | K992128 |
| Device Name: | DASH SILICONIZED POLYMER COATED POWDER FREE LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS |
| Classification | Latex Patient Examination Glove |
| Applicant | DASH MEDICAL GLOVES SDN BHD 10180 SOUTH 54TH ST. Franklin, WI 53132 |
| Contact | Robert J Sullivan Jr |
| Correspondent | Robert J Sullivan Jr DASH MEDICAL GLOVES SDN BHD 10180 SOUTH 54TH ST. Franklin, WI 53132 |
| Product Code | LYY |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-06-23 |
| Decision Date | 1999-09-14 |