The following data is part of a premarket notification filed by Shun Thai Rubber Gloves Industry Public Co., Ltd. with the FDA for Polymer Coated, Powder-free Latex Examination Gloves With Protein Labeling (less Than 50 Ug/g Per Glove).
| Device ID | K040408 |
| 510k Number | K040408 |
| Device Name: | POLYMER COATED, POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN LABELING (LESS THAN 50 UG/G PER GLOVE) |
| Classification | Latex Patient Examination Glove |
| Applicant | SHUN THAI RUBBER GLOVES INDUSTRY PUBLIC CO., LTD. 198 AVENUE DE LA D'EMERALD Sparks, NV 89434 |
| Contact | Janna P Tucker |
| Correspondent | Janna P Tucker SHUN THAI RUBBER GLOVES INDUSTRY PUBLIC CO., LTD. 198 AVENUE DE LA D'EMERALD Sparks, NV 89434 |
| Product Code | LYY |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-02-17 |
| Decision Date | 2004-03-17 |