The following data is part of a premarket notification filed by Shun Thai Rubber Gloves Industry Public Co., Ltd. with the FDA for Powdered Latex Surgeon's Glove.
| Device ID | K052031 |
| 510k Number | K052031 |
| Device Name: | POWDERED LATEX SURGEON'S GLOVE |
| Classification | Surgeon's Gloves |
| 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 | KGO |
| CFR Regulation Number | 878.4460 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-07-27 |
| Decision Date | 2005-09-12 |