The following data is part of a premarket notification filed by Shun Thai Rubber Gloves Industry Co., Ltd. with the FDA for Boston Medical Latex Exam Gloves.
| Device ID | K952695 |
| 510k Number | K952695 |
| Device Name: | BOSTON MEDICAL LATEX EXAM GLOVES |
| Classification | Latex Patient Examination Glove |
| Applicant | SHUN THAI RUBBER GLOVES INDUSTRY CO., LTD. 198 AVENUE DE LA D'EMERALD Sparks, NV 89434 -9550 |
| Contact | William C Lowenkamp |
| Correspondent | William C Lowenkamp SHUN THAI RUBBER GLOVES INDUSTRY CO., LTD. 198 AVENUE DE LA D'EMERALD Sparks, NV 89434 -9550 |
| Product Code | LYY |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-06-14 |
| Decision Date | 1995-08-11 |