The following data is part of a premarket notification filed by Shun Thai Rubber Gloves Industry Co., Ltd. with the FDA for Shun-thai - Safe-contact, Boston Medical Latex Exam Glove, Shun-thai Latex Exmination Glove.
| Device ID | K982416 |
| 510k Number | K982416 |
| Device Name: | SHUN-THAI - SAFE-CONTACT, BOSTON MEDICAL LATEX EXAM GLOVE, SHUN-THAI LATEX EXMINATION GLOVE |
| Classification | Latex Patient Examination Glove |
| Applicant | SHUN THAI RUBBER GLOVES INDUSTRY CO., LTD. 1034-1054 LOWENKAMP LN. PO BOX 878 Hazelhurst, MS 39083 -0878 |
| Contact | William C Lowenkamp |
| Correspondent | William C Lowenkamp SHUN THAI RUBBER GLOVES INDUSTRY CO., LTD. 1034-1054 LOWENKAMP LN. PO BOX 878 Hazelhurst, MS 39083 -0878 |
| Product Code | LYY |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-07-13 |
| Decision Date | 1998-11-24 |