The following data is part of a premarket notification filed by Thai Medical Industries Co., Ltd. with the FDA for Accutouch Patient Exam Gloves.
| Device ID | K892977 |
| 510k Number | K892977 |
| Device Name: | ACCUTOUCH PATIENT EXAM GLOVES |
| Classification | Latex Patient Examination Glove |
| Applicant | THAI MEDICAL INDUSTRIES CO., LTD. 1920 N STREET, N.W. Washington, DC 20036 |
| Contact | Norman J Philion |
| Correspondent | Norman J Philion THAI MEDICAL INDUSTRIES CO., LTD. 1920 N STREET, N.W. Washington, DC 20036 |
| Product Code | LYY |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-04-12 |
| Decision Date | 1989-08-01 |