The following data is part of a premarket notification filed by Tong Ruhn Medical Products Co., Ltd. with the FDA for Powder Free Synthetic Vinyl Patient Exam Glove.
| Device ID | K010671 |
| 510k Number | K010671 |
| Device Name: | POWDER FREE SYNTHETIC VINYL PATIENT EXAM GLOVE |
| Classification | Vinyl Patient Examination Glove |
| Applicant | TONG RUHN MEDICAL PRODUCTS CO., LTD. 1202 S. RTE 31 Mchenry, IL 60050 |
| Contact | Antonio L Giaccio |
| Correspondent | Antonio L Giaccio TONG RUHN MEDICAL PRODUCTS CO., LTD. 1202 S. RTE 31 Mchenry, IL 60050 |
| Product Code | LYZ |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-03-06 |
| Decision Date | 2001-04-09 |