The following data is part of a premarket notification filed by Rex Latex Products Co., Ltd. with the FDA for Disposable Latex Examination Gloves.
| Device ID | K892179 |
| 510k Number | K892179 |
| Device Name: | DISPOSABLE LATEX EXAMINATION GLOVES |
| Classification | Latex Patient Examination Glove |
| Applicant | REX LATEX PRODUCTS CO., LTD. 28-32 YUKOL 1 ROAD, SUAN MALI Bangkok, TH |
| Contact | Chen Niruttinanon |
| Correspondent | Chen Niruttinanon REX LATEX PRODUCTS CO., LTD. 28-32 YUKOL 1 ROAD, SUAN MALI Bangkok, TH |
| Product Code | LYY |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-04-04 |
| Decision Date | 1989-08-25 |