The following data is part of a premarket notification filed by Ruhn Chang Industrial Co., Ltd. with the FDA for Latex Examination Gloves.
| Device ID | K891003 |
| 510k Number | K891003 |
| Device Name: | LATEX EXAMINATION GLOVES |
| Classification | Latex Patient Examination Glove |
| Applicant | RUHN CHANG INDUSTRIAL CO., LTD. 14 DELTA DR. New City, NY 10956 |
| Contact | Oliver Chiang |
| Correspondent | Oliver Chiang RUHN CHANG INDUSTRIAL CO., LTD. 14 DELTA DR. New City, NY 10956 |
| Product Code | LYY |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-02-28 |
| Decision Date | 1989-03-17 |