The following data is part of a premarket notification filed by Ruhn Chang Industrial Co., Ltd. with the FDA for Sterile Natural Latex Surgical Gloves.
| Device ID | K892108 |
| 510k Number | K892108 |
| Device Name: | STERILE NATURAL LATEX SURGICAL GLOVES |
| Classification | Surgeon's Gloves |
| 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 | KGO |
| CFR Regulation Number | 878.4460 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-04-03 |
| Decision Date | 1989-09-08 |