The following data is part of a premarket notification filed by Ct Intl. with the FDA for Sterile Surgical Natural Latex Gloves.
| Device ID | K891622 |
| 510k Number | K891622 |
| Device Name: | STERILE SURGICAL NATURAL LATEX GLOVES |
| Classification | Surgeon's Gloves |
| Applicant | CT INTL. 330 GOLDEN SHORE DR. #280 Long Beach, CA 90802 |
| Contact | Michael Kyle |
| Correspondent | Michael Kyle CT INTL. 330 GOLDEN SHORE DR. #280 Long Beach, CA 90802 |
| Product Code | KGO |
| CFR Regulation Number | 878.4460 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-03-23 |
| Decision Date | 1989-09-06 |