The following data is part of a premarket notification filed by Jet Far Industries, Inc. with the FDA for Surgical Gloves.
| Device ID | K895080 |
| 510k Number | K895080 |
| Device Name: | SURGICAL GLOVES |
| Classification | Dislodger, Stone, Flexible |
| Applicant | JET FAR INDUSTRIES, INC. COMPREG ADMINISTRATION, INC. P.O. BOX 3119 Seal Beach, CA 90740 |
| Contact | James E Lenick |
| Correspondent | James E Lenick JET FAR INDUSTRIES, INC. COMPREG ADMINISTRATION, INC. P.O. BOX 3119 Seal Beach, CA 90740 |
| Product Code | FGO |
| CFR Regulation Number | 876.4680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-08-14 |
| Decision Date | 1990-01-24 |