The following data is part of a premarket notification filed by Green Cross Medical Supplies Corp. with the FDA for Surgical Gloves.
| Device ID | K894010 |
| 510k Number | K894010 |
| Device Name: | SURGICAL GLOVES |
| Classification | Surgeon's Gloves |
| Applicant | GREEN CROSS MEDICAL SUPPLIES CORP. 301 NORTH WASHINGTON ST. P.O. BOX 747 Falls Church, VA 22046 |
| Contact | Joseph A Kolasch |
| Correspondent | Joseph A Kolasch GREEN CROSS MEDICAL SUPPLIES CORP. 301 NORTH WASHINGTON ST. P.O. BOX 747 Falls Church, VA 22046 |
| Product Code | KGO |
| CFR Regulation Number | 878.4460 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-06-02 |
| Decision Date | 1989-10-27 |