The following data is part of a premarket notification filed by Mirage Medical & Chemical, Inc. with the FDA for Latex Surgical Sterile Gloves.
| Device ID | K903212 |
| 510k Number | K903212 |
| Device Name: | LATEX SURGICAL STERILE GLOVES |
| Classification | Surgeon's Gloves |
| Applicant | MIRAGE MEDICAL & CHEMICAL, INC. 15932 W. STATE RD. 84 NO. 151 Sunrise, FL 33326 |
| Contact | Joaquim M Rola |
| Correspondent | Joaquim M Rola MIRAGE MEDICAL & CHEMICAL, INC. 15932 W. STATE RD. 84 NO. 151 Sunrise, FL 33326 |
| Product Code | KGO |
| CFR Regulation Number | 878.4460 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-07-11 |
| Decision Date | 1990-08-01 |