The following data is part of a premarket notification filed by Makintech Corp. with the FDA for Latex Surgical Glove (non Sterile).
| Device ID | K883556 |
| 510k Number | K883556 |
| Device Name: | LATEX SURGICAL GLOVE (NON STERILE) |
| Classification | Surgeon's Gloves |
| Applicant | MAKINTECH CORP. 21215 DETROIT RD., #112B Cleveland, OH 44116 |
| Contact | Mak, Phd |
| Correspondent | Mak, Phd MAKINTECH CORP. 21215 DETROIT RD., #112B Cleveland, OH 44116 |
| Product Code | KGO |
| CFR Regulation Number | 878.4460 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-08-19 |
| Decision Date | 1989-02-03 |