The following data is part of a premarket notification filed by Makintech Corp. with the FDA for Latex Examination Gloves.
| Device ID | K893176 |
| 510k Number | K893176 |
| Device Name: | LATEX EXAMINATION GLOVES |
| Classification | Latex Patient Examination Glove |
| Applicant | MAKINTECH CORP. 21215 DETROIT RD., #112B Cleveland, OH 44116 |
| Contact | Mak, Ph.d. |
| Correspondent | Mak, Ph.d. MAKINTECH CORP. 21215 DETROIT RD., #112B Cleveland, OH 44116 |
| Product Code | LYY |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-04-17 |
| Decision Date | 1989-07-14 |