The following data is part of a premarket notification filed by Koolsum Ent., Inc. with the FDA for Vecom Brand Patient Examination Gloves.
| Device ID | K892778 |
| 510k Number | K892778 |
| Device Name: | VECOM BRAND PATIENT EXAMINATION GLOVES |
| Classification | Latex Patient Examination Glove |
| Applicant | KOOLSUM ENT., INC. 11211 NORTH FREEWAY Houston, TX 77037 |
| Contact | Julian Langham |
| Correspondent | Julian Langham KOOLSUM ENT., INC. 11211 NORTH FREEWAY Houston, TX 77037 |
| Product Code | LYY |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-04-11 |
| Decision Date | 1989-08-10 |