The following data is part of a premarket notification filed by Digitcare Corp. with the FDA for Seamless Latex Patient Examination Gloves.
| Device ID | K891491 |
| 510k Number | K891491 |
| Device Name: | SEAMLESS LATEX PATIENT EXAMINATION GLOVES |
| Classification | Latex Patient Examination Glove |
| Applicant | DIGITCARE CORP. 300 S. BEVERLY DR. Beverly Hils, CA 90212 |
| Contact | Wool, Md |
| Correspondent | Wool, Md DIGITCARE CORP. 300 S. BEVERLY DR. Beverly Hils, CA 90212 |
| Product Code | LYY |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-03-16 |
| Decision Date | 1989-05-08 |