The following data is part of a premarket notification filed by Inter Continental Health Care with the FDA for Surgicare (r) Latex Examination Gloves.
| Device ID | K893651 |
| 510k Number | K893651 |
| Device Name: | SURGICARE (R) LATEX EXAMINATION GLOVES |
| Classification | Latex Patient Examination Glove |
| Applicant | INTER CONTINENTAL HEALTH CARE ATTN: DR. KRISHNA MENON 41 WOOD AVENUE Boston, MA 02126 |
| Contact | Surgicare, Inc. |
| Correspondent | Surgicare, Inc. INTER CONTINENTAL HEALTH CARE ATTN: DR. KRISHNA MENON 41 WOOD AVENUE Boston, MA 02126 |
| Product Code | LYY |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-05-15 |
| Decision Date | 1989-08-10 |