The following data is part of a premarket notification filed by Modern Health Care Products with the FDA for Excelcare Patient Examination Gloves.
| Device ID | K891500 |
| 510k Number | K891500 |
| Device Name: | EXCELCARE PATIENT EXAMINATION GLOVES |
| Classification | Latex Patient Examination Glove |
| Applicant | MODERN HEALTH CARE PRODUCTS PLOT 268, LORONG PERUSAHAAN DUABELAS, KAWASAN PERUSAHAAN Perai, MY 13600 |
| Contact | Siew Weng |
| Correspondent | Siew Weng MODERN HEALTH CARE PRODUCTS PLOT 268, LORONG PERUSAHAAN DUABELAS, KAWASAN PERUSAHAAN Perai, MY 13600 |
| 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 | 1989-07-14 |