The following data is part of a premarket notification filed by M.m.r. Gloves Private Ltd. with the FDA for Powder-free Latex Examination Glove.
| Device ID | K952473 |
| 510k Number | K952473 |
| Device Name: | POWDER-FREE LATEX EXAMINATION GLOVE |
| Classification | Latex Patient Examination Glove |
| Applicant | M.M.R. GLOVES PRIVATE LTD. 748 MOUNT RD. Madras, IN 600 002 |
| Contact | R Ashokan |
| Correspondent | R Ashokan M.M.R. GLOVES PRIVATE LTD. 748 MOUNT RD. Madras, IN 600 002 |
| Product Code | LYY |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-05-26 |
| Decision Date | 1995-10-12 |