The following data is part of a premarket notification filed by Tillotson Healthcare Corp. with the FDA for Accutouch Powder Free Natural Rubber Latex Patient Examination Glove.
| Device ID | K992428 |
| 510k Number | K992428 |
| Device Name: | ACCUTOUCH POWDER FREE NATURAL RUBBER LATEX PATIENT EXAMINATION GLOVE |
| Classification | Latex Patient Examination Glove |
| Applicant | TILLOTSON HEALTHCARE CORP. 360 ROUTE 101 Bedford, NH 03110 |
| Contact | Thomas N Tillotson |
| Correspondent | Carole Stamp TUV PRODUCT SERVICE, INC. 1775 OLD HIGHWAY 8 New Brighton, MN 55112 -1891 |
| Product Code | LYY |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 1999-07-21 |
| Decision Date | 1999-08-09 |
| Summary: | summary |