The following data is part of a premarket notification filed by Tillotson Healthcare Corp. with the FDA for Powder Free Hyproallergenic Examination Glove (with Low Protein Claim).
| Device ID | K974065 |
| 510k Number | K974065 |
| Device Name: | POWDER FREE HYPROALLERGENIC EXAMINATION GLOVE (WITH LOW PROTEIN CLAIM) |
| Classification | Latex Patient Examination Glove |
| Applicant | TILLOTSON HEALTHCARE CORP. 360 ROUTE 101 Bedford, NH 03110 |
| Contact | Edward Markovic |
| Correspondent | Edward Markovic TILLOTSON HEALTHCARE CORP. 360 ROUTE 101 Bedford, NH 03110 |
| Product Code | LYY |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-10-27 |
| Decision Date | 1998-01-06 |
| Summary: | summary |