The following data is part of a premarket notification filed by Tillotson Healthcare Corp. with the FDA for Formula One Powdered Latex Examination Glove, With Protein Content Labeling Claim 200 Micrograms Or Less And Made From A.
| Device ID | K002719 |
| 510k Number | K002719 |
| Device Name: | FORMULA ONE POWDERED LATEX EXAMINATION GLOVE, WITH PROTEIN CONTENT LABELING CLAIM 200 MICROGRAMS OR LESS AND MADE FROM A |
| Classification | Latex Patient Examination Glove |
| Applicant | TILLOTSON HEALTHCARE CORP. 360 ROUTE 101 Bedford, NH 03110 -5030 |
| Contact | F.w. Perrella |
| Correspondent | F.w. Perrella TILLOTSON HEALTHCARE CORP. 360 ROUTE 101 Bedford, NH 03110 -5030 |
| Product Code | LYY |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-08-31 |
| Decision Date | 2001-01-26 |