The following data is part of a premarket notification filed by Tillotson Healthcare Corp. with the FDA for Formula One Sterile Latex Examination Gloves With Protein Content Labeling Claim (200 Micrograms Or Less) Made From Allo.
| Device ID | K002720 |
| 510k Number | K002720 |
| Device Name: | FORMULA ONE STERILE LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (200 MICROGRAMS OR LESS) MADE FROM ALLO |
| 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 | 2000-11-09 |