The following data is part of a premarket notification filed by Chester Labs, Inc. with the FDA for Bioshield Blue Powder Free Glove.
| Device ID | K940254 |
| 510k Number | K940254 |
| Device Name: | BIOSHIELD BLUE POWDER FREE GLOVE |
| Classification | Latex Patient Examination Glove |
| Applicant | CHESTER LABS, INC. 385-J FRANKLIN AVE. Rockaway, NJ 07866 |
| Contact | Robert S Kennedy, Ph.d. |
| Correspondent | Robert S Kennedy, Ph.d. CHESTER LABS, INC. 385-J FRANKLIN AVE. Rockaway, NJ 07866 |
| Product Code | LYY |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-01-21 |
| Decision Date | 1994-03-23 |