The following data is part of a premarket notification filed by Mexpo Intl., Inc. with the FDA for Blossom Powder Free Latex Examination Gloves With Protein Content Labeling Claim 50 Mcgm Or Less Of Total Water Extracta.
| Device ID | K992337 |
| 510k Number | K992337 |
| Device Name: | BLOSSOM POWDER FREE LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM 50 MCGM OR LESS OF TOTAL WATER EXTRACTA |
| Classification | Patient Examination Glove |
| Applicant | MEXPO INTL., INC. 2671 MCCONE AVE. Hayward,, CA 94545 |
| Contact | Tim Thai |
| Correspondent | Tim Thai MEXPO INTL., INC. 2671 MCCONE AVE. Hayward,, CA 94545 |
| Product Code | FMC |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-07-13 |
| Decision Date | 1999-08-17 |