The following data is part of a premarket notification filed by Mexpo Intl., Inc. with the FDA for Powdered Latex Examination Gloves With Protein Content Labeling Claim (100 Micrograms Or Less Of Total Water Extractabp.
| Device ID | K990210 |
| 510k Number | K990210 |
| Device Name: | POWDERED LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (100 MICROGRAMS OR LESS OF TOTAL WATER EXTRACTABP |
| Classification | Latex 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 | LYY |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-01-21 |
| Decision Date | 1999-03-29 |