K992337 is an FDA 510(k) clearance for the BLOSSOM POWDER FREE LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM 50 MCGM OR LESS OF TOTAL WATER EXTRACTA. This device is classified as a Patient Examination Glove (Class I - General Controls, product code FMC).
Submitted by Mexpo Intl., Inc. (Hayward,, US). The FDA issued a Cleared decision on August 17, 1999, 35 days after receiving the submission on July 13, 1999.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.6250.
| 510(k) Number | K992337 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 13, 1999 |
| Decision Date | August 17, 1999 |
| Days to Decision | 35 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Statement |
| Product Code | FMC — Patient Examination Glove |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 880.6250 |