K042618 is an FDA 510(k) clearance for the LAGLOVE BRAND DOUBLE POLYMER COATED NITRILE EXAMINATION GLOVES (POWDER FREE - BLUE COLOR). This device is classified as a Patient Examination Glove (Class I - General Controls, product code FMC).
Submitted by La Glove (M) Sdn. Bhd. (Kajang Selangpr D.E., MY). The FDA issued a Cleared decision on November 26, 2004, 60 days after receiving the submission on September 27, 2004.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.6250.
| 510(k) Number | K042618 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 27, 2004 |
| Decision Date | November 26, 2004 |
| Days to Decision | 60 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 |