The following data is part of a premarket notification filed by Laglove (m) Sdn. Bhd. with the FDA for Laglove Brand Double Polymer Coated Nitrile Examination Gloves (powder Free - Blue Color).
| Device ID | K042618 |
| 510k Number | K042618 |
| Device Name: | LAGLOVE BRAND DOUBLE POLYMER COATED NITRILE EXAMINATION GLOVES (POWDER FREE - BLUE COLOR) |
| Classification | Patient Examination Glove |
| Applicant | LAGLOVE (M) SDN. BHD. LOT 478, JALAN SIMPANG BALAK, OFF BATU 13, JALAN CHERAS Kajang, Selangor, Darul Ehsan, MY 43000 |
| Contact | G. Baskaran |
| Correspondent | G. Baskaran LAGLOVE (M) SDN. BHD. LOT 478, JALAN SIMPANG BALAK, OFF BATU 13, JALAN CHERAS Kajang, Selangor, Darul Ehsan, MY 43000 |
| Product Code | FMC |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-09-27 |
| Decision Date | 2004-11-26 |