The following data is part of a premarket notification filed by Laglove (m) Sdn. Bhd. with the FDA for Laglove Brand Latex Examination Gloves (low Protein).
| Device ID | K990285 |
| 510k Number | K990285 |
| Device Name: | LAGLOVE BRAND LATEX EXAMINATION GLOVES (LOW PROTEIN) |
| Classification | Latex 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 | LYY |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-01-29 |
| Decision Date | 1999-02-18 |