The following data is part of a premarket notification filed by Laglove (m) Sdn. Bhd. with the FDA for Laglove Brand Blue Color Latex Examination Glove, Powder Free Containing 50 Mlgm Or Less Of Water Extractable Protein Pe.
| Device ID | K991749 |
| 510k Number | K991749 |
| Device Name: | LAGLOVE BRAND BLUE COLOR LATEX EXAMINATION GLOVE, POWDER FREE CONTAINING 50 MLGM OR LESS OF WATER EXTRACTABLE PROTEIN PE |
| 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 | 1999-05-24 |
| Decision Date | 1999-06-23 |