The following data is part of a premarket notification filed by Laglove (m) Sdn. Bhd. with the FDA for Laglove Brand Colored Nitrile Examination Gloves (powder Free).
| Device ID | K990882 |
| 510k Number | K990882 |
| Device Name: | LAGLOVE BRAND COLORED NITRILE EXAMINATION GLOVES (POWDER FREE) |
| Classification | Polymer Patient Examination Glove |
| Applicant | LAGLOVE (M) SDN. BHD. JALAN SIMPANG BALAK, OFF BATU 13, JALAN CHERAS, 43000 KAJANG Selangor Darul Ehsan Mala, MG |
| Contact | G. Baskaran |
| Correspondent | G. Baskaran LAGLOVE (M) SDN. BHD. JALAN SIMPANG BALAK, OFF BATU 13, JALAN CHERAS, 43000 KAJANG Selangor Darul Ehsan Mala, MG |
| Product Code | LZA |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-03-16 |
| Decision Date | 1999-05-21 |