The following data is part of a premarket notification filed by Laglove (m) Sdn. Bhd. with the FDA for Laglove Brand Nitrile Examination Gloves, Powder Free, Non-sterile (pink Color).
| Device ID | K093335 |
| 510k Number | K093335 |
| Device Name: | LAGLOVE BRAND NITRILE EXAMINATION GLOVES, POWDER FREE, NON-STERILE (PINK COLOR) |
| Classification | Polymer 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 | LZA |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-10-26 |
| Decision Date | 2010-06-18 |