The following data is part of a premarket notification filed by La Glove (m) Sdn. Bhd. with the FDA for La Glove Brand Colored Latex Examination Gloves, Powder Free, Non Sterile (pink/ Green/ Violet).
| Device ID | K093193 |
| 510k Number | K093193 |
| Device Name: | LA GLOVE BRAND COLORED LATEX EXAMINATION GLOVES, POWDER FREE, NON STERILE (PINK/ GREEN/ VIOLET) |
| Classification | Latex Patient Examination Glove |
| Applicant | LA GLOVE (M) SDN. BHD. LOT 478 JALAN SIMPANG BALAK, OFF BATU 13, JALAN CHERAS Kajang Selangpr D.e., MY 43000 |
| Contact | G Baskaran |
| Correspondent | G Baskaran LA GLOVE (M) SDN. BHD. LOT 478 JALAN SIMPANG BALAK, OFF BATU 13, JALAN CHERAS Kajang Selangpr D.e., 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 | 2009-10-13 |
| Decision Date | 2010-06-08 |