The following data is part of a premarket notification filed by Laglove (m) Sdn. Bhd. with the FDA for Latex Examination Gloves.
| Device ID | K912988 |
| 510k Number | K912988 |
| Device Name: | LATEX EXAMINATION GLOVES |
| Classification | Latex Patient Examination Glove |
| Applicant | LAGLOVE (M) SDN. BHD. JALAN SIMPANG BALAK, OFF BATU 13, JALAN CHERAS, 43000 KAJANG Selangor Darul Ehsan Mala, MG |
| Contact | Lot 478 |
| Correspondent | Lot 478 LAGLOVE (M) SDN. BHD. JALAN SIMPANG BALAK, OFF BATU 13, JALAN CHERAS, 43000 KAJANG Selangor Darul Ehsan Mala, MG |
| Product Code | LYY |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-07-05 |
| Decision Date | 1991-08-02 |