The following data is part of a premarket notification filed by Laglove (m) Sdn. Bhd. with the FDA for Laglove Powdered Latex Surgical Gloves With Protein Content Labeling Claim (150 Micrograms Or Less).
| Device ID | K992018 |
| 510k Number | K992018 |
| Device Name: | LAGLOVE POWDERED LATEX SURGICAL GLOVES WITH PROTEIN CONTENT LABELING CLAIM (150 MICROGRAMS OR LESS) |
| Classification | Surgeon's Gloves |
| 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 | KGO |
| CFR Regulation Number | 878.4460 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-06-16 |
| Decision Date | 1999-07-30 |