The following data is part of a premarket notification filed by Top Glove Sdn. Bhd. with the FDA for Green Powdered Latex Examination Gloves.
| Device ID | K993452 |
| 510k Number | K993452 |
| Device Name: | GREEN POWDERED LATEX EXAMINATION GLOVES |
| Classification | Latex Patient Examination Glove |
| Applicant | TOP GLOVE SDN. BHD. LOT 4968, BT 6, JALAN TERATAI OFF JALAN MERU Klang, Selangor, MY 41050 |
| Contact | T.s. Puon |
| Correspondent | T.s. Puon TOP GLOVE SDN. BHD. LOT 4968, BT 6, JALAN TERATAI OFF JALAN MERU Klang, Selangor, MY 41050 |
| Product Code | LYY |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-10-13 |
| Decision Date | 1999-12-20 |