The following data is part of a premarket notification filed by Top Glove Sdn. Bhd. with the FDA for Polymer Coated Powderfree Latex Examintation Gloves.
| Device ID | K990690 |
| 510k Number | K990690 |
| Device Name: | POLYMER COATED POWDERFREE LATEX EXAMINTATION GLOVES |
| Classification | Latex Patient Examination Glove |
| Applicant | TOP GLOVE SDN. BHD. 41050 KLANG,SELANGOR Darul Ehsan, MY |
| Contact | Lim Wee Chai |
| Correspondent | Lim Wee Chai TOP GLOVE SDN. BHD. 41050 KLANG,SELANGOR Darul Ehsan, MY |
| Product Code | LYY |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-03-03 |
| Decision Date | 1999-05-20 |