The following data is part of a premarket notification filed by Top Glove Sdn. Bhd. with the FDA for Synthetic Vinyl Medical Examination Powder Free Glove.
| Device ID | K993680 |
| 510k Number | K993680 |
| Device Name: | SYNTHETIC VINYL MEDICAL EXAMINATION POWDER FREE GLOVE |
| Classification | Vinyl Patient Examination Glove |
| Applicant | TOP GLOVE SDN. BHD. 41050 KLANG,SELANGOR Darul Ehsan, MY |
| Contact | Wee-chai Lim |
| Correspondent | Wee-chai Lim TOP GLOVE SDN. BHD. 41050 KLANG,SELANGOR Darul Ehsan, MY |
| Product Code | LYZ |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-11-01 |
| Decision Date | 1999-12-13 |