The following data is part of a premarket notification filed by Top Glove Sdn. Bhd. with the FDA for Nitrile Latex Powdered Examination Glove.
| Device ID | K983816 |
| 510k Number | K983816 |
| Device Name: | NITRILE LATEX POWDERED EXAMINATION GLOVE |
| Classification | Polymer Patient Examination Glove |
| Applicant | TOP GLOVE SDN. BHD. 41050 KLANG,SELANGOR Darul Ehsan, MY |
| Contact | T.s. Puon |
| Correspondent | T.s. Puon TOP GLOVE SDN. BHD. 41050 KLANG,SELANGOR Darul Ehsan, MY |
| Product Code | LZA |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-10-29 |
| Decision Date | 1998-12-04 |