The following data is part of a premarket notification filed by P.t. Latexindo Tobaperkasa with the FDA for Powder Free Nitrile Examination Gloves - Polymer Coated.
| Device ID | K974443 |
| 510k Number | K974443 |
| Device Name: | POWDER FREE NITRILE EXAMINATION GLOVES - POLYMER COATED |
| Classification | Vinyl Patient Examination Glove |
| Applicant | P.T. LATEXINDO TOBAPERKASA JALAN RAYA BINJAI KM. 11. Medan, ID |
| Contact | Hendra Ramali |
| Correspondent | Hendra Ramali P.T. LATEXINDO TOBAPERKASA JALAN RAYA BINJAI KM. 11. Medan, ID |
| Product Code | LYZ |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-11-25 |
| Decision Date | 1998-01-05 |