The following data is part of a premarket notification filed by Hanwella Rubber Products Ltd. with the FDA for Hanwella Latex Patient Exam. Gloves Powder-free.
| Device ID | K000351 |
| 510k Number | K000351 |
| Device Name: | HANWELLA LATEX PATIENT EXAM. GLOVES POWDER-FREE |
| Classification | Latex Patient Examination Glove |
| Applicant | HANWELLA RUBBER PRODUCTS LTD. 46/34 NAVAM MAWATHA, Colombo 2, LK |
| Contact | B. Damitha P Dharmasena |
| Correspondent | B. Damitha P Dharmasena HANWELLA RUBBER PRODUCTS LTD. 46/34 NAVAM MAWATHA, Colombo 2, LK |
| Product Code | LYY |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-02-04 |
| Decision Date | 2000-06-23 |