The following data is part of a premarket notification filed by Purnabina Sdn Bhd with the FDA for Polymer Coated Powder Free Latex Examination Gloves.
| Device ID | K003904 |
| 510k Number | K003904 |
| Device Name: | POLYMER COATED POWDER FREE LATEX EXAMINATION GLOVES |
| Classification | Latex Patient Examination Glove |
| Applicant | PURNABINA SDN BHD PLO 5 JLN. MAHSURI 1, KAWASAN PERINDUSTRAIN KLUANG Kluang, Jahor, MY 86007 |
| Contact | Liew Yoon Fong |
| Correspondent | Liew Yoon Fong PURNABINA SDN BHD PLO 5 JLN. MAHSURI 1, KAWASAN PERINDUSTRAIN KLUANG Kluang, Jahor, MY 86007 |
| Product Code | LYY |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-12-19 |
| Decision Date | 2001-01-24 |