The following data is part of a premarket notification filed by Purnabina Sdn Bhd with the FDA for Powder Free Latex Examination Patient Gloves.
| Device ID | K994420 |
| 510k Number | K994420 |
| Device Name: | POWDER FREE LATEX EXAMINATION PATIENT GLOVES |
| Classification | Latex Patient Examination Glove |
| Applicant | PURNABINA SDN BHD PLOT 5, JALAN MAHSURI 1, 7.5KM J. MERSING, KLUANG IND. AREA Kluang, Johor D. Takzim, MY 86000 |
| Contact | Liew Yoon Fong |
| Correspondent | Liew Yoon Fong PURNABINA SDN BHD PLOT 5, JALAN MAHSURI 1, 7.5KM J. MERSING, KLUANG IND. AREA Kluang, Johor D. Takzim, MY 86000 |
| Product Code | LYY |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-12-29 |
| Decision Date | 2000-09-18 |