The following data is part of a premarket notification filed by Qube Medical Product Sdn Bhd with the FDA for Powder Free Latex Examination Gloves.
| Device ID | K123537 |
| 510k Number | K123537 |
| Device Name: | POWDER FREE LATEX EXAMINATION GLOVES |
| Classification | Latex Patient Examination Glove |
| Applicant | QUBE MEDICAL PRODUCT SDN BHD NO 10, JALAN KPK 1/1, KAWASAN PERINDUSTRIAN KUNDANG Kundang, MY 48020 |
| Contact | Terence Lim |
| Correspondent | Terence Lim QUBE MEDICAL PRODUCT SDN BHD NO 10, JALAN KPK 1/1, KAWASAN PERINDUSTRIAN KUNDANG Kundang, MY 48020 |
| Product Code | LYY |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-11-16 |
| Decision Date | 2014-02-12 |