The following data is part of a premarket notification filed by Qube Medical Product Sdn Bhd with the FDA for Powder Free Blue Nitrile Examination Glove.
| Device ID | K153732 |
| 510k Number | K153732 |
| Device Name: | Powder Free Blue Nitrile Examination Glove |
| Classification | Polymer Patient Examination Glove |
| Applicant | QUBE MEDICAL PRODUCT SDN BHD NO. 9, JALAN KPK 1/1, KAWASAN PERINDUSTRIAN KUNDANG Rawang, MY 48020 |
| Contact | Teo Siong Yam |
| Correspondent | Davendran Tangaya QUBE MEDICAL PRODUCT SDN BHD NO. 9, JALAN KPK 1/1, KAWASAN PERINDUSTRIAN KUNDANG Rawang, MY 48020 |
| Product Code | LZA |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-12-28 |
| Decision Date | 2016-07-29 |