The following data is part of a premarket notification filed by Hartalega Ngc Sdn. Bhd. with the FDA for Nitrile Powder Free Examination Glove With Colloidal Oatmeal Usp Skin Protectant - White, Nitrile Powder Free Examination Glove With Colloidal Oatmeal Usp Skin Protectant - Dawn Blue, Nitrile Powder Free Examination Glove With Colloidal Oatmeal Usp S.
| Device ID | K150110 |
| 510k Number | K150110 |
| Device Name: | Nitrile Powder Free Examination Glove With Colloidal Oatmeal USP Skin Protectant - White, Nitrile Powder Free Examination Glove With Colloidal Oatmeal USP Skin Protectant - Dawn Blue, Nitrile Powder Free Examination Glove With Colloidal Oatmeal USP S |
| Classification | Polymer Patient Examination Glove |
| Applicant | HARTALEGA NGC SDN. BHD. KAWASAN PERINDUSTRIAN TANJUNG, JALAN B20 Sepang, MY 64000 |
| Contact | Kuan Mun Leong |
| Correspondent | Nurul Aisyah Kong HARTALEGA NGC SDN. BHD. DATARAN SD PJU 9 Bandar Sri Damansara, MY 52200 |
| Product Code | LZA |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-01-20 |
| Decision Date | 2015-04-23 |