The following data is part of a premarket notification filed by Hartalega Sdn Bhd with the FDA for Powder Free Examination Gloves With Colloidal Oatmeal Usp And Tested For Use With Chemotherapy Drugs - (lemon Green).
| Device ID | K180645 |
| 510k Number | K180645 |
| Device Name: | Powder Free Examination Gloves With Colloidal Oatmeal USP And Tested For Use With Chemotherapy Drugs - (Lemon Green) |
| Classification | Polymer Patient Examination Glove |
| Applicant | Hartalega Sdn Bhd C-G-9, Jalan Dataran Sd 1 Dataran Sd Pju 9 Bandar Sri Damansara, MY 52200 |
| Contact | Mr. Kuan Kam Hon |
| Correspondent | Nural Aisyah Kong Hartalega Sdn. Bhd. NO.7, Kawasan Perusahaan Suria Bestari Jaya, MY 52200 |
| Product Code | LZA |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | Yes |
| Date Received | 2018-03-12 |
| Decision Date | 2018-11-16 |