The following data is part of a premarket notification filed by Hartalega Sdn. Bhd. with the FDA for Nitrile Powder Free Examination Glove With Colloidal Oatmeal Usp Skin Protectant And Tested For Use With Chemotherapy Drugs (dawn Blue).
| Device ID | K171874 |
| 510k Number | K171874 |
| Device Name: | Nitrile Powder Free Examination Glove With Colloidal Oatmeal USP Skin Protectant And Tested For Use With Chemotherapy Drugs (Dawn Blue) |
| Classification | Polymer Patient Examination Glove |
| Applicant | HARTALEGA SDN. BHD. DATARAN SD PJU 9 Bandar Sri Damansara, MY 52200 |
| Contact | Kuan Kam Hon |
| Correspondent | Nurul Aisyah Kong HARTALEGA SND. BHD. NO. 7, KAWASAN PERUSAHAAN SURIA Bestari Jaya, MY 45600 |
| Product Code | LZA |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-06-23 |
| Decision Date | 2017-10-12 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10850043811296 | K171874 | 000 |
| 10850043811289 | K171874 | 000 |
| 10850043811272 | K171874 | 000 |
| 10850043811265 | K171874 | 000 |
| 10850043811258 | K171874 | 000 |