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 With Low-dermatitis Potential Claim And Tested For Use With Chemotherapy Drugs (white).
| Device ID | K180505 |
| 510k Number | K180505 |
| Device Name: | Nitrile Powder Free Examination Glove With Colloidal Oatmeal USP With Low-Dermatitis Potential Claim And Tested For Use With Chemotherapy Drugs (White) |
| Classification | Polymer Patient Examination Glove |
| Applicant | Hartalega Sdn. Bhd. Dataran SD PJU9 Bandar Sri Damansara, MY 52200 |
| Contact | Kuan Kam Hon |
| Correspondent | Nurul Aisyah Kong Hartalega Sdn. 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 | Yes |
| Date Received | 2018-02-26 |
| Decision Date | 2018-06-14 |