The following data is part of a premarket notification filed by Hartalega Sdn. Bhd. with the FDA for Latex Powder Free Polymer Coated Examination Glove With Protein Labeling Claim Of 50 Microgram Or Less Per Gram Of Glove.
| Device ID | K161006 |
| 510k Number | K161006 |
| Device Name: | Latex Powder Free Polymer Coated Examination Glove With Protein Labeling Claim Of 50 Microgram Or Less Per Gram Of Glove |
| Classification | Latex Patient Examination Glove |
| Applicant | HARTALEGA SDN. BHD. DATARAN SD PJU 9 Bandar Sri Damansara, MY 52200 |
| Contact | Kuan Kam Hon |
| Correspondent | Nurul Aisyah Kong Bt Abdullah HARTALEGA SDN. BHD. NO. 7 KAWASAN PERUSAHAAN SURIA Bestari Jaya, MY 45600 |
| Product Code | LYY |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-04-11 |
| Decision Date | 2016-08-04 |