The following data is part of a premarket notification filed by Hartalega Sdb. Bhd. with the FDA for Latex Polymer Coated Powder Free Surgical Glove With Protein Labeling Claim Of 50 Microgram Or Less Per Gram Of Glove (natural), Latex Polymer Coated Powder Free Surgical Glove With Protein Labeling Claim Of 50 Microgram Or Less Per Gram Of Glove (gr.
| Device ID | K160928 |
| 510k Number | K160928 |
| Device Name: | Latex Polymer Coated Powder Free Surgical Glove With Protein Labeling Claim Of 50 Microgram Or Less Per Gram Of Glove (Natural), Latex Polymer Coated Powder Free Surgical Glove With Protein Labeling Claim Of 50 Microgram Or Less Per Gram Of Glove (Gr |
| Classification | Surgeon's Gloves |
| Applicant | HARTALEGA SDB. BHD. DATARAN SD PJU9 Bandar Sri Damansara, MY 52200 |
| Contact | Kuan Kam Hon |
| Correspondent | Nurul Aisyah Kong HARTALEGA SDB. BHD. NO. 7 KAWASAN PERUSAHAAN SURIA Bestari Jaya, MY 45600 |
| Product Code | KGO |
| CFR Regulation Number | 878.4460 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-04-04 |
| Decision Date | 2016-12-20 |