The following data is part of a premarket notification filed by Hartalega Sdn Bhd with the FDA for Latex Powder Free Surgical Glove With Protein Labelling Claim Of 50 Microgram Or Less Per Gram Of Glove And Tested For Use With Chemotherapy Drugs.
| Device ID | K201748 |
| 510k Number | K201748 |
| Device Name: | Latex Powder Free Surgical Glove With Protein Labelling Claim Of 50 Microgram Or Less Per Gram Of Glove And Tested For Use With Chemotherapy Drugs |
| Classification | Surgeon's Gloves |
| Applicant | Hartalega SDN BHD Dataran SD PJU 9 Bandar Sri Damansara, MY 52200 |
| Contact | Kuan Kam Hon |
| Correspondent | Dave Yungvirt THIRD PARTY REVIEW GROUP, LLC 25 Independence Blvd Warren, NJ 07059 |
| Product Code | KGO |
| CFR Regulation Number | 878.4460 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2020-06-26 |
| Decision Date | 2020-10-02 |