The following data is part of a premarket notification filed by Hartalega Ngc Sdn. Bhd. with the FDA for Latex Powder Free Surgical Glove With Protein Labeling Claim Of 50 Microgram Or Less Per Gram Of Glove And Tested For Use With Chemotherapy Drugs.
| Device ID | K214074 |
| 510k Number | K214074 |
| Device Name: | Latex Powder Free Surgical Glove With Protein Labeling Claim Of 50 Microgram Or Less Per Gram Of Glove And Tested For Use With Chemotherapy Drugs |
| Classification | Surgeon's Gloves |
| Applicant | Hartalega NGC SDN. BHD. No. 1 Persiaran Tanjung Sepang, MY 43900 |
| Contact | Kuan Mun Leong |
| Correspondent | Nurul Aisyah Kong Hartalega NGC SDN. BHD. No. 1 Persiaran Tanjung Sepang, MY 43900 |
| Product Code | KGO |
| CFR Regulation Number | 878.4460 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-12-27 |
| Decision Date | 2022-05-26 |