The following data is part of a premarket notification filed by Hartalega Ngc Sdn. Bhd. with the FDA for Nitrile Powder Free Examination Glove With Low Dermatitis Potential Claim (white).
| Device ID | K192232 |
| 510k Number | K192232 |
| Device Name: | Nitrile Powder Free Examination Glove With Low Dermatitis Potential Claim (White) |
| Classification | Polymer Patient Examination Glove |
| Applicant | Hartalega NGC Sdn. Bhd. No. 1, Persiaran Tanjung Kawasan Perindustrian Tanjung Sepang, MY 43900 |
| Contact | Kuan Mun Leong |
| Correspondent | Nurul Aisyah Kong Hartalega NGC Sdn. Bhd. No. 1, Persiaran Tanjung Kawasan Perindustrian Tanjung Sepang, MY 43900 |
| Product Code | LZA |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-08-16 |
| Decision Date | 2019-11-08 |