The following data is part of a premarket notification filed by Hartalega Ngc Sdn Bhd with the FDA for Nitrile Powder Free Examination Gloves-pink, Nitrile Powder Free Examination Gloves-green,nitrile Powder Free Examination Gloves-orange, Nitrile Powder Free Examination Gloves-black.
| Device ID | K151836 |
| 510k Number | K151836 |
| Device Name: | NITRILE POWDER FREE EXAMINATION GLOVES-PINK, NITRILE POWDER FREE EXAMINATION GLOVES-GREEN,NITRILE POWDER FREE EXAMINATION GLOVES-ORANGE, NITRILE POWDER FREE EXAMINATION GLOVES-BLACK |
| Classification | Polymer Patient Examination Glove |
| Applicant | HARTALEGA NGC SDN BHD NO. 1, PERSIARAN TANJUNG, LOT PT4330 KAWASAN PERINDUSTRIAN TANJUNG, JALAN B20, Sepang, MY 64000 |
| Contact | Kuan Mun Leong |
| Correspondent | Nurul Aisyah King Abdullah HARTALEGA NGC SDN BHD NO. 1, PERSIARAN TANJUNG, LOT PT4330 KAWASAN PERINDUSTRIAN TANJUNG, JALAN B20, Sepang, MY 64000 |
| Product Code | LZA |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-07-06 |
| Decision Date | 2015-10-21 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00841277103168 | K151836 | 000 |
| 00841277103151 | K151836 | 000 |
| 00841277103144 | K151836 | 000 |
| 00841277103137 | K151836 | 000 |
| 00841277103120 | K151836 | 000 |
| 00841277103113 | K151836 | 000 |