| Primary Device ID | 19551007775708 |
| NIH Device Record Key | 881cbcb2-2dfb-4761-8da8-ab9e8f9940c7 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | PROFENCE Nitrile Powder Free Examination Gloves |
| Version Model Number | NITRILE VB35104 |
| Company DUNS | 865807689 |
| Company Name | HARTALEGA NGC SDN. BHD. |
| Device Count | 100 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Phone | +60387073000 |
| liyana.harun@hartalega.com.my | |
| Phone | +60387073000 |
| liyana.harun@hartalega.com.my | |
| Phone | +60387073000 |
| liyana.harun@hartalega.com.my | |
| Phone | +60387073000 |
| liyana.harun@hartalega.com.my | |
| Phone | +60387073000 |
| liyana.harun@hartalega.com.my | |
| Phone | +60387073000 |
| liyana.harun@hartalega.com.my | |
| Phone | +60387073000 |
| liyana.harun@hartalega.com.my | |
| Phone | +60387073000 |
| liyana.harun@hartalega.com.my | |
| Phone | +60387073000 |
| liyana.harun@hartalega.com.my | |
| Phone | +60387073000 |
| liyana.harun@hartalega.com.my | |
| Phone | +60387073000 |
| liyana.harun@hartalega.com.my | |
| Phone | +60387073000 |
| liyana.harun@hartalega.com.my | |
| Phone | +60387073000 |
| liyana.harun@hartalega.com.my | |
| Phone | +60387073000 |
| liyana.harun@hartalega.com.my | |
| Phone | +60387073000 |
| liyana.harun@hartalega.com.my | |
| Phone | +60387073000 |
| liyana.harun@hartalega.com.my |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 09551007775701 [Primary] |
| GS1 | 09551007775916 [Unit of Use] |
| GS1 | 19551007775708 [Package] Contains: 09551007775701 Package: Case [10 Units] In Commercial Distribution |
| LZA | Polymer Patient Examination Glove |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-04-12 |
| Device Publish Date | 2022-04-04 |
| 19551007775715 | XL - PROFENCE Nitrile Powder Free Examination Gloves |
| 19551007775708 | L - PROFENCE Nitrile Powder Free Examination Gloves |
| 19551007775692 | M- PROFENCE Nitrile Powder Free Examination Gloves |
| 19551007775685 | S - PROFENCE Nitrile Powder Free Examination Gloves |
| 19551007775678 | XS - PROFENCE Nitrile Powder Free Examination Gloves |
| 19551007775647 | XL - PROFENCE Nitrile Powder Free Examination Gloves |
| 19551007775630 | L - PROFENCE Nitrile Powder Free Examination Gloves |
| 19551007775623 | M- PROFENCE Nitrile Powder Free Examination Gloves |
| 19551007775616 | S - PROFENCE Nitrile Powder Free Examination Gloves |
| 19551007775609 | XS-PROFENCE Nitrile Powder Free Examination Gloves |