| Primary Device ID | 08994452290138 |
| NIH Device Record Key | db8918bf-a061-4aaa-afe1-e7eaaa266106 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Nitrile Examination Gloves Powder Free |
| Version Model Number | XX - Large |
| Company DUNS | 565034612 |
| Company Name | PT. SINTONG UNIGOLDEN GLOVE |
| 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 | true |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 08994452290077 [Primary] |
| GS1 | 08994452290138 [Unit of Use] |
| GS1 | 18994452290074 [Package] Contains: 08994452290077 Package: Box [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 | 2024-03-04 |
| Device Publish Date | 2024-02-23 |
| 08994452290138 | Nitrile Examination Gloves Powder Free (Tested for use with Chemotherapy Drugs) - (XX - Large) |
| 18994452290067 | Nitrile Examination Gloves Powder Free (Tested for use with Chemotherapy Drugs) - (X - Large) |
| 18994452290050 | Nitrile Examination Gloves Powder Free (Tested for use with Chemotherapy Drugs) - (Large) |
| 18994452290043 | Nitrile Examination Gloves Powder Free (Tested for use with Chemotherapy Drugs) - (Medium) |
| 18994452290036 | Nitrile Examination Gloves Powder Free (Tested for use with Chemotherapy Drugs) - (Small) |
| 18994452290029 | Nitrile Examination Gloves Powder Free (Tested for use with Chemotherapy Drugs) - (X - Small) |