| Primary Device ID | 00383790011075 |
| NIH Device Record Key | 40499465-ed3a-408c-84e7-7a0336ac0285 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Nipro Latex Examination Gloves |
| Version Model Number | GU-XLARGE-PF-1KUS |
| Company DUNS | 797372554 |
| Company Name | NIPRO MEDICAL CORPORATION |
| 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 | false |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | true |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | true |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00383790011020 [Primary] |
| GS1 | 00383790011075 [Package] Contains: 00383790011020 Package: case [10 Units] In Commercial Distribution |
| GS1 | 00383790011563 [Unit of Use] |
| LYY | Latex 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 | 2022-11-08 |
| Device Publish Date | 2022-10-31 |
| 00383790011075 | Latex Examination Gloves, Size Extra Large |
| 00383790011068 | Latex Examination Gloves, Size Large |
| 00383790011051 | Latex Examination Gloves, Size Medium |
| 00383790011044 | Latex Examination Gloves, Size Small |
| 00383790011037 | Latex Examination Gloves, Size Extra Small |