| Primary Device ID | 20850074089043 |
| NIH Device Record Key | 7a9c6595-db1a-46c1-9847-25af0f2c58e0 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | JDL Sensitive |
| Version Model Number | 010-1280 |
| Company DUNS | 118768538 |
| Company Name | Surgyco LLC |
| Device Count | 200 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Safe |
| 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 | 00850074089049 [Unit of Use] |
| GS1 | 10850074089046 [Primary] |
| GS1 | 20850074089043 [Package] Contains: 10850074089046 Package: Case [2000 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 | 2025-07-21 |
| Device Publish Date | 2025-07-11 |
| 20850074089043 | JDL Sensitive Nitrile Examination Gloves X-large |
| 20850074089036 | JDL Sensitive Nitrile Examination Gloves Large |
| 20850074089029 | JDL Sensitive Nitrile Examination Gloves Medium |
| 20850074089012 | JDL Sensitive Nitrile Examination Gloves Small |