| Primary Device ID | 20038054686417 |
| NIH Device Record Key | bca0621d-dfee-4d71-99d4-ad8d79990b59 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | N-Dex |
| Version Model Number | XXL |
| Catalog Number | M7005PFXXL |
| Company DUNS | 807930412 |
| Company Name | SHOWA BEST GLOVE, INC. |
| Device Count | 90 |
| 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 | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Phone | 800-241-0323 |
| USA@Showagroup.com | |
| Phone | 800-241-0323 |
| USA@Showagroup.com | |
| Phone | 800-241-0323 |
| USA@Showagroup.com | |
| Phone | 800-241-0323 |
| USA@Showagroup.com | |
| Phone | 800-241-0323 |
| USA@Showagroup.com | |
| Phone | 800-241-0323 |
| USA@Showagroup.com | |
| Phone | 800-241-0323 |
| USA@Showagroup.com | |
| Phone | 800-241-0323 |
| USA@Showagroup.com | |
| Phone | 800-241-0323 |
| USA@Showagroup.com | |
| Phone | 800-241-0323 |
| USA@Showagroup.com | |
| Phone | 800-241-0323 |
| USA@Showagroup.com | |
| Phone | 800-241-0323 |
| USA@Showagroup.com | |
| Phone | 800-241-0323 |
| USA@Showagroup.com | |
| Phone | 800-241-0323 |
| USA@Showagroup.com | |
| Phone | 800-241-0323 |
| USA@Showagroup.com | |
| Phone | 800-241-0323 |
| USA@Showagroup.com | |
| Phone | 800-241-0323 |
| USA@Showagroup.com | |
| Phone | 800-241-0323 |
| USA@Showagroup.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00038054686413 [Primary] |
| GS1 | 10038054686410 [Unit of Use] |
| GS1 | 20038054686417 [Package] Contains: 00038054686413 Package: [20 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 | 2023-02-28 |
| Device Publish Date | 2023-02-20 |
| 20038054686493 | Biodegradable Exam Use, powder-free, low-modulus 100%-nitrile, 9-1/2", 4-mil, rolled cuff, blue/ |
| 20038054686486 | Biodegradable Exam Use, powder-free, low-modulus 100%-nitrile, 9-1/2", 4-mil, rolled cuff, blue/ |
| 20038054686479 | Biodegradable Exam Use, powder-free, low-modulus 100%-nitrile, 9-1/2", 4-mil, rolled cuff, blue/ |
| 20038054686462 | Biodegradable Exam Use, powder-free, low-modulus 100%-nitrile, 9-1/2", 4-mil, rolled cuff, blue/ |
| 20038054686417 | Biodegradable Exam Use, powder-free, low-modulus 100%-nitrile, 9-1/2", 4-mil, rolled cuff, blue/ |
| 20038054686400 | Biodegradable Exam Use, powder-free, low-modulus 100%-nitrile, 9-1/2", 4-mil, rolled cuff, blue/ |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() N-DEX 85629273 4278853 Live/Registered |
Showa Glove Co. 2012-05-18 |
![]() N-DEX 74201136 1701906 Live/Registered |
SHOWA GLOVE CO. 1991-09-06 |