Skintx
GUDID B754700101
Vinyl Powder Free Medical Gloves Size Medium
GD CARE INC.
Vinyl examination/treatment glove, non-powdered| Primary Device ID | B754700101 |
| NIH Device Record Key | b9b590a8-235b-446d-81c2-99901fef150c |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Skintx |
| Version Model Number | 70010 |
| Company DUNS | 080925610 |
| Company Name | GD CARE INC. |
| Device Count | 1 |
| 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 | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | false |
| OTC Over-The-Counter | false |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | B75470010 [Primary] |
| HIBCC | B754700101 [Package] Contains: B75470010 Package: Inner [100 Units] In Commercial Distribution |
| HIBCC | B754700102 [Package] Package: Carton [10 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K022600
FDA Product Code
| LYZ | Vinyl Patient Examination Glove |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-10-07 |
| Device Publish Date | 2022-09-29 |
On-Brand Devices [Skintx]
| B754BLK900201 | Black Latex Powder Free Medical Gloves Size XL |
| B754BLK900151 | Black Latex Powder Free Medical Gloves Size L |
| B754BLK900101 | Black Latex Powder Free Medical Gloves Size M |
| B754BLK900051 | Black Latex Powder Free Medical Gloves Size S |
| B754ET500251 | 10 Mil 12 Inches Nitrile Powder Free Medical Gloves Size XX-Large |
| B754ET500201 | 10 Mil 12 Inches Nitrile Powder Free Medical Gloves Size Extra Large |
| B754ET500151 | 10 Mil 12 Inches Nitrile Powder Free Medical Gloves Size Large |
| B754ET500101 | 10 Mil 12 Inches Nitrile Powder Free Medical Gloves Size Medium |
| B754ET500051 | 10 Mil 12 Inches Nitrile Powder Free Medical Gloves Size Small |
| B754CB2500201 | Cool Nitrile Powder Free Medical Gloves (180pcs) - Extra Large |
| B754CB2500151 | Cool Nitrile Powder Free Medical Gloves (200pcs) - Large |
| B754CB2500101 | Cool Nitrile Powder Free Medical Gloves (200pcs) - Medium |
| B754CB2500051 | Cool Nitrile Powder Free Medical Gloves (200pcs) - Small |
| B754CB2500001 | Cool Nitrile Powder Free Medical Gloves (200pcs) - Extra Small |
| B754BLK500251 | Black Nitrile Powder Free Examination Size Extra Extra Large |
| B754BLK500201 | Black Nitrile Powder Free Examination Size Extra Large |
| B754BLK500151 | Black Nitrile Powder Free Examination Size Large |
| B754BLK500101 | Black Nitrile Powder Free Examination Size Medium |
| B754BLK500051 | Black Nitrile Powder Free Examination Size Small |
| B754BLK500001 | Black Nitrile Powder Free Examination Size Extra Small |
| B75490020FIT1 | Latex FIT Powder Free Medical Gloves Size Extra Large |
| B754900201 | Latex Powder Free Medical Gloves Size Extra Large |
| B75490015FIT1 | Latex FIT Powder Free Medical Gloves Size Large |
| B754900151 | Latex Powder Free Medical Gloves Size Large |
| B75490010FIT1 | Latex FIT Powder Free Medical Gloves Size Medium |
| B754900101 | Latex Powder Free Medical Gloves Size Medium |
| B75490005FIT1 | Latex FIT Powder Free Medical Gloves Size Small |
| B754900051 | Latex Powder Free Medical Gloves Size Small |
| B75490000FIT1 | Latex FIT Powder Free Medical Gloves Size Extra Small |
| B754900001 | Latex Powder Free Medical Gloves Size Extra Small |
| B754700201 | Vinyl Powder Free Medical Gloves Size Extra Large |
| B754700151 | Vinyl Powder Free Medical Gloves Size Large |
| B754700101 | Vinyl Powder Free Medical Gloves Size Medium |
| B754700051 | Vinyl Powder Free Medical Gloves Size Small |
| B754500251 | Nitrile Powder Free Examination Gloves Size Extra Extra Large |
| B754500201 | Nitrile Powder Free Examination Gloves Size Extra Large |
| B754500151 | Nitrile Powder Free Examination Gloves Size Large |
| B754500101 | Nitrile Powder Free Examination Gloves Size Medium |
| B754500051 | Nitrile Powder Free Examination Gloves Size Small |
| B754500001 | Nitrile Powder Free Examination Size Extra Small |
Trademark Results [Skintx]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 SKINTX 87548017 5407211 Live/Registered |
GD Care Inc 2017-07-28 |
 SKINTX 76373774 2798709 Live/Registered |
GD CARE INC 2002-02-22 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.