GAMMEX 340002060
GUDID 25414566200603
GAMMEX 340002060 PI Hybrid Micro Size (6.0), Powder Free Polyisoprene Surgical Gloves
Ansell Healthcare Product
Polyisoprene surgical glove, non-powdered, non-antimicrobial| Primary Device ID | 25414566200603 |
| NIH Device Record Key | a78f0508-82de-428c-b177-44dee9f61572 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | GAMMEX |
| Version Model Number | 340002060 |
| Catalog Number | 340002060 |
| Company DUNS | 111267330 |
| Company Name | Ansell Healthcare Product |
| Device Count | 2 |
| 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 | true |
| RX Perscription | false |
| OTC Over-The-Counter | true |
Customer Support Contacts
| Phone | 775-470-7106 |
| don.cronk@ansell.com | |
| Phone | 775-470-7106 |
| don.cronk@ansell.com | |
| Phone | 775-470-7106 |
| don.cronk@ansell.com | |
| Phone | 775-470-7106 |
| don.cronk@ansell.com | |
| Phone | 775-470-7106 |
| don.cronk@ansell.com | |
| Phone | 775-470-7106 |
| don.cronk@ansell.com | |
| Phone | 775-470-7106 |
| don.cronk@ansell.com | |
| Phone | 775-470-7106 |
| don.cronk@ansell.com | |
| Phone | 775-470-7106 |
| don.cronk@ansell.com | |
| Phone | 775-470-7106 |
| don.cronk@ansell.com | |
| Phone | 775-470-7106 |
| don.cronk@ansell.com | |
| Phone | 775-470-7106 |
| don.cronk@ansell.com | |
| Phone | 775-470-7106 |
| don.cronk@ansell.com | |
| Phone | 775-470-7106 |
| don.cronk@ansell.com | |
| Phone | 775-470-7106 |
| don.cronk@ansell.com | |
| Phone | 775-470-7106 |
| don.cronk@ansell.com | |
| Phone | 775-470-7106 |
| don.cronk@ansell.com |
Device Dimensions
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 05414566200609 [Unit of Use] |
| GS1 | 15414566200606 [Primary] |
| GS1 | 25414566200603 [Package] Contains: 15414566200606 Package: Dispenser [50 Units] In Commercial Distribution |
| GS1 | 35414566200600 [Package] Package: Case [4 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K231902
FDA Product Code
| KGO | Surgeon'S Gloves |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-07-23 |
| Device Publish Date | 2024-07-15 |
On-Brand Devices [GAMMEX ]
| 20884792385279 | GAMMEX® Non-Latex PI Green Size 9, Sterile Polyisoprene Powder-Free Surgical Glove |
| 20884792385262 | GAMMEX® Non-Latex PI Green Size 8.5, Sterile Polyisoprene Powder-Free Surgical Glove |
| 20884792385255 | GAMMEX® Non-Latex PI Green Size 8, Sterile Polyisoprene Powder-Free Surgical Glove |
| 20884792385248 | GAMMEX® Non-Latex PI Green Size 7.5, Sterile Polyisoprene Powder-Free Surgical Glove |
| 20884792385231 | GAMMEX® Non-Latex PI Green Size 7, Sterile Polyisoprene Powder-Free Surgical Glove |
| 20884792385224 | GAMMEX® Non-Latex PI Green Size 6.5, Sterile Polyisoprene Powder-Free Surgical Glove |
| 20884792385217 | GAMMEX® Non-Latex PI Green Size 6, Sterile Polyisoprene Powder-Free Surgical Glove |
| 20884792385200 | GAMMEX® Non-Latex PI Green Size 5.5, Sterile Polyisoprene Powder-Free Surgical Glove |
| 20884792385170 | GAMMEX® Non-Latex Size 9, Sterile Neoprene Powder-Free Surgical Glove |
| 20884792385163 | GAMMEX® Non-Latex Size 8.5, Sterile Neoprene Powder-Free Surgical Glove |
| 20884792385156 | GAMMEX® Non-Latex Size 8, Sterile Neoprene Powder-Free Surgical Glove |
| 20884792385149 | GAMMEX® Non-Latex Size 7.5, Sterile Neoprene Powder-Free Surgical Glove |
| 20884792385132 | GAMMEX® Non-Latex Size 7, Sterile Neoprene Powder-Free Surgical Glove |
| 20884792385125 | GAMMEX® Non-Latex Size 6.5, Sterile Neoprene Powder-Free Surgical Glove |
| 20884792385118 | GAMMEX® Non-Latex Size 6, Sterile Neoprene Powder-Free Surgical Glove |
| 20884792385101 | GAMMEX® Non-Latex Size 5.5, Sterile Neoprene Powder-Free Surgical Glove |
| 20884792377274 | GAMMEX® Non-Latex Sensitive Size 9, Sterile Neoprene Powder-Free Surgical Glove |
| 20884792377267 | GAMMEX® Non-Latex Sensitive Size 8.5, Sterile Neoprene Powder-Free Surgical Glove |
| 20884792377250 | GAMMEX® Non-Latex Sensitive Size 8, Sterile Neoprene Powder-Free Surgical Glove |
| 20884792377243 | GAMMEX® Non-Latex Sensitive Size 7.5, Sterile Neoprene Powder-Free Surgical Glove |
| 20884792377236 | GAMMEX® Non-Latex Sensitive Size 7, Sterile Neoprene Powder-Free Surgical Glove |
| 20884792377229 | GAMMEX® Non-Latex Sensitive Size 6.5, Sterile Neoprene Powder-Free Surgical Glove |
| 20884792377212 | GAMMEX® Non-Latex Sensitive Size 6, Sterile Neoprene Powder-Free Surgical Glove |
| 20884792377205 | GAMMEX® Non-Latex Sensitive Size 5.5, Sterile Neoprene Powder-Free Surgical Glove |
| 20884792387273 | GAMMEX® Non-Latex PI Underglove Size 9, Sterile Polyisoprene Powder-Free Surgical Glove |
| 20884792387266 | GAMMEX® Non-Latex PI Underglove Size 8.5, Sterile Polyisoprene Powder-Free Surgical Glove |
| 20884792387259 | GAMMEX® Non-Latex PI Underglove Size 8, Sterile Polyisoprene Powder-Free Surgical Glove |
| 20884792387242 | GAMMEX® Non-Latex PI Underglove Size 7.5, Sterile Polyisoprene Powder-Free Surgical Glove |
| 20884792387235 | GAMMEX® Non-Latex PI Underglove Size 7, Sterile Polyisoprene Powder-Free Surgical Glove |
| 20884792387228 | GAMMEX® Non-Latex PI Underglove Size 6.5, Sterile Polyisoprene Powder-Free Surgical Glove |
| 20884792387211 | GAMMEX® Non-Latex PI Underglove Size 6, Sterile Polyisoprene Powder-Free Surgical Glove |
| 20884792387204 | GAMMEX® Non-Latex PI Underglove Size 5.5, Sterile Polyisoprene Powder-Free Surgical Glove |
| 20884792385576 | GAMMEX® Non-Latex PI Moisturizing Size 9, Sterile Polyisoprene Powder-Free Surgical Glove |
| 20884792385569 | GAMMEX® Non-Latex PI Moisturizing Size 8.5, Sterile Polyisoprene Powder-Free Surgical Glove |
| 20884792385552 | GAMMEX® Non-Latex PI Moisturizing Size 8, Sterile Polyisoprene Powder-Free Surgical Glove |
| 20884792385545 | GAMMEX® Non-Latex PI Moisturizing Size 7.5, Sterile Polyisoprene Powder-Free Surgical Glove |
| 20884792385538 | GAMMEX® Non-Latex PI Moisturizing Size 7, Sterile Polyisoprene Powder-Free Surgical Glove |
| 20884792385521 | GAMMEX® Non-Latex PI Moisturizing Size 6.5, Sterile Polyisoprene Powder-Free Surgical Glove |
| 20884792385514 | GAMMEX® Non-Latex PI Moisturizing Size 6, Sterile Polyisoprene Powder-Free Surgical Glove |
| 20884792385507 | GAMMEX® Non-Latex PI Moisturizing Size 5.5, Sterile Polyisoprene Powder-Free Surgical Glove |
| 20884792188276 | GAMMEX® Non-Latex PI Textured Size 9, Sterile Polyisoprene Powder-Free Surgical Glove |
| 20884792188269 | GAMMEX® Non-Latex PI Textured Size 8.5, Sterile Polyisoprene Powder-Free Surgical Glove |
| 20884792188252 | GAMMEX® Non-Latex PI Textured Size 8, Sterile Polyisoprene Powder-Free Surgical Glove |
| 20884792188245 | GAMMEX® Non-Latex PI Textured Size 7.5, Sterile Polyisoprene Powder-Free Surgical Glove |
| 20884792188238 | GAMMEX® Non-Latex PI Textured Size 7, Sterile Polyisoprene Powder-Free Surgical Glove |
| 20884792188221 | GAMMEX® Non-Latex PI Textured Size 6.5, Sterile Polyisoprene Powder-Free Surgical Glove |
| 20884792188214 | GAMMEX® Non-Latex PI Textured Size 6, Sterile Polyisoprene Powder-Free Surgical Glove |
| 20884792188207 | GAMMEX® Non-Latex PI Textured Size 5.5, Sterile Polyisoprene Powder-Free Surgical Glove |
| 20884792185978 | GAMMEX® Non-Latex PI Micro Size 9, Sterile Polyisoprene Powder-Free Surgical Glove |
| 20884792185961 | GAMMEX® Non-Latex PI Micro Size 8.5, Sterile Polyisoprene Powder-Free Surgical Glove |
Trademark Results [GAMMEX]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 GAMMEX 86338834 4663905 Live/Registered |
Ansell Limited 2014-07-16 |
 GAMMEX 85784909 4580922 Live/Registered |
Ansell Limited 2012-11-21 |
 GAMMEX 74588314 1933009 Live/Registered |
Gammex, Inc. 1994-10-17 |
 GAMMEX 73326422 not registered Dead/Abandoned |
ANSELL CORPORATION, THE 0000-00-00 |
 GAMMEX 73262992 1157174 Live/Registered |
Dunlop Australia Limited 1980-05-20 |
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