PHARMA-CHOICE PGNS12-M
GUDID 10075289715409
SURGICAL GLOVE, STERILE, NITRILE, 12" LENGTH, CHEMO APPROVED, POWDER FREE, WHITE, MEDIUM
McGowan Enterprises, Inc.
Nitrile surgical glove, non-powdered| Primary Device ID | 10075289715409 |
| NIH Device Record Key | af6c8376-ac36-49e6-93c5-e88577549040 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | PHARMA-CHOICE |
| Version Model Number | PGNS12-M |
| Catalog Number | PGNS12-M |
| Company DUNS | 029901019 |
| Company Name | McGowan Enterprises, 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 | 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
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00075289715402 [Primary] |
| GS1 | 10075289715409 [Package] Contains: 00075289715402 Package: BAG [50 Units] Discontinued: 2099-12-31 In Commercial Distribution |
| GS1 | 20075289715406 [Package] Package: CASE [200 Units] Discontinued: 2099-12-31 In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K180452
FDA Product Code
| KGO | Surgeon'S Gloves |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | true |
[10075289715409]
Radiation Sterilization
[10075289715409]
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[10075289715409]
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[10075289715409]
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[10075289715409]
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[10075289715409]
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[10075289715409]
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[10075289715409]
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[10075289715409]
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[10075289715409]
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[10075289715409]
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[10075289715409]
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[10075289715409]
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[10075289715409]
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[10075289715409]
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[10075289715409]
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[10075289715409]
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[10075289715409]
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[10075289715409]
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[10075289715409]
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[10075289715409]
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[10075289715409]
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[10075289715409]
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[10075289715409]
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[10075289715409]
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[10075289715409]
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[10075289715409]
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[10075289715409]
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[10075289715409]
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[10075289715409]
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[10075289715409]
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[10075289715409]
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[10075289715409]
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Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-11-23 |
| Device Publish Date | 2022-11-15 |
On-Brand Devices [PHARMA-CHOICE]
| 10075289715447 | SURGICAL GLOVE, STERILE, NITRILE, 12" LENGTH, CHEMO APPROVED, POWDER FREE, WHITE, 3XL |
| 10075289715430 | SURGICAL GLOVE, STERILE, NITRILE, 12" LENGTH, CHEMO APPROVED, POWDER FREE, WHITE, 2XL |
| 10075289715423 | SURGICAL GLOVE, STERILE, NITRILE, 12" LENGTH, CHEMO APPROVED, POWDER FREE, WHITE, X-LARGE |
| 10075289715409 | SURGICAL GLOVE, STERILE, NITRILE, 12" LENGTH, CHEMO APPROVED, POWDER FREE, WHITE, MEDIUM |
| 10075289715393 | SURGICAL GLOVE, STERILE, NITRILE, 12" LENGTH, CHEMO APPROVED, POWDER FREE, WHITE, SMALL |
Trademark Results [PHARMA-CHOICE]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 PHARMA-CHOICE 90041725 not registered Live/Pending |
The Tranzonic Companies 2020-07-08 |
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