| Primary Device ID | 10075289715386 |
| NIH Device Record Key | b694c4ad-9dc3-4d57-b223-734d90708283 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | PHARMA-GLOVE |
| Version Model Number | PGNS12-XS |
| Catalog Number | PGNS12-XS |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00075289715389 [Primary] |
| GS1 | 10075289715386 [Package] Contains: 00075289715389 Package: BAG [50 Units] In Commercial Distribution |
| GS1 | 20075289715383 [Package] Package: CASE [200 Units] In Commercial Distribution |
| KGO | Surgeon'S Gloves |
| Steralize Prior To Use | true |
| Device Is Sterile | true |
[10075289715386]
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| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-11-23 |
| Device Publish Date | 2022-11-15 |
| 10075289715416 | SURGICAL GLOVE, STERILE, NITRILE, 12" LENGTH, CHEMO APPROVED, POWDER FREE, WHITE, LARGE |
| 10075289715386 | SURGICAL GLOVE, STERILE, NITRILE, 12" LENGTH, CHEMO APPROVED, POWDER FREE, WHITE, X-SMALL |