| Primary Device ID | D1052219XLCS9 |
| NIH Device Record Key | 0f4d8ca2-7262-460a-81ab-e7c69817c0db |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | MacFit |
| Version Model Number | 2219-XL-CS |
| Company DUNS | 060635048 |
| Company Name | Surgimac LLC |
| Device Count | 2000 |
| 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 | true |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | true |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | D1052219XLCS1 [Primary] |
| HIBCC | D1052219XLCS9 [Unit of Use] |
| 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 | 2025-08-15 |
| Device Publish Date | 2025-08-07 |
| D1052319XLCS9 | Nitrile Exam Gloves MacFit, Blue, Chemo Tested, Extra Large, 3000/Case. TOP |
| D1052319XL9 | Nitrile Exam Gloves MacFit, Blue, Chemo Tested, Extra Large, 300/Box. TOP |
| D1052318LCS9 | Nitrile Exam Gloves MacFit, Blue, Chemo Tested, Large, 3000/Case. TOP |
| D1052318L9 | Nitrile Exam Gloves MacFit, Blue, Chemo Tested, Large, 300/Box. TOP |
| D1052317MCS9 | Nitrile Exam Gloves MacFit, Blue, Chemo Tested, Medium, 3000/Case. TOP |
| D1052317M9 | Nitrile Exam Gloves MacFit, Blue, Chemo Tested, Medium, 300/Box. TOP |
| D1052316SCS9 | Nitrile Exam Gloves MacFit, Blue, Chemo Tested, Small, 3000/Case. TOP |
| D1052316S9 | Nitrile Exam Gloves MacFit, Blue, Chemo Tested, Small, 300/Box. TOP |
| D1052315XSCS9 | Nitrile Exam Gloves MacFit, Blue, Chemo Tested, Extra Small, 3000/Case. TOP |
| D1052315XS9 | Nitrile Exam Gloves MacFit, Blue, Chemo Tested, Extra Small, 300/Box. TOP |
| D1052219XLCS9 | Nitrile Exam Gloves MacFit, Blue, Chemo Tested, Extra Large, 2000/Case. TOP |
| D1052219XL9 | Nitrile Exam Gloves MacFit, Blue, Chemo Tested, Extra Large, 200/Box. TOP |
| D1052218LCS9 | Nitrile Exam Gloves MacFit, Blue, Chemo Tested, Large, 2000/Case. TOP |
| D1052218L9 | Nitrile Exam Gloves MacFit, Blue, Chemo Tested, Large, 200/Box. TOP |
| D1052217MCS9 | Nitrile Exam Gloves MacFit, Blue, Chemo Tested, Medium, 2000/Case. TOP |
| D1052217M9 | Nitrile Exam Gloves MacFit, Blue, Chemo Tested, Medium, 200/Box. TOP |
| D1052216SCS9 | Nitrile Exam Gloves MacFit, Blue, Chemo Tested, Small, 2000/Case. TOP |
| D1052216S9 | Nitrile Exam Gloves MacFit, Blue, Chemo Tested, Small, 200/Box. TOP |
| D1052215XSCS9 | Nitrile Exam Gloves MacFit, Blue, Chemo Tested, Extra Small, 2000/Case. TOP |
| D1052215XS9 | Nitrile Exam Gloves MacFit, Blue, Chemo Tested, Extra Small, 200/Box. TOP |
| D1052119XLCS9 | Nitrile Exam Gloves MacFit, Blue, Chemo Tested, Extra Large, 1000/Case. TOP |
| D1052119XL9 | Nitrile Exam Gloves MacFit, Blue, Chemo Tested, Extra Large, 100/Box. TOP |
| D1052118LCS9 | Nitrile Exam Gloves MacFit, Blue, Chemo Tested, Large, 1000/Case. TOP |
| D1052118L9 | Nitrile Exam Gloves MacFit, Blue, Chemo Tested, Large, 100/Box. TOP |
| D1052117MCS9 | Nitrile Exam Gloves MacFit, Blue, Chemo Tested, Medium, 1000/Case. TOP |
| D1052117M9 | Nitrile Exam Gloves MacFit, Blue, Chemo Tested, Medium, 100/Box. TOP |
| D1052116SCS9 | Nitrile Exam Gloves MacFit, Blue, Chemo Tested, Small, 1000/Case. TOP |
| D1052116S9 | Nitrile Exam Gloves MacFit, Blue, Chemo Tested, Small, 100/Box. TOP |
| D1052115XSCS9 | Nitrile Exam Gloves MacFit, Blue, Chemo Tested, Extra Small, 1000/Case. TOP |
| D1052115XS9 | Nitrile Exam Gloves MacFit, Blue, Chemo Tested, Extra Small, 100/Box. TOP |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() MACFIT 86774811 not registered Dead/Abandoned |
Wayne Meier, Jr. 2015-10-01 |