Medline
Medline Restore Sense is a powder-free nitrile examination glove designed as a barrier for examination tasks. The listed green size S glove belongs to the Restore Sense family, which…
Medline Restore Sense is a powder-free nitrile examination glove designed as a barrier for examination tasks. The listed green size S glove belongs to the Restore Sense family, which includes multiple sizes.
Medline describes the Restore Sense glove as containing colloidal oatmeal in its maxOat+ formulation. The product is designated for examination use.
Listed Item
Glove,exam,nitrile,restore,sense,green,s
Family and Materials
The manufacturer lists size variants from XS through XL and identifies the green color and nitrile material. The size designation in the listed product is S.
The maxOat+ formulation distinguishes Restore Sense from other nitrile examination glove lines. Specific package quantities vary across sizes and catalog listings.
83manufacturers in China registered for this device type
255catalogue numbers in this listing
13510(k) clearances naming this product code
Who Else Makes It
Concentrated in Shandong (27), Guangdong (10), Jiangsu (8). 11 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| YUE Kang Anhui Medical Products Co., Ltd. | Huaibei | Anhui | Contract manufacturer | 5 |
| Opus Gloves Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 5 |
| Better Care Plastic Technology Co., Ltd. | Shenze County | Hebei | Contract manufacturer | 4 |
| Xingyu Medical Tech Co., Ltd. | Weifang | Shandong | Contract manufacturer | 4 |
| Lingshi Hongruida Health Protection Technology Co., Ltd. | Jinzhong | Shanxi | Contract manufacturer | 4 |
| Zhangjiagang Blackbox Plastic Products Co., Ltd. | Zhangjiagang | Jiangsu | Contract manufacturer | 4 |
| Zhangjiagang Dayu Rubber Products Co., Ltd. | Zhangjiagang | Jiangsu | Contract manufacturer | 4 |
| Xuzhou Full Sun Medical Products Ltd. | Pizhou | Jiangsu | Contract manufacturer | 3 |
| Zhongnuo Medical Products Co., Ltd. | Tangshan | Hebei | Contract manufacturer | 3 |
| Anhui Kindguard Medical Supplies Technology Co., Ltd. | Suzhou | Anhui | Contract manufacturer | 2 |
| Puyang Linshi Medical Supplies Co., Ltd. | Puyang | Henan | Contract manufacturer | 2 |
| Jiangsu NEW Pentastar Medical Products Co., Ltd. | Changzhou | Jiangsu | Exporter | 146 |
Showing 12 of 83. All 83 manufacturers in China registered for Polymer Patient Examination Glove
Record
| Listed by | Medline Industries, Inc., United States |
|---|---|
| FDA product code | LZA |
| Device type | Polymer Patient Examination Glove |
| Device class | Class 1 |
| Regulation | 21 CFR 880.6250 |
| 510(k) | K200150 |
| Record published | 2025-03-25 |
| Record revised | 2025-03-26 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Over the counter | Yes |
| Latex | Contains natural rubber latex |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Storage | Special storage condition: Protect from freezing, avoid excessive heat. Keep dry. Shield from direct sunlight, fluroescent lighting, x-rays, moistu |
| Packaging | Case of 10, case of 2500, case of 4, case of 1000 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| MDS6804 | 230 | In distribution | |
| MDS194285 | 100 | In distribution | |
| 485603 | 50 | In distribution | |
| SG313 | 250 | In distribution | |
| OAT4584 | 250 | In distribution | |
| MDS2503M | 250 | In distribution | |
| VS311LCF | 400 | In distribution | |
| NYU7583 | 250 | In distribution | |
| OAT6804 | 230 | In distribution | |
| MG2500 | 250 | In distribution | |
| TRG400M | 250 | In distribution | |
| NYU7584 | 250 | In distribution | |
| MDSXB7587 | Extra Large | 230 | In distribution |
| CR911XLX | 90 | In distribution | |
| MDSW7583 | 250 | In distribution | |
| SG311 | 250 | In distribution | |
| CS16M | 50 | In distribution | |
| MDS2584 | 250 | In distribution | |
| BCR911M | 100 | In distribution | |
| MDS2504 | 230 | In distribution | |
| CR911LX | 100 | In distribution | |
| OAT4583 | 250 | In distribution | |
| BVS311XL | 90 | In distribution | |
| MDS194286 | 100 | In distribution | |
| MG2501 | 250 | In distribution | |
| 73-20103 | 100 | In distribution | |
| MDS198517 | 100 | In distribution | |
| MDS2583 | 250 | In distribution | |
| MDS198515 | 100 | In distribution | |
| VAN2501 | 250 | In distribution | |
| MG6112 | 100 | In distribution | |
| MR2003 | 1,000 | In distribution | |
| FGS10 | In distribution | ||
| MDS2503 | 250 | In distribution | |
| SCN100L | 100 | In distribution | |
| MG5002 | 250 | In distribution | |
| MDS6803 | 250 | In distribution | |
| BVS311S | 100 | In distribution | |
| BCR911L | 100 | In distribution | |
| FRES2503 | 250 | In distribution | |
| CR911S | 100 | In distribution | |
| MDS198417 | 2 | In distribution | |
| TRG400XL | 230 | In distribution | |
| FG2601 | 250 | In distribution | |
| MG7587 | 230 | In distribution | |
| FG3004 | 250 | In distribution | |
| VAN2502 | 250 | In distribution | |
| MDS2501M | 250 | In distribution | |
| MG5001 | 250 | In distribution | |
| CS16XS | 50 | In distribution | |
| MDS2501 | 250 | In distribution | |
| CR911L | 100 | In distribution | |
| SCN101XS | 100 | In distribution | |
| MDS8084 | In distribution | ||
| FGS14 | 100 | In distribution | |
| MDS8086 | 150 | In distribution | |
| MDS7587 | 230 | In distribution | |
| MG2502 | 250 | In distribution | |
| CS16XL | 50 | In distribution | |
| RS2587 | 230 | In distribution | |
| CSTRG500XS | 250 | In distribution | |
| CSTRG500M | 250 | In distribution | |
| MDSX195087 | 100 | In distribution | |
| MDSXB2501 | 200 | In distribution | |
| NYU7585 | 250 | In distribution | |
| MDS1284 | 50 | In distribution | |
| DGN4024 | 250 | In distribution | |
| MG2504 | 230 | In distribution | |
| SG314 | 230 | In distribution | |
| TRG500XL | 230 | In distribution | |
| SYNAG250XS | 250 | In distribution | |
| CR911SX | 100 | In distribution | |
| CSTRG500XL | 230 | In distribution | |
| MDS195287 | 180 | In distribution | |
| MDS1287 | 45 | In distribution | |
| SG100M | 100 | In distribution | |
| SCN101XL | 100 | In distribution | |
| SCN100M | 100 | In distribution | |
| FGS21 | 2 | In distribution | |
| OAT6800 | 250 | In distribution | |
| CR911V1 | 100 | In distribution | |
| 73-20104 | 100 | In distribution | |
| FG2300 | FALS | 250 | In distribution |
| OAT4585 | 250 | In distribution | |
| MDSXB2502 | 200 | In distribution | |
| MDS2587 | 230 | In distribution | |
| FG2303 | 250 | In distribution | |
| VAN2503 | 250 | In distribution | |
| MDS198414 | 2 | In distribution | |
| MG100XL | 100 | In distribution | |
| FG100S | 100 | In distribution | |
| SG100L | 100 | In distribution | |
| OAT3001 | 300 | In distribution | |
| PEDS310 | 250 | In distribution | |
| BCH400S | 250 | In distribution | |
| FG2603 | 250 | In distribution | |
| MDS6801 | 250 | In distribution | |
| OAT6801 | 250 | In distribution | |
| SG312 | 250 | In distribution | |
| SCN101L | 100 | In distribution | |
| SCN101M | 100 | In distribution | |
| TRG300L | 300 | In distribution | |
| MG2503 | 250 | In distribution | |
| MG6111 | 100 | In distribution | |
| FG2301 | 250 | In distribution | |
| PRO31772 | 50 | In distribution | |
| MDS2502 | 250 | In distribution | |
| TRG300XS | 300 | In distribution | |
| MDS7586 | 250 | In distribution | |
| TRG500XS | 250 | In distribution | |
| BCH400XS | 250 | In distribution | |
| MDS2585 | 250 | In distribution | |
| BCR911S | 100 | In distribution | |
| MDS8085 | 150 | In distribution | |
| MG100M | 100 | In distribution | |
| 823-1 | 300 | In distribution | |
| MG6114 | 90 | In distribution | |
| MDSXB7584 | Small | 250 | In distribution |
| FGS24 | 2 | In distribution | |
| CR911XXL | 80 | In distribution | |
| MDSXB7586 | Large | 250 | In distribution |
| MG6113 | 100 | In distribution | |
| PEDS312 | 250 | In distribution | |
| OAT4586 | 250 | In distribution | |
| CS16L | 50 | In distribution | |
| FG100M | 100 | In distribution | |
| BCH400L | 250 | In distribution | |
| TRG400L | 250 | In distribution | |
| SCN101S | 100 | In distribution | |
| MG3004 | 250 | In distribution | |
| OAT2586 | 250 | In distribution | |
| MG5004 | 230 | In distribution | |
| CR911M | 100 | In distribution | |
| VS311L | 100 | In distribution | |
| FRES2501 | 250 | In distribution | |
| TRG300M | 300 | In distribution | |
| VS711S | 50 | In distribution | |
| MG7583 | 250 | In distribution | |
| CSTRG500S | 250 | In distribution | |
| FG100XL | 100 | In distribution | |
| TRG1285 | In distribution | ||
| TRG500S | 250 | In distribution | |
| MG100L | 100 | In distribution | |
| MDS198415 | 2 | In distribution | |
| MG7586 | 250 | In distribution | |
| FGS11 | 100 | In distribution | |
| MG7584 | 250 | In distribution | |
| FGS13 | 100 | In distribution | |
| BCR911XXL | 80 | In distribution | |
| PRO31771 | 50 | In distribution | |
| MG5000 | 250 | In distribution | |
| ES8417 | 1,800 | In distribution | |
| FG2600 | 250 | In distribution | |
| 486800PL | 200 | In distribution | |
| BCR911XL | 90 | In distribution | |
| BCH400M | 250 | In distribution | |
| RS2584 | 250 | In distribution | |
| PEDS313 | 250 | In distribution | |
| MDS194083 | 100 | In distribution | |
| RS2583 | 250 | In distribution | |
| SG310 | 250 | In distribution | |
| 486802PL | 200 | In distribution | |
| PEDS314 | 230 | In distribution | |
| FGS23 | 2 | In distribution | |
| MDSXB2504 | 180 | In distribution | |
| MR2002 | 1,000 | In distribution | |
| NYU7587 | 230 | In distribution | |
| TRG300S | 300 | In distribution | |
| DGN4025 | 250 | In distribution | |
| PRO31761 | 100 | In distribution | |
| VS311MCF | In distribution | ||
| SCN100XS | 100 | In distribution | |
| FG2604 | 230 | In distribution | |
| OAT6802 | 250 | In distribution | |
| VAN2504 | 230 | In distribution | |
| CS16S | 50 | In distribution | |
| FG100L | 100 | In distribution | |
| MG3000 | 300 | In distribution | |
| MDS2586 | 250 | In distribution | |
| MDS194088 | 50 | In distribution | |
| BVS311M | 100 | In distribution | |
| 73-20300 | 200 | In distribution | |
| FGS22 | 2 | In distribution | |
| MG3002 | 300 | In distribution | |
| MDS198416 | 2 | In distribution | |
| FG3001 | 300 | In distribution | |
| CR911MX | 100 | In distribution | |
| TRG500L | 250 | In distribution | |
| MDSXB2503 | 200 | In distribution | |
| FG2304 | 230 | In distribution | |
| 73-20102 | 100 | In distribution | |
| TRG400S | 250 | In distribution | |
| VS711XL | 50 | In distribution | |
| MDS194084 | 100 | In distribution | |
| NYU7586 | 250 | In distribution | |
| 73-20100 | 100 | In distribution | |
| 73-20101 | 100 | In distribution | |
| MDSXB2500 | 200 | In distribution | |
| CR911XXLX | 80 | In distribution | |
| VAN2500 | 250 | In distribution | |
| MDS2500 | 250 | In distribution | |
| DGN4026 | 250 | In distribution | |
| MDS7584 | 250 | In distribution | |
| CR911XL | 90 | In distribution | |
| FG100XS | 100 | In distribution | |
| FGS12 | 100 | In distribution | |
| SCN100S | 100 | In distribution | |
| MG5003 | 250 | In distribution | |
| FG3002 | 300 | In distribution | |
| TRG300XL | 250 | In distribution | |
| OAT6803 | 250 | In distribution | |
| CSTRG500L | 250 | In distribution | |
| TRG400XS | 250 | In distribution | |
| MDS2502M | 250 | In distribution | |
| MG100S | 100 | In distribution | |
| FG3003 | 300 | In distribution | |
| PRO31760 | 100 | In distribution | |
| FG3000 | 300 | In distribution | |
| FRES2500 | 250 | In distribution | |
| 486801PL | 200 | In distribution | |
| CUR4145R | In distribution | ||
| MG7585 | 250 | In distribution | |
| VS311M | 100 | In distribution | |
| MDS6802 | 250 | In distribution | |
| BCH400XL | 230 | In distribution | |
| MDS8087 | 140 | In distribution | |
| MDSXB7585 | Medium | 250 | In distribution |
| SCN100XL | 100 | In distribution | |
| VS311XL | In distribution | ||
| OAT4587 | 230 | In distribution | |
| FG2602 | 250 | In distribution | |
| PEDS311 | 250 | In distribution | |
| TRG500M | 250 | In distribution | |
| FRES2504 | 230 | In distribution | |
| MDS194086 | 50 | In distribution | |
| FRES2502 | 250 | In distribution | |
| OAT3002 | 300 | In distribution | |
| MG3001 | 300 | In distribution | |
| MG100XS | 100 | In distribution | |
| MDS2504M | 230 | In distribution | |
| VS711L | 50 | In distribution | |
| MDS6800 | 250 | In distribution | |
| MDS7583 | 250 | In distribution | |
| VS311S | 100 | In distribution | |
| 486804PL | 180 | In distribution | |
| 486803PL | 200 | In distribution | |
| MDS194082 | 100 | In distribution | |
| MDS8083 | 150 | In distribution | |
| BVS311L | 100 | In distribution | |
| VS711M | 50 | In distribution |
Showing 250 of 255 catalogue numbers.
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Microflex | Ansell Healthcare Product | 185 |
| FifthPulse | Jeg & Sons Inc. | 135 |
| SW | SW Safety Solutions Inc. | 130 |
| Halyard | O&M Halyard, Inc. | 120 |
| Basic | Intco Medical Industries, Inc. | 119 |
| Cranberry | Ascend Eagle, Inc. | 109 |
| 1st Choice | Ammex Corporation | 101 |
| JMU | JMU Dental, Inc | 90 |
| Vivit Supply | Vivit Supply LLC | 86 |
| McKesson | Mckesson Medical-Surgical Inc. | 75 |
| Natural Extensions | Benco Dental Supply Co. | 74 |
| Condor | Grainger International, Inc. | 72 |
Showing 12 of 930. All products under Polymer Patient Examination Glove
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K200150 | 2020-10-26 |
| K193666 | 2020-08-04 |
| K191753 | 2020-03-17 |
| K192315 | 2020-01-10 |
| K192104 | 2019-12-23 |
| K180696 | 2018-04-30 |
| K162982 | 2017-02-27 |
| K161473 | 2016-10-19 |
| K093726 | 2010-02-22 |
| K090568 | 2009-10-02 |
| K081594 | 2008-10-17 |
| K040841 | 2004-07-08 |
| K003353 | 2000-11-22 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.