Medline Industries, Inc.
Glove,exam,nitrile,restore,oat Sense,l
83manufacturers in China registered for this device type
23catalogue 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) | K093726 |
| Record published | 2018-08-28 |
| Record revised | 2022-06-17 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Over the counter | Yes |
| Supplied as a kit | Yes |
| Latex | Contains natural rubber latex |
| Label carries | lot or batch number, expiry 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 25, case of 2, case of 10, case of 1000 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| DYNJ55142 | In distribution | ||
| DYNJ55143 | In distribution | ||
| DYNJ55144A | In distribution | ||
| SYNJ10145 | In distribution | ||
| DYNJ55044 | In distribution | ||
| DYNDA1574A | In distribution | ||
| DYKM2689 | In distribution | ||
| DYNJ55144 | In distribution | ||
| DYKR1001 | In distribution | ||
| DYNDA1573A | In distribution | ||
| DYNJ55145 | In distribution | ||
| DYNDA2069 | In distribution | ||
| DYKR1002 | In distribution | ||
| RS2586 | 250 | In distribution | |
| RS2585 | 250 | In distribution | |
| DYNDA1572 | In distribution | ||
| SYNJ10142 | In distribution | ||
| DYKR1003 | In distribution | ||
| SYNJ10143 | In distribution | ||
| DYNDA1575A | In distribution | ||
| DYNDA2070 | In distribution | ||
| DYNJ55045 | In distribution | ||
| DYNDA1576A | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Medline | Medline Industries, Inc. | 255 |
| 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 |
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.