Medicom AssureTouch
Medicom AssureTouch Power - Nitrile Medical Examination Gloves with Textured Fingertips - Extended Cuffs - Chemotherapy Tested - Powder-Free - Non-Sterile - Blue - Sample 3 Pairs
48manufacturers in China registered for this device type
29catalogue numbers in this listing
Who Else Makes It
Concentrated in Shandong (18), Guangdong (5), Hebei (5). 9 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shanxi Hongjin Plastic Technology Co., Ltd. | Linfen | Shanxi | Contract manufacturer | 5 |
| 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 Dayu Rubber Products Co., Ltd. | Zhangjiagang | Jiangsu | Contract manufacturer | 4 |
| Jiangxi Zhonghong Pulin Medical Products Co., Ltd. | Jiujiang | Jiangxi | Contract manufacturer | 3 |
| Zhongnuo Medical Products Co., Ltd. | Tangshan | Hebei | Contract manufacturer | 3 |
| Jiangsu NEW Pentastar Medical Products Co., Ltd. | Changzhou | Jiangsu | Exporter | 146 |
| Allmed Medical Products Co., Ltd. | Zhijiang | Hubei | Contract manufacturer | 43 |
| Allmed Industrial Limited | Shenzhen | Guangdong | Manufacturer | 42 |
Showing 12 of 48. All 48 manufacturers in China registered for Medical Glove, Specialty
Record
| Listed by | AMD Medicom Inc., Canada |
|---|---|
| FDA product code | LZC |
| Device type | Medical Glove, Specialty |
| Device class | Class 1 |
| Regulation | 21 CFR 880.6250 |
| Establishment | Specification developer, Repacker / relabeller, Private-label distributor, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K091652 |
| Record published | 2022-09-28 |
| Record revised | 2022-07-11 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Over the counter | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, manufacturing date |
| Storage | Special storage condition: Cool dry place – Avoid excessive heat (40 °C, 104 °F) |
| Packaging | Outer case of 10 |
| Distribution end date | 2023-07-27 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 9998-C | Medium | 100 | In distribution |
| 9999-D | Large | 100 | In distribution |
| 9999-A | X-Small | 100 | In distribution |
| 9998-SP6 | 6 | In distribution | |
| 9970-C | Medium | 200 | In distribution |
| 9998-E | X-Large | 100 | In distribution |
| 9985-C | Medium | 100 | In distribution |
| 9999-B | Small | 100 | In distribution |
| 9970-E | X-Large | 200 | In distribution |
| 9985-A | X-Small | 100 | In distribution |
| 9985-E | X-Large | 100 | In distribution |
| 9970-A | X-Small | 200 | In distribution |
| 9999-C | Medium | 100 | In distribution |
| 9970-B | Small | 200 | In distribution |
| 9999-SP6 | 6 | In distribution | |
| 9985-SP6 | 100 | In distribution | |
| 9998-B | Small | 100 | In distribution |
| 9985-D | Large | 100 | In distribution |
| 9998-A | X-Small | 100 | In distribution |
| 9970-SP6 | 6 | In distribution | |
| 9998-D | Large | 100 | In distribution |
| 9970-D | Large | 200 | In distribution |
| 9985-B | Small | 100 | In distribution |
| 9999-E | X-Large | 100 | In distribution |
| 9985-B | Small | 100 | Withdrawn |
| 9985-E | X-Large | 100 | Withdrawn |
| 9985-C | Medium | 100 | Withdrawn |
| 9985-A | X-Small | 100 | Withdrawn |
| 9985-D | Large | 100 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Halyard | O&M Halyard, Inc. | 119 |
| Europapa | Europapa Handels GmbH | 40 |
| Tronex International, Inc. | Tronex International, Inc. | 37 |
| PremierPro | Prestige Ameritech | 37 |
| Ocean Pacific | AMD Medicom Inc. | 25 |
| MediChoice | Owens & Minor Distribution, Inc. | 24 |
| FreeStyle | Hourglass International Inc | 22 |
| Novaplus | Cardinal Health 200, LLC | 21 |
| Scion | Hourglass International Inc | 20 |
| Cardinal Health | Cardinal Health 200, LLC | 18 |
| Flexal | Cardinal Health 200, LLC | 18 |
| Ammex Professional | Ammex Corporation | 18 |
Showing 12 of 174. All products under Medical Glove, Specialty
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.