Medicom AssureTouch
Medicom AssureTouch Sense - Polychloroprene Surgical Gloves - Powder Free - Sterile - Natural White - Size 7.5
10manufacturers in China registered for this device type
16catalogue numbers in this listing
Who Else Makes It
Concentrated in Zhejiang (2), Shanghai (2), Guangxi (2).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Huzhou Junda Industry Co., Ltd. | Anji | Zhejiang | Contract manufacturer | 129 |
| Ningbo Risenmed Technology Co., Ltd. | Ningbo | Zhejiang | Contract manufacturer | 42 |
| Guangzhou Huada Biotechnology Co., Ltd. | Guangzhou | Guangdong | Contract manufacturer | 9 |
| Suzhou Colour-way New Material Co., Ltd. | Suzhou | Jiangsu | Manufacturer | 5 |
| Shanghai Motex Healthcare Co., Ltd. | Shanghai | Shanghai | Manufacturer | 4 |
| Motex Healthcare (Anhui) Co., Ltd. | Guangde City, Xuancheng | Anhui | Manufacturer | 4 |
| Shanghai Jinxiang Latex Products Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 3 |
| Guilin HBM Health Protections, Inc. | Guilin | Guangxi | Manufacturer | 2 |
| Puyang Linshi Medical Supplies Co., Ltd. | Puyang | Henan | Contract manufacturer | 2 |
| Guilin Huada Biotechnology Co., Ltd. | Guilin | Guangxi | Contract manufacturer | 1 |
Record
| Listed by | AMD Medicom Inc., Canada |
|---|---|
| FDA product code | KGO |
| Device type | Surgeon’S Gloves |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4460 |
| Establishment | Specification developer, Repacker / relabeller, Private-label distributor, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K112654 |
| Record published | 2024-03-05 |
| Record revised | 2024-07-25 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Over the counter | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Storage | Special storage condition: Store in a cool dry place. Avoid excessive heat (40°C, 104°F) |
| Packaging | Inner box of 50, outer case of 4 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 1145-7.5 | 7.5 | 2 | In distribution |
| 1147-7.5 | 7.5 | 2 | In distribution |
| 1145-8 | 8 | 2 | In distribution |
| 1147-7 | 7 | 2 | In distribution |
| 1145-7 | 7 | 2 | In distribution |
| 1145-9 | 9 | 2 | In distribution |
| 1147-8.5 | 8.5 | 2 | In distribution |
| 1147-8 | 8 | 2 | In distribution |
| 1145-6.5 | 6.5 | 2 | In distribution |
| 1147-6.5 | 6.5 | 2 | In distribution |
| 1147-5.5 | 5.5 | 2 | In distribution |
| 1147-9 | 9 | 2 | In distribution |
| 1145-5.5 | 5.5 | 2 | In distribution |
| 1145-8.5 | 8.5 | 2 | In distribution |
| 1145-6 | 6 | 2 | In distribution |
| 1147-6 | 6 | 2 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| MocareHealth | Motex Healthcare (Anhui) Co., Ltd. | 398 |
| Biogel | Bosma Enterprises | 149 |
| Protexis | Cardinal Health 200, LLC | 141 |
| Medline | Medline Industries, Inc. | 130 |
| Gammex | Ansell Healthcare Product | 126 |
| Medline Industries, Inc. | Medline Industries, Inc. | 118 |
| McKesson | Mckesson Medical-Surgical Inc. | 112 |
| Novaplus | Ansell Healthcare Product | 85 |
| PremierPro Surgeons Glove | Prestige Ameritech | 78 |
| Gammex | Bosma Enterprises | 63 |
| Protexis | Bosma Enterprises | 63 |
| Encore | Ansell Healthcare Product | 60 |
Showing 12 of 106. All products under Surgeon’S Gloves
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.