Hero
HERO® Disposable Latex Exam Gloves, Powder Free, Blue, 14 mil, Ex- Large, 50/bx, 10 bxs/cs
12manufacturers in China registered for this device type
4catalogue numbers in this listing
1recall
Who Else Makes It
Concentrated in Shandong (6), Guangdong (2), Shanghai (2). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Zhangjiagang Dayu Rubber Products Co., Ltd. | Zhangjiagang | Jiangsu | Contract manufacturer | 4 |
| Guangzhou Noval Medical Co., Ltd. | Guangzhou | Guangdong | Manufacturer | 9 |
| Shandong Intco Medical Products Co Ltd | Qingzhou | Shandong | Contract manufacturer | 6 |
| Alcatron Gloves Factory | Weifang | Shandong | Specification developer | 6 |
| Shanghai Motex Healthcare Co., Ltd. | Shanghai | Shanghai | Manufacturer | 4 |
| True Glove Factory | Weifang | Shandong | Specification developer | 4 |
| Motex Healthcare (Anhui) Co., Ltd. | Guangde City, Xuancheng | Anhui | Manufacturer | 4 |
| Novapro Co., Ltd. | Zibo | Shandong | Specification developer | 3 |
| Shandong Huayue Glove Co., Ltd. | Zibo | Shandong | Manufacturer | 3 |
| Huizhou Anboson Technology Co., Ltd. | Huizhou | Guangdong | Manufacturer | 3 |
| Shanghai Jinxiang Latex Products Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 3 |
| Zibo Blue Sail Health Technology Co., Ltd. | Zibo | Shandong | Specification developer | 3 |
Record
| Listed by | Adenna Inc |
|---|---|
| FDA product code | LYY |
| Device type | Latex Patient Examination Glove |
| Device class | Class 1 |
| Regulation | 21 CFR 880.6250 |
| Record published | 2020-04-17 |
| Record revised | 2023-06-15 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Over the counter | Yes |
| Latex | Contains natural rubber latex |
| Packaging | Box of 10 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| HER008 | 50 | In distribution | |
| HER002 | 50 | In distribution | |
| HER009 | 50 | In distribution | |
| HER006 | 50 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Microflex | Ansell Healthcare Product | 56 |
| Henry Schein | Henry Schein, Inc. | 36 |
| BioSkin | Liberty Glove & Safety, LLC | 30 |
| McKesson | Mckesson Medical-Surgical Inc. | 28 |
| Hopkins Medical Products® | Hopkins Uniform Company | 26 |
| Blossom | Mexpo International, Inc. | 25 |
| Cranberry | Ascend Eagle, Inc. | 24 |
| Darby Dental Supply, LLC | Darby Dental Supply, LLC | 23 |
| Tronex International, Inc. | Tronex International, Inc. | 20 |
| Ammex Professional | Ammex Corporation | 20 |
| AmbiCanner | Summit Glove, Inc. | 20 |
| Micro-Touch | Ansell Healthcare Product | 17 |
Showing 12 of 316. All products under Latex Patient Examination Glove
Recalls
The FDA has not published a severity grade for these. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2011-12-22 | Not classified | Release of Material/Component prior to receiving test results | The recall was initiated because Adenna Inc. distributed latex gloves that have been FDA refused. | 427 cartons | 2012-05-29 |
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.