Supergloves
Latex Examination Gloves Powder Free (X-Large)
12manufacturers in China registered for this device type
4catalogue numbers in this listing
3510(k) clearances naming this product code
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 | Mexpo International, Inc., United States |
|---|---|
| FDA product code | LYY |
| Device type | Latex Patient Examination Glove |
| Device class | Class 1 |
| Regulation | 21 CFR 880.6250 |
| Establishment | Contract manufacturer, Specification developer, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2022-02-22 |
| Record revised | 2023-06-14 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Latex | Contains natural rubber latex |
| Label carries | lot or batch number, expiry date, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| SG 8228-LTX-PF | 100 | In distribution | |
| SG 8229-LTX-PF | 100 | In distribution | |
| SG 8226-LTX-PF | 100 | In distribution | |
| SG 8227-LTX-PF | 100 | 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
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K990210 | 1999-03-29 |
| K984040 | 1999-01-13 |
| K974782 | 1998-02-24 |
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.