Dexters
Sterile Synthetic Polyisoprene Powder-Free Surgical Gloves, SIZE 8.5
10manufacturers in China registered for this device type
8catalogue numbers in this listing
2510(k) clearances naming this product code
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 | Guilin HBM Health Protections, Inc., China |
|---|---|
| FDA product code | KGO |
| Device type | Surgeon’S Gloves |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4460 |
| Establishment | Manufacturer |
| 510(k) | K203483 |
| Record published | 2023-08-30 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Packaging | Box of 4 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| DPIG70 | 50 | In distribution | |
| DPIG80 | 50 | In distribution | |
| DPIG65 | 50 | In distribution | |
| DPIG75 | 50 | In distribution | |
| DPIG85 | 50 | In distribution | |
| DPIG55 | 50 | In distribution | |
| DPIG60 | 50 | In distribution | |
| DPIG90 | 50 | 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
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K221748 | 2022-09-13 |
| K203483 | 2021-02-01 |
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.