Gammex
GAMMEX® PI Glove-in-Glove™ System Half Size Larger Size 7.5, Sterile Powder-Free Surgical Glove, pre-donned double gloving system of one polyisoprene (PI) surgical glove and one neoprene…
GAMMEX® PI Glove-in-Glove™ System Half Size Larger Size 7.5, Sterile Powder-Free Surgical Glove, pre-donned double gloving system of one polyisoprene (PI) surgical glove and one neoprene surgical glove
10manufacturers in China registered for this device type
126catalogue 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 | Ansell Healthcare Product |
|---|---|
| FDA product code | KGO |
| Device type | Surgeon’S Gloves |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4460 |
| Record published | 2022-02-07 |
| Record revised | 2024-08-28 (version 3) |
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 |
| Packaging | Case of 4, dispenser of 50, dispenser of 25, case of 50 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 8514 | 7 | 2 | In distribution |
| 20277290 | 9 | 2 | In distribution |
| 340002070 | 7.0 | 2 | In distribution |
| 20685590 | 9 | 2 | In distribution |
| 20685985 | 8.5 | 2 | In distribution |
| 20685265 | 6.5 | 2 | In distribution |
| 20685580 | 8 | 2 | In distribution |
| 20685790 | 9 | 2 | In distribution |
| 20685970 | 7 | 2 | In distribution |
| 340064090 | 9 | 2 | In distribution |
| 340084055 | 5.5 | 2 | In distribution |
| 340060055 | 5.5 | 2 | In distribution |
| 340060080 | 8 | 2 | In distribution |
| 20688255 | 5.5 | 2 | In distribution |
| 20687260 | 6 | 2 | In distribution |
| 340060090 | 9 | 2 | In distribution |
| 20277260 | 6 | 2 | In distribution |
| 340002055 | 5.5 | 2 | In distribution |
| 20277285 | 8.5 | 2 | In distribution |
| 20686575 | 7.5 | 2 | In distribution |
| 20685255 | 5.5 | 2 | In distribution |
| 20685280 | 8 | 2 | In distribution |
| 20685780 | 8 | 2 | In distribution |
| 340063070 | 7 | 2 | In distribution |
| 20685960 | 6 | 2 | In distribution |
| 20685755 | 5.5 | 2 | In distribution |
| 340069075 | 7.5 | 2 | In distribution |
| 20687270 | 7 | 2 | In distribution |
| 20685765 | 6.5 | 2 | In distribution |
| 340082080 | 8.0 | 2 | In distribution |
| 20688265 | 6.5 | 2 | In distribution |
| 8512 | 6 | 2 | In distribution |
| 340060065 | 6.5 | 2 | In distribution |
| 340060070 | 7 | 2 | In distribution |
| 340063080 | 8 | 2 | In distribution |
| 340084065 | 6.5 | 2 | In distribution |
| 20685785 | 8.5 | 2 | In distribution |
| 20687255 | 5.5 | 2 | In distribution |
| 20686580 | 8 | 2 | In distribution |
| 340082085 | 8.5 | 2 | In distribution |
| 20685585 | 8.5 | 2 | In distribution |
| 340063065 | 6.5 | 2 | In distribution |
| 340069085 | 8.5 | 2 | In distribution |
| 20688270 | 7 | 2 | In distribution |
| 340064070 | 7 | 2 | In distribution |
| 20686565 | 6.5 | 2 | In distribution |
| 20685775 | 7.5 | 2 | In distribution |
| 20277255 | 5.5 | 2 | In distribution |
| 340063055 | 5.5 | 2 | In distribution |
| 340002090 | 9.0 | 2 | In distribution |
| 20687285 | 8.5 | 2 | In distribution |
| 20685570 | 7 | 2 | In distribution |
| 20688280 | 8 | 2 | In distribution |
| 8517 | 8.5 | 2 | In distribution |
| 20688285 | 8.5 | 2 | In distribution |
| 20685965 | 6.5 | 2 | In distribution |
| 20685770 | 7 | 2 | In distribution |
| 20685575 | 7.5 | 2 | In distribution |
| 340084085 | 8.5 | 2 | In distribution |
| 8515 | 7.5 | 2 | In distribution |
| 20688275 | 7.5 | 2 | In distribution |
| 340069055 | 5.5 | 2 | In distribution |
| 20685975 | 7.5 | 2 | In distribution |
| 340069080 | 8 | 2 | In distribution |
| 340064065 | 6.5 | 2 | In distribution |
| 340002060 | 6.0 | 2 | In distribution |
| 340069060 | 6 | 2 | In distribution |
| 340082060 | 6.0 | 2 | In distribution |
| 340084075 | 7.5 | 2 | In distribution |
| 340082055 | 5.5 | 2 | In distribution |
| 340063060 | 6 | 2 | In distribution |
| 20687290 | 9 | 2 | In distribution |
| 340060060 | 6 | 2 | In distribution |
| 340082070 | 7.0 | 2 | In distribution |
| 20277280 | 8 | 2 | In distribution |
| 340060085 | 8.5 | 2 | In distribution |
| 20277270 | 7 | 2 | In distribution |
| 20685990 | 9 | 2 | In distribution |
| 340082075 | 2 | In distribution | |
| 340082090 | 9.0 | 2 | In distribution |
| 20685565 | 6.5 | 2 | In distribution |
| 340084060 | 6 | 2 | In distribution |
| 8516 | 8 | 2 | In distribution |
| 340002065 | 6.5 | 2 | In distribution |
| 20686585 | 8.5 | 2 | In distribution |
| 20685290 | 9 | 2 | In distribution |
| 340002085 | 8.5 | 2 | In distribution |
| 20687275 | 7.5 | 2 | In distribution |
| 340064075 | 7.5 | 2 | In distribution |
| 20686560 | 6 | 2 | In distribution |
| 20685760 | 6 | 2 | In distribution |
| 20685560 | 6 | 2 | In distribution |
| 340063085 | 8.5 | 2 | In distribution |
| 20685980 | 8 | 2 | In distribution |
| 20685275 | 7.5 | 2 | In distribution |
| 340082065 | 6.5 | 2 | In distribution |
| 340084080 | 8 | 2 | In distribution |
| 20688290 | 9 | 2 | In distribution |
| 340063075 | 7.5 | 2 | In distribution |
| 8513 | 6.5 | 2 | In distribution |
| 20685955 | 5.5 | 2 | In distribution |
| 20685285 | 8.5 | 2 | In distribution |
| 20685270 | 7 | 2 | In distribution |
| 340002080 | 8.0 | 2 | In distribution |
| 20277265 | 6.5 | 2 | In distribution |
| 20686570 | 7 | 2 | In distribution |
| 20685555 | 5.5 | 2 | In distribution |
| 340063090 | 9 | 2 | In distribution |
| 340069065 | 6.5 | 2 | In distribution |
| 340060075 | 7.5 | 2 | In distribution |
| 340064055 | 5.5 | 2 | In distribution |
| 8511 | 5.5 | 2 | In distribution |
| 20687265 | 6.5 | 2 | In distribution |
| 20688260 | 6 | 2 | In distribution |
| 20686590 | 9 | 2 | In distribution |
| 340084090 | 9 | 2 | In distribution |
| 20687280 | 8 | 2 | In distribution |
| 340064060 | 6 | 2 | In distribution |
| 340064080 | 8 | 2 | In distribution |
| 340069070 | 7 | 2 | In distribution |
| 20277275 | 7.5 | 2 | In distribution |
| 340064085 | 8.5 | 2 | In distribution |
| 20685260 | 6 | 2 | In distribution |
| 340084070 | 7 | 2 | In distribution |
| 340002075 | 7.5 | 2 | In distribution |
| 8518 | 9 | 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 |
| 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 |
| Halyard | Ansell Healthcare Product | 55 |
Showing 12 of 106. All products under Surgeon’S Gloves
Recalls Naming This Product
2 recalls name this product by its own identifiers, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Ansell Healthcare Products LLC | UDI-DI | 2023-08-03 | Class II | Process control | Some surgical glove sterile pouches were not completely sealed. | 1511 |
| Ansell Healthcare Products LLC | UDI-DI | 2022-02-19 | Class II | Other | Transport company failed to stop at the border for required FDA inspection. | 74 cases |
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.