Novaplus
NOVAPLUS® GAMMEX® Non-Latex PI Underglove Size 8.5, Sterile Polyisoprene Powder-Free Surgical Glove
10manufacturers in China registered for this device type
85catalogue 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 | 2022-03-10 |
| Record revised | 2023-05-03 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Over the counter | Yes |
| Latex | Contains natural rubber latex |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Packaging | Dispenser of 50, case of 4 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| V20688255 | 5.5 | In distribution |
| V5795001 | 6.0 | In distribution |
| V20688275 | 7.5 | In distribution |
| V20685775 | 7.5 | In distribution |
| V20685960 | 6 | In distribution |
| V5787002 | 6.5 | In distribution |
| V8518 | 9 | In distribution |
| V20688290 | 9 | In distribution |
| V20685990 | 9 | In distribution |
| V20277260 | 6 | In distribution |
| V8517 | 8.5 | In distribution |
| V5795007 | In distribution | |
| V5787004 | 7.5 | In distribution |
| V20277265 | 6.5 | In distribution |
| V20687285 | 8.5 | In distribution |
| V20277285 | 8.5 | In distribution |
| V20277280 | 8 | In distribution |
| V20688270 | 7 | In distribution |
| V20277270 | 7 | In distribution |
| V8513 | 6.5 | In distribution |
| V5788001 | 6.0 | In distribution |
| V5795000 | 5.5 | In distribution |
| V20687290 | 9 | In distribution |
| V5788003 | 7.0 | In distribution |
| V20688260 | 6 | In distribution |
| V5788007 | 9 | In distribution |
| V20685790 | 9 | In distribution |
| V5788002 | 6.5 | In distribution |
| V20685285 | 8.5 | In distribution |
| V20685265 | 6.5 | In distribution |
| V20687265 | 6.5 | In distribution |
| V5788006 | 8.5 | In distribution |
| V20687260 | 6 | In distribution |
| V20685980 | 8 | In distribution |
| V5788006 | 8.5 | In distribution |
| V5787005 | 8 | In distribution |
| V20685270 | 7 | In distribution |
| V20685975 | 7.5 | In distribution |
| V20685290 | 9 | In distribution |
| V20685955 | 5.5 | In distribution |
| V20687255 | 5.5 | In distribution |
| V20685260 | 6 | In distribution |
| V20685780 | 8 | In distribution |
| V5788001 | 6 | In distribution |
| V5787000 | 5.5 | In distribution |
| V8515 | 7.5 | In distribution |
| V5788003 | 7 | In distribution |
| V5788005 | 8 | In distribution |
| V20685280 | 8 | In distribution |
| V5795006 | 8.5 | In distribution |
| V5788004 | 7.5 | In distribution |
| V20685785 | 8.5 | In distribution |
| V20685985 | 8.5 | In distribution |
| V20685760 | 6 | In distribution |
| V5788005 | 8.0 | In distribution |
| V5788002 | 6.5 | In distribution |
| V20685275 | 7.5 | In distribution |
| V5795003 | 7.0 | In distribution |
| V8511 | 5.5 | In distribution |
| V20687275 | 7.5 | In distribution |
| V5788004 | 7.5 | In distribution |
| V20277275 | 7.5 | In distribution |
| V20277255 | 5.5 | In distribution |
| V20688285 | 8.5 | In distribution |
| V20685965 | 6.5 | In distribution |
| V20687280 | 8 | In distribution |
| V5788007 | 9.0 | In distribution |
| V20688280 | 8 | In distribution |
| V20685755 | 5.5 | In distribution |
| V20687270 | 7 | In distribution |
| V8512 | 6 | In distribution |
| V5787007 | 9 | In distribution |
| V20688265 | 6.5 | In distribution |
| V20277290 | 9 | In distribution |
| V5787003 | 7 | In distribution |
| V5795004 | 7.5 | In distribution |
| V5795005 | 8.0 | In distribution |
| V20685770 | 7 | In distribution |
| V20685255 | 5.5 | In distribution |
| V8516 | 8 | In distribution |
| V5795002 | 6.5 | In distribution |
| V20685765 | 6.5 | In distribution |
| V5787001 | 6 | In distribution |
| V8514 | 7 | In distribution |
| V20685970 | 7 | 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 |
| 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
1 recall names this product by its own identifier, 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. | 378 |
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.