Gammex
Gammex Non-Latex PI Underglove Surgical 5.5 - 50 Pair/Box
10manufacturers in China registered for this device type
63catalogue 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 | Bosma Enterprises |
|---|---|
| FDA product code | KGO |
| Device type | Surgeon’S Gloves |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4460 |
| Record published | 2021-07-01 |
| Record revised | 2026-05-19 (version 3) |
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 |
| Storage | Special storage condition: Protect from freezing, avoid excessive heat. Keep dry. Shield from direct sunlight, fluorescent lighting, x-rays, moistu |
| Packaging | Case of 4 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 71-AN87255 | 5.5 | 50 | In distribution |
| 71-AN87265 | 6.5 | 50 | In distribution |
| 71-20685280 | 8.0 | 50 | In distribution |
| 71-AN85775 | 7.5 | 50 | In distribution |
| 71-AN85760 | 6.0 | 50 | In distribution |
| 71-8516 | 8.0 | 50 | In distribution |
| 71-AN77290 | 9.0 | 50 | In distribution |
| 71-20685255 | 5.5 | 50 | In distribution |
| 71-8512 | 6.0 | 50 | In distribution |
| 71-AN77265 | 6.5 | 50 | In distribution |
| 71-AN77275 | 7.5 | 50 | In distribution |
| 71-AN85975 | 7.5 | 50 | In distribution |
| 71-20685275 | 7.5 | 50 | In distribution |
| 71-AN85990 | 9.0 | 50 | In distribution |
| 71-8514 | 7.0 | 50 | In distribution |
| 71-AN87275 | 7.5 | 50 | In distribution |
| 71-AN87280 | 8.0 | 50 | In distribution |
| 71-8515 | 7.5 | 50 | In distribution |
| 71-AN85755 | 5.5 | 50 | In distribution |
| 71-AN77280 | 8.0 | 50 | In distribution |
| 71-AN77270 | 7.0 | 50 | In distribution |
| 71-AN88285 | 8.5 | 50 | In distribution |
| 71-AN88290 | 9.0 | 50 | In distribution |
| 71-AN86575 | 7.5 | 50 | In distribution |
| 71-AN88265 | 6.5 | 50 | In distribution |
| 71-AN85985 | 8.5 | 50 | In distribution |
| 71-20685285 | 8.5 | 50 | In distribution |
| 71-8518 | 9.0 | 50 | In distribution |
| 71-20685270 | 7.0 | 50 | In distribution |
| 71-8513 | 6.5 | 50 | In distribution |
| 71-20685260 | 6.0 | 50 | In distribution |
| 71-AN87260 | 6.0 | 50 | In distribution |
| 71-AN86580 | 8.0 | 50 | In distribution |
| 71-AN86590 | 9.0 | 50 | In distribution |
| 71-AN85785 | 8.5 | 50 | In distribution |
| 71-AN86570 | 7.0 | 50 | In distribution |
| 71-AN87285 | 8.5 | 50 | In distribution |
| 71-AN86565 | 6.5 | 50 | In distribution |
| 71-AN86560 | 6.0 | 50 | In distribution |
| 71-AN77255 | 5.5 | 50 | In distribution |
| 71-AN86585 | 8.5 | 50 | In distribution |
| 71-AN85960 | 6.0 | 50 | In distribution |
| 71-AN85955 | 5.5 | 50 | In distribution |
| 71-AN85765 | 6.5 | 50 | In distribution |
| 71-AN88280 | 8.0 | 50 | In distribution |
| 71-AN77260 | 6.0 | 50 | In distribution |
| 71-20685265 | 6.5 | 50 | In distribution |
| 71-20685290 | 9.0 | 50 | In distribution |
| 71-AN85980 | 8.0 | 50 | In distribution |
| 71-AN87290 | 9.0 | 50 | In distribution |
| 71-AN87270 | 7.0 | 50 | In distribution |
| 71-AN77285 | 8.5 | 50 | In distribution |
| 71-AN85970 | 7.0 | 50 | In distribution |
| 71-AN88255 | 5.5 | 50 | In distribution |
| 71-AN88275 | 7.5 | 50 | In distribution |
| 71-AN85790 | 9.0 | 50 | In distribution |
| 71-AN88260 | 6.0 | 50 | In distribution |
| 71-AN85780 | 8.0 | 50 | In distribution |
| 71-AN85965 | 6.5 | 50 | In distribution |
| 71-8517 | 8.5 | 50 | In distribution |
| 71-8511 | 5.5 | 50 | In distribution |
| 71-AN88270 | 7.0 | 50 | In distribution |
| 71-AN85770 | 7.0 | 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 |
| Protexis | Bosma Enterprises | 63 |
| Encore | Ansell Healthcare Product | 60 |
| Halyard | Ansell Healthcare Product | 55 |
Showing 12 of 106. All products under Surgeon’S Gloves
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.