PremierPro Surgeons Glove
Pair of Polyisoprene, and Neoprene, Hybrid Gloves Size 9.0, COLOR: Natural 50pair/box, 4bx/case
10manufacturers in China registered for this device type
78catalogue 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 | Prestige Ameritech, United States |
|---|---|
| FDA product code | KGO |
| Device type | Surgeon’S Gloves |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4460 |
| Establishment | Contract manufacturer, Specification developer, Complaint-file establishment, Manufacturer |
| Record published | 2019-01-11 |
| Record revised | 2026-03-23 (version 4) |
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 | Case of 4, box of 50, case of 200 |
| Sizes | Length 12 in |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 44565 | Length 12 in | In distribution |
| 44685 | Length 12 in | In distribution |
| 43190 | In distribution | |
| 44160 | Length 12 in | In distribution |
| 44590 | Length 12 in | In distribution |
| 44560 | Length 12 in | In distribution |
| 43685 | Length 12 in | In distribution |
| 44180 | Length 12 in | In distribution |
| 43575 | In distribution | |
| 43675 | Length 12 in | In distribution |
| 43160 | In distribution | |
| 43375 | In distribution | |
| 43555 | In distribution | |
| 43490 | In distribution | |
| 44255 | Length 12 in | In distribution |
| 44660 | Length 12 in | In distribution |
| 44675 | Length 12 in | In distribution |
| 43360 | In distribution | |
| 43660 | In distribution | |
| 43380 | In distribution | |
| 44165 | Length 12 in | In distribution |
| 43570 | In distribution | |
| 43590 | Length 12 in | In distribution |
| 43165 | In distribution | |
| 43260 | In distribution | |
| 43285 | In distribution | |
| 43585 | Length 12 in | In distribution |
| 44185 | Length 12 in | In distribution |
| 43385 | In distribution | |
| 44570 | Length 12 in | In distribution |
| 44155 | Length 12 in | In distribution |
| 43580 | Length 12 in | In distribution |
| 44270 | Length 12 in | In distribution |
| 43455 | In distribution | |
| 43275 | In distribution | |
| 43470 | In distribution | |
| 43170 | In distribution | |
| 44260 | Length 12 in | In distribution |
| 43265 | In distribution | |
| 43485 | In distribution | |
| 44290 | Length 12 in | In distribution |
| 44285 | Length 12 in | In distribution |
| 43690 | Length 12 in | In distribution |
| 43680 | Length 12 in | In distribution |
| 43280 | In distribution | |
| 43560 | In distribution | |
| 44280 | Length 12 in | In distribution |
| 43480 | In distribution | |
| 43670 | Length 12 in | In distribution |
| 43365 | In distribution | |
| 44690 | Length 12 in | In distribution |
| 43270 | In distribution | |
| 43355 | In distribution | |
| 43255 | In distribution | |
| 44575 | Length 12 in | In distribution |
| 44275 | Length 12 in | In distribution |
| 43460 | In distribution | |
| 44580 | Length 12 in | In distribution |
| 43465 | In distribution | |
| 44585 | Length 12 in | In distribution |
| 44170 | Length 12 in | In distribution |
| 43185 | In distribution | |
| 43180 | In distribution | |
| 43565 | In distribution | |
| 43175 | In distribution | |
| 44265 | Length 12 in | In distribution |
| 44670 | Length 12 in | In distribution |
| 44555 | Length 12 in | In distribution |
| 44680 | Length 12 in | In distribution |
| 43155 | In distribution | |
| 44190 | Length 12 in | In distribution |
| 43290 | In distribution | |
| 43390 | In distribution | |
| 43475 | In distribution | |
| 43665 | In distribution | |
| 44665 | Length 12 in | In distribution |
| 43370 | In distribution | |
| 44175 | 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 |
| 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
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.