Biogel
Biogel Skinsense Indicator Underglove Surgical 8.0 - 50 Pair/Box
10manufacturers in China registered for this device type
149catalogue 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 | Contains natural rubber latex |
| 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, pack of 4 |
| Distribution end date | 2026-07-08 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 71-30460 | 6.0 | 50 | In distribution |
| 71-31290 | 9.0 | 40 | In distribution |
| 71-ML42965 | 6.5 | 50 | In distribution |
| 71-31455 | 5.5 | 50 | In distribution |
| 71-ML48555 | 5.5 | 50 | In distribution |
| 71-40890 | 9.0 | 40 | In distribution |
| 71-31255 | 5.5 | 50 | In distribution |
| 71-40680 | 8.0 | 50 | In distribution |
| 71-40660 | 6.0 | 50 | In distribution |
| 71-82565 | 6.5 | 50 | In distribution |
| 71-ML42955 | 5.5 | 50 | In distribution |
| 71-40670 | 7.0 | 50 | In distribution |
| 71-ML48580 | 8.0 | 50 | In distribution |
| 71-30480 | 8.0 | 50 | In distribution |
| 71-ML42185 | 8.5 | 50 | In distribution |
| 71-ML41670 | 7.0 | 50 | In distribution |
| 71-ML42665 | 6.5 | 50 | In distribution |
| 71-30470 | 7.0 | 50 | In distribution |
| 71-31460 | 6.0 | 50 | In distribution |
| 71-ML42685 | 8.5 | 50 | In distribution |
| 71-ML48565 | 6.5 | 50 | In distribution |
| 71-ML48980 | 8.0 | 50 | In distribution |
| 71-ML42690 | 9.0 | 40 | In distribution |
| 71-40860 | 6.0 | 50 | In distribution |
| 71-ML42160 | 6.0 | 50 | In distribution |
| 71-ML42980 | 8.0 | 50 | In distribution |
| 71-30580 | 8.0 | 50 | In distribution |
| 71-ML41675 | 7.5 | 50 | In distribution |
| 71-ML48560 | 6.0 | 50 | In distribution |
| 71-41160 | 6.0 | 50 | In distribution |
| 71-41165 | 6.5 | 50 | In distribution |
| 71-ML42175 | 7.5 | 50 | In distribution |
| 71-30560 | 6.0 | 50 | In distribution |
| 71-82555 | 5.5 | 50 | In distribution |
| 71-ML42675 | 7.5 | 50 | In distribution |
| 71-31280 | 8.0 | 50 | In distribution |
| 71-ML47685 | 8.5 | 40 | In distribution |
| 71-ML47960 | 6.0 | 50 | In distribution |
| 71-40880 | 8.0 | 50 | In distribution |
| 71-ML47975 | 7.5 | 50 | In distribution |
| 71-82590 | 9.0 | 40 | In distribution |
| 71-40690 | 9.0 | 40 | In distribution |
| 71-ML42170 | 7.0 | 50 | In distribution |
| 71-ML48965 | 6.5 | 50 | In distribution |
| 71-ML47675 | 7.5 | 40 | In distribution |
| 71-41180 | 8.0 | 50 | In distribution |
| 71-ML48585 | 8.5 | 50 | In distribution |
| 71-ML47690 | 9.0 | 40 | In distribution |
| 71-ML42655 | 5.5 | 50 | In distribution |
| 71-82570 | 7.9 | 50 | In distribution |
| 71-30490 | 9.0 | 40 | In distribution |
| 71-ML42970 | 7.0 | 50 | In distribution |
| 71-31490 | 9.0 | 40 | In distribution |
| 71-31270 | 7.0 | 50 | In distribution |
| 71-31480 | 8.0 | 50 | In distribution |
| 71-ML41665 | 6.5 | 50 | In distribution |
| 71-ML48990 | 9.0 | 40 | In distribution |
| 71-ML42180 | 8.0 | 50 | In distribution |
| 71-ML48970 | 7.0 | 50 | In distribution |
| 71-41185 | 8.5 | 50 | In distribution |
| 71-ML42990 | 9.0 | 40 | In distribution |
| 71-40885 | 8.5 | 50 | In distribution |
| 71-30575 | 7.5 | 50 | In distribution |
| 71-40675 | 7.5 | 50 | In distribution |
| 71-40685 | 8.5 | 50 | In distribution |
| 71-ML42680 | 8.0 | 50 | In distribution |
| 71-ML48955 | 5.5 | 50 | In distribution |
| 71-ML41655 | 5.5 | 50 | In distribution |
| 71-ML42985 | 8.5 | 50 | In distribution |
| 71-30475 | 7.5 | 50 | In distribution |
| 71-ML47980 | 8.0 | 50 | In distribution |
| 71-31260 | 6.0 | 50 | In distribution |
| 71-ML47670 | 7.0 | 40 | In distribution |
| 71-40665 | 6.5 | 50 | In distribution |
| 71-30455 | 5.5 | 50 | In distribution |
| 71-40875 | 7.5 | 50 | In distribution |
| 71-82580 | 8.0 | 50 | In distribution |
| 71-ML41690 | 9.0 | 40 | In distribution |
| 71-30485 | 8.5 | 50 | In distribution |
| 71-ML41660 | 6.0 | 50 | In distribution |
| 71-ML47965 | 6.5 | 50 | In distribution |
| 71-30565 | 6.5 | 50 | In distribution |
| 71-ML41680 | 8.0 | 50 | In distribution |
| 71-ML47660 | 6.0 | 40 | In distribution |
| 71-ML48570 | 7.0 | 50 | In distribution |
| 71-ML41685 | 8.5 | 50 | In distribution |
| 71-41170 | 7.0 | 50 | In distribution |
| 71-ML48985 | 8.5 | 50 | In distribution |
| 71-ML42165 | 6.5 | 50 | In distribution |
| 71-ML42960 | 6.0 | 50 | In distribution |
| 71-ML47665 | 6.5 | 40 | In distribution |
| 71-ML48575 | 7.5 | 50 | In distribution |
| 71-30570 | 7.0 | 50 | In distribution |
| 71-82585 | 8.5 | 50 | In distribution |
| 71-ML42670 | 7.0 | 50 | In distribution |
| 71-31485 | 8.5 | 50 | In distribution |
| 71-ML42975 | 7.5 | 50 | In distribution |
| 71-30555 | 5.5 | 50 | In distribution |
| 71-82575 | 7.5 | 50 | In distribution |
| 71-40870 | 7.0 | 50 | In distribution |
| 71-31465 | 6.5 | 50 | In distribution |
| 71-30465 | 6.5 | 50 | In distribution |
| 71-41175 | 7.5 | 50 | In distribution |
| 71-ML42155 | 5.5 | 50 | In distribution |
| 71-41155 | 5.5 | 50 | In distribution |
| 71-40655 | 5.5 | 50 | In distribution |
| 71-31275 | 7.5 | 50 | In distribution |
| 71-ML47680 | 8.0 | 40 | In distribution |
| 71-31475 | 7.5 | 50 | In distribution |
| 71-ML47990 | 9.0 | 40 | In distribution |
| 71-ML48960 | 6.0 | 50 | In distribution |
| 71-ML47970 | 7.0 | 50 | In distribution |
| 71-31470 | 7.0 | 50 | In distribution |
| 71-ML47985 | 8.0 | 50 | In distribution |
| 71-30590 | 9.0 | 40 | In distribution |
| 71-ML42190 | 9.0 | 40 | In distribution |
| 71-30585 | 8.5 | 50 | In distribution |
| 71-ML48975 | 7.5 | 50 | In distribution |
| 71-40855 | 5.5 | 50 | In distribution |
| 71-ML48590 | 9.0 | 40 | In distribution |
| 71-31265 | 6.5 | 50 | In distribution |
| 71-40865 | 6.5 | 50 | In distribution |
| 71-82560 | 6.0 | 50 | In distribution |
| 71-31285 | 8.5 | 50 | In distribution |
| 71-41190 | 9.0 | 40 | In distribution |
| 71-ML42660 | 6.0 | 50 | In distribution |
| 71-30655 | 5.5 | 50 | Withdrawn |
| 71-75290 | 9.0 | 40 | Withdrawn |
| 71-30690 | 9.0 | 40 | Withdrawn |
| 71-75260 | 6.0 | 50 | Withdrawn |
| 71-30680 | 8.0 | 50 | Withdrawn |
| 71-31075 | 7.5 | 40 | Withdrawn |
| 71-75265 | 6.5 | 50 | Withdrawn |
| 71-30685 | 8.5 | 50 | Withdrawn |
| 71-30670 | 7.0 | 50 | Withdrawn |
| 71-31085 | 8.5 | 40 | Withdrawn |
| 71-75275 | 7.5 | 50 | Withdrawn |
| 71-75280 | 8.0 | 50 | Withdrawn |
| 71-31060 | 6.0 | 40 | Withdrawn |
| 71-31065 | 6.5 | 40 | Withdrawn |
| 71-75270 | 7.0 | 50 | Withdrawn |
| 71-31070 | 7.0 | 40 | Withdrawn |
| 71-31080 | 8.0 | 40 | Withdrawn |
| 71-75255 | 5.5 | 50 | Withdrawn |
| 71-31090 | 9.0 | 40 | Withdrawn |
| 71-30660 | 6.0 | 50 | Withdrawn |
| 71-75285 | 8.5 | 50 | Withdrawn |
| 71-30665 | 6.5 | 50 | Withdrawn |
| 71-30675 | 7.5 | 50 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| MocareHealth | Motex Healthcare (Anhui) Co., Ltd. | 398 |
| 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 |
| 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.