Medline Industries, Inc.
Glove Size 6.5 (15 PR) Neopren
10manufacturers in China registered for this device type
118catalogue numbers in this listing
12510(k) clearances naming this product code
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 | Medline Industries, Inc., United States |
|---|---|
| FDA product code | KGO |
| Device type | Surgeon’S Gloves |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4460 |
| Record published | 2024-07-29 |
| Record revised | 2022-06-17 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Latex | Contains natural rubber latex |
| Label carries | lot or batch number, expiry date |
| Packaging | Case of 20, case of 25, case of 30, case of 40, case of 33, case of 15 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| DYNDA1278A | In distribution | |
| DYNJ62697 | In distribution | |
| DYNJ63897 | In distribution | |
| DYNJ63672D | In distribution | |
| DYNJ87225 | In distribution | |
| DYNJ62543 | In distribution | |
| DYNJ87408 | In distribution | |
| DYNDA1697A | In distribution | |
| DYNJ62695 | In distribution | |
| DYNJ63671C | In distribution | |
| DYNJ55045A | In distribution | |
| DYNJ85960 | In distribution | |
| DYNJ63673C | In distribution | |
| DYNJ63673D | In distribution | |
| DYNJ81676 | In distribution | |
| DYNJ81674 | In distribution | |
| DYNDA1694A | In distribution | |
| DYNJ63671A | In distribution | |
| DYNJ63126 | In distribution | |
| DYNJ69004 | In distribution | |
| DYNDA1279A | In distribution | |
| DYNJ63898 | In distribution | |
| DYNJ63896 | In distribution | |
| DYNJ69000 | In distribution | |
| DYNDA1699B | In distribution | |
| DYNJ61964A | In distribution | |
| DYNJ62699A | In distribution | |
| DYNJ63674 | In distribution | |
| DYNJ63672A | In distribution | |
| DYNDA1281A | In distribution | |
| DYNJ65406 | In distribution | |
| DYNDA1695A | In distribution | |
| DYNJ68360 | In distribution | |
| DYNJ63671D | In distribution | |
| DYNJ62698A | In distribution | |
| DYNJ61963 | In distribution | |
| DYNJ63675D | In distribution | |
| DYNJ61961 | In distribution | |
| DYNJ87227 | In distribution | |
| DYNJ61959 | In distribution | |
| DYNJ63671 | In distribution | |
| DYNJ61960 | In distribution | |
| DYNDA3021 | In distribution | |
| DYNJ63673A | In distribution | |
| DYNDA1277A | In distribution | |
| DYNJ63673B | In distribution | |
| DYNJ84299 | In distribution | |
| DYNJ84298 | In distribution | |
| DYNJ68359 | In distribution | |
| DYNJ63124 | In distribution | |
| DYNJ63898B | In distribution | |
| DYNJ65407 | In distribution | |
| DYNJ81677 | In distribution | |
| DYNJ55144B | In distribution | |
| DYNJ85962 | In distribution | |
| DYNJ63674D | In distribution | |
| DYNJ61958 | In distribution | |
| DYNJ63674C | In distribution | |
| DYNJ61964 | In distribution | |
| DYNJ55142A | In distribution | |
| DYNJ85963 | In distribution | |
| DYNJ65408 | In distribution | |
| DYNJ65409 | In distribution | |
| DYNJ63895A | In distribution | |
| DYNDA1698A | In distribution | |
| DYNDA2717 | In distribution | |
| DYNJ87222 | In distribution | |
| DYNJ80475 | In distribution | |
| DYNJ61962 | In distribution | |
| DYNJ62698 | In distribution | |
| DYNJ63125 | In distribution | |
| DYNJ81675 | In distribution | |
| DYNJ63122 | In distribution | |
| DYNJ63672 | In distribution | |
| DYNDA1694B | In distribution | |
| DYNJ62696 | In distribution | |
| DYNJ63121 | In distribution | |
| DYNJ63674A | In distribution | |
| DYNJ85961 | In distribution | |
| DYNJ87223 | In distribution | |
| DYNJ63674B | In distribution | |
| DYNJ63130 | In distribution | |
| DYNJ63675 | In distribution | |
| DYNJ63673 | In distribution | |
| DYNJ68358 | In distribution | |
| DYNJ62697A | In distribution | |
| DYNJ62696A | In distribution | |
| DYNJ55143A | In distribution | |
| DYNJ69002 | In distribution | |
| DYNJ63895 | In distribution | |
| DYNJ55044A | In distribution | |
| DYNJ63671B | In distribution | |
| DYNDA1699A | In distribution | |
| DYNJ65410 | In distribution | |
| DYNJ63675C | In distribution | |
| DYNJ55145A | In distribution | |
| DYNDA3022 | In distribution | |
| DYNJ63671F | In distribution | |
| DYNJ81678 | In distribution | |
| DYNJ62695A | In distribution | |
| DYNJ63672B | In distribution | |
| DYNJ63128 | In distribution | |
| DYNJ62700 | In distribution | |
| DYNJ62699 | In distribution | |
| DYNJ63129 | In distribution | |
| DYNJ68357 | In distribution | |
| DYNJ69001 | In distribution | |
| DYNJ84013 | In distribution | |
| DYNJ63123 | In distribution | |
| DYNJ63898A | In distribution | |
| DYNJ63897A | In distribution | |
| DYNJ68356 | In distribution | |
| DYNJ63675A | In distribution | |
| DYNJ63675B | In distribution | |
| DYNJ84297 | In distribution | |
| DYNJ63127 | In distribution | |
| DYNJ69003 | In distribution | |
| DYNDA1280A | 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 |
| 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
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K203538 | 2021-08-02 |
| K202668 | 2020-12-19 |
| K202449 | 2020-11-18 |
| K201829 | 2020-09-09 |
| K193217 | 2020-04-06 |
| K192988 | 2020-04-01 |
| K191915 | 2020-03-06 |
| K192820 | 2020-02-28 |
| K152428 | 2016-03-31 |
| K150238 | 2015-11-27 |
| K111807 | 2011-08-18 |
| K102177 | 2011-06-30 |
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 |
|---|---|---|---|---|---|---|
| Medline Industries, LP – Northfield | UDI-DI | 2026-02-27 | Class I | Under Investigation by firm | Medline Industries, LP has identified through post-market surveillance a potential risk of the syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection between the syringe and manifold. | 240 kits |
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.