Protexis
Sterile Synthetic Polyisoprene Powder-Free Surgical Gloves with Hydrogel Coating, Smooth Finish, Straight Finger
10manufacturers in China registered for this device type
141catalogue numbers in this listing
1510(k) clearance
25recalls on this 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 | Cardinal Health 200, LLC, United States |
|---|---|
| FDA product code | KGO |
| Device type | Surgeon’S Gloves |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4460 |
| Establishment | Contract manufacturer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Record published | 2018-04-13 |
| Record revised | 2026-04-10 (version 8) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Radiation Sterilization |
| 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, box of 40 |
| Distribution end date | 2022-11-30 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 2D73DP80 | In distribution | |
| 2D73ET60 | In distribution | |
| 2D72TG75 | In distribution | |
| 2D72PL65X | In distribution | |
| 2D72PL75X | In distribution | |
| 2D72NS65X | In distribution | |
| 2D73HT70 | In distribution | |
| 2D73DS70 | In distribution | |
| 2D72N60X | In distribution | |
| 2D72NS80X | In distribution | |
| 2D72LS75 | In distribution | |
| 2D73DS55 | In distribution | |
| 2D72TG80 | In distribution | |
| 2D73HT90 | In distribution | |
| 2D73ET65 | In distribution | |
| 2D73ET85 | In distribution | |
| 2D72LU80 | In distribution | |
| 2D72LS90 | In distribution | |
| 2D72PT75X | In distribution | |
| 2D72PT70X | In distribution | |
| 2D72NT75X | In distribution | |
| 2D72TG70 | In distribution | |
| 2D72LS60 | In distribution | |
| 2D72LS55 | In distribution | |
| 2D72N65X | In distribution | |
| 2D73HT75 | In distribution | |
| 2D73EB60 | In distribution | |
| 2D72LT75 | In distribution | |
| 2D72PL55X | In distribution | |
| 2D72LU85 | In distribution | |
| 2D73TE60 | In distribution | |
| 2D72LT60 | In distribution | |
| 2D72LU55 | In distribution | |
| 2D72PT55X | In distribution | |
| 2D72PL70X | In distribution | |
| 2D73EB85 | In distribution | |
| 2D73DP90 | In distribution | |
| 2D72LS65 | In distribution | |
| 2D73HT80 | In distribution | |
| 2D73DS75 | In distribution | |
| 2D72LT80 | In distribution | |
| 2D73TE90 | In distribution | |
| 2D72NT90X | In distribution | |
| 2D73EB75 | In distribution | |
| 2D72N70X | In distribution | |
| 2D73PM90 | In distribution | |
| 2D73TP75 | In distribution | |
| 2D73TP80 | In distribution | |
| 2D72N85X | In distribution | |
| 2D72LU60 | In distribution | |
| 2D73DS80 | In distribution | |
| 2D72TG90 | In distribution | |
| 2D73DP55 | In distribution | |
| 2D73EB90 | In distribution | |
| 2D73EB80 | In distribution | |
| 2D73HT65 | In distribution | |
| 2D72NT55X | In distribution | |
| 2D72N55X | In distribution | |
| 2D73TP55 | In distribution | |
| 2D72PL90X | In distribution | |
| 2D73TE85 | In distribution | |
| 2D72TG60 | In distribution | |
| 2D72LT70 | In distribution | |
| 2D72LS80 | In distribution | |
| 2D72LU70 | In distribution | |
| 2D72N80X | In distribution | |
| 2D73DP75 | In distribution | |
| 2D73TE55 | In distribution | |
| 2D72LU90 | In distribution | |
| 2D72TG65 | In distribution | |
| 2D72PT60X | In distribution | |
| 2D73TP65 | In distribution | |
| 2D72NS75X | In distribution | |
| 2D73EB70 | In distribution | |
| 2D73HT85 | In distribution | |
| 2D73TE80 | In distribution | |
| 2D72NS60X | In distribution | |
| 2D73PM55 | In distribution | |
| 2D72NT65X | In distribution | |
| 2D72NS70X | In distribution | |
| 2D72NS90X | In distribution | |
| 2D73PM80 | In distribution | |
| 2D73PM70 | In distribution | |
| 2D73DS85 | In distribution | |
| 2D73TP85 | In distribution | |
| 2D73TP70 | In distribution | |
| 2D72LT90 | In distribution | |
| 2D72NT60X | In distribution | |
| 2D72LS70 | In distribution | |
| 2D72LS85 | In distribution | |
| 2D72TG55 | In distribution | |
| 2D73PM60 | In distribution | |
| 2D72PT65X | In distribution | |
| 2D73DS60 | In distribution | |
| 2D73EB55 | In distribution | |
| 2D72LT85 | In distribution | |
| 2D73EB65 | In distribution | |
| 2D73TP60 | In distribution | |
| 2D72PL80X | In distribution | |
| 2D72N75X | In distribution | |
| 2D72N90X | In distribution | |
| 2D72PT90X | In distribution | |
| 2D72NS85X | In distribution | |
| 2D73DP65 | In distribution | |
| 2D72NS55X | In distribution | |
| 2D72LU65 | In distribution | |
| 2D72PL85X | In distribution | |
| 2D73PM75 | In distribution | |
| 2D73DS90 | In distribution | |
| 2D72LU75 | In distribution | |
| 2D73DP70 | In distribution | |
| 2D72NT85X | In distribution | |
| 2D72NT80X | In distribution | |
| 2D73HT60 | In distribution | |
| 2D72PT80X | In distribution | |
| 2D73PM85 | In distribution | |
| 2D73ET80 | In distribution | |
| 2D73DP85 | In distribution | |
| 2D73TE75 | In distribution | |
| 2D72LT65 | In distribution | |
| 2D73TP90 | In distribution | |
| 2D73TE65 | In distribution | |
| 2D72PT85X | In distribution | |
| 2D73PM65 | In distribution | |
| 2D72TG85 | In distribution | |
| 2D72PL60X | In distribution | |
| 2D73TE70 | In distribution | |
| 2D73DP60 | In distribution | |
| 2D73ET75 | In distribution | |
| 2D73ET70 | In distribution | |
| 2D73ET90 | In distribution | |
| 2D72NT70X | In distribution | |
| 2D73DS65 | In distribution | |
| 2D72LB60 | Withdrawn | |
| 2D72LB55 | Withdrawn | |
| 2D72LB80 | Withdrawn | |
| 2D72LB85 | Withdrawn | |
| 2D72LB90 | Withdrawn | |
| 2D72LB70 | Withdrawn | |
| 2D72LB65 | Withdrawn | |
| 2D72LB75 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| MocareHealth | Motex Healthcare (Anhui) Co., Ltd. | 398 |
| Biogel | Bosma Enterprises | 149 |
| 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
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K151778 | 2016-03-24 |
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 |
|---|---|---|---|---|---|---|
| Cardinal Health 200, LLC | UDI-DI | 2022-03-15 | Class II | Under Investigation by firm | Product was distributed without being sterilized. | 486,578 pairs |
Recalls
16 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2020-07-29 | Class II | Under Investigation by firm | A degradation defect was found that could lead to holes and donning tears at the folding area around the cuffs. | 7119625 total | |
| 2020-07-29 | Class II | Under Investigation by firm | A degradation defect was found that could lead to holes and donning tears at the folding area around the cuffs. | 7119625 total | |
| 2020-07-29 | Class II | Under Investigation by firm | A degradation defect was found that could lead to holes and donning tears at the folding area around the cuffs. | 7119625 total | |
| 2020-07-29 | Class II | Under Investigation by firm | A degradation defect was found that could lead to holes and donning tears at the folding area around the cuffs. | 7119625 total | |
| 2020-07-29 | Class II | Under Investigation by firm | A degradation defect was found that could lead to holes and donning tears at the folding area around the cuffs. | 7119625 total | |
| 2020-07-29 | Class II | Under Investigation by firm | A degradation defect was found that could lead to holes and donning tears at the folding area around the cuffs. | 7119625 total | |
| 2020-07-29 | Class II | Under Investigation by firm | A degradation defect was found that could lead to holes and donning tears at the folding area around the cuffs. | 7119625 total | |
| 2020-07-29 | Class II | Under Investigation by firm | A degradation defect was found that could lead to holes and donning tears at the folding area around the cuffs. | 7119625 total | |
| 2018-10-31 | Class II | Labeling mix-ups | Labeling issue in that the breakthrough (i.e., permeation) times for two chemotherapy drugs (Carmustine and Thiotepa) stated on the wallet (primary packaging) of the Protexis Neoprene surgical gloves are incorrect. Additionally, breakthr | 1,475,095 pairs total | 2025-08-12 |
| 2018-10-31 | Class II | Labeling mix-ups | Labeling issue in that the breakthrough (i.e., permeation) times for two chemotherapy drugs (Carmustine and Thiotepa) stated on the wallet (primary packaging) of the Protexis Neoprene surgical gloves are incorrect. Additionally, breakthr | 1,475,095 pairs total | 2025-08-12 |
| 2018-10-31 | Class II | Labeling mix-ups | Labeling issue in that the breakthrough (i.e., permeation) times for two chemotherapy drugs (Carmustine and Thiotepa) stated on the wallet (primary packaging) of the Protexis Neoprene surgical gloves are incorrect. Additionally, breakthr | 1,475,095 pairs total | 2025-08-12 |
| 2018-10-31 | Class II | Labeling mix-ups | Labeling issue in that the breakthrough (i.e., permeation) times for two chemotherapy drugs (Carmustine and Thiotepa) stated on the wallet (primary packaging) of the Protexis Neoprene surgical gloves are incorrect. Additionally, breakthr | 1,475,095 pairs total | 2025-08-12 |
| 2018-10-31 | Class II | Labeling mix-ups | Labeling issue in that the breakthrough (i.e., permeation) times for two chemotherapy drugs (Carmustine and Thiotepa) stated on the wallet (primary packaging) of the Protexis Neoprene surgical gloves are incorrect. Additionally, breakthr | 1,475,095 pairs total | 2025-08-12 |
| 2018-10-31 | Class II | Labeling mix-ups | Labeling issue in that the breakthrough (i.e., permeation) times for two chemotherapy drugs (Carmustine and Thiotepa) stated on the wallet (primary packaging) of the Protexis Neoprene surgical gloves are incorrect. Additionally, breakthr | 1,475,095 pairs total | 2025-08-12 |
| 2018-10-31 | Class II | Labeling mix-ups | Labeling issue in that the breakthrough (i.e., permeation) times for two chemotherapy drugs (Carmustine and Thiotepa) stated on the wallet (primary packaging) of the Protexis Neoprene surgical gloves are incorrect. Additionally, breakthr | 1,475,095 pairs total | 2025-08-12 |
| 2018-10-31 | Class II | Labeling mix-ups | Labeling issue in that the breakthrough (i.e., permeation) times for two chemotherapy drugs (Carmustine and Thiotepa) stated on the wallet (primary packaging) of the Protexis Neoprene surgical gloves are incorrect. Additionally, breakthr | 1,475,095 pairs total | 2025-08-12 |
| 2009-04-24 | Not classified | Device Design | Increase in the number of customer complaints due to cuff tears. | 29,697 cases total | 2010-05-11 |
| 2009-04-24 | Not classified | Device Design | Increase in the number of customer complaints due to cuff tears. | 29,697 cases total | 2010-05-11 |
| 2009-04-24 | Not classified | Device Design | Increase in the number of customer complaints due to cuff tears. | 29,697 cases total | 2010-05-11 |
| 2009-04-24 | Not classified | Device Design | Increase in the number of customer complaints due to cuff tears. | 29,697 cases total | 2010-05-11 |
| 2009-04-24 | Not classified | Device Design | Increase in the number of customer complaints due to cuff tears. | 29,697 cases total | 2010-05-11 |
| 2009-04-24 | Not classified | Device Design | Increase in the number of customer complaints due to cuff tears. | 29,697 cases total | 2010-05-11 |
| 2009-04-24 | Not classified | Device Design | Increase in the number of customer complaints due to cuff tears. | 29,697 cases total | 2010-05-11 |
| 2009-04-24 | Not classified | Device Design | Increase in the number of customer complaints due to cuff tears. | 29,697 cases total | 2010-05-11 |
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.