Nitrile Examination Gloves Powder Free
These powder free nitrile examination gloves are disposable gloves worn on the examiner’s hands to help prevent contamination between patient and examiner. They are made from carboxylated…
These powder free nitrile examination gloves are disposable gloves worn on the examiner’s hands to help prevent contamination between patient and examiner. They are made from carboxylated nitrile and are supplied nonsterile for single use.
The blue gloves have a textured surface, an ambidextrous shape and a beaded cuff. The size range extends from X Small to XX Large.
Listed Item
Nitrile Examination Gloves Powder Free (Tested for use with Chemotherapy Drugs) – (XX – Large)
Chemotherapy Handling
The gloves were tested against specified chemotherapy drugs, with resistance varying by drug. Carmustine and thiotepa had substantially shorter permeation times than the other tested agents, and the labeling warns against using these gloves with either drug.
Who Else Makes It
Concentrated in Shandong (27), Guangdong (10), Jiangsu (8). 11 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| YUE Kang Anhui Medical Products Co., Ltd. | Huaibei | Anhui | Contract manufacturer | 5 |
| Opus Gloves Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 5 |
| Better Care Plastic Technology Co., Ltd. | Shenze County | Hebei | Contract manufacturer | 4 |
| Xingyu Medical Tech Co., Ltd. | Weifang | Shandong | Contract manufacturer | 4 |
| Lingshi Hongruida Health Protection Technology Co., Ltd. | Jinzhong | Shanxi | Contract manufacturer | 4 |
| Zhangjiagang Blackbox Plastic Products Co., Ltd. | Zhangjiagang | Jiangsu | Contract manufacturer | 4 |
| Zhangjiagang Dayu Rubber Products Co., Ltd. | Zhangjiagang | Jiangsu | Contract manufacturer | 4 |
| Xuzhou Full Sun Medical Products Ltd. | Pizhou | Jiangsu | Contract manufacturer | 3 |
| Zhongnuo Medical Products Co., Ltd. | Tangshan | Hebei | Contract manufacturer | 3 |
| Anhui Kindguard Medical Supplies Technology Co., Ltd. | Suzhou | Anhui | Contract manufacturer | 2 |
| Puyang Linshi Medical Supplies Co., Ltd. | Puyang | Henan | Contract manufacturer | 2 |
| Jiangsu NEW Pentastar Medical Products Co., Ltd. | Changzhou | Jiangsu | Exporter | 146 |
Showing 12 of 83. All 83 manufacturers in China registered for Polymer Patient Examination Glove
Record
| Listed by | PT. Sintong Unigolden Glove, Indonesia |
|---|---|
| FDA product code | LZA |
| Device type | Polymer Patient Examination Glove |
| Device class | Class 1 |
| Regulation | 21 CFR 880.6250 |
| Establishment | Contract manufacturer, Manufacturer |
| 510(k) | K223235 |
| Record published | 2024-02-26 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Packaging | Box of 10 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| X – Large | 100 | In distribution | |
| Large | 100 | In distribution | |
| XX – Large | 100 | In distribution | |
| Small | 100 | In distribution | |
| X – Small | 100 | In distribution | |
| Medium | 100 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Medline | Medline Industries, Inc. | 255 |
| Microflex | Ansell Healthcare Product | 185 |
| FifthPulse | Jeg & Sons Inc. | 135 |
| SW | SW Safety Solutions Inc. | 130 |
| Halyard | O&M Halyard, Inc. | 120 |
| Basic | Intco Medical Industries, Inc. | 119 |
| Cranberry | Ascend Eagle, Inc. | 109 |
| 1st Choice | Ammex Corporation | 101 |
| JMU | JMU Dental, Inc | 90 |
| Vivit Supply | Vivit Supply LLC | 86 |
| McKesson | Mckesson Medical-Surgical Inc. | 75 |
| Natural Extensions | Benco Dental Supply Co. | 74 |
Showing 12 of 930. All products under Polymer Patient Examination Glove
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K223235 | 2022-10-26 |
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.