Medical Nitrile Examination Gloves (Power Free, Blue)
These blue powder free nitrile examination gloves are worn on the examiner’s hands to help prevent contamination between patient and examiner. They are disposable medical gloves supplied…
These blue powder free nitrile examination gloves are worn on the examiner’s hands to help prevent contamination between patient and examiner. They are disposable medical gloves supplied nonsterile for single use.
The nitrile gloves are offered in sizes from extra small to double extra large, with an additional intermediate width option. The specified minimum material thickness is 0.05 mm at the fingers, palm and cuff.
Listed Item
textured surface, powder free
Size Specifications
The smallest two sizes have a minimum length of 220 mm, while the remaining sizes have a minimum length of 230 mm. Palm width varies by size to provide fit options. The family is specified to meet ASTM D6319 requirements for medical nitrile examination gloves.
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 | Jiangxi Hongda Medical Equipment Group Ltd., China |
|---|---|
| FDA product code | LZA |
| Device type | Polymer Patient Examination Glove |
| Device class | Class 1 |
| Regulation | 21 CFR 880.6250 |
| Establishment | Manufacturer |
| 510(k) | K210578 |
| Record published | 2021-08-31 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Packaging | Pack of 10, pack of 20 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| S | 100 | In distribution | |
| L | 100 | In distribution | |
| XL | 100 | In distribution | |
| M | 100 | In distribution | |
| XL | 100 | In distribution | |
| M | 100 | In distribution | |
| S | 100 | In distribution | |
| XS | 100 | In distribution | |
| L | 100 | In distribution | |
| XS | 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 |
|---|---|
| K210578 | 2021-07-10 |
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.