Ambitex
Ambitex GLV Exam NON-Sterile Nitrile N720BLK Black Powder-Free Extra Extra Large Full Textured Standard Length 10/100
83manufacturers in China registered for this device type
28catalogue numbers in this listing
5recalls on this code
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 | Cardinal Health 200, LLC, United States |
|---|---|
| FDA product code | LZA |
| Device type | Polymer Patient Examination Glove |
| Device class | Class 1 |
| Regulation | 21 CFR 880.6250 |
| Establishment | Contract manufacturer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| 510(k) | K141279 |
| Record published | 2019-04-05 |
| Record revised | 2020-09-03 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Over the counter | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date |
| Packaging | Case of 10, case of 4 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| NMD720BLK | 100 | In distribution | |
| NXS400 | 100 | In distribution | |
| NXXL720BLK | 100 | In distribution | |
| NXL400W | 100 | In distribution | |
| NSM720BLK | 100 | In distribution | |
| 32370-4 | 50 | In distribution | |
| NMD400 | 100 | In distribution | |
| NXL200BLK | 100 | In distribution | |
| NMD200 | 100 | In distribution | |
| NMD200BLK | 100 | In distribution | |
| NXS402 | 200 | In distribution | |
| NXL200 | 100 | In distribution | |
| NLG200 | 100 | In distribution | |
| NLG200BLK | 100 | In distribution | |
| NXS200BLK | 100 | In distribution | |
| NMD400W | 100 | In distribution | |
| NXXL200BLK | 90 | In distribution | |
| NXL720BLK | 100 | In distribution | |
| NXL402 | 200 | In distribution | |
| NXL400 | 100 | In distribution | |
| NSM400 | 100 | In distribution | |
| NSM200 | 100 | In distribution | |
| NXS200 | 100 | In distribution | |
| NLG720BLK | 100 | In distribution | |
| NSM200BLK | 100 | In distribution | |
| NLG400W | 100 | In distribution | |
| NLG400 | 100 | In distribution | |
| NSM400W | 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
Recalls
5 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 |
|---|---|---|---|---|---|
| 2019-03-22 | Class II | Nonconforming Material/Component | Kit label states not made with natural rubber latex,however safety goggles within the kits contain natural rubber latex in the goggle strap | 3236 | 2021-08-06 |
| 2019-03-22 | Class II | Nonconforming Material/Component | Kit label states not made with natural rubber latex,however safety goggles within the kits contain natural rubber latex in the goggle strap | 5415 | 2021-08-06 |
| 2019-03-22 | Class II | Nonconforming Material/Component | Kit label states not made with natural rubber latex,however safety goggles within the kits contain natural rubber latex in the goggle strap | 11588 | 2021-08-06 |
| 2019-03-22 | Class II | Nonconforming Material/Component | Kit label states not made with natural rubber latex,however safety goggles within the kits contain natural rubber latex in the goggle strap | 21082 | 2021-08-06 |
| 2015-08-25 | Class II | Nonconforming Material/Component | Ambitex Nitrile NMD400 Exam Gloves size medium on exam hold were inadvertently placed into commerce. The product was under Exam Hold because samples pulled from a shipment manufactured by the firm failed the water leak test performed by FDA | 34 cases. | 2016-08-01 |
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.