Henry Schein
CRITERION LATEX EXTRA GRIP (USA) - XS-Oon
12manufacturers in China registered for this device type
36catalogue numbers in this listing
2recalls on this code
Who Else Makes It
Concentrated in Shandong (6), Guangdong (2), Shanghai (2). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Zhangjiagang Dayu Rubber Products Co., Ltd. | Zhangjiagang | Jiangsu | Contract manufacturer | 4 |
| Guangzhou Noval Medical Co., Ltd. | Guangzhou | Guangdong | Manufacturer | 9 |
| Shandong Intco Medical Products Co Ltd | Qingzhou | Shandong | Contract manufacturer | 6 |
| Alcatron Gloves Factory | Weifang | Shandong | Specification developer | 6 |
| Shanghai Motex Healthcare Co., Ltd. | Shanghai | Shanghai | Manufacturer | 4 |
| True Glove Factory | Weifang | Shandong | Specification developer | 4 |
| Motex Healthcare (Anhui) Co., Ltd. | Guangde City, Xuancheng | Anhui | Manufacturer | 4 |
| Novapro Co., Ltd. | Zibo | Shandong | Specification developer | 3 |
| Shandong Huayue Glove Co., Ltd. | Zibo | Shandong | Manufacturer | 3 |
| Huizhou Anboson Technology Co., Ltd. | Huizhou | Guangdong | Manufacturer | 3 |
| Shanghai Jinxiang Latex Products Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 3 |
| Zibo Blue Sail Health Technology Co., Ltd. | Zibo | Shandong | Specification developer | 3 |
Record
| Listed by | Henry Schein, Inc., United States |
|---|---|
| FDA product code | LYY |
| Device type | Latex Patient Examination Glove |
| Device class | Class 1 |
| Regulation | 21 CFR 880.6250 |
| 510(k) | K981917 |
| Record published | 2020-02-26 |
| Record revised | 2020-06-19 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Supplied as a kit | Yes |
| Latex | Contains natural rubber latex |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Storage | Special storage condition: FALSE |
| Packaging | Pack of 10, pack of 20 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 1139828 | 100 | In distribution | |
| 5703415 | 100 | In distribution | |
| 1131624 | 100 | In distribution | |
| 1132564 | 100 | In distribution | |
| 1087850 | 100 | In distribution | |
| 5703450 | 100 | In distribution | |
| 5703413 | 100 | In distribution | |
| 5703452 | 90 | In distribution | |
| 5703527 | 100 | In distribution | |
| 1132564 | 100 | In distribution | |
| 1135413 | 100 | In distribution | |
| 1087856 | 90 | In distribution | |
| 1088553 | 100 | In distribution | |
| 1032124 | 100 | In distribution | |
| 1032167 | 100 | In distribution | |
| 5703530 | 100 | In distribution | |
| 1134301 | 100 | In distribution | |
| 5703529 | 100 | In distribution | |
| 5703528 | 100 | In distribution | |
| 1131624 | 100 | In distribution | |
| 5703414 | 100 | In distribution | |
| 5703448 | 100 | In distribution | |
| 1134301 | 100 | In distribution | |
| 5703531 | 100 | In distribution | |
| 1032138 | 100 | In distribution | |
| 1087848 | 100 | In distribution | |
| 5703416 | 100 | In distribution | |
| 1087855 | 100 | In distribution | |
| 5703451 | 100 | In distribution | |
| 1131618 | 100 | In distribution | |
| 1135413 | 100 | In distribution | |
| 5703449 | 100 | In distribution | |
| 1131618 | 100 | In distribution | |
| 5703412 | 100 | In distribution | |
| 1139828 | 100 | In distribution | |
| 1032108 | 100 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Microflex | Ansell Healthcare Product | 56 |
| BioSkin | Liberty Glove & Safety, LLC | 30 |
| McKesson | Mckesson Medical-Surgical Inc. | 28 |
| Hopkins Medical Products® | Hopkins Uniform Company | 26 |
| Blossom | Mexpo International, Inc. | 25 |
| Cranberry | Ascend Eagle, Inc. | 24 |
| Darby Dental Supply, LLC | Darby Dental Supply, LLC | 23 |
| Tronex International, Inc. | Tronex International, Inc. | 20 |
| Ammex Professional | Ammex Corporation | 20 |
| AmbiCanner | Summit Glove, Inc. | 20 |
| Micro-Touch | Ansell Healthcare Product | 17 |
| The Orthodontic Store | Young Innovations Inc. | 16 |
Showing 12 of 316. All products under Latex Patient Examination Glove
Recalls
The FDA has not published a severity grade for these. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2003-06-27 | Not classified | Other | FDA’s analysis revealed defects (holes) in the latex gloves. | 40 boxes (100 gloves per box) | 2003-11-25 |
| 2003-06-27 | Not classified | Other | FDA’s analysis revealed defects (holes) in the latex gloves. | 56 boxes (100 gloves per box) | 2003-11-25 |
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.