Novaplus
Novaplus; Over the Head Isolation Gown with Thumbhooks and Elastic Wrists; Yellow; Universal Size
318manufacturers in China registered for this device type
11catalogue numbers in this listing
14recalls on this code
Who Else Makes It
Concentrated in Hubei (71), Jiangsu (59), Zhejiang (42). 83 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Hangzhou Rollmed Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 127 |
| Zogear Medical Co., Ltd. | Yizheng | Jiangsu | Contract manufacturer | 75 |
| GRI Medical & Electronic Technology Co., Ltd. | Jiaxing | Zhejiang | Contract manufacturer | 71 |
| Shanghai Joy Crown Industry Co., Ltd. | Pu Dong New Area | Shanghai | Contract manufacturer | 64 |
| Anqing Kangmingna Packaging Co., Ltd. | Anqing | Anhui | Contract manufacturer | 39 |
| BH Medical Products Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 37 |
| Taizhou Xinkang Medical Materials Co., Ltd. | Taizhou | Jiangsu | Contract manufacturer | 35 |
| Jiangsu Guangda Medical Material Group Co., Ltd. | Haian | Jiangsu | Contract manufacturer | 32 |
| Evereast Medical Products Group Co., Ltd. | Changyuan | Henan | Contract manufacturer | 30 |
| Ningbo Luke Medical Devices Co., Ltd. | Yuyao | Zhejiang | Contract manufacturer | 27 |
| Zhongshan Chukuang Textile Co., Ltd. | Zhongshan | Guangdong | Contract manufacturer | 26 |
| Jingmen Huasheng Asia Dynamics Sanitary Products Co., Ltd. | Jingmen | Hubei | Contract manufacturer | 23 |
Showing 12 of 318. All 318 manufacturers in China registered for Non-Surgical Gown
Record
| Listed by | Cardinal Health 200, LLC, United States |
|---|---|
| FDA product code | OEA |
| Device type | Non-Surgical Gown |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4040 |
| Establishment | Contract manufacturer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2019-01-08 |
| Record revised | 2025-06-06 (version 6) |
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 |
| Packaging | Case of 10, case of 5 |
| Distribution end date | 2025-06-06 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| V2100PG | 10 | In distribution | |
| V1100PG | 10 | In distribution | |
| V2101PG | 10 | In distribution | |
| V5213PG | 15 | Withdrawn | |
| V3111PG | 10 | Withdrawn | |
| VAT4437-XL | 10 | Withdrawn | |
| VAT4437-BD | 10 | Withdrawn | |
| V5210PG | 15 | Withdrawn | |
| VAT4437-XL | 10 | Withdrawn | |
| V3110PG | 10 | Withdrawn | |
| VAT4437-BD | 10 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Cardinal Health | Cardinal Health 200, LLC | 230 |
| Henry Schein | Henry Schein, Inc. | 144 |
| Darby Dental Supply, LLC | Darby Dental Supply, LLC | 118 |
| Medline | Medline Industries, Inc. | 99 |
| Precaution/Isolation Gown | Standard Textile Co., Inc. | 83 |
| PremierPro | Prestige Ameritech | 74 |
| Alleset | GRI Medical & Electronic Technology Co., Ltd. | 71 |
| Medicom Safewear | AMD Medicom Inc. | 70 |
| Maytex | Maytex Corp. | 67 |
| Precept® | Precept Medical Products, Inc. | 61 |
| 3D Dental-Essentials | 3D Dental Designs AND Development, LLC | 56 |
| Halyard | O&M Halyard, Inc. | 53 |
Showing 12 of 230. All products under Non-Surgical Gown
Recalls
14 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 |
|---|---|---|---|---|---|
| 2021-01-07 | Class II | Process change control | There is a potential for rips, holes, tears, incomplete and/or open seams, staining, foreign material or debris on the gowns and lab coats. | 29,810,665 total | |
| 2021-01-07 | Class II | Process change control | There is a potential for rips, holes, tears, incomplete and/or open seams, staining, foreign material or debris on the gowns and lab coats. | 29,810,665 total | |
| 2021-01-07 | Class II | Process change control | There is a potential for rips, holes, tears, incomplete and/or open seams, staining, foreign material or debris on the gowns and lab coats. | 29,810,665 total | |
| 2021-01-07 | Class II | Process change control | There is a potential for rips, holes, tears, incomplete and/or open seams, staining, foreign material or debris on the gowns and lab coats. | 29,810,665 total | |
| 2021-01-07 | Class II | Process change control | There is a potential for rips, holes, tears, incomplete and/or open seams, staining, foreign material or debris on the gowns and lab coats. | 29,810,665 total | |
| 2021-01-07 | Class II | Process change control | There is a potential for rips, holes, tears, incomplete and/or open seams, staining, foreign material or debris on the gowns and lab coats. | 29,810,665 total | |
| 2021-01-07 | Class II | Process change control | There is a potential for rips, holes, tears, incomplete and/or open seams, staining, foreign material or debris on the gowns and lab coats. | 29,810,665 total | |
| 2021-01-07 | Class II | Process change control | There is a potential for rips, holes, tears, incomplete and/or open seams, staining, foreign material or debris on the gowns and lab coats. | 29,810,665 total | |
| 2021-01-07 | Class II | Process change control | There is a potential for rips, holes, tears, incomplete and/or open seams, staining, foreign material or debris on the gowns and lab coats. | 29,810,665 total | |
| 2021-01-07 | Class II | Process change control | There is a potential for rips, holes, tears, incomplete and/or open seams, staining, foreign material or debris on the gowns and lab coats. | 29,810,665 total | |
| 2021-01-07 | Class II | Process change control | There is a potential for rips, holes, tears, incomplete and/or open seams, staining, foreign material or debris on the gowns and lab coats. | 29,810,665 total | |
| 2021-01-07 | Class II | Process change control | There is a potential for rips, holes, tears, incomplete and/or open seams, staining, foreign material or debris on the gowns and lab coats. | 29,810,665 total | |
| 2021-01-07 | Class II | Process change control | There is a potential for rips, holes, tears, incomplete and/or open seams, staining, foreign material or debris on the gowns and lab coats. | 29,810,665 total | |
| 2016-07-20 | Class II | Process control | Blue Impervious Gown with thumbhooks, X-large. All lots do not meet design specifications, specifically 16 CFR 1611 – Standard for the Flammability of Vinyl Plastic Film. The standard defines a specific test method that quantifies the rate | 4,062,511 eaches | 2018-03-02 |
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.