3m™ Vflex™
3M Vflex models 1804 and 1804S combine an N95 particulate respirator with a fluid-resistant surgical mask for operating room personnel. The flat-folded white respirator is available in…
3M Vflex models 1804 and 1804S combine an N95 particulate respirator with a fluid-resistant surgical mask for operating room personnel. The flat-folded white respirator is available in standard and small sizes.
Inner, filter and outer layers use polypropylene. An aluminum nose clip follows facial contours, while two polyisoprene elastic headbands secure the respirator. The materials are not made with natural rubber latex.
Listed Item
3M™ VFlex™ Health Care Particulate Respirator and Surgical Mask 1804S, N95 Small
Filtration and Fluid Resistance
The respirator has at least 95% filtration efficiency against non-oil particulate aerosols. As a surgical mask, it is designed to resist blood and body-fluid splash and spatter and meets the 80 mmHg fluid-resistance challenge described for these models.
Who Else Makes It
Concentrated in Jiangsu (27), Guangdong (22), Zhejiang (21). 12 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shanghai Joy Crown Industry Co., Ltd. | Pu Dong New Area | Shanghai | Contract manufacturer | 64 |
| Beijing Zksk Technology Co., Ltd. | Beijing | Beijing | Contract manufacturer | 38 |
| Shanghai Care Us Medical Product Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 30 |
| Anji Hengfeng Sanitary Material Co., Ltd. | Anji | Zhejiang | Contract manufacturer | 20 |
| Wellpower Sporting Goods Co., Ltd. | Dong Guan | Guangdong | Contract manufacturer | 18 |
| Henan Huibo Medical Co., Ltd. | Nanyang | Henan | Contract manufacturer | 17 |
| Tylenol Medical Instruments Co., Ltd. | Zhongshan | Guangdong | Contract manufacturer | 15 |
| Vistar Medical Supplies Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 11 |
| AAB (China) Co., Ltd. | Nanan | Fujian | Contract manufacturer | 9 |
| Jiangsu Hongxin Medical Technology Co., Ltd. | Shuyang | Jiangsu | Contract manufacturer | 7 |
| AOK Tooling Limited | Shen Zhen | Guangdong | Contract manufacturer | 6 |
| Coomex Sources Co., Ltd. | Qingdao | Shandong | Contract manufacturer | 6 |
Showing 12 of 118. All 118 manufacturers in China registered for Respirator, Surgical
Record
| Listed by | 3M Company, United States |
|---|---|
| FDA product code | MSH |
| Device type | Respirator, Surgical |
| Device class | Class 2 |
| Regulation | 21 CFR 878.4040 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| 510(k) | K171116 |
| Record published | 2018-02-21 |
| Record revised | 2024-01-25 (version 7) |
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 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 1804 | 50 | In distribution | |
| 1804S | 50 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Defend | Young Mydent, LLC | 43 |
| Halyard | O&M Halyard, Inc. | 17 |
| GPS | Group Practice Solutions | 10 |
| Moldex | Moldex/Metric, Inc. | 10 |
| Medline | Medline Industries, Inc. | 7 |
| Makrite Industries Inc. | Makrite Hubei Industrial Co., Ltd. | 7 |
| Perfetta Face Mask | PHU BAO Medical Co., Ltd. | 6 |
| Cardinal Health | Cardinal Health 200, LLC | 6 |
| Perfetta Ultra Face Mask | PHU BAO Medical Co., Ltd. | 4 |
| Medicom Safemask | AMD Medicom Inc. | 4 |
| 3M™ Aura™ | 3M Company | 4 |
| WeCare | Jeg & Sons Inc. | 4 |
Showing 12 of 88. All products under Respirator, Surgical
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K171116 | 2017-08-10 |
| K121069 | 2013-02-11 |
| K063023 | 2007-02-23 |
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.