Moldex
10 catalogue numbers from 2210GN95-XS, listed by Moldex/Metric, Inc., United States, under Respirator, Surgical. 118 manufacturers in China are registered for this product code.
118manufacturers in China registered for this device type
10catalogue numbers in this listing
2510(k) clearances naming this product code
2recalls on this code
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 | Moldex/Metric, Inc., United States |
|---|---|
| FDA product code | MSH |
| Device type | Respirator, Surgical |
| Device class | Class 2 |
| Regulation | 21 CFR 878.4040 |
| Establishment | Manufacturer |
| 510(k) | K062663 |
| Record published | 2016-09-16 |
| Record revised | 2023-09-13 (version 7) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Packaging | Pack of 8, pack of 12, pack of 10 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 2210GN95-XS | Extra Small | 20 | In distribution |
| 2211GN95-S | Small | 20 | In distribution |
| 1512 N95 | Medium | 20 | In distribution |
| 1510 N95 | Extra-Small | 20 | In distribution |
| 1511 N95 | Small | 20 | In distribution |
| 1712 N95 | Low Profile | 20 | In distribution |
| 1517 N95 | Low Profile | 20 | In distribution |
| 2217GN95-LP | Low Profile | 20 | In distribution |
| 1513 N95 | Large | 20 | In distribution |
| 2212GN95-M/L | Medium/Large | 20 | 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 |
| 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 |
| Dukal | Dukal LLC | 3 |
Showing 12 of 88. All products under Respirator, Surgical
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K102173 | 2010-09-13 |
| K062663 | 2006-10-11 |
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 |
|---|---|---|---|---|---|
| 2008-07-23 | Not classified | Packaging process control | Display boxes labeled as FRN95-MLEZ, Medium/Large Size Respirators were inadvertently mixed with Display Boxes labeled for FRN95-SEZ Small Size Respirators. | 80 cases | 2009-07-17 |
| 2006-02-20 | Not classified | Other | Mislabeling-A customer reported mislabeled product display boxes. Review of complaint samples and inventory confirmed that some product display boxes are labeled with incorrect model/size number | 40 cases ( 6, 400 respirators ) | 2007-01-29 |
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.