What is FDA product code MSH?

A surgical N95 respirator or N95 filtering facepiece respirator is not exempt if it is intended to prevent specific diseases or infections, or it is labeled or otherwise represented as filtering surgical smoke or plumes, filtering specific amounts of viruses or bacteria, reducing the amount of and/or killing viruses, bacteria, or fungi, or affecting allergenicity, or it contains coating technologies unrelated to filtration (e.g., to reduce and or kill microorganisms). Surgical N95 respirators and N95 filtering facepiece respirators are exempt from the premarket notification procedures subject to 21 CFR 878.9 and the conditions for exemption identified in 21 CFR 878.4040(b)(1).

General & Plastic Surgery › SurgicalRespirator, Surgical

Medava

Name: Medava
Brand: Medava

Medava N95 Fold Style Respirator. Disposable Surgical N95 Respirator. Manufactured by Louis M. Gerson Co., Inc. for Medava.

Registry build 21.09.26

118manufacturers in China registered for this device type

1catalogue number

3510(k) clearances naming this product 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.

Chinese manufacturers registered for FDA product code MSH
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

Regulatory record for Medava
Listed by	Louis M. Gerson Co., Inc., United States
FDA product code	MSH
Device type	Respirator, Surgical
Device class	Class 2
Regulation	21 CFR 878.4040
Establishment	Manufacturer
Premarket notification	Exempt
Record published	2025-04-14

Specifications

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
Packaging	Case of 4
UDI direct marking	Exempt

Catalogue Numbers

Catalogue numbers for Medava
Catalogue number	Size	Per pack	Status
USAMN95F50		50	In distribution

Same Product Code

Other products under the same FDA 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

FDA 510(k) clearances naming this product code
Clearance	Decision date
K061375	2006-11-17
K050193	2005-04-11
K960778	1996-05-09

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.