Who else makes this device?

Name: Face Mask earloop
Brand: Face Mask earloop

General & Plastic Surgery › SurgicalMask, Surgical

Face Mask Earloop

Catalogue number NM-MA-010, listed by Shanghai NEO-Medical Import & Export Co., Ltd., China, under Mask, Surgical. 125 manufacturers in China are registered for this product code.

Registry build 21.09.26

125manufacturers in China registered for this device type

1catalogue number

1510(k) clearance

Who Else Makes It

Concentrated in Hubei (38), Jiangsu (22), Zhejiang (13). 27 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code FXX
Manufacturer	City	Province	Registered as	Device types
Principle & Will Biotech (Pinghu) Co., Ltd.	Pinghu	Zhejiang	Contract manufacturer	39
Dongguan Shin YI Healthcare Products Factory	Dong Guan	Guangdong	Contract manufacturer	30
H&K International Trade Limited (China)	Jinhua	Zhejiang	Contract manufacturer	29
Anhui Ares Medical Technology Co., Ltd.	Tianchang	Anhui	Contract manufacturer	28
JM Medical Co., Ltd.	Liaocheng	Shandong	Contract manufacturer	25
Wellpower Sporting Goods Co., Ltd.	Dong Guan	Guangdong	Contract manufacturer	18
Guangzhou Fuzelong Hygiene Material Co., Ltd.	Guangzhou	Guangdong	Contract manufacturer	17
Changzhou DSB Medical Co., Ltd.	Changzhou	Jiangsu	Contract manufacturer	16
Lianyungang Bronson Non-woven Products Co., Ltd.	Lianyungang	Jiangsu	Contract manufacturer	16
Zhende Medical Co., Ltd.	Shaoxing	Zhejiang	Contract manufacturer	14
Foshan Nanhai Plus Medical Co Ltd	Foshan	Guangdong	Contract manufacturer	12
Hubei Weikang Protective Products Co., Ltd.	Xiantao	Hubei	Contract manufacturer	12

Showing 12 of 125. All 125 manufacturers in China registered for Mask, Surgical

Record

Regulatory record for Face Mask earloop
Listed by	Shanghai NEO-Medical Import & Export Co., Ltd., China
FDA product code	FXX
Device type	Mask, Surgical
Device class	Class 2
Regulation	21 CFR 878.4040
Establishment	Exporter
Record published	2020-06-24

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Single use	Yes
Over the counter	Yes
Label carries	lot or batch number, expiry date, manufacturing date

Catalogue Numbers

Catalogue numbers for Face Mask earloop
Catalogue number	Size	Per pack	Status
NM-MA-010		50	In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Primed	Primed Medical Products Inc.	119
Halyard	O&M Halyard, Inc.	103
Precept®	Precept Medical Products, Inc.	77
Henry Schein	Henry Schein, Inc.	77
Medline	Medline Industries, Inc.	66
Convertors	Cardinal Health 200, LLC	51
ProGear	Prestige Ameritech	41
Vivit Supply	Vivit Supply LLC	38
Critical Cover	Alpha Pro Tech, Inc.	35
JMU	JMU Dental, Inc	34
Darby Dental Supply, LLC	Darby Dental Supply, LLC	31
AOK	AOK Tooling Limited	31

Showing 12 of 415. All products under Mask, Surgical

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K111559	2011-09-16

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.