What is FDA product code NZJ?

It is intended to cover the nose and mouth of the wearer to help reduce wearer exposure to pathogenic biological airborne particulates during public health medical emergencies, such as influenza pandemic and also protects the wearer from splash and spray of body fluids.

General Hospital › MiscellaneousRespirator, N95, For Use By The General Public In Public Health Medical Emergencies

Pasture F550G Respirator

Name: Pasture F550G Respirator
Brand: Pasture F550G Respirator

This device is a disposable filtering facepiece respirators intended for use by the general public in public health medical emergencies.

Registry build 21.09.26

4manufacturers in China registered for this device type

2catalogue numbers in this listing

1510(k) clearance

Who Else Makes It

Concentrated in Zhejiang (2), Hubei (1), Guangdong (1).

Chinese manufacturers registered for FDA product code NZJ
Manufacturer	City	Province	Registered as	Device types
Xiantao Zhongyi Safety & Protection Products Co., Ltd.	Xiantao	Hubei	Manufacturer	10
Wenzhou Sanshan Optics Co., Ltd.	Wenzhou	Zhejiang	Manufacturer	8
Chengde Technology Co., Ltd.	Longgang	Zhejiang	Manufacturer	5
Shenzhen Mondial Technology Co., Ltd.	Shenzhen	Guangdong	Contract manufacturer	5

Record

Regulatory record for Pasture F550G Respirator
Listed by	Pasture Pharma PTE Ltd, Singapore
FDA product code	NZJ
Device type	Respirator, N95, For Use By The General Public In Public Health Medical Emergencies
Device class	Class 2
Regulation	21 CFR 880.6260
Establishment	Contract manufacturer, Manufacturer, Exporter
510(k)	K083176
Record published	2018-01-03
Record revised	2023-09-13 (version 5)

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
Storage	Handling environment temperature 5 to 50 °C; Handling environment humidity up to 50 % RH

Catalogue Numbers

Catalogue numbers for Pasture F550G Respirator
Catalogue number	Size	Per pack	Status
F550G		3	In distribution
F550G		20	In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Curaplex	Bound Tree Medical, LLC	3
Pasture A520G Respirator	Pasture Pharma PTE Ltd	1

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K083176	2009-01-23

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.