What is FDA product code PXC?

This product code has been established in accordance with the May 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.

General Hospital › MiscellaneousPersonal Protection Kit

Afflink

Name: Afflink
Brand: Afflink

Wounded Warrior PPE Kit- Extra Large; Each Kit Includes Extra Large Nitrile Exam Glove (2), 2 oz Scented Hand Sanitizer, Large Alcohol Prep Pad (4), and 3 Ply Mask.

Registry build 21.09.26

8manufacturers in China registered for this device type

4catalogue numbers in this listing

Who Else Makes It

Concentrated in Guangdong (2), Jiangsu (1), Shandong (1).

Chinese manufacturers registered for FDA product code PXC
Manufacturer	City	Province	Registered as	Device types
Jiangsu NEW Pentastar Medical Products Co., Ltd.	Changzhou	Jiangsu	Exporter	146
Hynaut Health Technology Co., Ltd.	Qingdao	Shandong	Contract manufacturer	68
Hubei Qianjiang Kingphar Medical Material Co., Ltd.	Qianjiang	Hubei	Contract manufacturer	52
Shaoxing Songqiao Textile Co., Ltd.	Shaoxing	Zhejiang	Manufacturer	26
Minlong Pharmaceutical Biotechnology (Shenzhen) Co., Ltd.	Shenzhen	Guangdong	Repacker / relabeller	21
Ming FAI Enterprise International Co., Ltd.	Kowloon	Hong Kong	Exporter	18
Dongguan Luda Industrial Co., Ltd.	Dongguan	Guangdong	Manufacturer	8
Hefei Juniushangmao Co., Ltd.	Hefei	Anhui	Repacker / relabeller	7

Record

Regulatory record for Afflink
Listed by	Bosma Enterprises
FDA product code	PXC
Device type	Personal Protection Kit
Device class	Class 1
Regulation	21 CFR 880.6250
Premarket notification	Exempt
Record published	2021-07-02
Record revised	2024-03-20 (version 3)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Single use	Yes
Supplied as a kit	Yes
Storage	Special storage condition: Avoid excessive heat. Keep dry.
Packaging	Case of 30
Distribution end date	2024-03-19

Catalogue Numbers

Catalogue numbers for Afflink
Catalogue number	Size	Status
10-90702LG	Large	Withdrawn
10-90702XL	Extra Large	Withdrawn
10-90702S	Small	Withdrawn
10-90702MD	Medium	Withdrawn

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Regard™	ROi CPS LLC	19
MedSource Gloves	Medsource International, LLC	7
Bosma Enterprises	Bosma Enterprises	5
Stradis Healthcare	Stradis Healthcare	4
Stradis Medical, LLC.	Stradis Healthcare	2
NAR	North American Rescue, LLC.	2
McKesson	Mckesson Medical-Surgical Inc.	2
Cardinal Health	Cardinal Health 200, LLC	1
Curaplex	Bound Tree Medical, LLC	1

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.