Puritan®

Puritan® Tipped Proctoscopic Applicators

Registry build 21.09.26
186manufacturers in China registered for this device type
36catalogue numbers in this listing

Who Else Makes It

Concentrated in Zhejiang (40), Jiangsu (35), Guangdong (32). 24 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code KXF
Manufacturer City Province Registered as Device types
Hangzhou Rollmed Co., Ltd. Hangzhou Zhejiang Contract manufacturer 127
Shanghai Joy Crown Industry Co., Ltd. Pu Dong New Area Shanghai Contract manufacturer 64
Shenzhen Denco Medical Co., Ltd. Shenzhen Guangdong Contract manufacturer 52
Allmed Medical Products Co., Ltd. Zhijiang Hubei Contract manufacturer 43
BH Medical Products Co., Ltd. Changzhou Jiangsu Contract manufacturer 37
Taizhou Xinkang Medical Materials Co., Ltd. Taizhou Jiangsu Contract manufacturer 35
Planet (Anhui) Medical Products Co., Ltd. Chuzhou Anhui Contract manufacturer 30
Weihai Kangzheng Medical Equipments Technology Co., Ltd. Weihai Shandong Contract manufacturer 26
Yiwu Haoding Medical Co., Ltd. Yiwu Zhejiang Contract manufacturer 23
Goodwood Medical Care Ltd Dalian Liaoning Contract manufacturer 19
Hangzhou Aosi Healthcare Co., Ltd. Hangzhou Zhejiang Contract manufacturer 18
Sino-Vista Dental Instruments Co., Ltd. Zibo Shandong Contract manufacturer 15

Showing 12 of 186. All 186 manufacturers in China registered for Applicator, Absorbent Tipped, Non-Sterile

Record

Regulatory record for Puritan®
Listed by Puritan Medical Products Company LLC, United States
FDA product code KXF
Device type Applicator, Absorbent Tipped, Non-Sterile
Device class Class 1
Regulation 21 CFR 880.6025
Establishment Contract manufacturer, Specification developer, Repacker / relabeller, Manufacturer
Premarket notification Exempt
Record published 2026-07-20

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Single use Yes
Label carries lot or batch number, expiry date, manufacturing date
Distribution end date 2026-07-21

Catalogue Numbers

Catalogue numbers for Puritan®
Catalogue number Size Per pack Status
8060-PC EX BINDER 1,000 In distribution
806-PD 1,000 In distribution
803-WCL 500 In distribution
808 50 In distribution
823-WC 1,000 In distribution
806-WC 100 In distribution
806-PR 1,000 In distribution
876-WC 1,000 In distribution
816 50 In distribution
833-WCS 5,000 In distribution
808 BULK 500 In distribution
826-WC 100 In distribution
803-PC 1,000 In distribution
806-PD 5-1 GB 1,000 In distribution
868-WCS 100 In distribution
816 BULK 500 In distribution
803-WC 100 In distribution
861-WC DBL 500 In distribution
806-PC SOLID S 1,000 In distribution
808 REVLON 500 In distribution
808-PR EX BINDER 50 In distribution
808 100 100 In distribution
806-WCXL 500 In distribution
821-WC 100 In distribution
869-WCS 100 In distribution
804-PC UNBRK 1,000 In distribution
806-PD SC 2 5/8 1,000 In distribution
808 COTTON 50 In distribution
806-PPR 1,000 In distribution
8060-WC EX BINDER 1,000 In distribution
806-WCL 500 In distribution
838-WCS 1,000 In distribution
806-PC 1,000 In distribution
821-WC DBL 500 In distribution
8030-PC EX BINDER 1,000 In distribution
806-PC 145MM 1,000 Withdrawn

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
JMU JMU Dental, Inc 22
Helmut Zepf Helmut Zepf Medizintechnik Gmbh 21
SmartPractice Smarthealth, Inc. 21
Cardinal Health Cardinal Health 200, LLC 16
Avanos Avanos Medical, Inc. 16
Q-Care Sage Products LLC 13
Ballard™ SunMed Group Holdings, LLC 13
Medicon Medicon eG. Chirurgiemechaniker-Genossenschaft 10
Alleset GRI Medical & Electronic Technology Co., Ltd. 10
Puritan® PurFlock Ultra® Puritan Medical Products Company LLC 9
Plasdent Plasdent Corp. 9
AMD-Ritmed Solon AMD Medicom Inc. 9

Showing 12 of 98. All products under Applicator, Absorbent Tipped, Non-Sterile

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.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer