Sion Biotext Medical Ltd.

The Lubricating Jelly is sterile, clear, colorless, non-sticky, non-greasy, non-staining, non-irritating lubricant. It is water soluble, high viscosity gel-like liquid for use as a…

Registry build 21.09.26

The Lubricating Jelly is sterile, clear, colorless, non-sticky, non-greasy, non-staining, non-irritating lubricant. It is water soluble, high viscosity gel-like liquid for use as a lubricating media for insertion of medical instruments during medical procedures. It is easily rinsed off with water. The Lubricating Jelly is designed for medical purposes to lubricate body orifices, assisting in the insertion of devices for diagnostic and therapeutic purposes. It is a water-soluble jelly that spreads easily to form a translucent film and is easily washed away. Typical uses of the lubricating jelly include (but not limited) insertion of catheters, endoscopes surgical instruments, gynecological, rectal, oral and rubber or plastic etc. The product is packaged in a convenient plastic dispenser, laminate tube with a flip top cap, in an aluminum foil/plastic laminate sachet or syringe. The lubricant is sterilized using gamma radiation.

33manufacturers in China registered for this device type
3catalogue numbers in this listing
1510(k) clearance

Who Else Makes It

Concentrated in Jiangsu (11), Guangdong (7), Zhejiang (6). 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code KMJ
Manufacturer City Province Registered as Device types
Yangzhou Fartley Medical Instrument Technology Co., Ltd. Yangzhou Jiangsu Contract manufacturer 24
Primecare Medical (Huzhou) Co., Ltd. Hu Zhou Zhejiang Contract manufacturer 9
Nantong Health & Beyond Hygienic Products Inc. Rugao Jiangsu Contract manufacturer 2
Boen Healthcare Co., Ltd. Suzhou Jiangsu Specification developer 263
Jiangsu NEW Pentastar Medical Products Co., Ltd. Changzhou Jiangsu Exporter 146
Shanghai JPY ION-Tech Co., Ltd. Shanghai Shanghai Contract manufacturer 70
Conod Medical Co., Limited Changshu Jiangsu Contract manufacturer 48
Yiwu Ori-Power Medtech Co., Ltd. Yiwu Zhejiang Contract manufacturer 46
Hangzhou Fushan Medical Appliance Co., Ltd. Hangzhou Zhejiang Contract manufacturer 44
Xiamen Firstcare IMP. & EXP. Co., Ltd. Xiamen Fujian Exporter 40
Emsrun Group Wuxi Jiangsu Specification developer 34
Hangzhou Primecare Medical Co., Ltd. Hangzhou Zhejiang Contract manufacturer 29

Showing 12 of 33. All 33 manufacturers in China registered for Lubricant, Patient

Record

Regulatory record for Sion Biotext Medical Ltd.
Listed by Sion Biotext Medical Ltd, Israel
FDA product code KMJ
Device type Lubricant, Patient
Device class Class 1
Regulation 21 CFR 880.6375
Establishment Contract manufacturer, Contract steriliser, Specification developer, Manufacturer
Record published 2023-09-19
Record revised 2025-04-03 (version 2)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Sterilisation Radiation Sterilization
Supplied sterile Yes
Single use Yes
Label carries lot or batch number, expiry date, manufacturing date, serial number

Catalogue Numbers

Catalogue numbers for Sion Biotext Medical Ltd.
Catalogue number Size Per pack Status
1 144 In distribution
1 144 In distribution
1 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Surgilube HR Pharmaceuticals Inc. 8
HR Lubricating Jelly HR Pharmaceuticals Inc. 8
EndoGlide+™ Jianerkang Medical Co., Ltd. 8
HCS Dyad Medical Sourcing, LLC 7
Cardinal Health Cardinal Health 200, LLC 6
Curaplex Bound Tree Medical, LLC 6
Aquagel Parker Laboratories, Inc. 5
Dukal Dukal LLC 5
Regard™ Resource Optimization & Innovation, L.L.C. 5
EZ Lubricating HR Pharmaceuticals Inc. 4
PremierPro Prestige Ameritech 4
Medline Medline Industries, Inc. 4

Showing 12 of 53. All products under Lubricant, Patient

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance Decision date
K142473 2015-04-13

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