SOL-Guard™ Insulin Safety Syringe With Fixed Needle

The SOL-GUARD™ Safety Syringe is intended for the delivery of U-100 insulin. The SOL-GUARD™ Safety Sleeve covers the needle when activated. In the activated position, the Safety Shield…

Registry build 21.09.26

The SOL-GUARD™ Safety Syringe is intended for the delivery of U-100 insulin. The SOL-GUARD™ Safety Sleeve covers the needle when activated. In the activated position, the Safety Shield guards against accidental needle stick. 1.0 ml Insulin Syringe with 31g x 5/16″ needle

39manufacturers in China registered for this device type
7catalogue numbers in this listing
2510(k) clearances naming this product code

Who Else Makes It

Concentrated in Jiangsu (10), Zhejiang (10), Shanghai (7). 6 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code MEG
Manufacturer City Province Registered as Device types
Ningbo Risenmed Technology Co., Ltd. Ningbo Zhejiang Contract manufacturer 42
Jiangsu Caina Medical Co., Ltd. Jiangyin Jiangsu Contract manufacturer 20
Yangzhou Medline Industry Co., Ltd. Yangzhou Jiangsu Contract manufacturer 11
Wenzhou Baiyu Glasses Technology Co., Ltd. Wenzhou Zhejiang Contract manufacturer 10
Anhui Tiankang Medical Technology Co., Ltd. Tianchang Anhui Contract manufacturer 9
Zhejiang INI Medical Devices Co., Ltd. Wenzhou Zhejiang Contract manufacturer 4
Sterigenics Shanghai ETO Ltd. Shanghai Shanghai Contract manufacturer 65
Shanghai Hua En Industrial Co Ltd Shanghai Shanghai Contract manufacturer 52
Jiangsu WLD Medical Co., Ltd. Yizheng Jiangsu Contract manufacturer 50
Zhejiang Huanyi Sterilization Technology Co., Ltd. Huzhou Zhejiang Contract manufacturer 25
Nanjing Anjian Medical Device Co., Ltd. Nanjing Jiangsu Contract manufacturer 22
Wellmien Healthcare Tech.(Suzhou) Co., Ltd. Suzhou Jiangsu Contract manufacturer 22

Showing 12 of 39. All 39 manufacturers in China registered for Syringe, Antistick

Record

Regulatory record for SOL-Guard™ Insulin Safety Syringe with Fixed Needle
Listed by Sol-Millennium Medical, Inc., United States
FDA product code MEG
Device type Syringe, Antistick
Device class Class 2
Regulation 21 CFR 880.5860
Establishment Specification developer, Complaint-file establishment, Manufacturer
Record published 2016-09-16
Record revised 2025-05-02 (version 4)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Supplied sterile Yes
Single use Yes
Prescription Prescription only
Over the counter Yes
Latex Labelled latex-free
Label carries lot or batch number, expiry date
Packaging Case of 8, box of 100
Sizes Needle gauge 1 to 31 G; total volume 0.3 to 1 ml; length 8 to 12.5 mm

Catalogue Numbers

Catalogue numbers for SOL-Guard™ Insulin Safety Syringe with Fixed Needle
Catalogue number Size Status
2531516SG Needle Gauge 31 G In distribution
200091SG Needle Gauge 31 G In distribution
200017SG Needle Gauge 29 G In distribution
2331516SG Total Volume 0.3 ml In distribution
200003SG Length 12.5 mm In distribution
200092SG Total Volume 1 ml In distribution
200002SG Length 12.5 mm In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
SURGUARD2 Terumo (Philippines) Corporation 59
VanishPoint® Retractable Technologies, Inc. 51
EasyTouch MHC Medical Products 50
McKesson Mckesson Medical-Surgical Inc. 47
Wealy® Reli® Myco Medical Supplies, Inc. 39
SOL-Care™ Luer Lock Safety Syringe with Exchangeable Needle Sol-Millennium Medical, Inc. 29
Securegard SafeGard Medical /Hungary/ Gyogyaszati Eszkozgyarto es Forgalmazo Korlatolt Felelossegu Tarsasag 24
Syringe with safety needle Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd. 20
SURGUARD3 Terumo (Philippines) Corporation 20
Reli Myco Medical Supplies, Inc. 17
SOL-Care™ Safety Syringe with Fixed Needle Sol-Millennium Medical, Inc. 17
Syringe with needle Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd. 16

Showing 12 of 106. All products under Syringe, Antistick

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance Decision date
K162030 2016-08-19
K132681 2014-05-22

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