ONE-Care Plus Safety Lancets

Contact-activated ONE-CARE PLUS Safety Lancets 21G x 1.8 mm are designed with an ergonomic body for a comfortable grip, ensuring ease of use during procedures. The reliable safety…

Registry build 21.09.26

Contact-activated ONE-CARE PLUS Safety Lancets 21G x 1.8 mm are designed with an ergonomic body for a comfortable grip, ensuring ease of use during procedures. The reliable safety activation mechanism guarantees consistent performance, while the wide cap allows for easy twist-off, facilitating straightforward preparation for use. This innovative design provides an optimal combination of safety, comfort, and convenience.

36manufacturers in China registered for this device type
6catalogue numbers in this listing

Who Else Makes It

Concentrated in Jiangsu (11), Zhejiang (9), Guangdong (5). 5 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code FMK
Manufacturer City Province Registered as Device types
Acon Biotech (Hangzhou) Co., Ltd. Hangzhou Zhejiang Contract manufacturer 29
Hochuen Medical Technology Co., Ltd. Shenzhen Guangdong Contract manufacturer 20
Providence Enterprise Limited Shenzhen Guangdong Contract manufacturer 9
Huaian Hening Medical Instruments Co., Ltd. and its Subsidiary Huaian Junran IMP.&EXP. Trading Co., Ltd. Huaian Jiangsu Contract manufacturer 4
Jetcrown Industrial (Dong Guan) Ltd. Guangdong Guangdong Contract manufacturer 3
Jiangsu NEW Pentastar Medical Products Co., Ltd. Changzhou Jiangsu Exporter 146
Zhejiang Mediunion Healthcare Group Co., Ltd. Ningbo Zhejiang Contract manufacturer 105
GRI Medical & Electronic Technology Co., Ltd. Jiaxing Zhejiang Contract manufacturer 71
Shanghai JPY ION-Tech Co., Ltd. Shanghai Shanghai Contract manufacturer 70
Shandong Zhushi Pharmaceutical Group Co., Ltd. Heze Shandong Contract manufacturer 65
Jiangsu WLD Medical Co., Ltd. Yizheng Jiangsu Contract manufacturer 50
Hefei Mlush Sanitary Products Co., Ltd. Hefei Anhui Manufacturer 48

Showing 12 of 36. All 36 manufacturers in China registered for Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature

Record

Regulatory record for ONE-Care Plus Safety Lancets
Listed by MediVena, LLC
FDA product code FMK
Device type Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature
Device class Class 2
Regulation 21 CFR 878.4850
510(k) K222408
Record published 2025-02-16

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Supplied sterile Yes
Single use Yes
Over the counter Yes
Latex Labelled latex-free
Label carries lot or batch number, expiry date, manufacturing date, serial number
Storage Storage environment temperature 32 to 104 °F
Packaging Case of 20
Sizes Needle gauge 21 to 30 G; length 1.5 to 2.8 mm

Catalogue Numbers

Catalogue numbers for ONE-Care Plus Safety Lancets
Catalogue number Size Status
1004 ONE-CARE PLUS Safety Lancets 21G x 1.8mm, NormalFlow, Blue, 100/bx, 20bx/cs Needle Gauge 21 G In distribution
1006 ONE-CARE PLUS Safety Lancets 21G / 2.8mm, MaxFlow, Orange, 100/bx, 20bx/cs Needle Gauge 21 G In distribution
1001 ONE-CARE PLUS Safety Lancets 30G x 1.5mm, MicroFlow, Purple, 100/bx, 20bx/c Needle Gauge 30 G In distribution
1003 ONE-CARE PLUS Safety Lancets 25G x 1.8mm, LowFlow, Sky Blue, 100/bx, 20bx/c Needle Gauge 25 G In distribution
1002 ONE-CARE PLUS Safety Lancets 28G x 1.8mm, MiniFlow, Pink, 100/bx, 20bx/cs Needle Gauge 28 G In distribution
1005 ONE-CARE PLUS Safety Lancets 21G x 2.4mm, ExtraFlow, Green, 100/bx, 20bx/cs Needle Gauge 21 G In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Cardinal Health Cardinal Health 200, LLC 35
Verifine Promisemed Medical Devices Inc. 32
McKesson Mckesson Medical-Surgical Inc. 29
Medline Medline Industries, Inc. 28
SurgiLance Safety Lancet Medipurpose PTE. Ltd. 26
Twist Lancet (32G) Shandong Lianfa Medical Plastic Products Co., Ltd. 25
xinle Hebei Xinle SCI&Tech Co., Ltd. 24
Twist Lancet (31G) Shandong Lianfa Medical Plastic Products Co., Ltd. 24
Twist Lancet (33G) Shandong Lianfa Medical Plastic Products Co., Ltd. 23
Twist Lancet (30G) Shandong Lianfa Medical Plastic Products Co., Ltd. 19
Unistik 3 Owen Mumford Limited 18
Safety Lancet (21GBlade) Shandong Lianfa Medical Plastic Products Co., Ltd. 16

Showing 12 of 345. All products under Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature

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