SurgiLance Safety Lancet
SurgiLance Safety Lancet is a sterile puncture device for obtaining a small blood sample, usually from a fingertip. A needle or blade makes the puncture, then retracts into the plastic…
SurgiLance Safety Lancet is a sterile puncture device for obtaining a small blood sample, usually from a fingertip. A needle or blade makes the puncture, then retracts into the plastic housing.
The sharp is concealed before and after activation. Contact with the sampling site activates the mechanism, which becomes inoperative after use to prevent another firing.
Listed Item
SurgiLance Safety Lancet, 21G Needle 2.2 mm Orange, 2/bag, 430 bags/case
Sampling Configurations
The range includes color-coded low-, medium- and high-flow models with different needle or blade forms and penetration depths. The sharps are stainless steel, the housing components are plastic, and each device is intended for one patient.
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.
| 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
| Listed by | Medipurpose PTE. Ltd., Singapore |
|---|---|
| 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 |
| Establishment | Specification developer, Private-label distributor, Manufacturer, Exporter |
| 510(k) | K222224 |
| Record published | 2025-02-12 |
| Record revised | 2025-02-13 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Packaging | Case of 15, case of 750, case of 430, case of 860, case of 75, pack of 860 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| SLN242 | 2 | In distribution | |
| SLB250 | 100 | In distribution | |
| SLN170S | 100 | In distribution | |
| SLN302 | 20 | In distribution | |
| SLN304 | In distribution | ||
| SLB200 | 100 | In distribution | |
| SLN202 | 2 | In distribution | |
| SLB252 | 2 | In distribution | |
| SLN300 | 100 | In distribution | |
| SLN240 | 100 | In distribution | |
| SLN200 | 100 | In distribution | |
| SLN240S | 100 | In distribution | |
| SLB254 | In distribution | ||
| SLN304W | In distribution | ||
| SLB250S | 100 | In distribution | |
| SLN200S | 100 | In distribution | |
| SLN1030 | 1,500 | In distribution | |
| SLB202 | 2 | In distribution | |
| SLN100S | 100 | In distribution | |
| SLB204 | In distribution | ||
| SLN100 | 100 | In distribution | |
| SLB200S | 100 | In distribution | |
| SLN102 | 2 | In distribution | |
| SLN170 | 100 | In distribution | |
| SLN3010 | 1,500 | In distribution | |
| SLN300S | 100 | In distribution |
Same 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 |
| 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 |
| Safety Lancet (18GBlade) | 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
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K222224 | 2022-09-22 |
| K130132 | 2013-02-11 |
| K101145 | 2010-10-21 |
| K101417 | 2010-10-19 |
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.