STERiLANCE Elite Disposable Safety Lancet
The STERiLANCE Elite Disposable Safety Lancet takes a small capillary blood sample for diagnostic testing. A spring loaded puncturing element opens the skin to release a drop of blood. The…
The STERiLANCE Elite Disposable Safety Lancet takes a small capillary blood sample for diagnostic testing. A spring loaded puncturing element opens the skin to release a drop of blood. The device is intended for use by healthcare professionals and by lay users.
Its puncturing element is mounted in a base with an integrated sharps protection feature. After one activation, the mechanism makes the lancet inoperable so it cannot be reused. The device is supplied sterile for a single sampling use.
Needle and Depth Options
The lancet family includes different needle gauges and penetration depths, with Elite specifically identified among the depth configurations. The skin contacting needle is made from stainless steel.
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 | Sterilance Medical (Suzhou) Inc., China |
|---|---|
| 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 | Contract manufacturer, Manufacturer, Exporter |
| 510(k) | K233796 |
| Record published | 2024-05-22 |
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 |
| Packaging | Pack of 20 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 05-211720B | 100 | In distribution | |
| 05-213015 | 100 | In distribution | |
| 05-212812 | 100 | In distribution | |
| 05-212818 | 100 | In distribution | |
| 05-212618 | 100 | In distribution | |
| 05-212620 | 100 | In distribution | |
| 05-212118 | 100 | In distribution | |
| 05-212118 | 100 | In distribution | |
| 05-213012 | 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 |
| 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
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K244036 | 2025-02-26 |
| K233796 | 2024-01-16 |
| K221521 | 2022-10-28 |
| K210745 | 2021-08-26 |
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.