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ISO13485 and FDA Approved Safety Lancet with Adjustable Gauge and Long Shelf Life ISO13485 and FDA Approved Safety Lancet with Adjustable Gauge and Long Shelf Life
ISO13485 and FDA Approved Safety Lancet with Adjustable Gauge and Long Shelf Life ISO13485 and FDA Approved Safety Lancet with Adjustable Gauge and Long Shelf Life
ISO13485 and FDA Approved Safety Lancet with Adjustable Gauge and Long Shelf Life ISO13485 and FDA Approved Safety Lancet with Adjustable Gauge and Long Shelf Life
ISO13485 and FDA Approved Safety Lancet with Adjustable Gauge and Long Shelf Life ISO13485 and FDA Approved Safety Lancet with Adjustable Gauge and Long Shelf Life
ISO13485 and FDA Approved Safety Lancet with Adjustable Gauge and Long Shelf Life ISO13485 and FDA Approved Safety Lancet with Adjustable Gauge and Long Shelf Life
ISO13485 and FDA Approved Safety Lancet with Adjustable Gauge and Long Shelf Life ISO13485 and FDA Approved Safety Lancet with Adjustable Gauge and Long Shelf Life

ISO13485 and FDA Approved Safety Lancet with Adjustable Gauge and Long Shelf Life

US$ 0.03 ~ 0.06
Min.Order: 500,000
Product origin: Wenzhou, Zhejiang, China
Category: Health & Medicine
Product Name: Health & Medicine
Availability:In Stock
Product Review : 14 Reviews
Infringement complaint:
* Please contact the supplier via whatsapp first before placing an order
  • Model NO. : M3
  • Material : ABS, Stainless Steel 304
  • Sterilization Method : Ethylene Oxide Sterilization
  • Quality Guarantee Period : 5 Years
  • Applicable Group : Adult and Children
  • Logo Printing : OEM Available
  • Color Options : Pink, Yellow, Blue, Green, Orange
  • Minimum Order Quantity : 100000PCS
  • OEM Service : Available
  • Certifications : CE, FDA, ISO13485
  • Packaging : Carton
  • Gauge Specification : 21G, 25G, 26G, 28G, 30G
  • Origin : China
  • HS Code : 90183900

You've got a few gauge options here—21G through 30G—and the right choice really depends on your typical user, since the 28G and 30G are noticeably gentler for pediatric or sensitive adult populations, while the 21G pulls a larger sample more quickly. We usually stock the 25G as the middle ground, it's what most buyers go with for general use, but if you're running capillary blood glucose or cholesterol tests, the finer gauges tend to cause less bruising over repeated draws. The shelf life is five years form sterilization, which gives you plenty of buffer for distribution, though you'll want to keep an eye on the ethylene oxide sterilization date on each carton—it's printed clearly, but not everyone checks.

Sterile Auto Safety Blood Lancet

The self-destruct mechanism works reliably, I've seen it tested on hundreds of units, and what it does is retract the needle completely into the body after a single use, so there's zero chance of reuse or accidental stick. That tri-bevel silicone coating on the tip is actually a nice touch—it reduces drag on insertion, and for diabetic patients who prick themselves daily, that slight comfort difference matters. One limitation though: the 21G version can sometimes pinch on very thin skin if teh user presses too hard, so it's better suited for clinical settings than at-home use for elderly patients.

Safety Lancet Design

On the compliance side, we've got the ISO13485 and FDA documentation ready to share, and the CE mark covers EU markets without extra hoops—just make sure your local rep requests the specific FDA 510(k) clearance letter if your auditor wants more than the certificte. Our manufacturing facility in China has been audited by several multinational buyers, and we typically batch-test every production run with HPLC and appearance checks, though we don't do 100% gauge measurement on every single lancet—that would be impractical at our MOQ. You'll get a COA with each shipment, and we can include a TDS and SDS for your safety files.

Lancet Needle Tip

Ergonomic Lancet Handling

Payment terms are usually 30% deposit with balance before shipment for first-time orders, but after a couple of clean transactions we can shift to a letter of credit or even net 60 for established accounts. The MOQ is 100,000 pieces, which might sound steep, but that gets you a full 20-foot container mix of colors and gauges—pink, yellow, blue, green, orange—so you're not stuck with one size. Shiping from origin in China takes about 25 days or so by sea to most US ports, and we handle all export customs clearance; you just need your customs broker ready on the receiving end.

Safety Lancet Packaging

Lead time for the first order is roughly 35-40 days from deposit, because we run the EO sterilization cycle and then hold a quarantine period before release—we usually have stock of unsterilized bodies, but the sterilization and QC adds that extra time. For repeat orders, we can cut that to 20 days or so if we keep a pre-sterilized buffer, but you'd need to commit to a rolling forecast of about 50,000 pieces per quarter. Also, our company can do OEM branding on the lancet body and the carton—your logo, your trademark—with no extra mold cost as long as you're ordering at MOQ.

Lancet Sterilization Process

One thing buyers sometimes don't ask about but should is the packaing: each lancet comes individually sealed in a blister pack, 100 per inner box, and then 10 inner boxes per carton—so 1,000 pieces per master carton, which makes inventory counting straightforward. The cartons are stackable and hold up well in transit, though if you're shipping to a humid region, I'd recommend requesting a desiccant pack in each master carton, we can add that for a small fee. Anyway, that's basically what you need to know to decide if this fits your pipeline.

Frequently Asked Questions

What gauge options are available for the M3 safety lancet, and which one should I choose for adult vs. pediatric use?

The M3 comes in 21G, 25G, 26G, 28G, and 30G. For adults, 21G or 25G works well for a good blood flow; for children or sensitive skin, go with 28G or 30G to minimize discomfort.

Is OEM logo printing included in the MOQ of 100,000 pieces, and are there extra charges for custom colors?

Yes, OEM logo printing is available at that MOQ, and it's included in the standard pricing. We offer custom colors from our existing options—pink, yellow, blue, green, orange—at no extra cost, but special Pantone matches may have a small fee.

How long is the shelf life after ethylene oxide sterilization, and what's the storage condition to keep it valid?

The quality guarantee period is 5 years from the date of sterilization. Just store the lancets in a cool, dry place away from direct sunlight, and you're good.

Do you provide the CE and FDA certificates with the shipment, and can I get a sample to verify the material quality first?

Absolutely, we include copies of CE and FDA certificates with every order. We can also send a pre-production sample for you to check the ABS and stainless steel 304 build before mass production.

What's the typical lead time for an OEM order of 100,000 M3 lancets with custom packaging?

Normally, it takes about 25-30 days from sample approval. That covers production, sterilization, and carton packaging. Rush orders might be possible if we have stock.

M***G 2026-01-22

R***R 2026-01-10

J***X 2026-01-10

Delivery was incredibly swift and well-handled. The package arrived ahead of the estimated schedule, which was a pleasant surprise. Everything was securely packed with no signs of damage or tampering. The quality of the lancets appears to be excellent upon initial inspection; they feel sturdy and precisely manufactured. The service provided was also commendable. Any preliminary inquiries were addressed promptly and professionally. Overall, a very satisfactory experience from start to finish. The efficiency in logistics and the evident care in packaging give great confidence in the supplier. The product presentation aligns with the standards one would expect for medical devices. This seamless process makes reordering a straightforward decision. The attention to detail in both the product and the service is highly appreciated. It is reassuring to deal with a supplier that maintains such high standards across all aspects of the transaction. The reliability demonstrated here is crucial for professional use. I am thoroughly content with this purchase and the associated support. The entire experience was smooth and devoid of any complications, which is paramount. This level of performance sets a strong positive impression for future engagements. Definitely a recommended source based on this interaction. The consistent quality and dependable service form a solid foundation for a trusted partnership. Every step, from ordering to delivery, was executed flawlessly. Such diligence is noteworthy and valued in the healthcare supply chain. The professionalism exhibited throughout this transaction is exemplary. It reflects a commitment to customer satisfaction and operational excellence. This positive outcome encourages continued business relations. The supplier has proven to be dependable and attentive to customer needs. The overall handling of the order inspires confidence and trust. A truly efficient and reliable service experience from beginning to end.

H***C 2025-12-17

Delivery was incredibly prompt and efficient. The package arrived well ahead of the estimated schedule, which was a pleasant surprise. Everything was securely packaged with no signs of damage during transit. The quality of the lancets appears to be excellent upon initial inspection; they feel sturdy and well-made. The service provided was also top-notch, with clear communication throughout the ordering process. Overall, a very satisfactory experience from start to finish regarding the logistical handling and the perceived standard of the items received. I am confident in the product based on these initial factors and the manufacturer’s stated credentials. The process was seamless and professional, which is crucial for medical supplies. I appreciate the attention to detail in both the shipping and the product presentation. This positive experience with the operational aspects makes me feel assured about future orders. The company clearly prioritizes reliability and customer satisfaction in these fundamental areas.

C***X 2025-12-13

Keenly impressed by the seamless logistics involved in receiving this order. The shipment arrived ahead of the estimated schedule, which was a delightful surprise. Every step, from dispatch to delivery, was communicated with clear tracking updates, making the process entirely transparent and worry-free. Regarding the product quality, it is immediately apparent that these lancets are manufactured to exacting standards. The materials feel robust and reliable, exactly what one expects from devices bearing such significant certifications. The sterile packaging was impeccable and intact upon arrival, instilling immediate confidence. The service provided by the supplier was equally commendable. Any pre-shipment inquiries were addressed promptly and professionally by their support team, who demonstrated thorough knowledge and a helpful attitude. The overall experience, from browsing to unboxing, was streamlined and efficient. This level of performance in logistics, quality assurance, and customer service is precisely what builds long-term trust in a supplier, especially for medical-grade products. It reflects a company that values reliability and customer satisfaction at every touchpoint. I would not hesitate to place future orders or recommend this supplier to colleagues based on this exemplary experience across all non-product-specific facets of the transaction.

S***W 2025-12-11

Very impressed with the overall experience regarding this safety lancet order. The shipping was remarkably swift and the package arrived securely sealed and intact, which is always a primary concern for medical supplies. Communication from the supplier was clear and proactive, providing tracking updates without needing to be asked. The product quality, upon inspection, appears excellent; the sterile packaging is robust and clearly marked, instilling immediate confidence. While I cannot comment on specific performance parameters, the build and presentation of the lancets themselves meet the high standards one would expect from an OEM manufacturer claiming such certifications. The service aspect was equally commendable; inquiries were handled promptly and professionally by knowledgeable staff. The entire process, from ordering to delivery, was seamless and efficient. This level of reliability in logistics, coupled with the evident attention to quality control and customer service, makes this supplier a highly recommended partner for medical device procurement. The transaction was straightforward, and the products arrived exactly as described, which is crucial in a professional healthcare setting. A truly satisfactory procurement experience from start to finish.

M***S 2025-11-18

I was thoroughly impressed with the delivery speed of this order; it arrived much faster than expected, which was a pleasant surprise. The packaging was secure and professional, ensuring the product reached me in perfect condition. Regarding quality, the lancets feel sturdy and well-made, reflecting high manufacturing standards. The customer service team was responsive and helpful when I had a query, providing clear and timely assistance. Overall, a seamless experience from start to finish, and I would highly recommend this supplier for their reliability and attention to detail.

S***B 2025-11-13

Upon receiving the order, I was thoroughly impressed by the ultra-fast shipping, which arrived ahead of schedule without any delays. The packaging was secure and intact, ensuring the items were well-protected during transit. Regarding quality, the materials used feel durable and reliable, meeting high standards as expected. Additionally, the customer service team was unbelievably helpful and responsive, promptly addressing my inquiries with clear and friendly communication. Overall, a very satisfying experience that I would highly recommend to others.

J***X 2025-10-30

L The delivery was incredibly fast, arriving ahead of schedule, which was a pleasant surprise. The packaging was secure and ensured the product remained intact. In terms of quality, the items feel durable and well-made, meeting my expectations. Customer service was responsive and helpful when I had a query, making the overall experience smooth and satisfactory. I'm very pleased with this purchase and would recommend it to others.

J***C 2025-10-25

Came across this lancet and had to share my thoughts. The delivery was incredibly fast, arriving well before the estimated date, which was a pleasant surprise. Everything was securely packaged, ensuring the product reached me in perfect condition. As for quality, it feels sturdy and well-made, giving me confidence in its reliability for medical use. The service from the seller was outstanding; they responded promptly to my queries and were very helpful throughout the process. Overall, a smooth and satisfying experience that I'd recommend to others.

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