Ecoship Disposable Sharps Container is intended to be used in healthcare facilities, including nursing stations, medication carts, laboratories, dental offices, emergency rooms, surgical rooms, treatment rooms, emergency vehicles, veterinarian offices and other small quantity waste generators for the safe disposal of hazardous sharps. The single-use device is intended for "Overthe-Counter" use. The container is eventually disposed of through a mail-back system or otherwise in accordance with local regulations. The manufacturer's bracket is required if the device is used on medication carts or in emergency vehicles.

Device Description

Ecoship Disposable Sharps Containers are single-use sharps containers designed for point-first disposal of sharps. The containers are intended for over-the-counter use for the safe disposal of sharps, i.e. articles that can penetrate human skin. This definition includes, but is not limited to needles, scalpels, syringes with needles, disposable scissors, suture needles, stylets, trocars and broken test tubes. The containers are intended to be used in supervised areas of human and veterinary healthcare facilities. These areas may include nursing stations, laboratories, dental offices, physician offices, clinics, emergency rooms, surgical rooms, treatment rooms, research facilities, veterinarian practices and other small quantity waste generators. The devices are also intended to be used in healthcare facility mail-back programs and in home healthcare by clinical staff.

Two Ecoship Disposable Sharps Container models are described in this submission:

D2-ES is 2 liters with fill capacity of 1.5 liters .
- o Tare: 192 grams (6.77 oz)
- o Dimensions: (L) 142 mm x (W) 142 mm x (H) 151 mm
D4-ES is 4 liters with fill capacity of 3 liters .
- o Tare: 304 grams (10.72 oz)
- Dimensions: (L) 142 mm x (W) 142 mm x (H) 303 mm o

AI/ML Overview

The document provided is a 510(k) summary for the Ecoship Disposable Sharps Container, filed by Daniels Sharpsmart, Inc. This summary outlines the device's intended use, description, equivalence to marketed devices, and performance testing.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. A table of acceptance criteria and the reported device performance:

Test Method (Reference Standard)	Acceptance Criteria	Reported Device Performance
Puncture Resistance (CSA Z316.6-07)	Force required to puncture container sections > 20 N	Met: Puncture resistance of each section was greater than 20 N.
Toppling Resistance (CSA Z316.6-07)	Container remains standing after tilting to a 15° angle.	Met: Container remained standing after being tilted to a 15° angle with nominal capacity of representative sharps material.
Toppling Resistance (ISO 23907)	Container does not slide and remains standing after tilting to a 15° angle.	Met: Container did not slide and remained standing after being tilted to a 15° angle using worst-case challenge configurations with nominal capacity of representative sharps material.
Impact Resistance (CSA Z316.6-07)	Containers do not rupture, tear, crack, open, or leak after dropping from ≥ 1 meter.	Met: Five containers did not rupture, tear, crack, open, or leak when conditioned at 23°C and dropped in a specific orientation from a height of no less than 1 meter.
Cold Impact Resistance (CSA Z316.6-07)	Containers do not rupture, tear, crack, open, or leak after dropping from ≥ 1.2 meters at -18°C.	Met: Five containers did not rupture, tear, crack, open, or leak when conditioned at -18°C and dropped in a specific orientation from a height of no less than 1.2 meters.
Handle Strength (CSA Z316.6-07)	Container remains intact, and handle does not rupture, tear, crack, or separate for 1 hour.	Met: Container remained intact and the handle did not rupture, tear, crack, or separate from the container after suspending for 1 hour with nominal capacity of material (bulk density 1 kg/liter).
Drop Test (UN Recommendations on the Transport of Dangerous Goods – Model Regulations, Part 6)	Containers are not damaged after dropping from ≥ 1.2 meters at -18°C.	Met: Six containers were not damaged when conditioned at -18°C and dropped in one of two specific orientations from a height of no less than 1.2 meters, filled to 95% capacity with polycarbonate granules.
Stacking Test (UN Recommendations on the Transport of Dangerous Goods – Model Regulations, Part 6)	Containers are not damaged after being stacked with an 81 kg mass for 24 hours.	Met: Three empty containers were not damaged after an 81 kg mass was applied to the top of the stack for 24 hours at room temperature.
Vibration Test (49 CFR Part 178.608)	Containers do not rupture, leak, or deteriorate after 60 minutes of vibration at room temperature.	Met: Three containers did not rupture, leak or deteriorate after being vibrated (25 mm peak to peak at a frequency inducing 1.6 mm displacement) for 60 minutes at room temperature, filled to 95% capacity.
Conformity to US OSHA 29 CFR 1910.1030 Bloodborne Pathogens	Device conforms to regulations.	Met: The devices conform to regulations per US OSHA 29 CFR 1910.1030 Bloodborne Pathogens.

2. Sample sizes used for the test set and the data provenance:

Puncture Resistance: "various sections of a container" (specific number not given).
Toppling Resistance (CSA Z316.6-07): "a container" (singular).
Toppling Resistance (ISO 23907): "a container" (singular).
Impact Resistance: Five containers.
Cold Impact Resistance: Five containers.
Handle Strength: "a container" (singular).
Drop Test: Six containers.
Stacking Test: Three empty containers.
Vibration Test: Three containers.

Data Provenance: The tests described are "non-clinical data submitted, referenced, or relied upon" for the 510(k) submission. These are laboratory-based engineering and physical tests, not human or patient data. The reference standards are international and national standards (CSA, ISO, UN, CFR), implying the tests were conducted under controlled laboratory conditions, likely in a prospective manner for the purpose of this submission. The country of origin of the testing is not explicitly stated but is implicitly tied to the manufacturer (Daniels Sharpsmart, Inc. in Chicago, IL, USA, with representatives in San Diego, CA, USA).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This information is not applicable as the document describes physical engineering tests on a medical device (a sharps container), not diagnostic or clinical accuracy studies that would require expert-established ground truth. The "ground truth" for these tests is defined by the objective pass/fail criteria of the referenced engineering standards.

4. Adjudication method for the test set:

This information is not applicable for these types of physical engineering tests. Adjudication methods like "2+1" typically apply to cases where human interpretation or consensus is required (e.g., in medical image reading). For these tests, the outcome is objectively measured against a predefined standard.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

This is not applicable. The device is a physical sharps container, not an AI-powered diagnostic tool. Therefore, no MRMC study involving human readers or AI assistance was conducted or mentioned.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

This is not applicable. The device is a physical product and does not involve an algorithm or AI. The tests described are for the physical integrity and performance of the container itself.

7. The type of ground truth used:

For all the tests described, the "ground truth" is established by the objective, empirically measurable criteria defined within the referenced international and national engineering standards (CSA Z316.6-07, ISO 23907, UN Recommendations on the Transport of Dangerous Goods – Model Regulations, 49 CFR Part 178.608, and US OSHA 29 CFR 1910.1030). These standards specify the methodology and acceptable limits for each physical property being tested.

8. The sample size for the training set:

This is not applicable. The device is a physical product, and the described tests are performance validation tests, not machine learning model training.

9. How the ground truth for the training set was established:

This is not applicable as there is no training set mentioned or implied for a physical device like a sharps container.

Summary

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510(k) Summary

Ecoship Disposable Sharps Container

JAN 3 1 2014

510(k) Summary

Daniels Sharpsmart, Inc. Ecoship Disposable Sharps Container K132792

December 30, 2013

ADMINISTRATIVE INFORMATION

Manufacturer Name

Official Contact

Representative/Consultant

Daniels Sharpsmart, Inc. 111 W Jackson Blvd., Suite 720 Chicago, IL 60604 Telephone: +1 (312) 546-8925 Fax: +1 (312) 276-4714

Alan Larosee Director of Compliance

Allison C. Komiyama, Ph.D. Floyd G. Larson PaxMed International, LLC 12264 El Camino Real, Suite 400 San Diego, CA 92130 Telephone: +1 (858) 792-1235 +1 (858) 792-1236 Fax: Email: akomiyama@paxmed.com flarson@paxmed.com

DEVICE NAME AND CLASSIFICATION

Trade/Proprietary Name Common Name

Classification Name Classification Regulations Product Code

Classification Panel Reviewing Branch

Ecoship Disposable Sharps Container Container, sharps

Hypodermic single lumen needle 21 CFR 880.5570, Class II MMK

General Hospital Infection Control Devices Branch

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INTENDED USE

DEVICE DESCRIPTION

Two Ecoship Disposable Sharps Container models are described in this submission:

D2-ES is 2 liters with fill capacity of 1.5 liters .
- o Tare: 192 grams (6.77 oz)
- o Dimensions: (L) 142 mm x (W) 142 mm x (H) 151 mm
D4-ES is 4 liters with fill capacity of 3 liters .
- o Tare: 304 grams (10.72 oz)
- Dimensions: (L) 142 mm x (W) 142 mm x (H) 303 mm o

EQUIVALENCE TO MARKETED DEVICE

Daniels Sharpsmart, Inc. Ecoship Disposable Sharps Container is substantially equivalent in indications and design principles to the following predicate devices:

Daniels Corporation PTY, INC., Sharpsmart S2 Disposable Sharps Container (K091736) .
Sharps Compliance, Inc., Sharps Compliance Container (K083129) .
Oak Ridge Products L.L.C., Oak Ridge Products Sharps Containers (K130281) .

The D2-ES (2 liter) and D4-ES (4 liter) Ecoship Disposable Sharps Containers have a similar design and dimensions, use similar materials, and are similar in color to those cleared under K091736. K083129 and K130281. The subject device has similar fill capacity and locking

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mechanisms to those cleared in K091736 and K130281. The access opening is similar in size and shape to K091736 and K083129. A return mail-back carton is provided similar to K083129.

No FDA performance standards for Ecoship Disposable Sharps Container have been established. The following tests were performed to ensure that the performance of the subject device meets Daniels Sharpsmart, Inc. requirements.

Pucture Resistance (per CSA Z316.6-07 Evaluation of single-use and reusable medical sharps containers for biohazardous and cytotoxic waste)

Needle puncture resistance was measured by taking various sections of a container and subjecting them to penetration with a 0.8 mm diameter needle. The force required to puncture the container was measured. The puncture resistance of each section of the container was greater than 20 N and the passing criterion was met.

Toppling Resistance (per CSA Z316.6-07 Evaluation of single-use and reusable medical sharps containers for biohazardous and cytotoxic waste)

Toppling resistance was measured by filling a container to nominal capacity with representative sharps material with a bulk density of 0.2 kg/liter and tilting it to a 15° angle. The container remained standing after being tilted, and the passing criterion was met.

Toppling Resistance (per ISO 23907 Sharps injury protection - Requirements and test methods -Sharps containers)

Toppling resistance was measured by filling a container to nominal capacity with representative sharps material with a bulk density of 0.2 kg/liter and tilting it to a 15° angle using the worst case challenge configurations. The container did not slide, and remained standing after being tilted, and the passing criteria were met.

Impact Resistance (per CSA Z316.6-07 Evaluation of single-use and reusable medical sharps containers for biohazardous and cytotoxic waste)

Impact resistance was measured by filling five containers to nominal capacity with representative sharps material with a bulk density of 0.2 kg/liter and surfactant solution equal to 6% of the nominal capacity. The containers were then conditioned at 23°C and dropped in a specific orientation from a height of no less than 1 meter. The containers did not rupture, tear, crack, open, or leak, and the passing criteria were met.

Cold Impact Resistance (per CSA Z316.6-07 Evaluation of single-use and reusable medical sharps containers for biohazardous and cytotoxic waste)

Cold impact resistance was measured by filling five containers with representative sharps material with a bulk density of 0.2 kg/liter. The containers were then conditioned at -18°C and dropped in a specific orientation from a height of no less than 1.2 meters. The containers did not rupture, tear, crack, open, or leak, and the passing criteria were met.

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Handle Strength (per CSA Z316.6-07 Evaluation of single-use and reusable medical sharps containers for biohazardous and cytotoxic waste)

Handle strength was measured by filling a container to nominal capacity with material with a bulk density of 1 kg/liter and suspending it from the handle for 1 hour. The container remained intact and the handle did not rupture, tear, crack, or separate from the container. Therefore, the passing criteria were met.

Drop Test (per United Nations Recommendations on the Transport of Dangerous Goods – Model Regulations, Part 6, "Requirements For the construction and testing of packagings, intermediate bulk containers (IBCs), large packagings and portable tanks)

This test was performed by filling six containers with no less than 1.2 kg of polycarbonate granules to a minimum of 95% capacity and prepared as they would be used in transport. The containers were then conditioned at -18°C and dropped in one of two specific orientations from a height of no less than 1.2 meters. The containers were not damaged, and the passing criterion was met.

Stacking Test (per United Nations Recommendations on the Transport of Dangerous Goods -Model Regulations, Part 6, "Requirements For the construction and testing of packagings, intermediate bulk containers (IBCs), large packagings and portable tanks)

This test was performed by stacking three empty containers and prepared as they would be used in transport. A mass of 81 kg was then applied to the top of the stack for 24 hours at room temperature. The containers were not damaged, and the passing criterion was met.

Vibration Test (per 49 CFR Part 178.608 Specifications for Packagings - Vibration Standard)

This test was performed by filling three containers with polycarbonate granules to a minimum of 95% capacity, prepared as they would be used in transport. The containers were then vibrated (25 mm peak to peak at a frequency that induces displacement of 1.6 mm from the vibration plate) for 60 minutes at room temperature. The containers did not rupture, leak or deteriorate, and the passing criteria were met.

All testing demonstrated that the subject device is safe and effective for its intended use.

The devices conform to regulations per US OSHA 29 CFR 1910.1030 Bloodborne Pathogens.

Non-clinical data submitted, referenced, or relied upon to demonstrate substantial equivalence include engineering analysis and dimensional analysis.

Clinical data were not submitted in this premarket notification.

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The subject device and the predicate devices have the same intended use, have similar technological characteristics, and are made of similar materials. The subject device and predicate devices encompass the same range of physical dimensions, including fill capacity and access opening size. The subject and predicate devices are packaged in similar materials. Any differences in the technological characteristics do not raise new issues of safety or efficacy. The device is safe and effective for its intended use and performs as well as or better than the predicate devices.

Overall, the Ecoship Disposable Sharps Container has the following similarities to the predicate devices:

has the same intended use, .
. uses the same operating principle,
incorporates the same basic design,
incorporates the same or very similar materials, and .
has similar packaging. .

Therefore, the information provided within the 510(k) is sufficient to demonstrate that the subject device is substantially equivalent to the predicates.

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aditional 510(k) Premarket Notification

ummary: Table of Substantial Equivalenc

Subject DeviceEcoship DisposableSharps Container		Sharpsmart™ S2Disposable SharpsContainer	Daniels Corporation PTY,INC.K091736	Predicate DevicesSharps ComplianceContainer	Sharps Compliance, Inc.K083129	Oak Ridge Products SharpsContainers	Oak Ridge Products L.L.C.K130281
Indicationsfor Use	Daniels Sharpsmart, Inc.		Sharpsmart™ S2 disposablesharps container are intended tobe used in healthcare facilities,including nursing stations,medication carts, laboratories,dental offices, emergency rooms,surgical rooms, treatment rooms,emergency vehicles, veterinarianoffice and other small quantitywaste generators for the safedisposal of hazardous sharps. Thisdevice is intended for "Over-the-Counter" use.Physical Attributes: S2 model is a1 quart size. The container has avolume of 1.6 quarts, fill capacityof 1.16 quarts and an emptyweight of 0.95 lb.S2 model Color - Red withtranslucent lid or yellow withtranslucent lid.S2 model outer dimensions of7.50 "h x 4.50"w x 5.50 "d.(190mm x 115mm x 140mm).	The Sharps ComplianceContainer is a disposableinfectious waste container in 1gallon, 2 gallon and 3 gallonsizes, intended for use bylaypersons or healthprofessionals, in small usageareas in clinical and non-clinical settings, such as:phlebotomy, nursing homes,homes, isolation, doctors office,clinics, labs, or school nursesoffice. The Sharps ComplianceContainer is eventuallydisposed of through a mail-back system or otherwise inaccordance with localregulations.	Oak Ridge Products Sharps containersare single-use, disposable, non-sterilecontainers intended to be used forhealthcare purposes for safe disposalof hazardous sharps such ashypodermic needles, syringes, lancets,and blood needles. The targetpopulation is for trained healthcareprofessionals.The 1 quart Phlebotomy container isintended to be used with anappropriate mounting device.The 5.4 quart is intended to be usedwith an appropriate mounting device.The 2 gallon container is intended tobe used in areas where there is nounsupervised patient access.
	Ecoship Disposable SharpsContainer is intended to be usedin healthcare facilities,including nursing stations,medication carts, laboratories,dental offices, emergencyrooms, surgical rooms,treatment rooms, emergencyvehicles, veterinarian officesand other small quantity wastegenerators for the safe disposalof hazardous sharps. The deviceis intended for "Over-the-Counter" use. The container iseventually disposed of througha mail-back system orotherwise in accordance withlocal regulations.

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Traditional 510(k) Premarket Notificatio

Ecoship Disposable Sharps Contain

	Subject DeviceEcoship DisposableSharps Container	Daniels S2 DisposableSharps Container	Predicate DevicesSharps ComplianceContainer	Oak Ridge Products SharpsContainers
	Daniels Sharpsmart, Inc.	The Daniels CorporationK091736	Sharps Compliance, Inc.K083129	Oak Ridge Products L.L.C.K130281
Size (model)	2 liter (D2-ES)4 liter (D4-ES)	1.6 quart (S2)	1 gallon2 gallon3 gallon	1 quart (Phlebotomy red)5.4 quart (Universal clear)5.4 quart (Universal red)2 gallon (Nestable red)
Material	Polypropylene	Polypropylene	Polypropylene	Polypropylene
Color of base	Red	Red or yellow	Red	Red or clear
Fill LineCapacity	1.5 liters (D2-ES)3 liters (D4-ES)	1.51 liters (1.6 quarts)	3.79 liters (1 gallon)7.57 liters (2 gallon)11.36 liters (3 gallon)	0.76 liters (1 quart)4.07 liters (5.4 quart)6.8 liters (2 gallon)
Size (mm)L x W x H	142 x 142 x 151 (D2-ES)142 x 142 x 303 (D4-ES)	190 x 115 x 140	222 x 140 x 178 (1 gal)222 x 140 x 273 (2 gal)222 x 140 x 426 (3 gal)	115 x 115 x 190 (1 quart)280 x 115 x 267 (5.4 quart)262 x 178 x 257 (2 gallon)
Containerclosure	Screw-on cap	Hinged friction fit door	Snap-on cap	Slide or rotating door
Lockingmechanism	Yes	Yes	No	Yes
Access openingsize	45 mm (diameter)	31.75 mm (diameter)	Unknown	50.8 x 38.1 mm203.1 x 35.6 mm142.2 x 58.4 mm
NeedleRemovalMechanism	No	Yes	No	No
Brackets	Available but notnecessary for use	Available but notnecessary for use	Not available	Available and necessaryfor 1 quart and 5.4 quart models
Return shippingprovided	Yes	No	Yes	No

Page 13 of 40

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/7/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird-like figure.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

January 31, 2014

Daniels Sharpsmart, Incorporated Dr. Allison Komiyama Senior Regulatory Specialist PaxMed International, LLC 12264 El Camino Real, Suite 400 San Diego, CA 92130

Re: K132792

Trade/Device Name: Ecoship Disposable Sharps Container Regulation Number: 21 CFR 880.5570 Regulation Name: Hypodermic Single-Lumen Needle Regulatory Class: II Product Code: MMK Dated: December 30, 2013 Received: December 31, 2013

Dear Dr. Komiyama:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration. Iisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

{8}------------------------------------------------

Page 2 - Ms. Komiyana

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

for

Erin I. Keith, M.S. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Ecoship Disposable Sharps Container

IFU Statement

Indications for Use

K132792 510(k) Number:

Device Name:

Ecoship Disposable Sharps Container Model D2=ES: 2 liters with fill capacity of 1.5 liters Model D4-ES: 4 liters with fill capacity of 3 liters

Indications:

Ecoship Disposable Sharps Container is intended to be used in healthcare facilities, including nursing stations, medication carts, laboratories, dental offices, emergency rooms, surgical rooms, treatment. rooms, emergency vehicles, veterinarian offices and other small quantity waste generators for the safe disposal of hazardous sharps. The single-use device is intended for "Over-the-Counter" use. The container is eventually disposed of through a mail-back system or otherwise in accordance with local regulations. The manufacturer's bracket is required if the device is used on medication carts or in emergency vehicles.

Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use AND/OR (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH. Office of Device Evaluation (ODE)

Page I of I

Digitally signed by Sreekanth U.S. Government, ou=HHS, ou=FDA, ou=People, 0.9.2342.19200300.100.1.1=2000 540490-cn=Sreekanth Gutala -S Date: 2014.01.28 13:08:15 -05'00'

Regulation Number and Section

§ 880.5570 Hypodermic single lumen needle.

(a)
Identification. A hypodermic single lumen needle is a device intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin. The device consists of a metal tube that is sharpened at one end and at the other end joined to a female connector (hub) designed to mate with a male connector (nozzle) of a piston syringe or an intravascular administration set.(b)
Classification. Class II (performance standards).