Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus on the physical properties and safety features of a reusable sharps container, with no mention of AI or ML.

Therapeutic

No.
The device is a sharps container used for the safe disposal of hazardous sharps and does not directly treat or diagnose any medical condition.

Diagnostic

No

Explanation: The device is a sharps container designed for the safe disposal, storage, and transportation of hazardous sharps. Its functionalities and performance tests (e.g., puncture resistance, leak-resistance) are related to containment and safety, not diagnostic purposes.

SaMD (Software as a Medical Device)

No

The device description clearly states it is made of injection-molded polypropylene plastic and describes physical characteristics and performance testing related to the container's material and structure, indicating it is a physical hardware device.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use is for the safe disposal, storage, and transportation of hazardous sharps. This is a physical containment and handling function, not a diagnostic test performed on biological samples in vitro (outside the body).
Device Description: The device is a container made of plastic. It does not involve any reagents, instruments, or procedures for analyzing biological specimens.
Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in biological samples
- Providing information for diagnosis, monitoring, or treatment decisions based on biological analysis.

The device is clearly a medical device for waste management, not an IVD.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Tiger Reusable Sharps Containers and accessories are intended to be used in healthcare facilities including nursing stations, medication carts, laboratories, dental offices, emergency rooms, treatment rooms, emergency vehicles, veterinarian offices and other small quantity waste generators for the safe disposal, storage and transportation of hazardous sharps.

Product codes (comma separated list FDA assigned to the subject device)

MMK

Device Description

Tiger Reusable Sharps Containers are of injection-molded polypropylene plastic, designed for reusable by healthcare professionals. No part of the container is intended to come in contact with patients. The containers are designed to be puncture-resistant, leak-resistant on the sides and bottom, impact-resistant, closable, and stable.

The base is made from a high-strength material to support the capacity of the container. The recommended fill level is engraved onto the plastic and corresponds to the product identification label's level line.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

qualified personnel in healthcare facilities and other facilities in which medical sharps may be used. All device models are not for use in areas with unsupervised patient access.

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Performance testing was provided to demonstrate that the Tiger Reusable Sharps Container met the acceptance criteria or specifications found in the standards and guidance. Tests included: Puncture Resistance, DOT Drop Test, DOT Stacking Test, DOT Vibration standard, Container stability, Aperture and closure, Resistance to penetration, Resistance to damage or leakage after dropping, Resistance to spillage by toppling, Accessory strength test, Fill line, Lifespan simulation testing, Cytotoxicity Tests, Skin Sensitization Test, Skin Irritation Test, Chemical Residues Test, Cleaning Validation, Disinfection Validation. All tests passed.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K153363

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

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).

Summary

0

Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

August 11, 2021

International Marketing Specialists Inc. % Charles Mack Principal Engineer IRC 2950 E Lindrick Drive Chandler, Arizona 85249

Re: K203305

Trade/Device Name: Tiger Reusable Sharps Container Regulation Number: 21 CFR 880.5570 Regulation Name: Hypodermic Single Lumen Needle Regulatory Class: Class II Product Code: MMK

Dear Charles Mack:

The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated 8/6/21. Specifically, FDA is updating this SE Letter as an administrative correction.

Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Clarence Murray, OHT4: Office of Surgical and Infection Control Devices, 301-796-0270, Clarence.Murray(@fda.hhs.gov.

Sincerely,

Clarence W. Murray III -S

Clarence W. Murray, III, Ph.D. Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

1

Image /page/1/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath.

August 6, 2021

International Marketing Specialists, Inc % Charles Mack Correspondent International Marketing Specialists, Inc. Contact Address

Re: K203305

Trade/Device Name: Tiger Reusable Sharps Container Regulation Number: 21 CFR 880.5570 Regulation Name: Hypodermic Single Lumen Needle Regulatory Class: Class II Product Code: MMK Dated: July 21, 2021 Received: July 26, 2021

Dear Charles Mack:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing 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.

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

2

801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE(@tda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerelv.

Clarence W. Murray

Clarence W. Murray, III, Ph.D. Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

3

Indications for Use

510(k) Number (if known) K203305

Device Name Tiger Reusable Sharps Container

Indications for Use (Describe)

Tiger Reusable Sharps Containers and accessories are intended to be used in healthcare facilities including nursing stations, medication carts, laboratories, dental offices, emergency rooms, treatment rooms, emergency vehicles, veterinarian offices and other small quantity waste generators for the safe disposal, storage and transportation of hazardous sharps.

Type of Use (Select one or both, as applicable)

|--|--|

| | Prescription Use (Part 21 CFR 801 Subpart D)

|X | Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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4

K203305

510(k) Summary (21 CFR §807.92)

Date of Preparation: August 4,2021

I. Submitter Information:

Submitter Name:	International Marketing Specialists, Inc.
Address:	1278 Highway 461, Somerset, Kentucky 42503
Contact Person:	Mr. Rod Calderon, General Manager

US Agent and Correspondent

Mr. Charles Mack Principal Engineer IRC 2950 E Lindrick Drive, Chandler, Arizona 85249 USA Tel: 931-625-4938 Email: charliemack@jrc-us.com

II. Device

Trade Name:	Tiger Reusable Sharps Container
Common Name:	container, sharps
Regulation Number:	21 CFR§880.5570
Regulation Name:	Hypodermic single lumen needle
Regulatory Class:	II
Product Code:	MMK

III. Predicate Device Information

Manufacturer	Predicate Device	510(k) Number
Triumvirate
Environmental, Inc.	Red2Green Reusable
Sharps Container	K153363

5

IV. Device Description:

Tiger Reusable Sharps Containers are of injection-molded polypropylene plastic, designed for reusable by healthcare professionals. No part of the container is intended to come in contact with patients. The containers are designed to be puncture-resistant, leak-resistant on the sides and bottom, impact-resistant, closable, and stable.

The base is made from a high-strength material to support the capacity of the container. The recommended fill level is engraved onto the plastic and corresponds to the product identification label's level line.

| Parts &
Accessories | Material | Material Specification | Patient Contact
(Direct /Indirect)? |
|------------------------|-------------------------------|--------------------------------------|----------------------------------------|
| Base | Polypropylene | INEOS PP N02G-00 | No |
| Lid | Polyethylene, High
Density | ExxonMobil TM HDPE HD
6719 Series | No |
| Color
power | Hififast Scarlet
HF4Y | PPR007BTS | No |

V. Indications for Use

Tiger Reusable Sharps Containers and accessories are 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, storage, and transportation of hazardous sharps.

VI. Intended Use

The containers are 100 times reusable, non-sterile, intended to be used for healthcare purposes for safe disposal of hazardous sharps such as hypodermic needles, syringes, lancets, and blood needles. The target population is qualified personnel in healthcare facilities and other facilities in which medical sharps may be used. All device models are not for use in areas with unsupervised patient access.

All device models only are used with appropriate mounting accessories.

6

| Model | Weight
(empty) | Capacity
(total) | Capacity
(full
line) | Dimensions of
finished goods
(mm)
(L x W x H) | Colors | Acceptable sites of use |
|---------------------|-------------------|---------------------|----------------------------|--------------------------------------------------------|------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 2 Gallon
Cap | 875 g | 7.8
Quarts | 6 Quarts | 331.98 x 154.48 x
324.2 | Red base
and white
lid | The target population is
qualified personnel in
health care facilities and
other facilities in which
medical sharps may be
used. All the containers
are intended to be used
in areas where there is
no unsupervised patient
access. |
| 2 Gallon
mailbox | 1042 g | 7.8
Quarts | 6 Quarts | 332.09 x 154.78
x 398.37 | lid | |
| 3 Gallon
Cap | 1187 g | 2.9
gallons | 2.45
gallons | 331.98 x 154.48 x
475.2 | | |
| 3 Gallon
mailbox | 1354 g | 2.9
gallons | 2.45
gallons | 332.09 x 154.78 x
549.37 | | |
| 8 Gallon | 1400 g | 7.8 Gal | 6.5 Gal | 306.36 x 328.41 x
479.1 | | |

| Model | Lid
configuration | Dimensions
of lid
opening
(aperture) | Permanent
Locking
mechanism | Temporary
Locking
mechanism lid
to
container | Requirements for
mounting |
|---------------------|----------------------|-----------------------------------------------|------------------------------------------|----------------------------------------------------------|-------------------------------------------------|
| 2-gallon
cap | Cap/drop | 63.54 mm | Hand pressure
tight | Catamount
Standard
Cable
ties on each side. | a. Locking wall
bracket
b. Wall enclosure |
| 2-gallon
mailbox | Mailbox | 21.63 mm | Counterbalance
door/ hinge
closure | Catamount
Standard
Cable ties on
each side | a. Locking wall
bracket
b. Wall enclosure |
| 3-gallon
cap | Cap/drop | 63.54 mm | Hand pressure
tight | Catamount
Standard
Cable ties on
each side | a. Locking wall
bracket
b. Wall enclosure |
| 3-gallon
mailbox | Mailbox | 21.63 mm | Counterbalance
door/ hinge
closure | Catamount
Standard
Cable ties on
each side | a. Locking wall
bracket
b. Wall enclosure |
| 8-gallon | Cap/drop | 63.54 mm | Hand pressure
tight | Catamount
Standard Cable
ties on each side | Stainless steel or plastic
stabilizer/holder |

7

Element of comparison	Subject Device	Predicate Device	Comparison
Company	International Marketing Specialists, Inc.	Triumvirate Environmental, Inc.	N/A
FDA510(K) Number	Pending	K153363	N/A
Device Name	Tiger Reusable Sharps Container	Red2Green Reusable Sharps Container	N/A
Model Types	2 Gallon cap
2 Gallon mailbox
3 Gallon cap
3 Gallon mailbox
8 Gallon	2 Gallon
3 Gallon
8 Gallon	Identical
Indications for Use	Tiger Reusable Sharps Containers and accessories are 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, storage, and transportation of hazardous sharps.	Red2Green Reusable Sharps Containers and accessories are 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, storage, and transportation of hazardous sharps.	Identical
Product Code	MMK	MMK	Identical
Regulation Number	21CFR880.5570	21CFR880.5570	Identical
Class	2	2	Identical
Prescribed	OTC	OTC	Identical
Material	Polyethylene	Polyethylene	Identical
Dimensions (L x W x H)	2 Gallon cap: 331.98 x 154.48 x 324.2 (mm)
2 Gallon mailbox: 332.09 x 154.78 x 398.37 (mm)
3 Gallon cap: 331.98 x 154.48 x 475.2 (mm)
3 Gallon mailbox: 332.09 x 154.78 x 549.37 (mm)
8 Gallon: 306.36 x 328.41 x 479.1 (mm)	2 gallon: 6.3 x 12.8 x 10.4 (inches)
3 gallon: 6.3 x 12.8 x 15.3 (inches)
8 gallon: 13 x 13 x 17.4 (inches)	The same capacity but dimension difference doesn't raise new safety and effectiveness issues and confirm the design requirement.
Intended Location of Use	Health care facilities	Health care facilities	Identical
Element of
comparison	Subject Device	Predicate Device	Comparison
Color	Red	Red or yellow	Identical
Needle Removal
Mechanism	No	No	Identical
Sharps access
and closure	Gravity-activated	Gravity-activated	Identical
Container Closure	Vertical and horizontal drop, lab lid,
transportation lid	Vertical and horizontal drop, lab lid,
transportation lid	Identical
Accessories	Wall enclosure, wall brackets	Stabilizing tray, wall enclosure, wall bracket,
rolling dolly, foot pedal dolly	Identical
Reusable or Non-
reusable Container	Reusable	Reusable	Identical
Non-sterile	Yes	Yes	Identical
Performance testing	Container stability
Strength of handles
Aperture and closure
Resistance to penetration
Resistance to damage or leakage after dropping
Resistance to spillage by toppling
Fill line
Accessory strength	Puncture resistance
Impact w/ leak
Stability
Accessory strength	The subject device confirms the
FDA recently recognized
performance standards for reusable
sharps containers, including ISO
23907 First edition 2012-09-01,
ISO 23907-2 First edition 2019-11,
ASTM F2132-01 (reapproved
2008).

The test conducted by predict
device at past now already included
in the FDA recognized
performance standards. |
| Element of
comparison | Subject Device | Predicate Device | Comparison |
| Lifespan Simulation
Testing | Lifespan tumbling simulation
Lifespan transport simulations
Lifespan processing simulation | Repeated opening
Life cycle | The subject device confirms to the
FDA recently recognized
performance standards for reusable
sharps containers, including ISO
23907 First edition 2012-09-01,
ISO 23907-2 First edition 2019-11,
ASTM F2132-01 (reapproved
2008); |
| Transportation Test | Impact
Stacking
Vibration | Impact
Stacking
Vibration | Identical:
Conforms to 49 CFR 178.603
Conforms to 49 CFR 178.606
Conforms to 49 CFR 178.608 |
| Biological Testing | ISO 0993-5, ISO 10993-10, ISO/DIS 15883-5,
In vitro cytotoxicity, skin sensitization, cleaning
efficacy. | The predicate is N/A for this testing. | N/A |
| Disinfection | Microbiological Challenge Test,
Decontamination Assurance Level of 10-4 | The predicate is N/A for this testing. | N/A |

Comparison of Technological Characteristics with the Predicate Device VII.

8

9

10

IX. Summary of Non-Clinical Testing

Performance Data

Performance testing was provided to demonstrate that the Tiger Reusable Sharps Container met the acceptance criteria or specifications found in the standards and guidance provided below.

| Test | Standard | Acceptance
Criteria | Results |
|-------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------|
| Puncture Resistance
of Materials Used in
Containers for
Discarded Medical
Needles and Other
Sharps | ASTM F 2132 -01
(Reapproved 2008)e1 | The force needed to
penetrate test
specimens shall be
a minimum of 20 N
or greater. | Pass |
| DOT Drop Test | 49 CFR 178.603 | There is no damage
to the outer
packaging likely to
adversely affect
safety during
transport, there is
no leakage of the
filling substance
from the inner
packaging。 | Pass |
| DOT Stacking Test | 49 CFR 178.606 | No test sample may
show any
deterioration or
distortion
, which could
adversely affect
safety or container
strength during
transport causing
instability in stacks
of packages. | Pass |
| Test | Standard | Acceptance Criteria | Results |
| DOT Vibration
standard | 49 CFR 178.608 | A packaging passes
the vibration test if
there is no
rupture or leakage
from any of the
packages. No test
sample should
show any
deterioration which
could
adversely affect
transportation
safety or any
distortion
liable to reduce
packaging strength. | Pass |
| Container stability | ISO 23907
ISO 23907-2 | The container shall
not topple over
when tested | Pass |
| Aperture and closure | ISO 23907
ISO 23907-2 | It shall be possible
to place sharps into
the sharps container
without using a
second hand to
manipulate the
aperture. The
aperture of
containers intended
to be placed in
public access areas
should be designed
to restrict hand
entry and removal
of contents from the
container.
The aperture should
be designed to
prevent the risk of
overfilling. | Pass |
| Resistance to
penetration | ISO 23907
ISO 23907-2
ASTM F2132-01 | The force needed to
penetrate test
specimens shall be
a minimum of 20 N
or greater. | Pass |
| Test | Standard | Acceptance Criteria | Results |
| Resistance to
damage or leakage
after dropping | ISO 23907
ISO 23907-2 | There shall be no
evidence of
leakage and no
breach of
the sharps
containment area.
Minimum five
minutes after every
topple:

There shall be no
evidence that the
performance or
function of the
container has been
compromised.
The container's
temporary closure
shall remain intact. | Pass |
| Resistance to
spillage by toppling | ISO 23907
ISO 23907-2 | There shall be no
evidence of leakage
and no breach of
the sharps
containment area.
Minimum five
minutes after every
topple:
There shall be no
evidence that the
performance or
function of the
container has been
compromised.
The container's
temporary closure
shall remain intact. | Pass |
| Test | Standard | Acceptance Criteria | Results |
| Accessory strength test | ISO 23907
ISO 23907-2 | The strength of Wall Enclosures and Metal Wall brackets shall be tested by filling their associated sharps container with water. The filled container shall be placed into one of each of the respective wall-mounted accessories. After 48 hours, the containers shall be removed, and the accessories shall be inspected for any loss of integrity. There shall be no evidence of sagging, breakage, liquid leakage, or changes in performance for the locking mechanisms | Pass |
| Fill line | ISO 23907
ISO 23907-2 | The fill line indicator shall be determined by the design of the container, considering the risk of sharps extending above the fill line. It shall be at a level no greater than 85 % of the total capacity of the container. | Pass |
| Test | Standard | Acceptance Criteria | Results |
| Lifespan
simulation
testing | ISO 23907 First
edition 2012-09-
01
ASTM F2132-01
(reapproved

2 Evaluation
pass/fail criteria for
residual TOC by
total organic carbon
analyzer (Method
2) | Pass |
| Test | Standard | Acceptance
Criteria | Results |
| Disinfection
Validation | FDA Guidance
AAMI TIR 30
ISO/DIS 15883-5 | The disinfection
process should be
deemed effective if
all three of the
following are met:
The concentration
of the challenge
suspension meets
1.1.2 c)
requirements.
The positive
control 1.2.2 e)
shows microbial
growth of each
challenge
organism.
After processing,
no challenge
organism was
recovered at any
site. | Pass |

Performance Testing

11

12

13

14

15

The test results demonstrate the subject devices comply with the applicable requirements.

Clinical Test:

Not applicable.

X Conclusions:

The non-clinical data demonstrate that the Tiger Reusable Sharps Container is as safe, as effective, and performs as well as or better than the predicate device, Red2Green Reusable Sharps Container (K153363) manufactured by Triumvirate Environmental, Inc.