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 sharps container, with no mention of AI or ML technology.

Therapeutic

No
The device is a sharps container for disposing of contaminated medical sharps and does not directly treat or prevent a disease or condition.

Diagnostic

No

Explanation: The device is a sharps container designed for the safe disposal of used medical sharps. Its function is to contain waste, not to diagnose medical conditions or provide diagnostic information.

SaMD (Software as a Medical Device)

No

The device description clearly states it is a physical sharps container made of polypropylene, a hardware component. The performance studies also focus on physical properties like puncture resistance and stability.

IVD (In Vitro Diagnostic)

Based on the provided information, the Nitta M&T Safety Boxes are not an In Vitro Diagnostic (IVD) device.

Here's why:

Intended Use: The intended use is to provide a receptacle for used medical sharps and act as an enclosure for transport and disposal. This is a physical containment and disposal function, not a diagnostic test performed on samples taken from the human body.
Device Description: The device is described as a disposable, non-sterile sharps container made of puncture-resistant material. This aligns with a physical containment device, not a diagnostic instrument or reagent.
Lack of Diagnostic Function: There is no mention of the device being used to analyze samples (blood, urine, tissue, etc.) or provide any diagnostic information about a patient's health.
No Contact with Patient: The intended use explicitly states the device is "not in contact with or available to the patient in normal use," which is typical for disposal containers and not for devices used for in vitro diagnostics.

IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The Nitta M&T Safety Boxes do not perform any such function.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Nitta M&T Safety Boxes are intended to provide a receptacle for used, contaminated medical sharps and act as an enclosure during transport to ultimate disposal. The device is intended to be used for safe disposal of hazardous sharps such as hypodermic needles, syringes, lancets, and blood needles by qualified personnel in health care facilities and other facilities in which medical sharps may be used. The device is not in contact with or available to the patient in normal use.

Product codes

MMK

Device Description

Nitta M&T Safety Boxes are disposable and non-sterile sharps container and its lid are made of puncture resistant, leak proof polypropylene. These containers are offered in various volumes, sizes, and lid styles. Mounting accessories (brackets) are available for use with 1.0L, 1.5L, 3.2L and 7.6L containers in locking and non-locking variations. Equipped with visible final lock mechanism. A design that allows you to determine and clearly differentiate the permanent and temporary closure engagement by the position of final lock claws.

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 health care facilities and other facilities in which medical sharps may be used.

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 validate and verify that the subject device met all of the requirements of related international standards, including biocompatibility, sterility, and product specifications. Results of these tests demonstrate the subject device met the acceptance criteria or specification in consensus standards provided below.

Summary of Performance Testing:

Container Stability: Meets ISO23907-1:2019 Requirements - No more than 0 failures per container were observed.
Handle Strength: Meets ISO23907-1:2019 Requirements - No failures were observed.
Puncture resistance: Meets ISO23907-1:2019 Requirements - As such, all Nitta M&T products were found to meet the acceptance criteria. Testing resulted minimum force of 18.6 N was observed.
Resistance to Damage (Drop/Impact Test): Meets ISO23907-1:2019 Requirements - No evidence of leakage or damage resulting in a breach of the sharps containment area were observed. As such, all Nitta M&T products were found to meet the acceptance criteria for resistance to damage from a vertical drop.

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.

K152340, K190240

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.

September 14, 2021

Nitta M&T (Thailand) Co., Ltd. % Vaibhav Rajal Official Correspondent for Nitta M&T (Thailand) Co., Ltd. mdi Consultants Inc. 55 Northern Blvd. Suite 200 Great Neck, New York 11021

Re: K211464

Trade/Device Name: Nitta M&T Safety Box Regulation Number: 21 CFR 880.5570 Regulation Name: Hypodermic single lumen needle Regulatory Class: Class II Product Code: MMK Dated: August 4, 2021 Received: August 4, 2021

Dear Vaibhav Rajal:

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

1

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 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@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

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

2

Indications for Use

510(k) Number (if known) K211464

Device Name Nitta M&T Safety Box

Indications for Use (Describe)

Nitta M&T Safety Boxes are intended to provide a receptacle for used, contaminated medical sharps and act as an enclosure during transport to ultimate disposal. The device is intended to be used for safe disposal of hazardous sharps such as hypodermic needles, syringes, and blood needles by qualified personnel in health care facilities and other facilities in which medical sharps may be used. The device is not in contact with or available to the patient in normal use.

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

Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)
----------------------------------------------	---------------------------------------------

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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3

General Specifications Table

| Model No. | Weight(g
) | Capacity
(Total)
ml | Capacity
(Full
line) | Dimensions of
goods (mm) (L x
W x H) | Colors |
|----------------|---------------|---------------------------|----------------------------|--------------------------------------------|------------------------------------------|
| NT-
001*/** | 149 | 1,000 | 735 | 113 x 109 x 135 | Red / Yellow |
| NT-
002*/** | 210 | 1,970 | 1,490 | 151 x 150 x 137 | Red / Yellow base and
transparent lid |
| NT-
003*/** | 441 | 3,350 | 2,780 | 132 x 246 x 198 | Red / Yellow base and
transparent lid |
| NT-004* | 563 | 5,060 | 3,750 | 136 x 279 x 210 | Red / Yellow |
| NT-
005*/** | 660 | 8,015 | 6,750 | 132 x 246 x 400 | Red / Yellow base and
transparent lid |
| NT-
006*/** | 456 | 3,350 | 2,500 | 136 x 235 x 210 | Red / Yellow base and
transparent lid |
| NT-
007*/** | 674 | 8,015 | 6,750 | 136 x 245 x 422 | Red / Yellow base and
transparent lid |
| NT-008 | 48 g | 210 | 160 | 78 x 50 x 82 | Red / Yellow |

Intended to be used in areas where there is no unsupervised patient access.

** Intended for use with mounting accessories.

| Model
No. | Lid
configuration | Locking
mechanism | Dimension
s of
aperture
(mm) | Needle unwinder | Mounting Accessories |
|--------------|----------------------|----------------------|---------------------------------------|-----------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------|
| NT-001 | Opening Hinge | Hinged closure | 45 x 38 | Luer slip and luer lock needle unwinder, and Pen-needle unwinding port are in the lid and above the containment area. | A) Freestanding
B) Rubber Stabilizer
C) Metal pole mounting bracket
D) Metal hook bracket |
| NT-002 | Opening Hinge | Hinged closure | 106 x 41.6 | | A) Freestanding
B) Rubber Stabilizer
C) Metal pole mounting bracket
D) Metal hook bracket |
| NT-003 | Opening Hinge | Hinged closure | 185 x 44.8 | | A) Freestanding
B) Lockable wall mount cabinet
C) Metal pole mounting bracket
D) Metal hook bracket |
| NT-005 | Opening Hinge | Hinged closure | 185 x 44.8 | | A) Freestanding
B) Rubber Stabilizer
C) Metal pole mounting bracket |

4

Nitta M&T

ni 12120 Thailand

| NT-004 | Openin
g Hinge | Hinged
closure | 240 x 55.8 | Luer slip and luer lock
needle unwinder is in the
lid and above the
containment area. | D) Metal hook bracket
A) Freestanding |
|--------|--------------------|--------------------|------------|------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------|
| NT-006 | Counter
Balance | Counter
Balance | 198 x 55 | n/a | A) Freestanding
B) Lockable wall mount
cabinet
C) Metal pole mounting
bracket
D) Metal hook bracket |
| NT-007 | Counter
Balance | Counter
Balance | 198 x 55 | n/a | A) Freestanding
B) Rubber Stabilizer
C) Metal pole mounting
bracket
D) Metal hook bracket |
| NT-008 | Openin
g Hinge | Hinged
closure | n/a | Pen-needle unwinding
port is in the lid and
above the containment
area. | A) Freestanding |

Accessories

Nitta M&T offers several mounting accessories for own sharps containers.

Manufacture	Part Number	Description
SARAYA	77251 1L Rubber stands	Table top Rubber Stabilizer of NT-001
SARAYA	77248 1L SS pole bracket	Holding bracket for pole mounting of NT-001
SARAYA	77256 1L SS hook type bracket	Hook type bracket of NT-001
FINEPRO	77252 1.5L Rubber stand	Table top Rubber Stabilizer of NT-002
SARAYA	77249 1.5L SS pole bracket	Holding bracket for pole mounting of NT-002
SARAYA	77257 1.5L SS hook type bracket	Hook type bracket of NT-002
SARAYA	77250 3.2L/7.6L SS pole bracket	Table top Rubber Stabilizer of NT-003, NT-005, NT-006, NT-007
SARAYA	77258 3.2L/7.6L SS hook type bracket	Holding bracket for pole mounting of NT-003, NT-005, NT-006, NT-007
Nitta M&T	NT-010 3.2L Lockable wall mount cabinet	Lockable wall mounting cabinet of NT-003, NT-006
Nitta M&T	NT-016 Rubber Stabilizer for 3.2L/7.6L
Safety Box	Table top Rubber Stabilizer of NT-003, NT-005, NT-006, NT-007
Nitta M&T	NT-017 7.6L Lockable wall mount cabinet	Lockable wall mounting cabinet of NT-005,007

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Image /page/5/Picture/0 description: The image shows the logo for Nitta M&T. The logo is written in a cursive font and is blue. The logo has a shadow effect, which makes it appear to be three-dimensional. The logo is simple and easy to read.

i 12120 Thailand

510(k) Summary

The assigned 510(k) number is K211464

1. Submitter's Identification:

Nitta M&T (Thailand) Co., Ltd. 19/52 Unit G5, Phaholyothin Road, Moo 10 Khlong Hueng Khlong Luang Pathumthani, 12120 Thailand.

Date: July 28, 2021

Contact: Mr. Mamiko Oshiro

Nitta M&T (Thailand) Co., Ltd. 19/52 Unit G5, Phaholyothin Road, Moo 10 Khlong Hueng Khlong Luang Pathumthani, 12120 Thailand Email: osiromamiko@nittamold.com

2. Name of the Device:

Nitta M&T Safety Box

Regulation Description: Hypodermic single lumen needle. Product Code: MMK Regulation Number: 880.5570 Device Class: ll

3. Information on Predicate Devices:

Predicate Device:

Trade/Device Name: North American Rescue Sharps Shuttle
. Regulation Number: 21 CFR 880.5570
Regulation Name: Hypodermic Single Lumen Needle
Regulatory Class: Class II
Product Code: MMK

Second Predicate Device:

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

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Image /page/6/Picture/0 description: The image shows the logo for Nitta M&T. The logo is written in a cursive font and is a light blue color. The letters are connected to each other, and the logo has a shadow effect.

i 12120 Thailand

4. Indications for Use Statement:

Nitta M&T Safety Boxes are intended to provide a receptacle for used, contaminated medical sharps and act as an enclosure during transport to ultimate disposal. The device is intended to be used for safe disposal of hazardous sharps such as hypodermic needles, syringes, lancets, and blood needles by qualified personnel in health care facilities and other facilities in which medical sharps may be used. The device is not in contact with or available to the patient in normal use.

General Specifications Table

| Model No. | Weight(g) | Capacity
(Total) ml | Capacity
(Full line) | Dimensions of
goods (mm) (L x
W x H) | Colors |
|----------------|-----------|------------------------|-------------------------|--------------------------------------------|------------------------------------------|
| NT-
001*/** | 149 | 1,000 | 735 | 113 x 109 x 135 | Red / Yellow |
| NT-
002*/** | 210 | 1,970 | 1,490 | 151 x 150 x 137 | Red / Yellow base and
transparent lid |
| NT-
003*/** | 441 | 3,350 | 2,780 | 132 x 246 x 198 | Red / Yellow base and
transparent lid |
| NT-004* | 563 | 5,060 | 3,750 | 136 x 279 x 210 | Red / Yellow |
| NT-
005*/** | 660 | 8,015 | 6,750 | 132 x 246 x 400 | Red / Yellow base and
transparent lid |
| NT-
006*/** | 456 | 3,350 | 2,500 | 136 x 235 x 210 | Red / Yellow base and
transparent lid |
| NT-
007*/** | 674 | 8,015 | 6,750 | 136 x 245 x 422 | Red / Yellow base and
transparent lid |
| NT-008 | 48 g | 210 | 160 | 78 x 50 x 82 | Red / Yellow |

Intended to be used in areas where there is no unsupervised patient access.

** Intended for use with mounting accessories.

| Model
No. | Lid
configuration | Locking
mechanism | Dimension
s of
aperture
(mm) | Needle unwinder | Mounting Accessories |
|--------------|----------------------|----------------------|---------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------|
| NT-001 | Openin
g Hinge | Hinged
closure | 45 x 38 | Luer slip and luer lock
needle unwinder, and
Pen-needle unwinding
port are in the lid and
above the containment
area. | A) Freestanding
B) Rubber Stabilizer
C) Metal pole mounting
bracket
D) Metal hook bracket |
| NT-002 | Openin
g Hinge | Hinged
closure | 106 x 41.6 | | A) Freestanding
B) Rubber Stabilizer |

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Image /page/7/Picture/0 description: The image shows the logo for Nitta M&T. The logo is written in a cursive font and is a light blue color. The logo is slightly tilted to the right. The background is white.

ani 12120 Thailand

| NT-003 | Openin
g Hinge | Hinged closure | 185 x 44.8 | | C) Metal pole mounting
bracket
D) Metal hook bracket |
|--------|--------------------|--------------------|------------|------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------|
| NT-005 | Openin
g Hinge | Hinged closure | 185 x 44.8 | | A) Freestanding
B) Lockable wall mount
cabinet
C) Metal pole mounting
bracket
D) Metal hook bracket |
| NT-004 | Openin
g Hinge | Hinged closure | 240 x 55.8 | Luer slip and luer lock
needle unwinder is in the
lid and above the
containment area. | A) Freestanding |
| NT-006 | Counter
Balance | Counter
Balance | 198 x 55 | n/a | A) Freestanding
B) Lockable wall mount
cabinet
C) Metal pole mounting
bracket
D) Metal hook bracket |
| NT-007 | Counter
Balance | Counter
Balance | 198 x 55 | n/a | A) Freestanding
B) Rubber Stabilizer
C) Metal pole mounting
bracket
D) Metal hook bracket |
| NT-008 | Openin
g Hinge | Hinged closure | n/a | Pen-needle unwinding
port is in the lid and
above the containment
area | A) Freestanding |

Accessories

Nitta M&T offers several mounting accessories for own sharps containers.

Manufacture	Part Number	Description
SARAYA	77251 1L Rubber stands	Table top Rubber Stabilizer of NT-001
SARAYA	77248 1L SS pole bracket	Holding bracket for pole mounting of NT-
001
SARAYA	77256 1L SS hook type bracket	Hook type bracket of NT-001
FINEPRO	77252 1.5L Rubber stand	Table top Rubber Stabilizer of NT-002

8

Image /page/8/Picture/0 description: The image shows the logo for Nitta M&T. The logo is written in a stylized, cursive font. The color of the text is a gradient of blue, with the top of the letters being a lighter shade of blue and the bottom of the letters being a darker shade of blue. The logo is set against a white background.

ni 12120 Thailand

| SARAYA | 77249 1.5L SS pole bracket | Holding bracket for pole mounting of NT-
002 |
|-----------|------------------------------------------------------|------------------------------------------------------------------------|
| SARAYA | 77257 1.5L SS hook type bracket | Hook type bracket of NT-002 |
| SARAYA | 77250 3.2L/7.6L SS pole bracket | Table top Rubber Stabilizer of
NT-003, NT-005, NT-006, NT-007 |
| SARAYA | 77258 3.2L/7.6L SS hook type bracket | Holding bracket for pole mounting of
NT-003, NT-005, NT-006, NT-007 |
| Nitta M&T | NT-010 3.2L Lockable wall mount cabinet | Lockable wall mounting cabinet of
NT-003, NT-006 |
| Nitta M&T | NT-016 Rubber Stabilizer for 3.2L/7.6L
Safety Box | Table top Rubber Stabilizer of NT-003,
NT-005, NT-006, NT-007 |
| Nitta M&T | NT-017 7.6L Lockable wall mount cabinet | Lockable wall mounting cabinet of NT-
005,007 |

5. Device Description:

Nitta M&T Safety Boxes are disposable and non-sterile sharps container and its lid are made of puncture resistant, leak proof polypropylene. These containers are offered in various volumes, sizes, and lid styles. Mounting accessories (brackets) are available for use with 1.0L, 1.5L, 3.2L and 7.6L containers in locking and non-locking variations. Equipped with visible final lock mechanism. A design that allows you to determine and clearly differentiate the permanent and temporary closure engagement by the position of final lock claws.

Device Parts:

| Parts &
Accessories | Product | Material | Patient Contact
(Direct/Indirect)? |
|------------------------|-----------------------------------------------------|---------------|---------------------------------------|
| Lid | All | Polypropylene | No |
| Base | All | Polypropylene | No |
| Lever | NT-001 / NT-002 / NT-003 / NT-004 / NT-005 / NT-008 | ABS | Yes |

6. Technological Characteristic Comparison Table:

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Image /page/9/Picture/0 description: The image shows the logo for Nitta M&T. The logo is written in a cursive font and is blue. The letters are connected and flow together.

Nitta M&T (Thailand) Co., Ltd.

19/52 Unit G5, Phaholyothin Rd., Moo 10
Khlong Nueng, Khlong Luang Pathumthani 12120 Thailand

Characteristic	Submitted Subject Device	Predicate Device	Second Predicate Device	Comparison
510(k)	NA	K152340	K190240	n/a
Device Name	Nitta M&T Safety Box	North American
Rescue Sharps Shuttle	Tiger Sharps Containers	n/a
Product code	MMK	MMK	MMK	Same
Regulation No.	21 CRF 880.5570	21 CRF 880.5570	21 CRF 880.5570	Same
Class	II	II	II	Same
Size	0.2 / 1L / 1.5L / 3.2L / 5.0L /
7.6L	-	1 Quart / 5 Quart / 2 Gallon / 2
Gallon
B / 15 Liter
3 Gallon/ 8 Gallon	Different
Dimensions
(mm)	113 x 109 x 135 / 151 x 150 x
137 / 132 x 246 x 198 / 136 x
279 x 210 / 132 x 246 x 400 /
136 x 235 x 210 / 136 x 245 x
422 / 78 x 50 x 82	Approximately 6.41"
(H) (163mm) by 1.33"
(W I.D.) (34mm)	3.91x3.91x6.37 / 10.60
x4.70x10.64 / 10.84x6.86x10.36
/ 10.22x7.02x13.30 /
9.50x14.77x12.03 /
14.86x7.25x14.00/
10.92x15.61x17.27	Different
Weight range	48-674 g	Approximately 1.5oz	109-1172 g	Different
No. of Pieces	2-6	2-3	2-3	Different
Material	Poly-propylene	Poly-propylene	Poly-propylene	Different
Base Color	Red / Yellow	Non-colored	Red	Different
Clarity	Opaque/translucent	translucent	Opaque/translucent	Different
Method of
Manufacture	Injection Molded	Injection Molded	Injection Molded	Same
Performance
testing
(puncture,
impact,
drop, stability,
integrity)	Pass	Pass	Pass	Same
Standards	ISO23907-1:2019	ISO 23907, ASTM F
2132-01	ISO 23907, ASTM F 2132	Same
Technical
characteristics	Refer to statement in
Summary of Technological
Characteristics section	Refer to statement in
Summary of
Technological
Characteristics section	Refer to statement in Summary
of Technological Characteristics
section	Yes
Lid
configurations
/
aperture
dimensions	Refer to table below in
Indication for Use
section	Refer to table below in
Indication for Use
section	Refer to table below in
Indication for Use
section	Yes
Accessories	Mounting accessories
(brackets) are available for
use with 1.0L, 1.5L, 3.2L and
7.6L containers in locking and
non-locking variations.	Mounting accessories
(brackets) are available
for use with 1g and 2g
containers in locking
and non-locking
variations.	Mounting accessories
(brackets) are available for use
with 1qt, 5qt, 2g and 3g
containers in locking and non-
locking variations.	Different

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i 12120 Thailand

7. Summary of Non-Clinical Tests:

Performance testing was provided to validate and verify that the subject device met all of the requirements of related international standards, including biocompatibility, sterility, and product specifications. Results of these tests demonstrate the subject device met the acceptance criteria or specification in consensus standards provided below.

Summary of Performance Testing:

Test Objective	Testing Standards	Test method	Performance Results
Container Stability	ISO 23907-1:2019	The sharps containers were filled to fill line with material of a density of $(0.20±0.01)$ Kg/l. Placed the container in the most adverse position on its base for toppling on a surface with a minimum inclination angle of 15°	Meets ISO23907-1:2019 Requirements - No more than 0 failures per container were observed.
Handle Strength	ISO 23907-1:2019	The sharps containers were filled to 150% of the manufacturer's allowable gross mass and were	Meets ISO23907-1:2019 Requirements - No failures were observed.

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12120 Thailand

		then suspended by the handles for
		a period of at least 60 minutes.
Puncture
resistance	ISO 23907-1:2019	Fix a hypodermic needle of nominal
size 0.8mm x 25mm conform to
ISO7864 in the needle holder. Place
the test specimen centrally on the
test specimen support (having
6mm diameter hole) with the
inside container surface facing
upwards and lower the 21-gauge
needle vertically (90 $\pm$ 5°) towards
the test specimen at a rate of
(100 $\pm$ 10) mm/min. Allow the
needle to pass through the test
specimen and penetration
resistance was recorded.
Per the acceptance criteria, the
average force was required to be
minimum of 16 N and an average
of 18 N or greater.	Meets ISO23907-1:2019
Requirements -
As such, all Nitta M&T
products were found to meet
the acceptance criteria.
Testing resulted minimum
force of 18.6 N was observed.
Resistance to
Damage
(Drop/Impact
Test)	ISO 23907-1:2019	Sharps container at (23 $\pm$ 5) C or at
least 2 h and carry out the test the
same temperature. These are
designed to conform to specific
shipping and transportation
requirements such as UN
regulations and ADR regulations.
Drop tested at height of 1m per
test standard.	Meets ISO23907-1:2019
Requirements -
No evidence of leakage or
damage resulting in a breach
of the sharps containment
area were observed. As such,
all Nitta M&T products were
found to meet the
acceptance criteria for
resistance to damage from a
vertical drop.

8. Sterility Information

The subject device container is non-sterile; therefore, no sterility testing was performed.

9. Clinical Testing:

Not Applicable.

10. Conclusion:

The conclusions drawn from the non-clinical performance testing data demonstrate that the subject device is as safe, as effective, and performs as well as or better than the legally marketed predicate devices.