Nitta M&T Safety Box
Device Facts
| Record ID | K211464 |
|---|---|
| Device Name | Nitta M&T Safety Box |
| Applicant | Nitta M&T (Thailand) Co., Ltd. |
| Product Code | MMK · General Hospital |
| Decision Date | Sep 14, 2021 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 880.5570 |
| Device Class | Class 2 |
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, 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.
Device Story
Nitta M&T Safety Boxes are puncture-resistant, leak-proof polypropylene containers for disposal of contaminated medical sharps; used in healthcare facilities by qualified personnel. Containers feature various volumes, lid styles (hinged or counter-balance), and locking mechanisms to secure contents during transport. Some models include integrated needle unwinder ports for luer slip/lock and pen needles. Accessories include mounting brackets (freestanding, pole, wall-mount, hook) for operational stability. Device is non-sterile and intended for areas without unsupervised patient access. Output is a secured, enclosed container for sharps disposal, reducing risk of accidental needlestick injuries to healthcare workers.
Clinical Evidence
No clinical data. Bench testing only. Performance validated against ISO 23907-1:2019 standards, including container stability, handle strength, puncture resistance (min 18.6 N observed), and drop/impact testing (1m height).
Technological Characteristics
Materials: Polypropylene (container/lid), ABS (lever). Construction: Injection molded. Energy: None (mechanical). Connectivity: None. Sterilization: Non-sterile. Standards: ISO 23907-1:2019. Features: Puncture-resistant, leak-proof, various volumes (0.2L-7.6L), locking mechanisms, integrated needle unwinders, mounting accessories.
Indications for Use
Indicated for safe disposal of hazardous sharps (hypodermic needles, syringes, lancets, blood needles) by qualified personnel in healthcare and other facilities where sharps are used. Not for patient contact or patient access.
Regulatory Classification
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.
Predicate Devices
Submission Summary (Full Text)
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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
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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
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# 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) |
|----------------------------------------------|---------------------------------------------|
|----------------------------------------------|---------------------------------------------|
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# General Specifications Table
| Model No. | Weight(g<br>) | Capacity<br>(Total)<br>ml | Capacity<br>(Full<br>line) | Dimensions of<br>goods (mm) (L x<br>W x H) | Colors |
|----------------|---------------|---------------------------|----------------------------|--------------------------------------------|------------------------------------------|
| NT-<br>001*/** | 149 | 1,000 | 735 | 113 x 109 x 135 | Red / Yellow |
| NT-<br>002*/** | 210 | 1,970 | 1,490 | 151 x 150 x 137 | Red / Yellow base and<br>transparent lid |
| NT-<br>003*/** | 441 | 3,350 | 2,780 | 132 x 246 x 198 | Red / Yellow base and<br>transparent lid |
| NT-004* | 563 | 5,060 | 3,750 | 136 x 279 x 210 | Red / Yellow |
| NT-<br>005*/** | 660 | 8,015 | 6,750 | 132 x 246 x 400 | Red / Yellow base and<br>transparent lid |
| NT-<br>006*/** | 456 | 3,350 | 2,500 | 136 x 235 x 210 | Red / Yellow base and<br>transparent lid |
| NT-<br>007*/** | 674 | 8,015 | 6,750 | 136 x 245 x 422 | Red / Yellow base and<br>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<br>No. | Lid<br>configuration | Locking<br>mechanism | Dimension<br>s of<br>aperture<br>(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<br>B) Rubber Stabilizer<br>C) Metal pole mounting bracket<br>D) Metal hook bracket |
| NT-002 | Opening Hinge | Hinged closure | 106 x 41.6 | | A) Freestanding<br>B) Rubber Stabilizer<br>C) Metal pole mounting bracket<br>D) Metal hook bracket |
| NT-003 | Opening Hinge | Hinged closure | 185 x 44.8 | | A) Freestanding<br>B) Lockable wall mount cabinet<br>C) Metal pole mounting bracket<br>D) Metal hook bracket |
| NT-005 | Opening Hinge | Hinged closure | 185 x 44.8 | | A) Freestanding<br>B) Rubber Stabilizer<br>C) Metal pole mounting bracket |
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Nitta M&T
# ni 12120 Thailand
| NT-004 | Openin<br>g Hinge | Hinged<br>closure | 240 x 55.8 | Luer slip and luer lock<br>needle unwinder is in the<br>lid and above the<br>containment area. | D) Metal hook bracket<br>A) Freestanding |
|--------|--------------------|--------------------|------------|------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------|
| NT-006 | Counter<br>Balance | Counter<br>Balance | 198 x 55 | n/a | A) Freestanding<br>B) Lockable wall mount<br>cabinet<br>C) Metal pole mounting<br>bracket<br>D) Metal hook bracket |
| NT-007 | Counter<br>Balance | Counter<br>Balance | 198 x 55 | n/a | A) Freestanding<br>B) Rubber Stabilizer<br>C) Metal pole mounting<br>bracket<br>D) Metal hook bracket |
| NT-008 | Openin<br>g Hinge | Hinged<br>closure | n/a | Pen-needle unwinding<br>port is in the lid and<br>above the containment<br>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<br>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<br>(Total) ml | Capacity<br>(Full line) | Dimensions of<br>goods (mm) (L x<br>W x H) | Colors |
|----------------|-----------|------------------------|-------------------------|--------------------------------------------|------------------------------------------|
| NT-<br>001*/** | 149 | 1,000 | 735 | 113 x 109 x 135 | Red / Yellow |
| NT-<br>002*/** | 210 | 1,970 | 1,490 | 151 x 150 x 137 | Red / Yellow base and<br>transparent lid |
| NT-<br>003*/** | 441 | 3,350 | 2,780 | 132 x 246 x 198 | Red / Yellow base and<br>transparent lid |
| NT-004* | 563 | 5,060 | 3,750 | 136 x 279 x 210 | Red / Yellow |
| NT-<br>005*/** | 660 | 8,015 | 6,750 | 132 x 246 x 400 | Red / Yellow base and<br>transparent lid |
| NT-<br>006*/** | 456 | 3,350 | 2,500 | 136 x 235 x 210 | Red / Yellow base and<br>transparent lid |
| NT-<br>007*/** | 674 | 8,015 | 6,750 | 136 x 245 x 422 | Red / Yellow base and<br>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<br>No. | Lid<br>configuration | Locking<br>mechanism | Dimension<br>s of<br>aperture<br>(mm) | Needle unwinder | Mounting Accessories |
|--------------|----------------------|----------------------|---------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------|
| NT-001 | Openin<br>g Hinge | Hinged<br>closure | 45 x 38 | Luer slip and luer lock<br>needle unwinder, and<br>Pen-needle unwinding<br>port are in the lid and<br>above the containment<br>area. | A) Freestanding<br>B) Rubber Stabilizer<br>C) Metal pole mounting<br>bracket<br>D) Metal hook bracket |
| NT-002 | Openin<br>g Hinge | Hinged<br>closure | 106 x 41.6 | | A) Freestanding<br>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<br>g Hinge | Hinged closure | 185 x 44.8 | | C) Metal pole mounting<br>bracket<br>D) Metal hook bracket |
|--------|--------------------|--------------------|------------|------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------|
| NT-005 | Openin<br>g Hinge | Hinged closure | 185 x 44.8 | | A) Freestanding<br>B) Lockable wall mount<br>cabinet<br>C) Metal pole mounting<br>bracket<br>D) Metal hook bracket |
| NT-004 | Openin<br>g Hinge | Hinged closure | 240 x 55.8 | Luer slip and luer lock<br>needle unwinder is in the<br>lid and above the<br>containment area. | A) Freestanding |
| NT-006 | Counter<br>Balance | Counter<br>Balance | 198 x 55 | n/a | A) Freestanding<br>B) Lockable wall mount<br>cabinet<br>C) Metal pole mounting<br>bracket<br>D) Metal hook bracket |
| NT-007 | Counter<br>Balance | Counter<br>Balance | 198 x 55 | n/a | A) Freestanding<br>B) Rubber Stabilizer<br>C) Metal pole mounting<br>bracket<br>D) Metal hook bracket |
| NT-008 | Openin<br>g Hinge | Hinged closure | n/a | Pen-needle unwinding<br>port is in the lid and<br>above the containment<br>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-<br>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 |
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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-<br>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<br>NT-003, NT-005, NT-006, NT-007 |
| SARAYA | 77258 3.2L/7.6L SS hook type bracket | Holding bracket for pole mounting of<br>NT-003, NT-005, NT-006, NT-007 |
| Nitta M&T | NT-010 3.2L Lockable wall mount cabinet | Lockable wall mounting cabinet of<br>NT-003, NT-006 |
| Nitta M&T | NT-016 Rubber Stabilizer for 3.2L/7.6L<br>Safety Box | Table top Rubber Stabilizer of NT-003,<br>NT-005, NT-006, NT-007 |
| Nitta M&T | NT-017 7.6L Lockable wall mount cabinet | Lockable wall mounting cabinet of NT-<br>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 &<br>Accessories | Product | Material | Patient Contact<br>(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<br>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 /<br>7.6L | - | 1 Quart / 5 Quart / 2 Gallon / 2<br>Gallon<br>B / 15 Liter<br>3 Gallon/ 8 Gallon | Different |
| Dimensions<br>(mm) | 113 x 109 x 135 / 151 x 150 x<br>137 / 132 x 246 x 198 / 136 x<br>279 x 210 / 132 x 246 x 400 /<br>136 x 235 x 210 / 136 x 245 x<br>422 / 78 x 50 x 82 | Approximately 6.41"<br>(H) (163mm) by 1.33"<br>(W I.D.) (34mm) | 3.91x3.91x6.37 / 10.60<br>x4.70x10.64 / 10.84x6.86x10.36<br>/ 10.22x7.02x13.30 /<br>9.50x14.77x12.03 /<br>14.86x7.25x14.00/<br>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<br>Manufacture | Injection Molded | Injection Molded | Injection Molded | Same |
| Performance<br>testing<br>(puncture,<br>impact,<br>drop, stability,<br>integrity) | Pass | Pass | Pass | Same |
| Standards | ISO23907-1:2019 | ISO 23907, ASTM F<br>2132-01 | ISO 23907, ASTM F 2132 | Same |
| Technical<br>characteristics | Refer to statement in<br>Summary of Technological<br>Characteristics section | Refer to statement in<br>Summary of<br>Technological<br>Characteristics section | Refer to statement in Summary<br>of Technological Characteristics<br>section | Yes |
| Lid<br>configurations<br>/<br>aperture<br>dimensions | Refer to table below in<br>Indication for Use<br>section | Refer to table below in<br>Indication for Use<br>section | Refer to table below in<br>Indication for Use<br>section | Yes |
| Accessories | Mounting accessories<br>(brackets) are available for<br>use with 1.0L, 1.5L, 3.2L and<br>7.6L containers in locking and<br>non-locking variations. | Mounting accessories<br>(brackets) are available<br>for use with 1g and 2g<br>containers in locking<br>and non-locking<br>variations. | Mounting accessories<br>(brackets) are available for use<br>with 1qt, 5qt, 2g and 3g<br>containers in locking and non-<br>locking variations. | Different |
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Image /page/10/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 have a shadow effect.
# 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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Image /page/11/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 is on a white background. The letters are connected and have a shadow effect.
# 12120 Thailand
| | | then suspended by the handles for | |
|--------------------------------------------------|------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | | a period of at least 60 minutes. | |
| Puncture<br>resistance | ISO 23907-1:2019 | Fix a hypodermic needle of nominal<br>size 0.8mm x 25mm conform to<br>ISO7864 in the needle holder. Place<br>the test specimen centrally on the<br>test specimen support (having<br>6mm diameter hole) with the<br>inside container surface facing<br>upwards and lower the 21-gauge<br>needle vertically (90 $\pm$ 5°) towards<br>the test specimen at a rate of<br>(100 $\pm$ 10) mm/min. Allow the<br>needle to pass through the test<br>specimen and penetration<br>resistance was recorded.<br>Per the acceptance criteria, the<br>average force was required to be<br>minimum of 16 N and an average<br>of 18 N or greater. | Meets ISO23907-1:2019<br>Requirements -<br>As such, all Nitta M&T<br>products were found to meet<br>the acceptance criteria.<br>Testing resulted minimum<br>force of 18.6 N was observed. |
| Resistance to<br>Damage<br>(Drop/Impact<br>Test) | ISO 23907-1:2019 | Sharps container at (23 $\pm$ 5) C or at<br>least 2 h and carry out the test the<br>same temperature. These are<br>designed to conform to specific<br>shipping and transportation<br>requirements such as UN<br>regulations and ADR regulations.<br>Drop tested at height of 1m per<br>test standard. | Meets ISO23907-1:2019<br>Requirements -<br>No evidence of leakage or<br>damage resulting in a breach<br>of the sharps containment<br>area were observed. As such,<br>all Nitta M&T products were<br>found to meet the<br>acceptance criteria for<br>resistance to damage from a<br>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.
