Tiger Reusable Sharps Container

K203305 · International Marketing Specialists, Inc. · MMK · Aug 6, 2021 · General Hospital

Device Facts

• Record ID: K203305
• Device Name: Tiger Reusable Sharps Container
• Applicant: International Marketing Specialists, Inc.
• Product Code: MMK · General Hospital
• Decision Date: Aug 6, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5570
• Device Class: Class 2

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.

Device Story

Tiger Reusable Sharps Containers are injection-molded polypropylene/polyethylene receptacles for hazardous sharps (needles, syringes, lancets). Used in healthcare settings by qualified personnel; not for areas with unsupervised patient access. Containers are puncture-resistant, leak-resistant, and impact-resistant; feature gravity-activated apertures and permanent/temporary locking mechanisms. Mounted via wall brackets or enclosures. Reusable up to 100 times; requires cleaning and disinfection between cycles. Provides safe containment during storage and transport; prevents accidental needlestick injuries.

Clinical Evidence

No clinical data. Bench testing only. Performance testing included puncture resistance (ASTM F2132-01), DOT drop/stacking/vibration tests (49 CFR 178), container stability, aperture/closure integrity, and accessory strength (ISO 23907). Biological testing (ISO 10993-5, -10) confirmed non-cytotoxic, non-sensitizing, and non-irritating properties. Cleaning and disinfection validation (AAMI TIR 30, ISO/DIS 15883-5) confirmed efficacy with a decontamination assurance level of 10^-4.

Technological Characteristics

Materials: Polypropylene (INEOS PP N02G-00) base, HDPE (ExxonMobil 6719) lid. Design: Injection-molded, reusable, non-sterile. Features: Gravity-activated aperture, permanent/temporary locking mechanisms. Standards: ISO 23907, ISO 23907-2, ASTM F2132-01, 49 CFR 178.603/606/608. Connectivity: None. Energy: None (mechanical).

Indications for Use

Indicated for safe disposal, storage, and transportation of hazardous sharps 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.

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

• Red2Green Reusable Sharps Container (K153363)

Submission Summary (Full Text)

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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

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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

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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 [phone] 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

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### 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)

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### 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: [phone] Email: [e-mail]

### 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<br>Environmental, Inc. | Red2Green Reusable<br>Sharps Container | K153363 |

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

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

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

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| 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<br>2 Gallon mailbox<br>3 Gallon cap<br>3 Gallon mailbox<br>8 Gallon | 2 Gallon<br>3 Gallon<br>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)<br>2 Gallon mailbox: 332.09 x 154.78 x 398.37 (mm)<br>3 Gallon cap: 331.98 x 154.48 x 475.2 (mm)<br>3 Gallon mailbox: 332.09 x 154.78 x 549.37 (mm)<br>8 Gallon: 306.36 x 328.41 x 479.1 (mm) | 2 gallon: 6.3 x 12.8 x 10.4 (inches)<br>3 gallon: 6.3 x 12.8 x 15.3 (inches)<br>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<br>comparison | Subject Device | Predicate Device | Comparison |
| Color | Red | Red or yellow | Identical |
| Needle Removal<br>Mechanism | No | No | Identical |
| Sharps access<br>and closure | Gravity-activated | Gravity-activated | Identical |
| Container Closure | Vertical and horizontal drop, lab lid,<br>transportation lid | Vertical and horizontal drop, lab lid,<br>transportation lid | Identical |
| Accessories | Wall enclosure, wall brackets | Stabilizing tray, wall enclosure, wall bracket,<br>rolling dolly, foot pedal dolly | Identical |
| Reusable or Non-<br>reusable Container | Reusable | Reusable | Identical |
| Non-sterile | Yes | Yes | Identical |
| Performance testing | Container stability<br>Strength of handles<br>Aperture and closure<br>Resistance to penetration<br>Resistance to damage or leakage after dropping<br>Resistance to spillage by toppling<br>Fill line<br>Accessory strength | Puncture resistance<br>Impact w/ leak<br>Stability<br>Accessory strength | The subject device confirms the<br>FDA recently recognized<br>performance standards for reusable<br>sharps containers, including ISO<br>23907 First edition 2012-09-01,<br>ISO 23907-2 First edition 2019-11,<br>ASTM F2132-01 (reapproved<br>2008).<br><br>The test conducted by predict<br>device at past now already included<br>in the FDA recognized<br>performance standards. |
| Element of<br>comparison | Subject Device | Predicate Device | Comparison |
| Lifespan Simulation<br>Testing | Lifespan tumbling simulation<br>Lifespan transport simulations<br>Lifespan processing simulation | Repeated opening<br>Life cycle | The subject device confirms to the<br>FDA recently recognized<br>performance standards for reusable<br>sharps containers, including ISO<br>23907 First edition 2012-09-01,<br>ISO 23907-2 First edition 2019-11,<br>ASTM F2132-01 (reapproved<br>2008); |
| Transportation Test | Impact<br>Stacking<br>Vibration | Impact<br>Stacking<br>Vibration | Identical:<br>Conforms to 49 CFR 178.603<br>Conforms to 49 CFR 178.606<br>Conforms to 49 CFR 178.608 |
| Biological Testing | ISO 0993-5, ISO 10993-10, ISO/DIS 15883-5,<br>In vitro cytotoxicity, skin sensitization, cleaning<br>efficacy. | The predicate is N/A for this testing. | N/A |
| Disinfection | Microbiological Challenge Test,<br>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.

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### 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<br>Criteria | Results |
|-------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------|
| Puncture Resistance<br>of Materials Used in<br>Containers for<br>Discarded Medical<br>Needles and Other<br>Sharps | ASTM F 2132 -01<br>(Reapproved 2008)e1 | The force needed to<br>penetrate test<br>specimens shall be<br>a minimum of 20 N<br>or greater. | Pass |
| DOT Drop Test | 49 CFR 178.603 | There is no damage<br>to the outer<br>packaging likely to<br>adversely affect<br>safety during<br>transport, there is<br>no leakage of the<br>filling substance<br>from the inner<br>packaging。 | Pass |
| DOT Stacking Test | 49 CFR 178.606 | No test sample may<br>show any<br>deterioration or<br>distortion<br>, which could<br>adversely affect<br>safety or container<br>strength during<br>transport causing<br>instability in stacks<br>of packages. | Pass |
| Test | Standard | Acceptance Criteria | Results |
| DOT Vibration<br>standard | 49 CFR 178.608 | A packaging passes<br>the vibration test if<br>there is no<br>rupture or leakage<br>from any of the<br>packages. No test<br>sample should<br>show any<br>deterioration which<br>could<br>adversely affect<br>transportation<br>safety or any<br>distortion<br>liable to reduce<br>packaging strength. | Pass |
| Container stability | ISO 23907<br>ISO 23907-2 | The container shall<br>not topple over<br>when tested | Pass |
| Aperture and closure | ISO 23907<br>ISO 23907-2 | It shall be possible<br>to place sharps into<br>the sharps container<br>without using a<br>second hand to<br>manipulate the<br>aperture. The<br>aperture of<br>containers intended<br>to be placed in<br>public access areas<br>should be designed<br>to restrict hand<br>entry and removal<br>of contents from the<br>container.<br>The aperture should<br>be designed to<br>prevent the risk of<br>overfilling. | Pass |
| Resistance to<br>penetration | ISO 23907<br>ISO 23907-2<br>ASTM F2132-01 | The force needed to<br>penetrate test<br>specimens shall be<br>a minimum of 20 N<br>or greater. | Pass |
| Test | Standard | Acceptance Criteria | Results |
| Resistance to<br>damage or leakage<br>after dropping | ISO 23907<br>ISO 23907-2 | There shall be no<br>evidence of<br>leakage and no<br>breach of<br>the sharps<br>containment area.<br>Minimum five<br>minutes after every<br>topple:<br>- There shall be no<br>evidence that the<br>performance or<br>function of the<br>container has been<br>compromised.<br>- The container's<br>temporary closure<br>shall remain intact. | Pass |
| Resistance to<br>spillage by toppling | ISO 23907<br>ISO 23907-2 | There shall be no<br>evidence of leakage<br>and no breach of<br>the sharps<br>containment area.<br>Minimum five<br>minutes after every<br>topple:<br>- There shall be no<br>evidence that the<br>performance or<br>function of the<br>container has been<br>compromised.<br>- The container's<br>temporary closure<br>shall remain intact. | Pass |
| Test | Standard | Acceptance Criteria | Results |
| Accessory strength test | ISO 23907<br>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<br>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<br>simulation<br>testing | ISO 23907 First<br>edition 2012-09-<br>01<br>ASTM F2132-01<br>(reapproved<br>2008)<br>ISO 23907-2<br>First edition<br>2019-11 | To verify the<br>performance of the<br>devices conforms to<br>the applicable<br>performance<br>standards<br>requirement after<br>Lifespan<br>Simulation Testing. | Pass |
| Cytotoxicity<br>Tests | ISO10993-5 | 8.6 Evaluation<br>Criteria | Based on the conditions of<br>the test, the device was found<br>to be non-cytotoxic |
| Skin<br>Sensitization<br>Test | ISO10993-10 | 9.4 Evaluation of<br>results | Based on the conditions of<br>the test, the device was found<br>to be non-sensitizing |
| Skin Irritation<br>Test | ISO10993-10 | 9.4 Evaluation of<br>results | Based on the conditions of<br>the test, the device was found<br>to be non-irritating |
| Chemical<br>Residues Test | ISO/DIS 15883-5 | 5.3 Quantitative<br>Study of Extracts | Pass |
| Cleaning<br>Validation | FDA Guidance<br>AAMI TIR 30<br>ISO/DIS 15883-5 | 1 Evaluation<br>pass/fail criteria for<br>the residual protein<br>and hemoglobin<br>(blood) by<br>Spectrophotometric<br>method (Method 1)<br><br>2 Evaluation<br>pass/fail criteria for<br>residual TOC by<br>total organic carbon<br>analyzer (Method<br>2) | Pass |
| Test | Standard | Acceptance<br>Criteria | Results |
| Disinfection<br>Validation | FDA Guidance<br>AAMI TIR 30<br>ISO/DIS 15883-5 | The disinfection<br>process should be<br>deemed effective if<br>all three of the<br>following are met:<br>The concentration<br>of the challenge<br>suspension meets<br>1.1.2 c)<br>requirements.<br>The positive<br>control 1.2.2 e)<br>shows microbial<br>growth of each<br>challenge<br>organism.<br>After processing,<br>no challenge<br>organism was<br>recovered at any<br>site. | Pass |

### Performance Testing

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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.