Disposable Sterile Syringe, with/without needle;luer/luer-lock, Disposable insulin syringe, Disposable Hypodermic needle

K212033 · Shandong Zhushi Pharmaceutical Group Co., Ltd. · FMF · Aug 17, 2022 · General Hospital

Device Facts

• Record ID: K212033
• Device Name: Disposable Sterile Syringe, with/without needle;luer/luer-lock, Disposable insulin syringe, Disposable Hypodermic needle
• Applicant: Shandong Zhushi Pharmaceutical Group Co., Ltd.
• Product Code: FMF · General Hospital
• Decision Date: Aug 17, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5860
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Sterile Hypodermic Syringe for Single Use with/without need for medical purposes to inject fluid into or withdraw fluid from body. The sterile insulin syringe for single use with needle, with the callbration unit of insulin for U-100, is a device intended for medical purposes for the manual aspiration of insulin, and for the injection of insulin into parts of the body below the surface skin. The sterile insulin syringe for single use with needle, with the callbration unit of insulin for U-40 is a device intended for medical purposes for the manual aspiration of insulin and for the injection of insulin into parts of the body below the surface skin. The Sterile Hypodermic Needle for single use is intended for use with syringes and injection devices for general purpose fluid injection/aspiration.

Device Story

Manual, single-use sterile hypodermic syringes and needles; used by medical professionals, caregivers, or patients for fluid injection/aspiration or insulin delivery. Device consists of barrel, plunger, piston (isoprene rubber), and needle (SUS304). Operation involves manual plunger movement to aspirate or expel fluids. Syringes feature luer/luer-lock tips; insulin syringes include U-100 or U-40 calibration. Devices are EO sterilized. Output is the delivery or withdrawal of fluids/insulin. Benefits include precise manual dosing and sterile fluid administration.

Clinical Evidence

No clinical data. Bench testing only, including performance testing per ISO 7886-1, ISO 7864, ISO 9626, ISO 8537, and ISO 80369-7. Biocompatibility testing conducted per ISO 10993-4/5/10/11/12 and ISO 10993-7.

Technological Characteristics

Materials: PP (barrel, plunger, hub, cap), SUS304 (needle), Isoprene Rubber (piston), PE (insulin syringe caps), Epoxy resin (adhesive). Standards: ISO 7886-1, ISO 7864, ISO 9626, ISO 8537, ISO 80369-7. Sterilization: EO (SAL 10^-6). Connectivity: None. Form factor: Manual piston syringe with luer/luer-lock or fixed needle.

Indications for Use

Indicated for medical professionals, trained caregivers, or patients requiring manual aspiration and injection of fluids or insulin into the body via hypodermic syringe or needle.

Regulatory Classification

Identification

A piston syringe is a device intended for medical purposes that consists of a calibrated hollow barrel and a movable plunger. At one end of the barrel there is a male connector (nozzle) for fitting the female connector (hub) of a hypodermic single lumen needle. The device is used to inject fluids into, or withdraw fluids from, the body.

Predicate Devices

• Sterile Hypodermic Syringe for Single use with/without needle (K190002)

Submission Summary (Full Text)

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August 17, 2022

Shandong Zhushi Pharmaceutical Group Co., Ltd % Bruce Cai Technical Manager Humiss Inc. 5#501, No. 445, Renmin Road, Qingcun Town, Fengxian District Shanghai, 201414 China

Re: K212033

Trade/Device Name: Disposable Sterile Syringe, with/without needle; luer/luer-lock: Sterile Insulin Syringe for Single use, with needle: Sterile Hypodermic needle for Single use Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: Class II Product Code: FMF, FMF, FMI Dated: July 5, 2022 Received: July 11, 2022

Dear Bruce Cai:

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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

CAPT Alan M. Stevens Assistant Director DHT3C: Division of Drug Delivery and General Hospital Devices, and Human Factors OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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#### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

# Indications for Use

510(k) Number (if known) K212033

Device Name

Disposable Sterile Syringe, with/without needle; luer/luer-lock

Indications for Use (Describe)

The Sterile Hypodermic Syringe for Single Use with/without need for medical purposes to inject fluid into or withdraw fluid from body.

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

X 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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Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.

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#### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

# Indications for Use

510(k) Number (if known)

K212033

Device Name

Sterile Insulin Syringe for Single use, with needle

Indications for Use (Describe)

The sterile insulin syringe for single use with needle, with the callbration unit of insulin for U-100, is a device intended for medical purposes for the manual aspiration of insulin, and for the injection of insulin into parts of the body below the surface skin.

The sterile insulin syringe for single use with needle, with the callbration unit of insulin for U-40 is a device intended for medical purposes for the manual aspiration of insulin and for the injection of insulin into parts of the body below the surface skin.

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.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

#### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff [e-mail]

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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#### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

# Indications for Use

510(k) Number (if known)

K212033

Device Name

Sterile Hypodermic needle for Single use

Indications for Use (Describe)

The Sterile Hypodermic Needle for single use is intended for use with syringes and injection devices for general purpose fluid injection/aspiration.

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

X Prescription Use (Part 21 CFR 801 Subpart D)

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

### CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

#### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff [e-mail]

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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# K212033 510(k) SUMMARY

# I. PREPARATION DATE: August 8, 2022

# II. SUBMITTER

Manufacturer name: Shandong Zhushi Pharmaceutical Group Co., Ltd. Address; No. 6, Shande Road, Shan County, Heze City, Shandong Province, 274300, China Contact Person: Junhui Zhu Title: Manager Tel: [phone] Fax: [phone] E-mail: [e-mail]

# III. Correspondent Contact Information

Bruce Cai (Contact Person) Humiss Inc. Tel: [phone] E-mail: [e-mail] Summary Preparation Date: 2021.4.21

# IV. DEVICE

| Name of Device: | - Disposable Sterile Syringe, with/without needle; luer/luer-lock<br>- Sterile Insulin Syringe for Single use, with needle<br>- Sterile Hypodermic needle for Single use |
|---------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common Name | - Disposable Sterile Syringe<br>- Disposable insulin syringe<br>- Disposable Hypodermic needle |
| Classification Name | - Piston Syringe<br>- Piston Syringe<br>- Hypodermic Single Lumen Needle |
| Regulation Number | - 21 CFR 880.5860<br>- 21 CFR 880.5860<br>- 21 CFR 880.5570 |
| Product Code | - FMF<br>- FMF<br>- FMI |
| Device Class | - Class II |

# V. PREDICATE DEVICE

K190002- Sterile Hypodermic Syringe for Single use with/without needle,

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Sterile Insulin Syringe for Single use with needle, Sterile Hypodermic needle for Single use.

# VI. Device Description

| Models | Subject Device |
|--------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product name | Disposable Sterile Syringe, with/without needle; luer/luer-lock |
| Indications for use | The Sterile Hypodermic Syringe for Single Use with/without needle is intended to be used for medical purposes to inject fluid into or withdraw fluid from body. |
| Configuration | Piston, Plunger, Barrel |
| Sterility condition | EO Sterilized |
| Environment of use | Prescription use |
| Intended users | Medical professionals and trained care givers |
| Single use | Yes |
| Operation mode | The plunger of syringe can be pulled and pushed along inside the barrel, allowing the syringe to take in and expel the fluids through the connector to the patient. |
| Length | 83-152mm |
| Diameter | 50-31mm |
| Tip type | luer/luer-lock |
| Needle tip configuration | The blade angle of the injection needle is the long bevel angle. |
| Nozzle type | Luer / Lock, %6 conical, 1,2 mm |
| Barrel marking specs | 0.01ml-0.5ml |
| Graduation legibility | Legible |
| Needle cover dimensions | |
| Needle cover color | Transparent |
| Lubricant composition | Dimethicone |
| Barrel transparency | Transparent/ UV resistant |
| Needle cover strength | 15N (min. 2N max. 15N) |
| Hub/needle bond strength | min. 22-69 N |
| Product performance | Complied with ISO 7886-1, ISO 7864, ISO 9626 |
| Volume | 1mL, 2mL, 2.5mL, 3mL, 5mL, 10mL, 20mL, 25mL, 30mL, 50mL |
| Sizes | 18G, 19G, 20G, 21G, 22G, 23G, 24G, 25G, 26G, 27G |
| Needle Lengths | 13-38 mm |
| Piston material | Isoprene Rubber |
| Barrel material | PP |
| Plunger material | PP |

Table 5.1. Device Description Summary for Disposable Sterile Syringe

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| Needle material | PP, SUS304 |
|------------------|-------------------------------------------------------------------------------------------------------------------------|
| SAL | 10-6 |
| Endotoxin Limit | 20 EU per device |
| Biocompatibility | Complied with ISO 10993-4/5/10/11 (Cytotoxicity, Irritation, Sensitization Acute Systemic Toxicity, Hemolytical effect) |

| Models | Subject Device |
|---------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product name | Sterile Insulin Syringe for Single use, with needle |
| Indications for use | The sterile insulin syringe for single use with needle, with<br>the calibration unit of insulin for U-100, is a device intended<br>for medical purposes for the manual aspiration of insulin,<br>and for the injection of insulin into parts of the body below<br>the surface skin.<br>The sterile insulin syringe for single use with needle, with<br>the calibration unit of insulin for U-40 is a device intended<br>for medical purposes for the manual aspiration of insulin,<br>and for the injection of insulin into parts of the body below<br>the surface skin. |
| Configuration | Needle Cap, Needle, Piston, Plunger, Barrel, End Cap |
| Sterility condition | EO Sterilized |
| Environment of use | Prescription use |
| Single use | Yes |
| Operation mode | The plunger of syringe can be pulled and pushed along<br>inside the barrel, allowing the syringe to take in and expel<br>the fluids through the connector to the patient. |
| Product performance | Complied with ISO 8537 |
| Volume | 0.5ml, 1ml volumes with fixed needle |
| Needle Lengths | 8mm |
| Piston material | Isoprene Rubber |
| Barrel material | PP |
| Plunger material | PP |
| Needle material | SUS304 |
| Needle Cap material | PE |
| End Cap material | PE |
| SAL | 10-6 |
| Endotoxin Limit | 20 EU per device |
| Biocompatibility | ISO 10993-4/5/10/11 (Cytotoxicity, Irritation, Sensitization<br>Acute Systemic Toxicity, Subchronic Toxicity, Hemolytical<br>effect |

# Table 5.2. Device Description Summary for Insulin Syringe

# Table 5.3. Device Description Summary for Needle

| Models | Subject device |
|--------|----------------|
|--------|----------------|

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| Product name | Sterile Hypodermic needle for Single use |
|--------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for use | The Sterile Hypodermic Needle for single use is intended for use with syringes and injection devices for general purpose fluid injection/aspiration. |
| Configuration | Protective cap, Needle, Adhesives, Needle hub |
| Sterility condition | EO Sterilized |
| Environment of use | Prescription use |
| Intended users | Medical professionals and trained care givers |
| Configuration | Protective cap, Needle, Adhesives, Needle hub |
| Single use | Yes |
| Operation mode | For Manual Use Only, For Single Use only |
| Product performance | Complied with: ISO 7864, ISO 9626 |
| Sizes | 18G, 19G, 20G, 21G, 22G, 23G, 24G, 25G, 26G, 27G, 28G, 30G |
| Needle Lengths | 13-38 mm |
| Protective cap materials | PP |
| Adhesive | Epoxy resin |
| Needle Hub materials | PP |
| Needle material | SUS304 |
| SAL | 10-6 |
| Endotoxin Limit | 20 EU per device |
| Biocompatibility | Complied with ISO 10993-4/5/10/11 (Cytotoxicity, Irritation, Sensitization Acute Systemic Toxicity, Hemolytical effect) |

# VII. Predicate Comparison

| Table 6.1 Sterile Hypodermic Syringe for Single use, with/without needle; luer/luer-lock |
|------------------------------------------------------------------------------------------|
| Predicate Comparison |

| Models | Subject Device | Predicate Device<br>K190002 | Comparison |
|------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| Product name | Disposable Sterile Syringe,<br>with/without needle;<br>luer/luer-lock | Sterile Hypodermic<br>Syringe for Single use,<br>with/without needle | Similar |
| Product code | FMF | FMF | Same |
| Regulation<br>number | 21 CFR 880.5860 | 21 CFR 880.5860 | Same |
| Class | II | II | Same |
| Indications for<br>use | The Sterile Hypodermic<br>Syringe for Single Use<br>with/without needle is<br>intended to be used for<br>medical purposes to inject<br>fluid into or withdraw fluid | The Sterile Hypodermic<br>Syringe for Single Use<br>with/without needle is<br>intended to be used for<br>medical purposes to inject<br>fluid into or withdraw | Same |

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| | from body. | fluid from body. | |
|----------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------|
| Configuration | Piston, Plunger, Barrel | Piston, Plunger, Barrel | Same |
| Sterility condition | EO Sterilized | EO Sterilized | Same |
| Environment of use | Prescription use | Prescription use | Same |
| Intended users | Medical professionals and trained care givers | Medical professionals and trained care givers | Same |
| Single use | Yes | Yes | Same |
| Operation mode | The plunger of syringe can be pulled and pushed along inside the barrel, allowing the syringe to take in and expel the fluids through the connector to the patient. | The plunger of syringe can be pulled and pushed along inside the barrel, allowing the syringe to take in and expel the fluids through the connector to the patient. | Same |
| Label/labeling | Complied with 21 CFR part 801 | Complied with 21 CFR part 801 | Same |
| Product performance | Complied with ISO 7886-1, ISO 7864, ISO 9626 | Complied with ISO 7886-1, ISO 7864, ISO 9626 | Same |
| Volume | 1mL, 2mL, 2.5mL, 3mL, 5mL, 10mL, 20mL, 25mL, 30mL, 50mL | 1mL, 3mL, 5mL, 6mL, 10mL, 20mL, 30mL, 35mL, 50mL and 60 mL | Difference 1 |
| Sizes | 18G, 19G, 20G, 21G, 22G, 23G, 24G, 25G, 26G, 27G | 18G, 19G, 20G, 21G, 22G, 23G, 24G, 25G, 26G, 27G, 28G, 29G, 30G | Difference 2 |
| Needle Lengths | 13-38 mm | 4-38 mm | Difference 3 |
| Patient contact component and material | | | |
| Piston | Isoprene Rubber | Isoprene Rubber | Same |
| Barrel | PP | PP | Same |
| Plunger | PP | PP | Same |
| Needle | PP, SUS304 | PP, SUS304 | Same |
| Sterilization | | | |
| SAL | 10-6 | 10-6 | Same |
| Endotoxin Limit | 20 EU per device | 20 EU per device | Same |

# Table 6.2. Sterile Insulin Syringe for Single use, with needle Predicate Comparison

| Models | Subject Device | Predicate Device<br>K190002 | |
|--------------|--------------------------------------------------------|-------------------------------|------|
| Product name | Sterile Insulin Syringe for<br>Single use, with needle | Disposable insulin<br>syringe | Same |

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| Product code | FMF | FMF | Same |
|----------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------|
| Regulation<br>number | 21 CFR 880.5860 | 21 CFR 880.5860 | Same |
| Class | II | II | Same |
| Indications for<br>use | The sterile insulin syringe<br>for single use with needle,<br>with the calibration unit of<br>insulin for U-100, is a device<br>intended for medical<br>purposes for the manual<br>aspiration of insulin, and for<br>the injection of insulin into<br>parts of the body below the<br>surface skin.<br>The sterile insulin syringe<br>for single use with needle,<br>with the calibration unit of<br>insulin for U-40 is a device<br>intended for medical<br>purposes for the manual<br>aspiration of insulin, and for<br>the injection of insulin into<br>parts of the body below the<br>surface skin. | The sterile insulin<br>syringe for single use<br>with needle, with the<br>calibration unit of<br>insulin for U-100, is a<br>device intended for<br>medical purposes for the<br>manual aspiration of<br>insulin, and for the<br>injection of insulin into<br>parts of the body below<br>the surface skin.<br>The sterile insulin<br>syringe for single use<br>with needle, with the<br>calibration unit of<br>insulin for U-40 is a<br>device intended for<br>medical purposes for the<br>manual aspiration of<br>insulin, and for the<br>injection of insulin into<br>parts of the body below<br>the surface skin. | Same |
| Configuration | Needle Cap, Needle, Piston,<br>Plunger, Barrel, End Cap | Needle Cap, Needle,<br>Piston, Plunger, Barrel,<br>End Cap | Same |
| Sterility<br>condition | EO Sterilized | EO Sterilized | Same |
| Environment of<br>use | Prescription use | Prescription use | Same |
| Intended users | Patient use | Patient use | Same |
| Single use | Yes | Yes | Same |
| Operation mode | The plunger of syringe can<br>be pulled and pushed along<br>inside the barrel, allowing<br>the syringe to take in and<br>expel the fluids through the<br>connector to the patient. | The plunger of syringe<br>can be pulled and<br>pushed along inside the<br>barrel, allowing the<br>syringe to take in and<br>expel the fluids through<br>the connector to the | Same |
| Label/labeling | Complied with 21 CFR part 801 | Complied with 21 CFR part 801 | Same |
| Product performance | Complied with ISO 8537 | Complied with ISO 8537 | Same |
| Volume | 0.5ml, 1ml volumes with fixed needle | 0.3ml, 0.5ml, 1ml volumes with fixed needle | Difference 4 |
| Needle Lengths | 8mm | 8mm, 13mm | Difference 5 |
| Patient contact component and material | | | |
| Piston | Isoprene Rubber | Isoprene Rubber | Same |
| Barrel | PP | PP | Same |
| Plunger | PP | PP | Same |
| Needle | PP, SUS304 | PP, SUS304 | Same |
| Needle cap / End Cap | PE/PE | PP/PP | Difference 6 |
| Sterilization | | | |
| SAL | 10-6 | 10-6 | Same |
| Endotoxin Limit | 20 EU per device | 20 EU per device | Same |

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Table 6.3. Sterile Hypodermic needle for Single use Predicate Comparison

| Models | Subject Device | Predicate Device K190002 | |
|---------------------|------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| Product name | Sterile Hypodermic needle for Single use | Sterile Hypodermic needle for Single use | |
| Product code | FMI | FMI | |
| Regulation number | 21 CFR 880.5570 | 21 CFR 880.5570 | |
| Class | II | II | |
| Intended users | The Sterile Hypodermic Needle for single use is intended for use with syringes and injection devices for general purpose fluid injection/aspiration. | The Sterile Hypodermic Needle for single use is intended for use with syringes and injection devices for general purpose fluid injection/aspiration. | |
| Configuration | Protective cap, Needle, Adhesives, Needle hub | Protective cap, Needle, Adhesives, Needle hub | |
| Sterility condition | EO Sterilized | EO Sterilized | |
| Environment of use | Prescription use | Prescription use | |
| Single use | Yes…