Blue Nitrile Examination Gloves Powder Free

K192333 · Jr Engineering & Medical Technologies (M) Sdn. Bhd. · LZA · Jan 24, 2020 · General Hospital

Device Facts

• Record ID: K192333
• Device Name: Blue Nitrile Examination Gloves Powder Free
• Applicant: Jr Engineering & Medical Technologies (M) Sdn. Bhd.
• Product Code: LZA · General Hospital
• Decision Date: Jan 24, 2020
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Intended Use

JR MEDIC Blue Nitrile Examination Gloves Powder Free is disposable devices intended for medical purpose that are worn on the examiner's hand to prevent contamination between patient and examiner.

Device Story

Disposable patient examination gloves; made from acrylonitrile-butadiene copolymer (nitrile). Worn by healthcare examiners to provide barrier protection; prevents cross-contamination between patient and examiner. Used in clinical settings; manual operation by clinician. Device is blue, powder-free, and features finger-textured surface. Provides physical barrier; performance verified against ASTM standards for tensile strength, elongation, and water-tightness. Benefits patient and clinician by reducing risk of infection transmission during physical examinations.

Clinical Evidence

Bench testing only. No clinical data provided. Performance verified via ASTM D6319-10 (dimensions, physical properties, thickness), ASTM D5151-06 (water-tightness), and ASTM D6124-06 (residual powder). Biocompatibility testing performed per ISO 10993-10 (irritation, sensitization), ISO 10993-5 (cytotoxicity), ISO 10993-11 (systemic toxicity), and USP 41 <151> (pyrogenicity).

Technological Characteristics

Material: Acrylonitrile-butadiene copolymer (nitrile). Form factor: Disposable, blue, powder-free, finger-textured. Standards: ASTM D6319-10, ASTM D5151-06, ASTM D6124-06, ISO 10993 series. Energy source: None (manual). Connectivity: None. Sterilization: Not specified.

Indications for Use

Indicated for use as a disposable medical glove worn on the examiner's hand to prevent contamination between patient and examiner. Suitable for general patient examination use.

Regulatory Classification

Identification

A non-powdered patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. A non-powdered patient examination glove does not incorporate powder for purposes other than manufacturing. The final finished glove includes only residual powder from manufacturing.

Predicate Devices

• MCare Blue Nitrile Examination Gloves Powder-free (K172930)

Submission Summary (Full Text)

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January 24, 2020

JR Engineering & Medical Technologies (M) SDN.BHD. % Manoj Zacharias Consultant Liberty Management Group Ltd. 75 Executive Dr. STE 114 Aurora, Illinois 60504

Re: K192333

Trade/Device Name: Blue Nitrile Examination Gloves Powder Free Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I Product Code: LZA Dated: December 11, 2019 Received: December 16, 2019

Dear Manoj Zacharias:

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.

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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 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 (OS) 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.

For Elizabeth Claverie, M.S. 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

Enclosure

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# Indications for Use

510(k) Number (if known) K192333

Device Name

Blue Nitrile Examination Gloves Powder Free

#### Indications for Use (Describe)

Blue Nitrile Examination Gloves Powder Free is disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.

| Type of Use (Select one or both, as applicable) |
|---------------------------------------------------------------------------------|
| <input type="checkbox"/> Prescription Use (Part 21 CFR 201 Subpart D) |
| <input checked="" type="checkbox"/> Over-The-Counter Use (21 CFR 201 Subpart C) |

__ Prescription Use (Part 21 CFR 801 Subpart D)

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

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SUBMISSION OF PREMARKET NOTIFICATION (510K) FOR BLUE NITRILE EXAMINATION GLOVES POWDER FREE

#### 510K SUMMARY as required by: 21CFR § 807.92(c) K192333

# A. APPLICANT INFORMATION

| 510(k) Owner's Name | JR Engineering & Medical Technologies (M) SDN.BHD. |
|---------------------|-----------------------------------------------------------------------------------------------------------------------------------|
| Address | Lot 8 & 10, Jalan Zurah 3, Lot 1 & 3, Jalan Zurah, 3A/1,<br>Pusat Perindustrian 2, 44200 Rasa, Selangor Darul<br>Ehsan, Malaysia. |
| Phone | [phone] |
| Fax | [phone] |
| E-mail | [e-mail] |
| Contact Person | Mr.Ganesan Subramaniam |
| Designation | Managing Director |
| Contact Number | [phone] |
| Contact Email | [e-mail] |
| Date Submitted | 5th Aug 2019 |

# B. DEVICE IDENTIFICATION

| Name of the device | Blue Nitrile Examination Gloves Powder Free |
|-----------------------------------|---------------------------------------------|
| Product proprietary or trade name | JR MEDIC |
| Common or usual name | Exam Gloves |
| Classification name | Patient Examination Gloves |
| Device Classification | Class-1 |
| Product Code | LZA |
| Regulation Number | 21 CFR 880.6250 |
| Review Panel | General Hospital |

# C. Predicate Device

| Predicate Device | MCare Blue Nitrile Examination Gloves<br>Powder-free |
|------------------|------------------------------------------------------|
| 510( k) Number | K172930 |
| Regulatory Class | 1 |
| Product code | LZA |

# D. DESCRIPTION OF THE DEVICE:

JR MEDIC Blue Nitrile Examination Gloves Powder Free are Class I patient examination gloves bearing the product code Nitrile - LZA (21CFR880.6250).

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SUBMISSION OF PREMARKET NOTIFICATION (510K) FOR BLUE NITRILE EXAMINATION GLOVES POWDER FREE

The gloves are made from acrylonitrile-butadiene copolymer dispersion. These gloves are blue in color and are powder free.

#### E.INTENDED USE OF THE DEVICE:

JR MEDIC Blue Nitrile Examination Gloves Powder Free is disposable devices intended for medical purpose that are worn on the examiner's hand to prevent contamination between patient and examiner.

# F. SUMMARY OF THE TECHNOLOGICAL CHARACTERISTICS OF THE DEVICE COMPARED TO THE PREDICATE DEVICE

| CHARACTERSTICS | STANDARDS | DEVICE PERFORMANCE | | Remarks |
|---------------------|-----------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------|
| | | PREDICATE | SUBJECT | |
| 510(k) Number | | K172930 | K192333 | ---- |
| Name of device | | MCare Blue Nitrile<br>Examination Gloves<br>Powder Free | JR MEDIC Blue<br>Nitrile Examination<br>Gloves Powder Free | ---- |
| Dimensions | ASTMD6319-10<br>(Reapproved 2015) | Length Min 230 m<br>Width Min 95+/-10<br>mm(for medium<br>size) | Length Min 230 mm<br>Width Min 95+/-10<br>mm<br>(for medium size) | Same |
| Physical Properties | ASTMD6319-10<br>(Reapproved 2015) | <b>Before Aging</b><br>Tensile Strength<br>min 14 Mpa<br>Ultimate Elongation<br>Min 500%<br><b>After Aging</b><br>Tensile Strength<br>min 14 Mpa<br>Ultimate Elongation<br>Min 400% | <b>Before Aging</b><br>Tensile Strength<br>min 14 Mpa<br>Ultimate Elongation<br>Min 500%<br><b>After Aging</b><br>Tensile Strength<br>min 14 Mpa<br>Ultimate Elongation<br>Min 400% | Same |
| Thickness | ASTMD6319-10<br>(Reapproved 2015) | Palm min 0.05 mm<br>Finger min 0.05 mm | Palm min 0.05 mm<br>Finger min 0.05 mm | Same |
| Powder Free | ASTMD6319-10 | ≤2 mg/glove | ≤2 mg/glove | Similar |
| Biocompatibility | Primary Skin<br>Irritation-ISO 10993-<br>10:2010(E) | Under the condition<br>of study not an<br>irritant | Under the condition<br>of study not an<br>irritant | Same |
| | Dermal Sensitization-<br>ISO 10993-10:2010(<br>E) | Under the conditions<br>of the study not a<br>sensitizer | Under the conditions<br>of the study not a<br>sensitizer | Same |
| | In vitro cytotoxicity<br>ISO10993-5 :2009(E) | Data Not available | Under the conditions<br>of the study,<br>cytotoxic.<br>Additional testing<br>was performed to<br>determine if this was<br>a systemic toxicity<br>concern | ---- |

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SUBMISSION OF PREMARKET NOTIFICATION (510K) FOR BLUE NITRILE EXAMINATION GLOVES POWDER FREE

| POWDER FREE | | | |
|----------------------------------------------------------------------------|--------------------|--------------------------------------------------------------------------------------------------------------------------------|-------|
| Acute Systemic<br>Toxicity Test ISO<br>10993-11:2017(E) | Data Not available | Under the condition<br>of study the device<br>extracts do not pose a<br>systemic toxicity<br>concern | ----- |
| Material Mediated<br>Pyrogenicity ISO<br>10993-11:2017(E) /<br>USP 41<151> | Data Not available | Under the conditions<br>of the study, the<br>device did not<br>demonstrate a<br>material mediated<br>pyrogenicity<br>response. | ----- |

| CHARACTERSTICS | STANDARDS | DEVICE PERFORMANCE | | Remarks |
|-----------------------|------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------|
| | | PREDICATE | CURRENT | |
| Water Tight (1000 ml) | ASTM D5151-06 | Passes | Passes AQL-2.5 | Similar |
| Intended use | | MCare Blue Nitrile<br>Examination<br>Gloves<br>Powder<br>free is disposable<br>devices<br>intended<br>for<br>medical<br>purpose that are<br>won on<br>the<br>examiner's hand to<br>prevent<br>contamination<br>between<br>patient<br>and examiner. | JR MEDIC Blue Nitrile<br>Examination<br>Gloves<br>Powder Free is disposable<br>devices intended<br>for<br>medical purpose that are<br>won on the examiner's<br>hand to<br>prevent<br>contamination<br>between<br>patient and examiner. | Similar |
| Material | ASTMD6910-10<br>(Reapproved<br>2015) | Nitrile | Nitrile | Same |
| Color | - | Blue | Blue | Same |
| Texture | - | Finger Texture | Finger texture | Same |
| Size | ASTMD6319-10<br>(Reapproved<br>2015) | Extra Small, Small,<br>Medium, Large,<br>Extra Large | Extra Small, Small,<br>Medium, Large, Extra<br>Large | Same |
| Single Use | Medical Glove<br>Guidance Manual<br>- Labeling | Single Use | Single Use | Same |
| Manufacturer(s) | - | Mercator Medical<br>(Thailand) LTD | JR Engineering &<br>Medical Technologies<br>(M) SDN.BHD.<br>Malaysia | ----- |

There are no significant differences between the two products and are identical in terms of intended use, materials, design, manufacturing methods. Both devices meet the ASTM standard D6913-10.

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SUBMISSION OF PREMARKET NOTIFICATION (510K) FOR BLUE NITRILE EXAMINATION GLOVES POWDER FREE

# G. Non-Clinical Testing Summary

PERFORMANCE DATA

| Test Method | Purpose | Acceptance Criteria | Result |
|------------------------------------------------------------------------------------------------------------------------|------------------------------------------|---------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------|
| ASTM D6319-10 (Reapproved<br>2015) Standard Specification<br>for Nitrile Examination Gloves<br>for Medical Application | To determine the<br>length of the gloves | Min 230 mm for all sizes | X-Small:-404 mm<br>Small:-404 mm<br>Medium:-405 mm<br>Large:-404 mm<br>X-Large:-404 mm |
| ASTM D6319-10 (Reapproved<br>2015) Standard Specification<br>for Nitrile Examination Gloves<br>for Medical Application | To determine the<br>width of the gloves | X-small:- 70+/-10 mm<br>Small:-80+/-10 mm<br>Medium:-95+/-10 mm<br>Large:-110+/-10 mm<br>X-Large:-120+/-10 mm | X-small:-74 mm<br>Small:-84 mm<br>Medium:-94 mm<br>Large:-105 mm<br>X-Large:-115 mm |

| Test Method | Purpose | Acceptance Criteria | Result |
|------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| ASTM D6319-10 (Reapproved<br>2015) Standard Specification<br>for Nitrile Examination Gloves<br>for Medical Application | To determine the<br>thickness of the<br>gloves | Palm 0.05 mm min<br>Finger 0.05 mm min<br>for all sizes | Size                Palm                Finger<br>X-Small                0.20mm                0.22mm<br>Small                    0.19mm                0.21mm<br>Medium                0.20mm                0.22mm<br>Large                    0.20mm                0.21mm<br>X-Large                0.20mm                0.22mm |
| | To Determine the<br>physical properties-<br>Tensile strength | Before Ageing<br>Tensile Strength<br>14Mpa Min for all<br>sizes<br>After Ageing<br>Tensile Strength<br>14Mpa Min for all<br>sizes | Size                Before                After<br>ageing                ageing<br>X-Small                22.0Mpa                18.5Mpa<br>Small                    23.0Mpa                20.5Mpa<br>Medium                25.6Mpa                22.0 Mpa<br>Large                    24.0Mpa                21.0Mpa<br>X-Large                24.5Mpa                21.7Mpa |
| ASTM D6319-10 (Reapproved<br>2015) Standard Specification<br>for Nitrile Examination Gloves<br>for Medical Application | To Determine the<br>physical properties-<br>Ultimate Elongation | Before Ageing<br>Ultimate Elongation<br>500% Min for all<br>sizes<br>After Ageing<br>Ultimate<br>Elongation 400%<br>Min for all sizes | Size                Before                After<br>ageing                ageing<br>X-Small                898%                    872%<br>Small                    896%                    861%<br>Medium                868%                    828%<br>Large                    899%                    869%<br>X-Large                874%                    853% |

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# SUBMISSION OF PREMARKET NOTIFICATION (510K) FOR BLUE NITRILE EXAMINATION GLOVES POWDER FREE

| Test Method | Purpose | Acceptance Criteria | Result |
|--------------------------------------------------------------------------------------------------------|------------------------------------------------------|---------------------|------------------------------------------------------------------------------------------------------------------------------|
| ASTM D5151-06 (Reapproved<br>2015) Standard Test Method<br>for Detection of Holes in<br>Medical Gloves | To determine the<br>holes in the gloves | AQL 2.5 | Gloves Passes AQL 1.5 |
| ASTM D6124-06 (Reapproved<br>2017) Standard Test Method<br>for Residual Powder on<br>Medical Gloves | To determine the<br>residual powder in the<br>gloves | 2 Mg/Glove Max | Size<br>X-small 0.16 mg/glove<br>Small 0.20 mg/glove<br>Medium 0.21 mg/glove<br>Large 0.20 mg/glove<br>X-Large 0.21 mg/glove |

### BIO-COMPATIBILITY DATA

| Test Method | Purpose | Acceptance Criteria | Result |
|---------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------|
| ISO<br>10993-10 Biological<br>Evaluation of Medical Devices<br>Test for Irritation and Skin<br>Sensitization. Test done for<br>irritation. | To determine the potential of<br>the material under test to<br>produce dermal irritation in<br>Rabbits | Under the condition<br>of study not an<br>irritant | Under the condition of<br>study not an irritant |
| ISO 10993-10 Biological<br>Evaluation of Medical Devices<br>Test for Irritation and Skin<br>Sensitization. Test done Skin<br>sensitization. | To determine the skin<br>sensitization potential of the<br>material both in terms of<br>induction and elicitation in<br>Guinea Pig. | Under the<br>conditions of the<br>study not a<br>sensitizer | Under the conditions of<br>the study not a<br>sensitizer |
| ISO 10993-5:2009 biological<br>evaluation of medical devices -<br>part 5, tests for in vitro<br>cytotoxicity. | To evaluate the in vitro<br>cytotoxic potential of the test<br>item (both inner and outer<br>surface) Extracts<br>in L-929<br>mouse fibroblasts cells using<br>elution method. | Under the<br>conditions of study<br>non cytotoxic | Under the conditions of<br>the study, cytotoxic.<br>Additional testing was<br>performed to determine<br>if this was a systemic<br>toxicity concern. |
| ISO 10993-11:2017 biological<br>evaluation of medical devices -<br>part 11, tests for systemic<br>toxicity. | To determine the acute<br>systemic toxicity potential of<br>the test item extracts (both<br>inside and outer surfaces) in<br>swiss Albino mice. | Under the<br>conditions of study<br>the device extracts<br>do not pose a<br>systemic toxicity<br>concern | Under the conditions<br>of study the device<br>extracts do not pose a<br>systemic toxicity<br>concern |
| USP 41<151> Pyrogen Test. | To determine the pyrogenic<br>potential of the test item<br>extract following intravenous<br>injection in New Zealand<br>white Rabbits. | Under the<br>conditions of the<br>study, the device<br>did not<br>demonstrate a<br>material mediated<br>pyrogenicity<br>response. | Under the conditions of<br>the study, the device did<br>not demonstrate a<br>material mediated<br>pyrogenicity response. |

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SUBMISSION OF PREMARKET NOTIFICATION (510K) FOR BLUE NITRILE EXAMINATION GLOVES POWDER FREE

# H. Clinical Testing Summary

Not applicable - Clinical data is not needed for gloves or for most devices cleared by the 510(k) process.

# I. CONCLUSION

The conclusions drawn from the nonclinical test demonstrate that the subject device in 510(K) submission K192333, Blue Nitrile Examination Gloves Powder Free is as safe, as effective, and performs as well as or better than the legally marketed predicate device K172930.