Blue Nitrile Examination Gloves Powder Free

K230601 · Latrile Gloves Private Limited · LZA · May 28, 2023 · General Hospital

Device Facts

• Record ID: K230601
• Device Name: Blue Nitrile Examination Gloves Powder Free
• Applicant: Latrile Gloves Private Limited
• Product Code: LZA · General Hospital
• Decision Date: May 28, 2023
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Intended Use

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.

Device Story

Blue Nitrile Examination Gloves are non-sterile, powder-free, disposable patient examination gloves made from acrylonitrile-butadiene copolymer. Used in clinical settings by healthcare providers to serve as a protective barrier, preventing contamination between the examiner and the patient. The device is available in multiple sizes (XS, S, M, L, XL) and features a textured finger surface to assist with grip. The gloves are intended for single use and do not involve electronic components, software, or automated processing.

Clinical Evidence

No clinical data. Bench testing only. Performance verified against ASTM D6319-2019 (dimensions, physical properties, thickness), ASTM D5151-2019 (water tightness/holes), and ASTM D6124-06 (residual powder). Biocompatibility testing performed per ISO 10993 standards (irritation, sensitization, cytotoxicity, systemic toxicity, and pyrogenicity).

Technological Characteristics

Material: Acrylonitrile-butadiene copolymer (nitrile). Standards: ASTM D6319-2019 (dimensions, physical properties, thickness), ASTM D5151-2019 (water tightness), ASTM D6124-06 (residual powder). Biocompatibility: ISO 10993-5, ISO 10993-10, ISO 10993-11. Form factor: Disposable, ambidextrous, finger-textured, powder-free. Non-sterile.

Indications for Use

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

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

• JR MEDIC Blue Nitrile Examination Gloves Powder-free (K192333)

Submission Summary (Full Text)

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May 28, 2023

Latrile Gloves Private Limited % Manoj Zacharias Consultant Liberty Management Group Ltd. 75 Executive Dr. STE114 Aurora, Illinois 60504

Re: K230601

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, reserved Product Code: LZA Dated: February 23, 2023 Received: March 3, 2023

Dear Manoi 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 (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 [phone] or 301-796-7100).

Sincerely.

# Bifeng Qian -S

Bifeng Qian, M.D., 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

Enclosure

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# Indications for Use

510(k) Number (if known) K230601

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) | |
|------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------|
| <span style="font-family: sans-serif;"> <input type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) </span> | <span style="font-family: sans-serif;"> <input checked="" type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C) </span> |

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### 510(K) SUMMARY K230601 As required by: 21CFR§807.92

#### A. APPLICANTINFORMATION

| 510(K) Owner's Name | Latrile Gloves Private Limited |
|---------------------|--------------------------------------------------------------------------------------------------------------------------|
| Address | Plot No : B5 - Sipcot Induatrial Complex, 8th Main road,<br>Pallapatti Village, Nilakottai Taluk, Dindigul Dist - 624201 |
| Phone | ----- |
| Fax | ----- |
| E-mail | [e-mail] |
| Contact Person | Ragu. M |
| Designation | QMS - Head |
| Contact Number | 8754672072 |
| Contact Email | [e-mail] |
| Date Submitted | 22nd February 2023 |

#### B. DEVICE IDENTIFICATION

| Name of the device | Blue Nitrile Examination Gloves Powder Free |
|-----------------------------------|---------------------------------------------|
| Product proprietary or trade name | Q-loves |
| Common or usual name | Exam Gloves |
| Classification name | Non-powdered patient examination glove |
| Device Classification | Class-1 |
| Product Code | LZA |
| Regulation Number | 21 CFR 880.6250 |
| Review Panel | General Hospital |

#### C. PREDICATE DEVICE

| Predicate Device | JR Engineering & Medical Technologies (M) SDN.BHD. |
|------------------|----------------------------------------------------|
| 510( K) Number | K192333 |
| Regulatory Class | 1 |
| Product code | LZA |

#### D. DESCRIPTION OF THEDEVICE:

Blue Nitrile Examination Gloves Powder Free are Class I patient examination gloves bearing the product code Nitrile - LZA (21CFR880.6250).The gloves are made from acrylonitrile-butadiene copolymer dispersion. These gloves are blue in color, powder free and non sterile. The device is available in Extra Small, Small, Medium, Large and Extra Large sizes.

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

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.

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

| Characteristics | Standards | Device Performance | | Remarks |
|-----------------------|----------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------|
| | | Predicate | Subject | |
| 510(K) Number | | K192333 | K230601 | ---- |
| Name of device | | JR MEDIC Blue Nitrile<br>Examination Gloves<br>Powder-free | Blue Nitrile<br>Examination Gloves<br>Powder Free | ---- |
| Dimensions | ASTM D6319-<br>2019 | Length Min 230 m Width<br>Min 95+/-10<br>mm(for medium size) | Length Min 230 mm Width<br>Min 95+/-10<br>mm(for medium size) | Same |
| Physical Properties | ASTM D6319-2019 | Before Aging<br>Tensile Strength<br>min 14 Mpa<br>Ultimate Elongation<br>Min 500%<br>After Aging<br>Tensile Strength<br>min 14 Mpa<br>Ultimate Elongation<br>Min 400% | Before Aging<br>Tensile Strength min<br>14 Mpa<br>Ultimate Elongation<br>Min 500%<br>After Aging<br>Tensile Strength<br>min 14 Mpa<br>Ultimate Elongation<br>Min 400% | Same |
| Thickness | ASTM D6319-2019 | Palm min 0.05 mm<br>Finger min 0.05 mm | Palm min 0.05 mm<br>Finger min 0.05 mm | Same |
| Powder Residue | ASTM D6319-2019 | ≤2 mg/glove | ≤2 mg/glove | Similar |
| Biocompatibility | Primary Skin<br>Irritation-<br>ISO 10993-<br>10:2010(E) | Under the condition of<br>study not an irritant | Under the condition<br>of study not an<br>irritant | Same |
| | Dermal<br>Sensitization- ISO<br>10993-10:2010(E) | Under the conditions of<br>the study not a sensitizer | Under the conditions<br>of the study not a<br>sensitizer | Same |
| | In vitro cytotoxicity<br>ISO10993-5<br>:2009(E) | Under the conditions of<br>the study, cytotoxic | Under the conditions<br>of the study cytotoxic | Same |
| | Acute Systemic<br>Toxicity Test ISO<br>10993-11:2017(E) | Under the conditions<br>of study the device<br>extracts do not pose a<br>systemic toxicity concern | Under the conditions<br>of study the device<br>extracts do not pose a<br>systemic toxicity<br>concern | Same |
| | Material Mediated<br>Pyrogenicity ISO<br>10993-11:2017(E) /<br>USP 41<151> | Under the conditions of<br>the study non pyrogenic | Under the conditions<br>of the study non<br>pyrogenic | Same |
| Characteristics | Standards | Device Performance | | Remarks |
| | | Predicate | Current | |
| Water Tight (1000 ml) | ASTM D5151-2019 | Passes AQL-1.5 | Passes AQL-1.5 | Similar |
| Intended use | | JR MEDIC Blue Nitrile<br>Examination Gloves<br>Powder-free is<br>disposable devices<br>intended for medical<br>purpose that are won on<br>the examiner's hand to<br>prevent contamination<br>between patient and<br>examiner. | Blue Nitrile<br>Examination Gloves<br>Powder free is<br>disposable devices<br>intended for medical<br>purpose that are worn<br>on the examiner's<br>hand to prevent<br>contamination<br>between patient and<br>examiner. | Similar |
| Material | ASTM<br>D6319-2019 | Nitrile | Nitrile | Same |
| Color | | Blue | Blue | Same |
| Texture | | Finger Texture | Finger texture | Same |
| Size | ASTM<br>D6319-2019 | Extra Small, Small,<br>Medium, Large, Extra<br>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) | | JR Engineering &<br>Medical<br>Technologies<br>(M) SDN.BHD.<br>Malaysia | Latrile Gloves Private<br>Limited | ----- |

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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 D6319-2019.

# NON-CLINICAL TESTING SUMMARY

| PERFORMANCE DATA | | | |
|--------------------------------------------------------------------------------------------------------|------------------------------------------|------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------|
| Test Method | Purpose | Acceptance Criteria | Result |
| ASTM D6319-2019 Standard<br>Specification for Nitrile<br>Examination Gloves for<br>Medical Application | To determine the<br>length of the gloves | Min 230 mm for all sizes | X-Small:- 245 mm<br>Small:- 245 mm<br>Medium:- 246mm<br>Large:- 248 mm<br>X-Large:- 248 mm |
| ASTM D6319-2019 Standard<br>Specification for Nitrile<br>Examination Gloves for<br>Medical Application | To determine the<br>width of the gloves | X-small:- 70+/-10 mm<br>Small:- 80+/-10 mm<br>Medium:- 95+/-10mm<br>Large:- 110+/-10 mm<br>X-Large:- 120+/-10 mm | X-small:- 76 mm<br>Small:- 84 mm<br>Medium:- 94 mm<br>Large:- 105 mm<br>X-Large:- 115 mm |

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| Test Method | Purpose | Acceptance<br>Criteria | Result | | |
|--------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------|------------------------------------------------------------------------------|-----------------------------------------------------------------------------|
| ASTM D6319-2019 Standard<br>Specification for Nitrile<br>Examination Gloves for<br>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<br>X-Small<br>Small<br>Medium<br>Large<br>X-Large | Palm<br>0.09mm<br>0.09mm<br>0.09mm<br>0.09mm<br>0.09mm | Finger<br>0.15mm<br>0.15mm<br>0.15mm<br>0.15mm<br>0.15mm |
| ASTM D6319-2019 Standard<br>Specification for Nitrile<br>Examination Gloves for<br>Medical Application | 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<br>X-Small<br>Small<br>Medium<br>Large<br>X-Large | Before<br>ageing<br>22.76Mpa<br>22.77Mpa<br>24.46Mpa<br>24.51Mpa<br>24.59Mpa | After<br>ageing<br>20.50Mpa<br>20.50Mpa<br>21.81Mpa<br>21.95Mpa<br>22.05Mpa |
| ASTM D6319-2019 Standard<br>Specification for Nitrile<br>Examination Gloves for<br>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<br>X-Small<br>Small<br>Medium<br>Large<br>X-Large | Before<br>ageing<br>884%<br>885%<br>888%<br>891%<br>892% | After<br>ageing<br>867%<br>868%<br>870%<br>872%<br>875% |

| Test Method | Purpose | Acceptance Criteria | Result |
|-----------------------------------------------------------------------------------------------------|------------------------------------------------------|---------------------|----------------------------------------------------------------------------------------------------------------------------|
| ASTM D5151-2019 Standard<br>Test Method for Detection of<br>Holes in Medical Gloves | To determine the<br>holes in the gloves | AQL 1.5 | 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<br>the gloves | 2 Mg/Glove Max | Size<br>X-small 0.16mg/glove<br>Small 0.16mg/glove<br>Medium 0.16 mg/glove<br>Large 0.16 mg/glove<br>X-Large 0.16 mg/glove |

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#### BIO-COMPATIBILITY DATA

| Test Method | Purpose | Acceptance<br>Criteria | Result |
|---------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------|
| ISO 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 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. |
| 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 |
| Material Mediated<br>Pyrogenicity ISO 10993-<br>11:2017(E) / USP 41<151> | 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. |

## G. Clinical Testing Summary

Not applicable - Clinical data is not needed for gloves.

# H. CONCLUSION

The conclusions drawn from the nonclinical tests demonstrate that the device is as safe, as effective, and performs as well as or better than the legally marketed device.