Sterile Latex Surgical Gloves Powder Free

K211478 · Aspen Glove Sdn. Bhd. · KGO · Sep 16, 2021 · General, Plastic Surgery

Device Facts

• Record ID: K211478
• Device Name: Sterile Latex Surgical Gloves Powder Free
• Applicant: Aspen Glove Sdn. Bhd.
• Product Code: KGO · General, Plastic Surgery
• Decision Date: Sep 16, 2021
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 878.4460
• Device Class: Class 1

Intended Use

A Sterile Latex Surgical Gloves Powder Free is a device made of natural rubber intended to be worn by operating room personnel to protect a surgical wound from contamination.

Device Story

Sterile, disposable natural rubber latex surgical gloves; worn by operating room personnel to protect surgical wounds from contamination. Device manufactured per ASTM D3577-09(2015) standards. Sterilized via Gamma radiation to achieve SAL 10^-6; packaged to maintain sterility for 3-year shelf life. Available in various sizes; natural color (no added color). Healthcare providers wear gloves during surgical procedures to maintain sterile field and prevent cross-contamination between patient and clinician. Benefits include barrier protection against contaminants during surgery.

Clinical Evidence

No clinical data. Bench testing only. Device performance verified against ASTM D3577-09, ASTM D5151-06, ASTM D6124-06, and ASTM D5712-15. Biocompatibility testing performed per ISO 10993-5, ISO 10993-10, and ISO 10993-11. All results met acceptance criteria.

Technological Characteristics

Material: Natural rubber latex (Type I). Standards: ASTM D3577-09(2015), ASTM D5151-06, ASTM D6124-06, ASTM D5712-15. Sterilization: Gamma radiation (SAL 10^-6). Form factor: Disposable surgical gloves, various sizes. Protein content: ≤ 50 µg/dm². Powder content: ≤ 2 mg/glove.

Indications for Use

Indicated for use by operating room personnel to protect a surgical wound from contamination. No specific age or gender restrictions; intended for use in surgical settings.

Regulatory Classification

Identification

A non-powdered surgeon's glove is a device intended to be worn on the hands of operating room personnel to protect a surgical wound from contamination. A non-powdered surgeon's glove does not incorporate powder for purposes other than manufacturing. The final finished glove includes only residual powder from manufacturing.

Predicate Devices

• JR Medic Latex Surgeon's Gloves Sterile Powder Free (K192328)

Submission Summary (Full Text)

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September 16, 2021

Aspen Glove Sdn. Bhd. % Manoj Zacharias Consultant Liberty Management Group Ltd. 75 Executive Dr. STE 114 Aurora, Illinois 60504

Re: K211478

Trade/Device Name: Sterile Latex Surgical Gloves powder free Regulation Number: 21 CFR 878.4460 Regulation Name: Non-Powdered Surgeon's Glove Regulatory Class: Class I, reserved Product Code: KGO Dated: August 16, 2021 Received: August 16, 2021

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.

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,

# 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

Enclosure

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# Indications for Use

510(k) Number (if known) K211478

#### Device Name

Sterile Latex Surgical Gloves powder free

#### Indications for Use (Describe)

A Sterile Latex Surgical Gloves Powder Free is a device made of natural rubber intended to be worn by operating room personnel to protect a surgical wound from contamination.

| Type of Use (Select one or both, as applicable) | |
|----------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------|
| <div style="display:inline-block;"><input type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D)</div> | <div style="display:inline-block;"><input checked="" type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C)</div> |

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## 510K SUMMARY K211478 As required by: 21CFR § 807.92

# A. APPLICANT INFORMATION

| 1. | Submitter Name | Aspen Glove Sdn. Bhd. |
|----|----------------|-------------------------------------------------------------------------------|
| 2 | Date Submitted | 14 September 2021 |
| 3 | Address | Aspen House, 300, JLN Macalister,<br>10450 Georgetown, Pulau Pinang, Malaysia |
| 4 | Phone | [phone] |
| 5 | Fax | [phone] |
| 6 | E-mail | [e-mail] |
| 7 | Contact Person | Mr. Iskandar Basha bin Abdul Kadir |
| 8 | Designation | Managing Director |
| 9 | Contact Number | 017 -550 0577 |
| 10 | Contact Email | [e-mail] |

## B. US AGENT & CONTACT PERSON INFORMATION

| 11 | US agent &<br>contact person name | Manoj Zacharias |
|----|-----------------------------------|----------------------------------------------------------------------------------|
| 12 | Address | Liberty Management Group Ltd.<br>75 Executive Dr. STE 114 Aurora, IL-60504, USA. |
| 13 | Phone | [phone] |
| 14 | Fax | [phone] |
| 15 | E-mail | [e-mail] |

## C. DEVICE IDENTIFICATION

| 16 | Common Name | Surgeon's Gloves |
|----|-----------------------------------|-------------------------------------------|
| 17 | Device Name | Sterile Latex Surgical Gloves Powder Free |
| | Product proprietary or trade name | AspenMed+S |
| 18 | Classification name | Surgeon's Gloves |
| 19 | Device Classification | 1 |
| 20 | Product Code | KGO |
| 21 | Regulation Number | 21 CFR 878.4460 |
| 22 | Regulation Name | Non-Powdered Surgeon's Glove |
| 23 | Review Panel | Gen & Plastic Surgery |

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#### D. PREDICATE DEVICE INFORMATION

| Description | Name of device | 510k<br>Number | 510K Owner |
|---------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | | | |
| Predicate<br>device | JR Medic Latex Surgeon's Gloves<br>Sterile Powder Free with protein<br>content labeling claim of 50 µg/<br>dm² or less per glove of<br>extractable protein | K192328 | <i>JR Engineering &amp; Medical<br/>Technologies (M) SDN.<br/>BHD.</i><br>Lot 8 &10, Jalan Zurah 3<br>& Lot 1&3, Jalan Zurah<br>3A/1, Pusat Perindustrian<br>2, 44200 Rasa, Hulu<br>Selangor, Selangor Darul<br>Ehsan, Malaysia. |

## E. DESCRIPTION OF THE DEVICE

The proposed device, Sterile Latex Surgical Gloves Powder Free is a sterile and disposable medical glove intended to be worn by operating room personnel to protect a surgical wound from contamination.

The proposed device is made of natural rubber latex, as per standard ASTM D3577 -09(2015), Standard Specification for Rubber Surgical Gloves.

The classification is: Type I - gloves compounded primarily from natural rubber latex.

The proposed device is Sterile Latex Surgical Gloves Powder Free, and variants of differentsizes.

All variants share the same natural color (No color is added).

The proposed device is sterilized using Gamma method to achieve the Sterility Assurance Level (SAL) of 10 and place in a sterility maintained package to ensure a shelf life of 3 years.

#### F. INDICATION FOR USE:

A Sterile Latex Surgical Gloves Powder Free is a device made of natural rubber intended to be worn by operating room personnel to protect a surgical wound from contamination.

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## G. TECHNOLOGICAL CHARACTERISTIC COMPARISON TABLE

| Characteristic | Subject device | Predicate device | Comparison |
|------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| | K211478 | K192328 | |
| Product Code | KGO | KGO | Same |
| Regulation No. | 21 CFR 878.4460 | 21 CFR 878.4460 | Same |
| Class | 1 | 1 | Same |
| Intended Use | A Sterile Latex Surgical<br>Gloves Powder Free is a<br>device made of natural<br>rubber intended to be worn<br>by operating room<br>personnel to protect a<br>surgical wound from<br>contamination. | A latex surgeon's glove is<br>a device made of natural<br>rubber intended to be<br>worn by operating room<br>personnel to protect a<br>surgical wound from<br>contamination. | Similar |
| Powdered or Powder<br>free | Powder free | Powder free | Same |
| Classification as per<br>ASTMD3577-09,<br>Standard<br>Specification for<br>Rubber Surgical<br>Gloves | Type I - gloves<br>compounded primarily<br>from natural rubber latex | Type I - gloves<br>compounded primarily<br>from natural rubber latex | Same |
| Sterilization | Radiation,<br>SAL- 10-6 | Radiation,<br>SAL- 10-6 | Same |
| Label and Labeling | Meet FDA's label<br>Requirements | Meet FDA's label<br>Requirements | Same |
| Special label claim | Protein content labeling<br>claim of 50µg/dm² or less<br>per glove of extractable<br>protein for Latex Surgeon's<br>Gloves Powder Free. | Protein content labeling<br>claim of 50µg/dm² or less<br>per glove of extractable<br>protein for Latex<br>Surgeon's<br>Gloves<br>Powder Free. | Same |
| Type of use | Over the counter use | Over the counter use | Same |

## a. General Characteristics Comparison

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## b. Technological Characteristics Comparison

| SI.<br>No | Criteria | Specification as<br>per ASTMD<br>3577-09,<br>Standard<br>Specification<br>for Rubber<br>Surgical Gloves | Subject<br>device<br>K211478 | Predicate<br>device<br>K192328 | Comparison |
|-----------|--------------------------------------------------------------|---------------------------------------------------------------------------------------------------------|-----------------------------------------------------|-------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 1 | | | | | |
| Length | | | | | |
| | Size 6 | Min 265mm | 385mm | 306mm | Similar<br>Meets ASTM D3577-<br>09(Reapproved 2015), Standard<br>Specification for Rubber<br>Surgical Gloves |
| | Size 6'/2 | Min 265mm | 386mm | 306mm | |
| | Size 7 | Min 265mm | 388mm | 305mm | |
| | Size 7'/2 | Min 265mm | 390mm | 305mm | |
| | Size 8 | Min 265mm | 392mm | 305mm | |
| | Size 8'/2 | Min 265mm | 394mm | 305mm | |
| | Size 9 | Min 265mm | 396mm | 305mm | |
| 2 | | | | | |
| Width | | | | | |
| | Size 6 | 76+/-6mm | 74mm | 78mm | Similar<br>Meets ASTM D3577-<br>09(Reapproved 2015), Standard<br>Specification for Rubber<br>Surgical Gloves |
| | Size 6'/2 | 83+/-6mm | 86mm | 85mm | |
| | Size 7 | 89+/-6mm | 92mm | 88mm | |
| | Size 7'/2 | 95+/-6mm | 98mm | 97mm | |
| | Size 8 | 102+/-6mm | 103mm | 103mm | |
| | Size 8'/2 | 108+/-6mm | 110mm | 110mm | |
| | Size 9 | 114+/-6mm | 116mm | 116mm | |
| 3 | Finger<br>Thickness<br>(All sizes) | Min 0.10mm | 0.20mm | 0.21mm | Similar<br>Meets ASTM D3577-<br>09(Reapproved 2015), Standard<br>Specification for Rubber<br>Surgical Gloves |
| 4 | Palm<br>Thickness<br>(All sizes) | Min 0.10mm | 0.15mm | 0.18mm | |
| 5 | Cuff<br>Thickness<br>(All sizes) | Min 0.10mm | 0.12mm | 0.11mm | |
| SI.<br>No | Criteria | Specification as per ASTMD<br>3577-09, Standard<br>Specification for Rubber Surgical<br>Gloves | Average Value of<br>Subject device<br>K211478 | Average Value of<br>Predicate device<br>K192328 | Comparison |
| 6 | Tensile Strength | | | | |
| | Before aging<br>(All sizes) | 24 Mpa minimum | 28.55 Mpa | 26.00 Mpa | Similar Meets ASTM<br>D3577-<br>09(Reapproved 2015), Standard<br>Specification for Rubber<br>Surgical Gloves |
| | After aging@<br>70°±2C for<br>166±2 hr<br>(All sizes) | 18 Mpa minimum | 23.48 Mpa | 22.00 Mpa | |
| 7 | Ultimate Elongation | | | | |
| | Before aging<br>(All sizes) | 750% minimum | 870% | 860% | |
| | After aging@<br>70°±2C for<br>166±2 hr<br>(All sizes) | 560% minimum | 731% | 725% | Similar Meets ASTM<br>D3577-09<br>(Reapproved 2015), Standard<br>Specification for Rubber<br>Surgical Gloves |
| 8 | Stress at<br>500% before<br>ageing<br>(All sizes) | 5.5 MPa Max | 5.1 Mpa | 2.7 Mpa | |
| 9 | Pinhole AQL | | | | |
| | Before aging<br>(All sizes) | Max 1.5 | 1.0 | 1.0 | Similar<br>Meets ASTM<br>D3577-09 (15) and<br>ASTM D5151-06,<br>( Reapproved<br>2015), Standard Test<br>Method for Detection of<br>Holes in Medical Gloves |
| | After aging@<br>70°C for 7<br>days<br>(All sizes) | Max 1.5 | 1.0 | 1.0 | |
| SI.<br>No | Criteria | Specification as<br>per ASTMD<br>3577-09,<br>Standard<br>Specification for<br>Rubber Surgical<br>Gloves | Average<br>Value of<br>Subject<br>device<br>K211478 | Average<br>Value of<br>Predicate<br>device<br>K192328 | Comparison |
| 10 | | | Powder Content | | |
| | Powder<br>residue for<br>powder free<br>glove<br>(All sizes) | Powder content<br>$\leq$ 2 mg/Glove | 0.40<br>mg/Glove | 0.34<br>mg/Glove | Similar<br>Meets ASTM D3577 and<br>ASTM D6124-06,(<br>Reapproved 2017),<br>Standard Test Method for<br>Residual Powder on<br>Medical Gloves |
| 11 | Protein Content | | | | |
| | Protein<br>Content | $\leq$ 50 µg/ dm² | 38 µg/ dm² | 43 µg/ dm² | Similar<br>Meets ASTM D3577,<br>ASTM D5712-15,<br>Standard Test Method for<br>the Analysis of Aqueous<br>Extractable Protein in<br>Natural<br>Rubber |

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## c. Biocompatibility Comparison

| Biocompatibility | Test Method | Subject<br>device<br>K211478 | Predicate device<br>K192328 | Comparison |
|--------------------------------------------|------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------|-------------------------------------|------------|
| Skin Irritation &<br>Skin<br>Sensitization | ISO 10993-<br>10,Biological<br>evaluation of medical<br>devices - Part 10:<br>Tests for irritation and<br>skin sensitization | Non- irritant<br>and Non-<br>Sensitizer | Non- irritant and<br>Non-Sensitizer | Same |

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| Biocompatibility | Test Method | Subject device<br>K211478 | Predicate device<br>K192328 | Comparison |
|--------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------|-----------------------------|------------|
| In vitro<br>cytotoxicity | ISO 10993-<br>5:2009(E),Biological<br>Evaluation of Medical<br>Devices - Part 5-Tests<br>for in vitro<br>Cytotoxicity | Cytotoxic | Cytotoxic | Same |
| Material<br>Mediated<br>pyrogenicity | ISO 10993-<br>11:2017(E),<br>Biological Evaluation<br>of Medical Devices -<br>Part 11, Tests for<br>Systemic Toxicity and<br>USP 41<br><151>Pyrogen Test | Non pyrogenic | Non pyrogenic | Same |
| Systemic<br>Toxicity | ISO 10993-<br>11:2017(E),<br>Biological Evaluation<br>of Medical Devices -<br>Part 11, Tests for<br>Systemic Toxicity | Under the<br>conditions<br>of study the<br>device extracts<br>do not pose a<br>systemic<br>toxicity<br>concern | No data available | ---- |
| Bacterial<br>Endotoxin | USP 42 <85> | <20EU/pair of<br>gloves | No data available | ---- |

## H. NON-CLINICAL TESTING SUMMARY

Bench tests were conducted to verify that the proposed device met all design specifications and acceptance criteria in the standard or test methodology. The test results demonstrated that the proposed device complies with the following standards:

| Test Method | Purpose | Acceptance Criteria | Result |
|----------------------------|------------------------------------------|-----------------------------|-----------------------------------------|
| ASTM<br>(Reapproved 2015), | To determine the<br>length of the gloves | Min 265 mm for all<br>sizes | Size 6     385mm<br>Size 6'/2     386mm |

## PERFORMANCE DATA

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| Standard Specification<br>for Rubber Surgical<br>Gloves | Size | mm |
|---------------------------------------------------------|-----------|-------|
| | Size 7 | 388mm |
| | Size 7'/2 | 390mm |
| | Size 8 | 392mm |
| | Size 8'/2 | 394mm |
| | Size 9 | 396mm |

| Test Method | Purpose | Acceptance Criteria | Result |
|------------------------------------------------------------------------------------------------|-----------------------------------------|------------------------|--------|
| ASTM D3577-09<br>(Reapproved 2015),<br>Standard Specification<br>for Rubber Surgical<br>Gloves | To determine the width<br>of the gloves | Size 6<br>76+/-6mm | 74mm |
| | | Size 6′/2<br>83+/-6mm | 86mm |
| | | Size 7<br>89+/-6mm | 92mm |
| | | Size 7′/2<br>95+/-6mm | 98mm |
| | | Size 8<br>102+/-6mm | 103mm |
| | | Size 8′/2<br>108+/-6mm | 110mm |
| | | Size 9<br>114+/-6mm | 116mm |

| Test Method | Purpose | Acceptance<br>Criteria | Result | | | |
|--------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------|--------------------------------------------------------------------------------------------------|--------|-----------------------|-----------------|--|
| | | | Size | Palm | Finger | |
| ASTM D3577-09<br>(Reapproved 2015),<br>Standard Specification<br>for Rubber Surgical<br>Gloves | To determine the<br>thickness of the<br>gloves | Palm 0.10 mm<br>min<br>Finger 0.10 mm<br>min<br>for all sizes | 6 | 0.15mm | 0.20mm | |
| | | | 6'/2 | 0.15mm | 0.20mm | |
| | | | 7 | 0.15mm | 0.20mm | |
| | | | 7'/2 | 0.15mm | 0.20mm | |
| | | | 8 | 0.15mm | 0.20mm | |
| | | | 8'/2 | 0.15mm | 0.20mm | |
| | | | 9 | 0.15mm | 0.20mm | |
| Test Method | Purpose | Acceptance<br>Criteria | Result | | | |
| ASTM<br>D3577-09<br>(Reapproved 2015),<br>Standard Specification<br>for Rubber Surgical<br>Gloves | To Determine the physical<br>properties-<br>Tensile strength | Before<br>Ageing<br>24Mpa Min<br>for all sizes<br><br>After Ageing<br>18Mpa Min for<br>all sizes | Size | Before<br>Ageing | After<br>Ageing | |
| | | | 6 | 27.2Mpa | 22.1Mpa | |
| | | | 6'/2 | 27.5Mpa | 22.6Mpa | |
| | | | 7 | 28.3Mpa | 23.4Mpa | |
| | | | 7'/2 | 28.5Mpa | 23.6Mpa | |
| | | | 8 | 29.2Mpa | 23.9Mpa | |
| | | | 8'/2 | 29.5Mpa | 24.3Mpa | |
| | | | 9 | 29.7Mpa | 24.5Mpa | |
| | To Determine the physical<br>properties-<br>Ultimate<br>Elongation | Before<br>Ageing<br>750% Min<br>for all sizes<br><br>After Ageing<br>560% Min<br>for all sizes | Size | Before<br>Ageing | After Ageing | |
| | | | 6 | 864% | 727% | |
| | | | 6'/2 | 867% | 729% | |
| | | | 7 | 869% | 730% | |
| | | | 7'/2 | 871% | 731% | |
| | | | 8 | 872% | 732% | |
| | | | 8'/2 | 873% | 733% | |
| | | | 9 | 874% | 734% | |
| Test Method | Purpose | Acceptance<br>Criteria | | Result | | |
| ASTM<br>D5151-06<br>(Reapproved 2015)<br>Standard Test Method for<br>Detection of Holes in<br>Medical Gloves | To determine the<br>holes in the gloves | AQL 1.5 | | Gloves Passes AQL 1.0 | | |
| ASTM<br>D6124-06<br>(Reapproved 2017)<br>Standard Test Method for<br>Residual Powder on<br>Medical Gloves | To determine the<br>residual powder in the<br>gloves | 2Mg/Glove<br>Max | | Size 6 | 0.26mg/glove | |
| | | | | Size 6'/2 | 0.29mg/glove | |
| | | | | Size 7 | 0.32mg/glove | |
| | | | | Size 7'/2 | 0.38mg/glove | |
| | | | | Size 8 | 0.44mg/glove | |
| | | | | Size 8'/2 | 0.52mg/glove | |
| | | | | Size 9 | 0.62mg/glove | |

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## BIO-COMPATIBILITY DATA

| Test Method | Purpose | Acceptance<br>Criteria | Result |
|------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------|
| ISO<br>10993-10<br>Biological Evaluation<br>of Medical Devices<br>Test for Irritation and<br>Skin Sensitization.<br>Test done for irritation. | To determine the potential of<br>the material under test to<br>produce dermal irritation in<br>Rabbits | Under<br>the<br>condition<br>of<br>study not an<br>irritant | Under the condition of study<br>not an irritant |
| ISO<br>10993-10<br>Biological Evaluation<br>of Medical Devices<br>Test for Irritation and<br>Skin Sensitization.<br>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<br>the<br>conditions<br>of<br>the study not a<br>sensitizer | Under the<br>conditions<br>of<br>study not<br>sensitizer |
| ISO 10993-5:2009<br>biological evaluation of<br>medical devices -part 5,<br>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<br>the<br>conditions<br>of<br>study<br>non<br>cytotoxic | Under the<br>conditions<br>of<br>study cytotoxic. |
| ISO 10993-11:2017<br>biological evaluation of<br>medical devices - part<br>11, tests for systemic<br>toxicity. | To determine the acute<br>systemic toxicity potential<br>of the test item extracts (both<br>inside and outer surfaces) in<br>Swiss Albino mice. | Under<br>the<br>conditions<br>of<br>study<br>the<br>device extracts<br>do not pose a<br>systemic<br>toxicity<br>concern | Under the<br>conditions<br>of study the device extracts<br>do not pose a systemic<br>toxicity concern |
| Material Mediated<br>Pyrogenicity ISO<br>10993-11:2017(E) /<br>USP 41<151> | To determine the pyrogenic<br>potential of the test item<br>extract<br>following<br>intravenous injection in New<br>Zealand white Rabbits. | Under<br>the<br>conditions of<br>the study, the<br>device did not<br>demonstrate a<br>material<br>mediated<br>pyrogenicity<br>response. | Under the<br>conditions of the study,<br>the device did not<br>demonstrate a material<br>mediated<br>pyrogenicity response. |
| Bacterial Endotoxin<br>test USP 42<85> | To determine the Bacterial<br>Endotoxin limit in the glove | NMT 20<br>EU/pair of<br>gloves | <20 EU/pair of<br>gloves |

# Summary of clinical performance data.

Clinical data was not required for this submission.

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## Conclusion

The conclusion drawn from the nonclinical tests demonstrates that the subject device in 510(K) submission Sterile Latex Surgical Gloves Powder Free is as safe, as effective, and performs as well as or better than the legally marketed predicated device K192328, JR MEDIC Latex Surgeon's Gloves Sterile Powder Free.