JR Medic
Device Facts
| Record ID | K221157 |
|---|---|
| Device Name | JR Medic |
| Applicant | Jr Engineering & Medical Technologies (M) Sdn. Bhd. |
| Product Code | LZC · General Hospital |
| Decision Date | Aug 30, 2022 |
| Decision | SESE |
| Submission Type | Abbreviated |
| Regulation | 21 CFR 880.6250 |
| Device Class | Class 1 |
Indications for Use
JR Medic Blue Latex Examination Powder Free Gloves Tested for use with Chemotherapy drugs are disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner. Additionally, the gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978-05 (2019) Standard Practice for Assessment of Medical Glove to Permeation by Chemotherapy Drugs.
Device Story
Disposable natural rubber latex examination glove; blue color; powder-free; non-sterile. Worn by healthcare examiners to prevent cross-contamination between patient and examiner. Tested for permeation resistance against specific chemotherapy drugs per ASTM D6978-05 (2019). Provides barrier protection; breakthrough times vary by drug; specific drugs (Carmustine, Thiotepa) show low permeation times and are contraindicated. Used in clinical settings; manual operation by healthcare personnel.
Clinical Evidence
Bench testing only. No clinical data provided. Performance verified via ASTM D3578-2019 (physical properties, dimensions, powder residue, protein content) and ASTM D6978-05(2019) (chemotherapy permeation). Biocompatibility assessed via ISO 10993-10 (irritation/sensitization), ISO 10993-5 (cytotoxicity), and ISO 10993-11 (pyrogenicity/systemic toxicity).
Technological Characteristics
Material: Natural Rubber Latex. Form factor: Powder-free, blue, finger-textured, non-sterile. Dimensions: Length >230mm, Palm/Finger thickness >0.08mm. Standards: ASTM D3578-2019 (physical properties), ASTM D6978-05(2019) (chemotherapy permeation), ASTM D6124-06 (residual powder), ASTM D5712-95 (protein content).
Indications for Use
Indicated for use as a disposable patient examination glove worn on the examiner's hand to prevent contamination between patient and examiner. Tested for use with specific chemotherapy drugs per ASTM D6978-05 (2019). Warning: Do not use with Carmustine or Thiotepa.
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
- Textured, Blue, Latex Powder Free Examination Gloves, Tested For Use With Chemotherapy Drugs With Protein Labeling Claim (K121926)
Submission Summary (Full Text)
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
August 30, 2022
JR Engineering & Medical Technologies (M) SDN.BHD. % Manoj Zacharias Consultant Liberty Management Group Ltd. 75 Executive Dr. STE 114 Aurora, Illinois 60504
Re: K221157
Trade/Device Name: JR Medic Blue Latex Examination Powder Free Gloves Tested for use with Chemotherapy drugs Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I. reserved Product Code: LYY, LZC, OPJ Dated: August 4. 2022 Received: August 4, 2022
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.
{1}------------------------------------------------
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); medical device reporting (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/combinationproducts/guidance-regulatory-information/postmarketing-safety-reporting-combination-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 mediation-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 (1-800-638-2041 or 301-796-7100).
Sincerely.
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
{2}------------------------------------------------
# Indications for Use
510(k) Number (if known) K221157
Device Name
JR Medic Blue Latex Examination Powder Free Gloves Tested for use with Chemotherapy drugs
#### Indications for Use (Describe)
JR Medic Blue Latex Examination Powder Free Gloves Tested for use with Chemotherapy drugs are disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner. Additionally, the gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978-05 (2019) Standard Practice for Assessment of Medical Glove to Permeation by Chemotherapy Drugs.
The tested chemotherapy drugs and their breakthrough detection times are as follows:
| Tested Chemotherapy Drug Name & Concentration | Minimum Breakthrough Detection Time |
|-----------------------------------------------|-------------------------------------|
| Carmustine (BCNU) (3.3 mg/ml) | 23.8 Minutes |
| Carboplatin (10 mg/ml) | >240 Minutes |
| Cisplatin (1 mg/ml) | >240 Minutes |
| Cyclophosphamide (Cytoxan) (20 mg/ml) | >240 Minutes |
| Dacarbazine (10.0 mg/ml) | >240 Minutes |
| Doxorubicin HCl (2 mg/ml) | >240 Minutes |
| Etoposide (20 mg/ml) | >240 Minutes |
| Fluorouracil (50 mg/ml) | >240 Minutes |
| Ifosfamide (50 mg/ml) | >240 Minutes |
| Methotrexate (25 mg/ml) | >240 Minutes |
| Mitomycin C (0.5 mg/ml) | >240 Minutes |
| Mitoxantrone (2 mg/ml) | >240 Minutes |
| Paclitaxel (6 mg/ml) | >240 Minutes |
| Thiotepa (10 mg/ml) | 24.1 Minutes |
| Vincristine Sulfate (1 mg/ml) | >240 Minutes |
Please note that the following drugs have low permeation times: Carmustine (BCNU) (3.3 mg/ml) 23.8 Minutes Thiotepa (10 mg/ml) 24.1 Minutes
Warning: Do not use with Carmustine or Thiotepa.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
#### CONTINUE ON A SEPARATE PAGE IF NEEDED.
{3}------------------------------------------------
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 PRAStaff@fda.hhs.gov
"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."
{4}------------------------------------------------
# 510K SUMMARY K221157
# As required by 21CFR§807.92(c)
#### 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, Hulu Selangor, Selangor<br>Darul Ehsan, Malaysia. |
| Phone | +603-60572081 |
| Fax | +603-60572181 |
| E-mail | ganeshjrmt@gmail.com |
| Contact Person | Mr. Ganesan Subramaniam |
| Designation | Managing Director |
| Contact Number | +6012 224 6677 |
| Contact Email | ganeshjrmt@gmail.com |
| Date Submitted | August 25, 2022 |
#### B. DEVICE IDENTIFICATION
| Name of the device | JR Medic Blue Latex Examination Powder Free Gloves<br>Tested for use with Chemotherapy drugs. |
|-----------------------------------|-----------------------------------------------------------------------------------------------|
| Product proprietary or trade name | JR MEDIC |
| Common or usual name | Exam Gloves |
| Classification name | Patient Examination Gloves, Specialty |
| Device Classification | Class-1 |
| Product Code | LYY, LZC, OPJ |
| Regulation Number | 21 CFR 880.6250 |
| Review Panel | General Hospital |
# C. PREDICATE DEVICE
| Predicate Device | Textured, Blue, Latex Powder Free Examination Gloves,<br>Tested For Use With Chemotherapy Drugs With Protein<br>Labeling Claim (50µg/dm² or Less of Water Soluble<br>Protein) |
|------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510( K) Number | K121926 |
| Regulatory Class | 1 |
| Product code | LZC |
### D. DESCRIPTION OF THE DEVICE:
The subject device in 510(K) notification K221157 is JR Medic Blue Latex Examination Powder Free Gloves tested for use with Chemotherapy drugs. The subject device is a patient examination glove made from Natural Rubber Latex, blue color, powder free and non-sterile (as per 21CFR 880.6250, class I).
{5}------------------------------------------------
The subject device meets all the current specifications listed under the ASTM Specification D3578-2019, Standard Specification for Rubber Examination Gloves for Medical Application. This device also complies with requirements for standard practice for assessment of medical gloves to permeation by chemotherapy drugs as per ASTM D6978- 05(2019).
#### E. INDICATIONS FOR USE/INTENDED USE OF THE DEVICE:
JR Medic Blue Latex Examination Powder Free Gloves Tested for use with Chemotherapy drugs are disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner. Additionally, the gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978-05 (2019) Standard Practice for Assessment of Medical Glove to Permeation by Chemotherapy Drugs
| Tested Chemotherapy Drug Name &<br>Concentration | Minimum Breakthrough Detection<br>Time (Minutes) |
|--------------------------------------------------|--------------------------------------------------|
| Carmustine (BCNU) (3.3 mg/ml) | 23.8 Minutes |
| Carboplatin (10 mg/ml) | >240 Minutes |
| Cisplatin (1 mg/ml) | >240 Minutes |
| Cyclophosphamide (Cytoxan) (20 mg/ml) | >240 Minutes |
| Dacarbazine (10.0 mg/ml) | >240 Minutes |
| Doxorubicin HCl (2 mg/ml) | >240 Minutes |
| Etoposide (20 mg/ml) | >240 Minutes |
| Fluorouracil (50 mg/ml) | >240 Minutes |
| Ifosfamide (50 mg/ml) | >240 Minutes |
| Methotrexate (25 mg/ml) | >240 Minutes |
| Mitomycin C (0.5 mg/ml) | >240 Minutes |
| Mitoxantrone (2 mg/ml) | >240 Minutes |
| Paclitaxel (6 mg/ml) | >240 Minutes |
| Thiotepa (10 mg/ml) | 24.1 Minutes |
| Vincristine Sulfate (1 mg/ml) | >240 Minutes |
The tested chemotherapy drugs and their breakthrough detection times are as follows:
{6}------------------------------------------------
#### F. SUMMARY OF THE TECHNOLOGICAL CHARACTERISTICS OF THE DEVICE COMPARED TO THE PREDICATE DEVICE
| CHARACTERSTICS | STANDARDS | DEVICE PERFORMANCE | | Comparison |
|---------------------------------------|-----------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| | | PREDICATE | PROPOSED<br>DEVICE | |
| 510(K) Number | - | K121926 | K221157 | |
| Name of device | - | Textured, Blue,<br>Latex Powder<br>Free Examination<br>Gloves, Tested<br>For Use With<br>Chemotherapy<br>Drugs With<br>Protein Labeling<br>Claim ( $50µg/dm²$<br>or Less of Water<br>Soluble Protein) | JR Medic<br>Blue Latex<br>Examination<br>Powder Free<br>Gloves Tested for<br>Use with<br>Chemotherapy<br>Drugs | Similar |
| Product Code | - | LZC | LYY, LZC | Same |
| Intended use / Indications<br>for Use | - | The examination<br>glove is a<br>disposable device<br>intended for<br>medical purposes<br>that is worn on<br>the examiner's<br>hand or finger to<br>prevent<br>contamination<br>between patient<br>and examiner.<br>In addition, these<br>gloves were<br>tested for use<br>with<br>chemotherapy<br>drugs in<br>accordance with<br>ASTM D6978-05<br>Standard Practice<br>for Assessment<br>of Medical | JR Medic Blue<br>Latex<br>Examination<br>Powder Free<br>Gloves Tested<br>for use with<br>Chemotherapy<br>drugs are<br>disposable<br>device intended<br>for medical<br>purpose that is<br>worn on the<br>examiner's hand<br>to prevent<br>contamination<br>between patient<br>and examiner.<br>Additionally,<br>the gloves were<br>tested for use<br>with<br>chemotherapy<br>drugs in<br>accordance with | Similar |
{7}------------------------------------------------
| Gloves to | ASTM D6978-<br>05 (2019)<br>Standard<br>Practice for |
|-----------|------------------------------------------------------|
|-----------|------------------------------------------------------|
| CHARACTERSTICS | STANDARDS | DEVICE PERFORMANCE | | Comparison |
|---------------------|---------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| | | PREDICATE<br>K121926 | PROPOSED<br>DEVICE<br>K221157 | |
| | | Permeation of<br>Chemotherapy<br>Drugs | Assessment of<br>Medical Glove to<br>Permeation by<br>Chemotherapy<br>Drugs. | |
| Regulation Number | - | 21 CFR 880.6250 | 21 CFR 880.6250 | Same |
| Material | - | Natural Latex | Natural Latex | Same |
| Color | - | Blue | Blue | Same |
| Texture | - | Finger Texture | Finger texture | Same |
| Size | ASTM D3578-<br>2019 | Small, Medium,<br>Large, Extra<br>Large | Small, Medium,<br>Large, Extra Large | Same |
| Single Use | Medical Glove<br>Guidance<br>Manual<br>- Labeling | Single Use | Single Use | Same |
| Sterile/nonsterile | - | Nonsterile | Nonsterile | Same |
| Dimensions | ASTM D3578-<br>2019 | Length: Small-<br>Min 220 mm &<br>Medium, Large<br>& Extra-large-<br>Min 230 mm<br>Width Min 95+/-<br>10 mm( Medium<br>Size) | Length > 230 mm<br>Width Min 95+/-10<br>mm(for medium<br>size) | Similar |
| Physical Properties | ASTM D3578-<br>2019 | Before Ageing<br>Tensile Strength<br>min 18 Mpa<br>Ultimate<br>Elongation<br>Min 650%<br>After Ageing<br>Tensile Strength<br>min 14 Mpa<br>Ultimate<br>Elongation<br>Min 500% | Before Ageing<br>Tensile Strength<br>> 18 Mpa<br>Ultimate<br>Elongation<br>>650%<br>After Ageing<br>Tensile Strength<br>>14 Mpa<br>Ultimate<br>Elongation<br>> 500% | Similar |
| Thickness | ASTM D3578-<br>2019 | Palm min 0.08<br>mm | Palm > 0.08 mm<br>Finger > 0.08 mm | Similar |
{8}------------------------------------------------
| | | Finger min 0.08 mm | | |
|-------------------------|---------------------------|-----------------------------|-----------------------------|---------|
| Powder Free<br>Residue | ASTM D3578-<br>2019 | $\leq 2$ mg/glove | $\leq 2$ mg/glove | Same |
| Watertight<br>(1000 ml) | ASTM D3578-<br>2019 | Passes AQL-2.5 | Passes AQL-1.5 | Similar |
| Label and Labeling | FDA Label<br>requirements | Meets FDA's<br>requirements | Meets FDA's<br>requirements | Same |
| CHARACTER<br>STICS | STANDARDS | DEVICE PERFORMANCE | | Comparison |
|--------------------|-----------------------------------------------------------------------------------|----------------------------------------------------------------|--------------------------------------------------------------------|------------|
| | | PREDICATE<br>K121926 | PROPOSED<br>DEVICE<br>K221157 | |
| Bio-compatibility | Primary Skin<br>Irritation-ISO<br>10993-10:2010<br>(E) | Gloves are non-<br>irritating | Under the condition<br>of study not an<br>irritant | Similar |
| Bio-compatibility | Dermal<br>Sensitization-<br>ISO 10993-<br>10:2010( E) | Gloves do not<br>display any<br>potential for<br>sensitization | Under the conditions<br>of the study not a<br>sensitizer | Similar |
| Bio-compatibility | In vitro<br>cytotoxicity<br>ISO10993-5<br>:2009(E) | No Data Available | Under the<br>conditions of the<br>study, cytotoxic | ---- |
| Bio-compatibility | Acute<br>systemic<br>toxicity | | Under the<br>conditions of the<br>study no<br>systemic<br>toxicity | |
| Bio-compatibility | Material<br>Mediated<br>Pyrogenicity<br>ISO 10993-<br>11:2017(E) /<br>USP 41<151> | No Data Available | Under the<br>conditions of the<br>study non<br>pyrogenic | ---- |
# Chemotherapy Drugs Tested with Minimum Breakthrough Detection Time as tested per
ASTM D6978
| Carmustine (BCNU) (3.3 mg/ml) | 15.4 Minutes | 23.8 Minutes | Different |
|------------------------------------------|--------------|--------------|-----------|
| Carboplatin (10 mg/ml) | Not Tested | >240 Minutes | Different |
| Cisplatin (1 mg/ml) | >240 Minutes | >240 Minutes | Same |
| Cyclophosphamide (Cytoxan)<br>(20 mg/ml) | >240 Minutes | >240 Minutes | Same |
| Dacarbazine (10.0 mg/ml) | >240 Minutes | >240 Minutes | Same |
| Doxorubicin HCl (2 mg/ml) | >240 Minutes | >240 Minutes | Same |
{9}------------------------------------------------
| Etoposide (20 mg/ml) | >240 Minutes | >240 Minutes | Same |
|-------------------------------|--------------|--------------|-----------|
| Fluorouracil (50 mg/ml) | >240 Minutes | >240 Minutes | Same |
| Ifosfamide (50 mg/ml) | Not Tested | >240 Minutes | Different |
| Methotrexate (25 mg/ml) | >240 Minutes | >240 Minutes | Same |
| Mitomycin C (0.5 mg/ml) | >240 Minutes | >240 Minutes | Same |
| Mitoxantrone (2 mg/ml) | Not Tested | >240 Minutes | Different |
| Paclitaxel (6 mg/ml) | >240 Minutes | >240 Minutes | Same |
| Thiotepa (10 mg/ml) | 1.6 Minutes | 24.1 Minutes | Different |
| Vincristine Sulfate (1 mg/ml) | >240 Minutes | >240 Minutes | Same |
{10}------------------------------------------------
# G. SUMMARY OF NON-CLINICAL PERFORMANCE DATA
| Test Method | Purpose | Acceptance Criteria | Result | |
|---------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------|
| ASTM D3578-2019 Standard<br>Specification for Rubber Examination<br>Gloves | To determine the<br>length of the gloves | Min 230 mm for all sizes | Small 304 mm<br>Medium 304 mm<br>Large 305 mm<br>X-Large 305 mm | |
| ASTM D3578-2019 Standard<br>Specification for Rubber Examination<br>Gloves | To determine the width<br>of the gloves | Small 80+/-10mm<br>Medium 95+/-10 mm<br>Large 111+/-10 mm<br>X-Large 115+/-10 mm | Small 84 mm<br>Medium 94 mm<br>Large 105 mm<br>X-Large 114 mm | |
| Test Method | Purpose | Acceptance<br>Criteria | Result | |
| ASTM D3578-2019 Standard<br>Specification for Rubber<br>Examination Gloves | To determine the thickness of<br>the gloves | Palm 0.08 mm min<br>Finger 0.08 mm min<br>for all sizes | Size<br>Small<br>Medium<br>Large<br>X-Large | Palm Finger<br>0.31mm 0.38mm<br>0.31mm 0.38mm<br>0.31mm 0.38mm<br>0.31mm 0.38mm |
| | To Determine the physical<br>properties-Tensile strength | Before Ageing<br>Tensile Strength<br>18Mpa Min for all<br>sizes<br>After Ageing<br>Tensile Strength<br>14Mpa Min for all<br>sizes | Size<br>Small<br>Medium<br>Large<br>X-Large | Before After<br>ageing ageing<br>33.16 Mpa 30.78 Mpa<br>32.93 Mpa 30.73 Mpa<br>32.43 Mpa 30.23 Mpa<br>32.36 Mpa 30.16 Mpa |
| ASTM D3578-2019<br>Standard Specification for<br>Rubber Examination Gloves | To Determine the physical<br>properties-Ultimate Elongation | Before Ageing<br>Ultimate Elongation<br>650% Min for all<br>sizes<br>After Ageing<br>Ultimate Elongation<br>500% Min for all<br>sizes | Size<br>Small<br>Medium<br>Large<br>X-Large | Before After<br>ageing ageing<br>1320% 1066%<br>1288% 1105%<br>1376% 1225%<br>1200% 1041% |
| | To Determine the physical<br>properties-stress at 500%<br>Elongation | Before Ageing<br>5.5 Mpa Max for all<br>sizes | Size<br>Small<br>Medium<br>Large<br>X-Large | Before<br>ageing NA<br>5.1 Mpa<br>5.2 Mpa<br>5.2 Mpa<br>5.2 Mpa |
| ASTM D5151-2019 Standard<br>Test Method for Detection of<br>Holes in Medical Gloves | To determine the holes in the<br>gloves | AQL 2.5 | Gloves Passes AQL 1.5 | |
| ASTM D6124-06<br>(Reapproved 2017) Standard<br>Test Method for Residual<br>Powder on Medical Gloves | To determine the residual<br>powder in the gloves | 2 Mg/Glove Max | Size<br>Small<br>Medium<br>Large<br>X-Large | Residual Powder<br>Content<br>0.21 mg/glove<br>0.22 mg/glove<br>0.22 mg/glove<br>0.22 mg/glove |
| ASTM D 5712-95 ( Re<br>approved 2010) Standard Test<br>Method for the Analysis of<br>Protein in Natural Rubber | To determine the extractable<br>protein in the gloves. | 200 µg/ dm² Max for<br>all sizes | Size<br>Small<br>Medium<br>Large<br>X-Large | Extractable<br>Protein content<br>43.12 µg/ dm²<br>41.16 µg/ dm²<br>42.06 µg/ dm²<br>46.24 µg/ dm² |
| Test Method | Purpose | Acceptance Criteria | Result | |
| ISO 10993-10 Biological<br>Evaluation of Medical<br>Devices Test for Irritation<br>and Skin Sensitization. Test<br>done for irritation. | To determine the potential<br>of the material under test to<br>produce dermal irritation in<br>Rabbits | Under the<br>condition of<br>study not an<br>irritant | Under the condition<br>of study not an irritant | |
| ISO 10993-10 Biological<br>Evaluation of Medical<br>Devices Test for Irritation<br>and Skin Sensitization. Test<br>done Skin 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<br>of the study not a<br>sensitizer | |
| ISO 10993-5:2009<br>biological evaluation of<br>medical devices - part 5,<br>tests for in vitro cytotoxicity. | To evaluate the in vitro<br>cytotoxic potential of the<br>test item (both inner and<br>outer surface) Extracts in L-<br>929 mouse fibroblasts cells<br>using elution method. | Under the<br>conditions of<br>study non<br>cytotoxic | Under the conditions<br>of the study cytotoxic. | |
| Acute systemic toxicity | To determine the acute<br>systemic toxicity potential<br>of the test item in Swiss<br>albino mice | | Under the conditions<br>of the study, no<br>systemic toxicity | |
| 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<br>intravenous injection in<br>New Zealand white Rabbits | Under the<br>conditions of the<br>study non<br>pyrogenic | Under the conditions of<br>the study non pyrogenic | |
{11}------------------------------------------------
#### H. BIO-COMPATIBILITY DATA
#### I. CLINICAL TESTING SUMMARY
Not applicable - Clinical data is not needed for gloves or for most devices cleared by the 510(K) process.
#### J. CONCLUSION
The conclusion drawn from the nonclinical tests demonstrates that the subject device in 510(K) submission JR Medic Blue Latex Examination Powder Free Gloves Tested for use with Chemotherapy drugs is as safe, as effective, and performs as well as or better than the legally marketed predicate device Textured, Blue, Latex Powder Free Examination Gloves, Tested For Use With Chemotherapy Drugs With Protein Labeling Claim (50µg/dm² or Less of Water-Soluble Protein) K121926.
