(131 days)
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.
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).
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).
The provided document describes the safety and performance testing of "JR Medic Blue Latex Examination Powder Free Gloves Tested for use with Chemotherapy drugs" to demonstrate substantial equivalence to a predicate device, rather than a study proving the device meets general acceptance criteria for a new medical device technology like an AI algorithm.
Therefore, the requested information elements related to AI/algorithm performance, such as sample size for test set with provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, training set details, and how ground truth was established for the training set are not applicable to this document.
The document focuses on the physical, chemical, and biological properties of examining gloves and their resistance to chemotherapy drugs.
However, I can extract the acceptance criteria and reported device performance from the provided "G. SUMMARY OF NON-CLINICAL PERFORMANCE DATA" section, focusing on the glove's performance criteria.
1. Table of Acceptance Criteria and the Reported Device Performance
| Test Method | Purpose | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| ASTM D3578-2019 Standard Specification for Rubber Examination Gloves | To determine the length of the gloves | Min 230 mm for all sizes | Small: 304 mm, Medium: 304 mm, Large: 305 mm, X-Large: 305 mm |
| ASTM D3578-2019 Standard Specification for Rubber Examination Gloves | To determine the width of the gloves | Small: 80+/-10mm, Medium: 95+/-10 mm, Large: 111+/-10 mm, X-Large: 115+/-10 mm | Small: 84 mm, Medium: 94 mm, Large: 105 mm, X-Large: 114 mm |
| ASTM D3578-2019 Standard Specification for Rubber Examination Gloves | To determine the thickness of the gloves | Palm: 0.08 mm min, Finger: 0.08 mm min for all sizes | Palm: 0.31mm (all sizes), Finger: 0.38mm (all sizes) |
| ASTM D3578-2019 Standard Specification for Rubber Examination Gloves | To Determine the physical properties - Tensile strength (Before Ageing) | 18Mpa Min for all sizes | Small: 33.16 Mpa, Medium: 32.93 Mpa, Large: 32.43 Mpa, X-Large: 32.36 Mpa |
| ASTM D3578-2019 Standard Specification for Rubber Examination Gloves | To Determine the physical properties - Tensile strength (After Ageing) | 14Mpa Min for all sizes | Small: 30.78 Mpa, Medium: 30.73 Mpa, Large: 30.23 Mpa, X-Large: 30.16 Mpa |
| ASTM D3578-2019 Standard Specification for Rubber Examination Gloves | To Determine the physical properties - Ultimate Elongation (Before Ageing) | 650% Min for all sizes | Small: 1320%, Medium: 1288%, Large: 1376%, X-Large: 1200% |
| ASTM D3578-2019 Standard Specification for Rubber Examination Gloves | To Determine the physical properties - Ultimate Elongation (After Ageing) | 500% Min for all sizes | Small: 1066%, Medium: 1105%, Large: 1225%, X-Large: 1041% |
| ASTM D3578-2019 Standard Specification for Rubber Examination Gloves | To Determine the physical properties - Stress at 500% Elongation (Before Ageing) | 5.5 Mpa Max for all sizes | Small: 5.1 Mpa, Medium: 5.2 Mpa, Large: 5.2 Mpa, X-Large: 5.2 Mpa |
| ASTM D5151-2019 Standard Test Method for Detection of Holes in Medical Gloves | To determine the holes in the gloves | AQL 2.5 | Gloves Passes AQL 1.5 |
| ASTM D6124-06 (Reapproved 2017) Standard Test Method for Residual Powder | To determine the residual powder in the gloves | 2 Mg/Glove Max | Small: 0.21 mg/glove, Medium: 0.22 mg/glove, Large: 0.22 mg/glove, X-Large: 0.22 mg/glove |
| ASTM D 5712-95 (Reapproved 2010) Standard Test Method for the Analysis of Protein | To determine the extractable protein in the gloves. | 200 µg/ dm² Max for all sizes | Small: 43.12 µg/ dm², Medium: 41.16 µg/ dm², Large: 42.06 µg/ dm², X-Large: 46.24 µg/ dm² |
| ISO 10993-10 Biological Evaluation of Medical Devices: Irritation Test | To determine the potential of the material under test to produce dermal irritation. | Under the condition of study not an irritant | Under the condition of study not an irritant |
| ISO 10993-10 Biological Evaluation of Medical Devices: Skin Sensitization Test | To determine the skin sensitization potential of the material. | Under the conditions of the study not a sensitizer | Under the conditions of the study not a sensitizer |
| ISO 10993-5:2009 Biological Evaluation of Medical Devices: Cytotoxicity Test | To evaluate the in vitro cytotoxic potential of the test item. | Under the conditions of study non cytotoxic | Under the conditions of the study cytotoxic. |
| Acute systemic toxicity | To determine the acute systemic toxicity potential of the test item. | No specific acceptance criteria stated in table, but implication is to show no systemic toxicity | Under the conditions of the study, no systemic toxicity |
| Material Mediated Pyrogenicity ISO 10993-11:2017(E) / USP 41<151> | To determine the pyrogenic potential of the test item extract. | Under the conditions of the study non pyrogenic | Under the conditions of the study non pyrogenic |
| ASTM D6978-05 (2019) Standard Practice for Assessment of Medical Glove to Permeation by Chemotherapy Drugs | To assess breakthrough time for various chemotherapy drugs. | Varies per drug, generally aiming for longer breakthrough times. Specific minimums were not explicitly stated as "acceptance criteria" but rather as "minimum breakthrough detection time" in the Indications for Use. | Carmustine (BCNU) (3.3 mg/ml): 23.8 MinutesCarboplatin (10 mg/ml): >240 MinutesCisplatin (1 mg/ml): >240 MinutesCyclophosphamide (Cytoxan) (20 mg/ml): >240 MinutesDacarbazine (10.0 mg/ml): >240 MinutesDoxorubicin HCl (2 mg/ml): >240 MinutesEtoposide (20 mg/ml): >240 MinutesFluorouracil (50 mg/ml): >240 MinutesIfosfamide (50 mg/ml): >240 MinutesMethotrexate (25 mg/ml): >240 MinutesMitomycin C (0.5 mg/ml): >240 MinutesMitoxantrone (2 mg/ml): >240 MinutesPaclitaxel (6 mg/ml): >240 MinutesThiotepa (10 mg/ml): 24.1 MinutesVincristine Sulfate (1 mg/ml): >240 Minutes |
Non-Applicable Information for this Document:
The following requested information is not applicable to the provided document as it describes the FDA 510(k) clearance for examination gloves and their resistance to chemotherapy drugs, which is a physical device, not an AI/algorithm-based diagnostic or therapeutic tool.
- Sample size used for the test set and the data provenance: Not applicable - tests are on gloves, not a data set for an algorithm.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable - "ground truth" concept does not apply in this context; instead, it's about objective physical/chemical measurements and biological responses.
- The sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
{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,Pusat Perindustrian 2, 44200 Rasa, Hulu Selangor, SelangorDarul Ehsan, Malaysia. |
| Phone | +603-60572081 |
| Fax | +603-60572181 |
| 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 GlovesTested 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,Tested For Use With Chemotherapy Drugs With ProteinLabeling Claim (50µg/dm² or Less of Water SolubleProtein) |
|---|---|
| 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 &Concentration | Minimum Breakthrough DetectionTime (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 | PROPOSEDDEVICE | |||
| 510(K) Number | - | K121926 | K221157 | |
| Name of device | - | Textured, Blue,Latex PowderFree ExaminationGloves, TestedFor Use WithChemotherapyDrugs WithProtein LabelingClaim ( $50µg/dm²$or Less of WaterSoluble Protein) | JR MedicBlue LatexExaminationPowder FreeGloves Tested forUse withChemotherapyDrugs | Similar |
| Product Code | - | LZC | LYY, LZC | Same |
| Intended use / Indicationsfor Use | - | The examinationglove is adisposable deviceintended formedical purposesthat is worn onthe examiner'shand or finger topreventcontaminationbetween patientand examiner.In addition, thesegloves weretested for usewithchemotherapydrugs inaccordance withASTM D6978-05Standard Practicefor Assessmentof Medical | JR Medic BlueLatexExaminationPowder FreeGloves Testedfor use withChemotherapydrugs aredisposabledevice intendedfor medicalpurpose that isworn on theexaminer's handto preventcontaminationbetween patientand examiner.Additionally,the gloves weretested for usewithchemotherapydrugs inaccordance with | Similar |
{7}------------------------------------------------
| Gloves to | ASTM D6978-05 (2019)StandardPractice for |
|---|---|
| ----------- | ------------------------------------------------------ |
| CHARACTERSTICS | STANDARDS | DEVICE PERFORMANCE | Comparison | |
|---|---|---|---|---|
| PREDICATEK121926 | PROPOSEDDEVICEK221157 | |||
| Permeation ofChemotherapyDrugs | Assessment ofMedical Glove toPermeation byChemotherapyDrugs. | |||
| 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 D3578-2019 | Small, Medium,Large, ExtraLarge | Small, Medium,Large, Extra Large | Same |
| Single Use | Medical GloveGuidanceManual- Labeling | Single Use | Single Use | Same |
| Sterile/nonsterile | - | Nonsterile | Nonsterile | Same |
| Dimensions | ASTM D3578-2019 | Length: Small-Min 220 mm &Medium, Large& Extra-large-Min 230 mmWidth Min 95+/-10 mm( MediumSize) | Length > 230 mmWidth Min 95+/-10mm(for mediumsize) | Similar |
| Physical Properties | ASTM D3578-2019 | Before AgeingTensile Strengthmin 18 MpaUltimateElongationMin 650%After AgeingTensile Strengthmin 14 MpaUltimateElongationMin 500% | Before AgeingTensile Strength> 18 MpaUltimateElongation>650%After AgeingTensile Strength>14 MpaUltimateElongation> 500% | Similar |
| Thickness | ASTM D3578-2019 | Palm min 0.08mm | Palm > 0.08 mmFinger > 0.08 mm | Similar |
{8}------------------------------------------------
| Finger min 0.08 mm | ||||
|---|---|---|---|---|
| Powder FreeResidue | ASTM D3578-2019 | $\leq 2$ mg/glove | $\leq 2$ mg/glove | Same |
| Watertight(1000 ml) | ASTM D3578-2019 | Passes AQL-2.5 | Passes AQL-1.5 | Similar |
| Label and Labeling | FDA Labelrequirements | Meets FDA'srequirements | Meets FDA'srequirements | Same |
| CHARACTERSTICS | STANDARDS | DEVICE PERFORMANCE | Comparison | |
|---|---|---|---|---|
| PREDICATEK121926 | PROPOSEDDEVICEK221157 | |||
| Bio-compatibility | Primary SkinIrritation-ISO10993-10:2010(E) | Gloves are non-irritating | Under the conditionof study not anirritant | Similar |
| Bio-compatibility | DermalSensitization-ISO 10993-10:2010( E) | Gloves do notdisplay anypotential forsensitization | Under the conditionsof the study not asensitizer | Similar |
| Bio-compatibility | In vitrocytotoxicityISO10993-5:2009(E) | No Data Available | Under theconditions of thestudy, cytotoxic | ---- |
| Bio-compatibility | Acutesystemictoxicity | Under theconditions of thestudy nosystemictoxicity | ||
| Bio-compatibility | MaterialMediatedPyrogenicityISO 10993-11:2017(E) /USP 41<151> | No Data Available | Under theconditions of thestudy nonpyrogenic | ---- |
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)(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 StandardSpecification for Rubber ExaminationGloves | To determine thelength of the gloves | Min 230 mm for all sizes | Small 304 mmMedium 304 mmLarge 305 mmX-Large 305 mm | |
| ASTM D3578-2019 StandardSpecification for Rubber ExaminationGloves | To determine the widthof the gloves | Small 80+/-10mmMedium 95+/-10 mmLarge 111+/-10 mmX-Large 115+/-10 mm | Small 84 mmMedium 94 mmLarge 105 mmX-Large 114 mm | |
| Test Method | Purpose | AcceptanceCriteria | Result | |
| ASTM D3578-2019 StandardSpecification for RubberExamination Gloves | To determine the thickness ofthe gloves | Palm 0.08 mm minFinger 0.08 mm minfor all sizes | SizeSmallMediumLargeX-Large | Palm Finger0.31mm 0.38mm0.31mm 0.38mm0.31mm 0.38mm0.31mm 0.38mm |
| To Determine the physicalproperties-Tensile strength | Before AgeingTensile Strength18Mpa Min for allsizesAfter AgeingTensile Strength14Mpa Min for allsizes | SizeSmallMediumLargeX-Large | Before Afterageing ageing33.16 Mpa 30.78 Mpa32.93 Mpa 30.73 Mpa32.43 Mpa 30.23 Mpa32.36 Mpa 30.16 Mpa | |
| ASTM D3578-2019Standard Specification forRubber Examination Gloves | To Determine the physicalproperties-Ultimate Elongation | Before AgeingUltimate Elongation650% Min for allsizesAfter AgeingUltimate Elongation500% Min for allsizes | SizeSmallMediumLargeX-Large | Before Afterageing ageing1320% 1066%1288% 1105%1376% 1225%1200% 1041% |
| To Determine the physicalproperties-stress at 500%Elongation | Before Ageing5.5 Mpa Max for allsizes | SizeSmallMediumLargeX-Large | Beforeageing NA5.1 Mpa5.2 Mpa5.2 Mpa5.2 Mpa | |
| ASTM D5151-2019 StandardTest Method for Detection ofHoles in Medical Gloves | To determine the holes in thegloves | AQL 2.5 | Gloves Passes AQL 1.5 | |
| ASTM D6124-06(Reapproved 2017) StandardTest Method for ResidualPowder on Medical Gloves | To determine the residualpowder in the gloves | 2 Mg/Glove Max | SizeSmallMediumLargeX-Large | Residual PowderContent0.21 mg/glove0.22 mg/glove0.22 mg/glove0.22 mg/glove |
| ASTM D 5712-95 ( Reapproved 2010) Standard TestMethod for the Analysis ofProtein in Natural Rubber | To determine the extractableprotein in the gloves. | 200 µg/ dm² Max forall sizes | SizeSmallMediumLargeX-Large | ExtractableProtein content43.12 µg/ dm²41.16 µg/ dm²42.06 µg/ dm²46.24 µg/ dm² |
| Test Method | Purpose | Acceptance Criteria | Result | |
| ISO 10993-10 BiologicalEvaluation of MedicalDevices Test for Irritationand Skin Sensitization. Testdone for irritation. | To determine the potentialof the material under test toproduce dermal irritation inRabbits | Under thecondition ofstudy not anirritant | Under the conditionof study not an irritant | |
| ISO 10993-10 BiologicalEvaluation of MedicalDevices Test for Irritationand Skin Sensitization. Testdone Skin sensitization. | To determine the skinsensitization potential of thematerial both in terms ofinduction and elicitation inGuinea Pig. | Under theconditions of thestudy not asensitizer | Under the conditionsof the study not asensitizer | |
| ISO 10993-5:2009biological evaluation ofmedical devices - part 5,tests for in vitro cytotoxicity. | To evaluate the in vitrocytotoxic potential of thetest item (both inner andouter surface) Extracts in L-929 mouse fibroblasts cellsusing elution method. | Under theconditions ofstudy noncytotoxic | Under the conditionsof the study cytotoxic. | |
| Acute systemic toxicity | To determine the acutesystemic toxicity potentialof the test item in Swissalbino mice | Under the conditionsof the study, nosystemic toxicity | ||
| Material MediatedPyrogenicity ISO 10993-11:2017(E) / USP 41<151> | To determine the pyrogenicpotential of the test itemextract followingintravenous injection inNew Zealand white Rabbits | Under theconditions of thestudy nonpyrogenic | Under the conditions ofthe 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.
§ 880.6250 Non-powdered patient examination glove.
(a)
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.(b)
Classification. Class I (general controls). The device, when it is a finger cot, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 880.9.