(94 days)
JR Medic Blue Nitrile Examination Gloves Powder Free tested for use with Chemotherapy drugs is a disposable device intended for medical purpose that is worn on the examination 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) | 35.0 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) | 64.9 Minutes |
| Vincristine Sulfate (1 mg/ml) | >240 Minutes |
The subject device in 510(K) notification is JR Medic blue nitrile examination gloves powder free tested for use with Chemotherapy drugs.
The subject device is a patient examination glove made from acrylonitrile-butadiene copolymer dispersion, 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 D 6319 -2019, Standard Specification for Nitrile Examination Gloves for Medical Application. This device also complies with requirements for standard practice for assessment of resistance of medical gloves to permeation by chemotherapy drugs as per ASTM D6978- 05(2019)
I am sorry, but the provided text does not describe a study involving an AI device or algorithm, and therefore all the requested information about acceptance criteria, study design, sample sizes, ground truth, expert involvement, and MRMC studies cannot be extracted.
The document is a 510(k) premarket notification for "JR Medic Blue Nitrile Examination Powder Free Gloves tested for use with chemotherapy drugs." It details the non-clinical testing performed on these medical gloves to demonstrate their safety and effectiveness, specifically their resistance to permeation by chemotherapy drugs, in accordance with established ASTM (American Society for Testing and Materials) standards.
The document focuses on the physical, chemical, and biocompatibility properties of the gloves, not on the performance of a software algorithm or AI.
{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.
December 6, 2021
JR Engineering & Medical Technologies (M) SDN.BHD. Manoj Zacharias Consultant Liberty Management Group Ltd. 75 Executive Dr. STE 114 Aurora, Illinois 60504
Re: K212827
Trade/Device Name: Jr Medic Blue Nitrile 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: LZA, LZC, OPJ Dated: November 2, 2021 Received: November 4, 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.
{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); 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 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.
For Clarence W. Murray III, PhD Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
{2}------------------------------------------------
Indications for Use
510(k) Number (if known) K212827
Device Name
JR Medic Blue Nitrile Examination Gloves Powder Free tested for use with Chemotherapy drugs
Indications for Use (Describe)
JR Medic Blue Nitrile Examination Gloves Powder Free tested for use with Chemotherapy drugs is a disposable device intended for medical purpose that is worn on the examination 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) | 35.0 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) | 64.9 Minutes |
| Vincristine Sulfate (1 mg/ml) | >240 Minutes |
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}------------------------------------------------
510(K) SUMMARY K212827 As required by: 21CFR§807.92(c)
A. APPLICANTINFORMATION
| 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 | 02 NOV 2021 |
B. DEVICE IDENTIFICATION
| Name of the device | JR Medic Blue Nitrile Examination Gloves PowderFree 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 I |
| Product Code | LZC, LZA, OPJ |
| Regulation Number | 21 CFR 880.6250 |
| Review Panel | General Hospital |
C. PREDICATE DEVICE
| Predicate Device | Harbour HealthPowder Free Nitrile Examination Glove, Blue (Tested foruse with Chemotherapy Drugs) |
|---|---|
| 510(K) Number | K210944 |
| Regulatory Class | 1 |
| Product code | LZA, LZC, OPJ |
D. DESCRIPTION OF THEDEVICE:
The subject device in 510(K) notification is JR Medic blue nitrile examination gloves powder free tested for use with Chemotherapy drugs.
The subject device is a patient examination glove made from acrylonitrile-butadiene copolymer dispersion, 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 D 6319 -2019, Standard Specification for Nitrile Examination Gloves for Medical Application. This device also complies with requirements for standard practice for assessment of resistance of medical gloves to permeation by chemotherapy drugs as per ASTM D6978- 05(2019)
E. INTENDED USE OF THE DEVICE:
JR Medic Blue Nitrile Examination Gloves Powder Free tested for use with Chemotherapy drugs is a 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) | 35.0 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) | 64.9 Minutes |
| Vincristine Sulfate (1 mg/ml) | >240 Minutes |
The tested chemotherapy drugs and their breakthrough detection times are as follows:
Please note that the following drugs have low permeation times: Carmustine (BCNU) (3.3 mg/ml) 35.0 Minutes Thiotepa (10 mg/ml) 64.9 Minutes
Warning: Do not use with Carmustine (BCNU) & Thiotepa
{6}------------------------------------------------
F. SUMMARY OF THE TECHNOLOGICAL CHARACTERISTICS OF THE DEVICE COMPARED TO THE PREDICATE DEVICE
| CHARACTERSTICS | STANDARDS | DEVICE PERFORMANCE | REMARKS | |
|---|---|---|---|---|
| PREDICATE | PROPOSEDDEVICE | |||
| 510(K) Number | - | K210944 | K212827 | |
| Name of device | - | Harbour HealthPowder FreeNitrileExaminationGlove, Blue(Tested for usewithChemotherapyDrugs) | JR MedicBlue NitrileExamination GlovesPowder Free testedfor use withChemotherapy drugs | Similar |
| Product Code | - | LZA, LZC, OPJ | LZC, LZA, OPJ | Similar |
| Intended use | - | Harbour HealthPowder FreeNitrileExaminationGlove, Blue(Tested for usewithChemotherapyDrugs) disposabledevice intended formedical purpose thatis worn on theexaminer's hand topreventcontaminationbetween patientand examiner.The proposeddevice was testedfor use withchemotherapydrugs as perASTM D6978-05(2019), StandardPractice forAssessment ofMedical Gloves toPermeation byChemotherapyDrugs | JR Medic BlueNitrile ExaminationGloves Powder Freetested for use withChemotherapy drugsis a disposabledevice intended formedical purpose thatis worn on theexaminer's hand topreventcontaminationbetween patient andexaminer.Additionally, thegloves were testedfor use withchemotherapy drugsin accordance withASTM D6978-05(2019) StandardPractice forAssessment ofMedical Glove toPermeation byChemotherapyDrugs. | Similar |
| CHARACTERSTICS | STANDARDS | DEVICE PERFORMANCE | REMARKS | |
| PREDICATEK210944 | PROPOSEDDEVICEK212827 | |||
| Regulation Number | - | 21 CFR880.6250 | 21 CFR880.6250 | Same |
| Material | - | Nitrile | Nitrile | Same |
| Color | - | Blue | Blue | Same |
| Texture | - | Finger Texture | Finger texture | Same |
| Size | ASTM D6319-2019 | Small, Medium,Large, ExtraLarge | Small, Medium,Large, ExtraLarge | Same |
| Single Use | Medical GloveGuidanceManual- Labeling | Single Use | Single Use | Same |
| Sterile/non sterile | - | Non sterile | Non sterile | Same |
| Dimensions | ASTM D6319-2019 | Length: Small-Min 220 mm &Medium, Large& Extra large-Min 230 mmWidth Min95+/-10 mm(Medium Size) | Length > 230mmWidth Min95+/-10 mm(formedium size) | Similar |
| Physical Properties | ASTM D6319-2019 | Before AgeingTensile Strengthmin 14 MpaUltimateElongationMin 500%After AgeingTensile Strengthmin 14 MpaUltimateElongationMin 400% | Before AgeingTensile Strength> 14 MpaUltimateElongation>500%After AgeingTensile Strength>14 MpaUltimateElongation> 400% | Same |
| Thickness | ASTM D6319-2019 | Palmmin 0.05 mmFingermin 0.05 mm | Palm >0.05 mmFinger > 0.05mm | Same |
| Powder FreeResidue | ASTM D6319-2019 | <2 mg/glove | <2 mg/glove | Same |
| Watertight(1000 ml) | ASTM D5151-2019 | 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 | REMARKS | |
| PREDICATEK210944 | PROPOSEDDEVICEK212827 | |||
| Bio-compatibility | Primary SkinIrritation-ISO 10993-10:2010(E) | Under the condition ofstudy not an irritant | Under the conditionof study not anirritant | Same |
| Dermal Sensitization-ISO 10993-10:2010(E) | Under the conditions ofthe study not asensitizer | Under the conditionsof the study not asensitizer | Same | |
| In vitrocytotoxicityISO10993-5 :2009(E) | Under theconditions of thestudy, potentiallycytotoxic | Under theconditions of thestudy, cytotoxic | Similar | |
| MaterialMediatedPyrogenicityISO 10993-11:2017(E) /USP 41<151> | No Data Available | Under theconditions of thestudy nonpyrogenic | ---- | |
| Acute SystemicToxicity Test ISO10993-11:2017(E) | Under the conditions ofthe study, the devicedoes not elicit asystemic toxicityresponse in the modelanimal | Under the conditionof study does notinduce any systemictoxic concern | Similar | |
| Chemotherapy Drugs Tested with Minimum Breakthrough Detection Time as tested per ASTM D6978-05 (2019) | ||||
| Busulfan (6mg/ml) | >240 Minutes | Not Tested | Different | |
| Carmustine (BCNU) (3.3 mg/ml) | 14.5 Minutes | 35.0 Minutes | Different | |
| Carboplatin (10 mg/ml) | >240 Minutes | >240 Minutes | Same | |
| Cisplatin (1 mg/ml) | >240 Minutes | >240 Minutes | Same | |
| Cyclophosphamide (Cytoxan) (20 mg/ml) | >240 Minutes | >240 Minutes | Same | |
| Cytarabine (100 mg/ ml) | >240 Minutes | Not Tested | Different | |
| Dacarbazine (10.0 mg/ml) | >240 Minutes | >240 Minutes | Same | |
| Docetaxel (10 mg/ml) | >240 Minutes | Not Tested | Different | |
| Doxorubicin HCl (2 mg/ml) | >240 Minutes | >240 Minutes | Same | |
| Etoposide (20 mg/ml) | >240 Minutes | >240 Minutes | Same | |
| Fluorouracil (50 mg/ml) | >240 Minutes | >240 Minutes | Same | |
| Ifosfamide (50 mg/ml) | >240 Minutes | >240 Minutes | Same | |
| MechlorethamineHCL (1 mg/ml) | >240 Minutes | Not Tested | 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) | >240 Minutes | >240 Minutes | Same | |
| Paclitaxel (6 mg/ml) | >240 Minutes | >240 Minutes | Same | |
| Thiotepa (10 mg/ml) | 47.4 Minutes | 64.9 Minutes | Different | |
| Vincristine Sulfate (1 mg/ml) | >240 Minutes | >240 Minutes | Same |
{7}------------------------------------------------
{8}------------------------------------------------
{9}------------------------------------------------
| Test Method | Purpose | Acceptance Criteria | Result |
|---|---|---|---|
| ASTM D6319-2019 StandardSpecification for NitrileExamination Gloves forMedical Application | To determine thelength of the gloves | Min 220 mm for Size Small& Min 230 mm for allother sizes | Small:- 404 mmMedium:- 405 mmLarge:- 405 mmX-Large:- 406 mm |
| ASTM D6319-2019 StandardSpecification for NitrileExamination Gloves forMedical Application | To determine thewidth of the gloves | Small:- 80+/-10 mmMedium:- 95+/-10mmLarge:- 110+/-10 mmX-Large:- 120+/-10 mm | Small:- 84 mmMedium:- 94 mmLarge:- 105 mmX-Large:- 115 mm |
G. NON-CLINICAL TESTING SUMMARY PERFORMANCE DATA
| Test Method | Purpose | Acceptance Criteria | Result |
|---|---|---|---|
| ASTM D6319-2019 StandardSpecification for NitrileExamination Gloves forMedical Application | To determine thethickness of thegloves | Palm 0.05 mm minFinger 0.05 mm minfor all sizes | Size Palm FingerSmall 0.19mm 0.21mmMedium 0.19mm 0.21mmLarge 0.19mm 0.21mmX-Large 0.19mm 0.21mm |
| ASTM D6319-2019 StandardSpecification for NitrileExamination Gloves forMedical Application | To Determine thephysical properties-Tensile strength | Before AgeingTensile Strength14Mpa Min for allsizesAfter Ageing TensileStrength 14Mpa Minfor all sizes | Size Beforeageing AfterageingSmall 22.77Mpa 20.50MpaMedium 24.46Mpa 21.81MpaLarge 24.51Mpa 21.95MpaX-Large 24.59Mpa 22.05Mpa |
| Before AgeingUltimate Elongation500% Min for allsizesAfter AgeingUltimate Elongation400% Min for allsizes | Size Beforeageing AfterageingSmall 885% 868%Medium 888% 870%Large 891% 872%X-Large 892% 875% |
{10}------------------------------------------------
| Test Method | Purpose | Acceptance Criteria | Result |
|---|---|---|---|
| ASTM D5151-2019 StandardTest Method for Detection ofHoles in Medical Gloves | To determine theholes in the gloves | AQL 2.5 | Gloves Passes AQL 1.5 |
| ASTM D6124-06 (Reapproved2017) Standard Test Methodfor Residual Powder onMedical Gloves | To determine theresidual powder inthe gloves | 2 Mg/Glove Max | SizeSmall 0.16 mg/gloveMedium 0.16 mg/gloveLarge 0.16 mg/gloveX-Large 0.16mg/glove |
H. BIO-COMPATIBILITY DATA
| Test Method | Purpose | Acceptance Criteria | Result |
|---|---|---|---|
| ISO 10993-10 BiologicalEvaluation of Medical DevicesTest for Irritation and SkinSensitization. Test done forirritation. | To determine the potential ofthe material under test toproduce dermal irritation inRabbits | Under the conditionof study not anirritant | Under the condition ofstudy not an irritant |
| ISO 10993-10 BiologicalEvaluation of Medical DevicesTest for Irritation and SkinSensitization. Test done Skinsensitization. | To determine the skinsensitization potential of thematerial both in terms ofinduction and elicitation inGuinea Pig. | Under theconditions of thestudy not asensitizer | Under the conditions ofthe study not asensitizer |
| ISO 10993-5:2009 biologicalevaluation of medical devices -part 5, tests for in vitrocytotoxicity. | To evaluate the in vitrocytotoxic potential of the testitem (both inner and outersurface) Extracts in L-929mouse fibroblasts cells usingelution method. | Under theconditions of studynon cytotoxic | Under the conditions ofthe study cytotoxic. |
| ISO 10993-11:2017 biologicalevaluation of medical devices -part 11, tests for systemictoxicity. | To determine the acutesystemic toxicity potential ofthe test item extracts (bothinside and outer surfaces) inSwiss Albino mice. | Under theconditions of studythe device extractsdo not pose asystemic toxicityconcern | Under the conditionsof study the deviceextracts do not pose asystemic toxicityconcern |
| Material MediatedPyrogenicity ISO 10993-11:2017(E) / USP 41<151> | To determine the pyrogenicpotential of the test itemextract following intravenousinjection in New Zealandwhite Rabbits. | Under theconditions of thestudy, the devicedid notdemonstrate amaterial mediatedpyrogenicityresponse. | Under the conditions ofthe study, the device didnot demonstrate amaterial mediatedpyrogenicity response. |
{11}------------------------------------------------
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 conclusions drawn from the non clinical test demonstrate that the subject device in 510(K) submission, JR Medic Blue Nitrile Examination Gloves Powder Free tested for use with Chemotherapy drugs is as safe, as effective, and performs as well as the legally marketed predicate device Harbour Health Powder Free Nitrile Examination Glove, Blue (Tested for use with Chemotherapy Drugs) K210944.
§ 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.