(79 days)
Nitrile Examination Gloves Powder Free is a disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.
JR MEDIC Nitrile Examination Gloves Powder Free (Orange, Purple) are Class I patient examination gloves bearing the product code Nitrile - LZA (21CFR880.6250). The gloves are made from acrylonitrile-butadiene copolymer dispersion. These gloves are available in Orange & Purple color and are powder free and are provided non-sterile. These gloves have a shelf life for 3 years.
This document describes the premarket notification (510k) for JR MEDIC Nitrile Examination Gloves Powder Free (Orange, Purple). This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving novel effectiveness. Therefore, the information provided focuses on comparative testing against established standards and a predicate device, rather than a clinical study with human subjects, AI algorithms, or ground truth established by experts.
Here's an analysis of the provided text in relation to your questions:
1. A table of acceptance criteria and the reported device performance
The document provides extensive tables detailing the acceptance criteria (standards) and the device's performance for both the orange and purple gloves. Below is a consolidated table with key physical, chemical, and biological performance characteristics.
| Characteristics | Standards / Purpose | Acceptance Criteria | Reported Device Performance (Orange Gloves) | Reported Device Performance (Purple Gloves) |
|---|---|---|---|---|
| Physical Dimensions | ||||
| Length | ASTM D6319-2019 (To determine length) | Min 220mm (XS, S), Min 230mm (M, L, XL) | XS: 236mm, S: 236mm, M: 238mm, L: 238mm, XL: 240mm | XS: 245mm, S: 245mm, M: 246mm, L: 248mm, XL: 248mm |
| Width | ASTM D6319-2019 (To determine width) | XS: 70+/-10mm, S: 80+/-10mm, M: 95+/-10mm, L: 110+/-10mm, XL: 120+/-10mm | XS: 74mm, S: 84mm, M: 94mm, L: 104mm, XL: 114mm | XS: 76mm, S: 85mm, M: 95mm, L: 104mm, XL: 115mm |
| Thickness (Palm) | ASTM D6319-2019 (To determine thickness) | Palm 0.05 mm min for all sizes | XS, S, M, L, XL: 0.18mm | XS, S, M, L, XL: 0.18mm |
| Thickness (Finger) | ASTM D6319-2019 (To determine thickness) | Finger 0.05 mm min for all sizes | XS, S, M, L, XL: 0.20mm | XS, S, M, L, XL: 0.21mm |
| Physical Properties | ||||
| Tensile Strength (Before Aging) | ASTM D6319-2019 (To determine tensile strength) | 14 Mpa Min for all sizes | XS: 22.77 Mpa, S: 22.80 Mpa, M: 24.46 Mpa, L: 24.51 Mpa, XL: 24.59 Mpa | XS: 22.78 Mpa, S: 22.82 Mpa, M: 24.47 Mpa, L: 24.52 Mpa, XL: 24.58 Mpa |
| Tensile Strength (After Aging) | ASTM D6319-2019 (To determine tensile strength) | 14 Mpa Min for all sizes | XS: 20.50 Mpa, S: 20.69 Mpa, M: 21.28 Mpa, L: 21.34 Mpa, XL: 21.36 Mpa | XS: 20.48 Mpa, S: 20.67 Mpa, M: 21.30 Mpa, L: 21.35 Mpa, XL: 21.36 Mpa |
| Ultimate Elongation (Before Aging) | ASTM D6319-2019 (To determine ultimate elongation) | 500% Min for all sizes | XS: 885%, S: 886%, M: 888%, L: 891%, XL: 892% | XS: 884%, S: 885%, M: 887%, L: 892%, XL: 893% |
| Ultimate Elongation (After Aging) | ASTM D6319-2019 (To determine ultimate elongation) | 400% Min for all sizes | XS: 760%, S: 764%, M: 767%, L: 769%, XL: 772% | XS: 759%, S: 763%, M: 766%, L: 768%, XL: 772% |
| Watertight (Holes) | ASTM D5151-2019 (To determine holes) | AQL 2.5 (for subject device K222349), AQL 1.5 (for predicate K192333) Note: AQL 2.5 is a less stringent acceptance criteria than AQL 1.5, which is noted as "Similar" in comparison analysis | Passes AQL 2.5 | Passes AQL 2.5 |
| Powder Residue | ASTM D6124-06 (Reapproved 2017) (To determine residual powder) | ≤2 mg/glove Max | XS, S, M, L, XL: 0.16 mg/glove | XS, S, M, L, XL: 0.16 mg/glove |
| Biocompatibility | ||||
| Primary Skin Irritation | ISO 10993-10 (To determine dermal irritation in Rabbits) | Under the condition of study not an irritant | Under the condition of study not an irritant | Under the condition of study not an irritant |
| Dermal Sensitization | ISO 10993-10 (To determine skin sensitization potential in Guinea Pig) | Under the conditions of the study not a sensitizer | Under the conditions of the study not a sensitizer | Under the conditions of the study not a sensitizer |
| In vitro Cytotoxicity | ISO 10993-5:2009 (To evaluate cytotoxic potential) | Under the conditions of study non cytotoxic | Under the conditions of the study, cytotoxic. Additional testing was performed to determine if this was a systemic toxicity concern. | Under the conditions of the study, cytotoxic. Additional testing was performed to determine if this was a systemic toxicity concern. |
| Acute Systemic Toxicity | ISO 10993-11:2017 (To determine acute systemic toxicity potential) | Under the conditions of study the device extracts do not pose a systemic toxicity concern | Under the conditions of study the device extracts do not pose a systemic toxicity concern | Under the conditions of study the device extracts do not pose a systemic toxicity concern |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not explicitly state the sample sizes used for each specific test. However, the tests are adherence to ASTM and ISO standards, which define the sample sizes and methodology for such testing. For example, ASTM D5151-2019 (Watertightness) involves sampling a number of gloves from a lot to determine AQL (Acceptance Quality Limit). The testing presumably took place in Malaysia, where the manufacturer is located. The nature of these tests (e.g., physical property measurements, biocompatibility) suggests they are prospective, as new gloves are being manufactured and tested to ensure they meet specifications.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This product is a medical glove, not a diagnostic AI device requiring expert interpretation of medical images or data. The "ground truth" for the test set is established by the specifications defined in the relevant ASTM and ISO standards for physical, chemical, and biological properties of examination gloves. Therefore, there are no "experts" in the sense of radiologists or clinicians establishing ground truth for the test set. The validation relies on standard laboratory testing procedures performed by qualified technicians/laboratories.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This is not a study involving human readers or interpretation of complex data where adjudication would be necessary. The testing involves objective measurements against predefined criteria.
5. 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. This is not an AI/software device or a diagnostic tool that involves human readers. It is a physical medical device (examination gloves).
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" in this context is based on standardized test methods and specifications (ASTM and ISO standards). For example:
- Physical Property Ground Truth: Defined by acceptable ranges for length, width, thickness, tensile strength, and elongation as per ASTM D6319-2019.
- Watertightness Ground Truth: Defined by an Acceptance Quality Limit (AQL) as per ASTM D5151-2019.
- Chemical Property Ground Truth: Defined by maximum allowable powder residue as per ASTM D6124-06.
- Biocompatibility Ground Truth: Defined by the absence of irritation, sensitization, or systemic toxicity as per ISO 10993 series, and a determination regarding cytotoxicity.
8. The sample size for the training set
Not applicable. As this is a traditional medical device (gloves) and not an AI/machine learning model, there is no "training set."
9. How the ground truth for the training set was established
Not applicable, as there is no training set for this type of device submission.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA acronym and full name on the right. The FDA part of the logo is in blue, with the acronym in a square and the full name, "U.S. Food & Drug Administration," written out next to it.
October 21, 2022
JR Engineering & Medical Technologies (M) SDN.BHD. % Manoj Zacharias Consultant Liberty Management Group Ltd. 75 Executive Dr. STE114 Aurora, Illinois 60504
Re: K222349
Trade/Device Name: JR MEDIC Nitrile Examination Gloves Powder Free (Orange, Purple) Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I, reserved Product Code: LZA Dated: August 1, 2022 Received: August 3, 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.
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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about 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
Enclosure
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Indications for Use
510(k) Number (if known) K222349
Device Name
JR MEDIC Nitrile Examination Gloves Powder Free (Orange, Purple)
Indications for Use (Describe)
Nitrile Examination Gloves Powder Free is a disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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SUBMISSION OF PREMARKET NOTIFICATION (510k) FOR JR MEDIC NITRILE EXAMINATION GLOVES POWDER FREE (ORANGE, PURPLE)
510(k) SUMMARY As required by: 21CFR§807.92(c) K222349
| 510(k Owner's Name | JR Engineering & Medical Technologies (M) Sdn. Bhd. |
|---|---|
| Address | Lot 8 &10, Jalan Zurah 3 & Lot 1 & 3, Jalan Zurah3A/1, Pusat Perindustrian 2, 44200 Rasa, HuluSelangor, 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 |
| Official 510k Correspondent | Manoj Zacharias, ConsultantOfficial Contact for JR Engineering & MedicalTechnologies (M) Sdn. Bhd |
| Official 510k Correspondent Firm | Liberty Management Group Ltd75 Executive Dr. STE114, Aurora, IL 60504 USA(630) 270-2921 [voice] (815) 986-2632 [fax]manoj@libertymanagement.us |
| Date Summary Prepared | 19 OCTOBER 2022 |
APPLICANT INFORMATION ব
B. DEVICE IDENTIFICATION
| Name of the device | JR MEDIC Nitrile Examination Gloves Powder Free (Orange, Purple) |
|---|---|
| Product proprietary or trade name | JR MEDIC Nitrile Examination Gloves Powder Free (Orange, Purple) |
| Common or usual name | Exam Gloves |
| Classification name | Polymer Patient Examination Glove |
| Device Classification | Class-1 |
| Product Code | LZA |
| Regulation Number | 21 CFR 880.6250 |
| Review Panel | General Hospital |
C. PREDICATE DEVICE
| Predicate Device | Blue Nitrile Examination Gloves Powder Free |
|---|---|
| Manufacturer | JR Engineering & Medical Technologies (M)SDN.BHD. |
| 510(k) Number | K192333 |
| Regulatory Class | 1 |
| Product code | LZA |
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SUBMISSION OF PREMARKET NOTIFICATION (510k) FOR JR MEDIC NITRILE EXAMINATION GLOVES POWDER FREE (ORANGE, PURPLE)
D. DESCRIPTION OF THEDEVICE:
JR MEDIC Nitrile Examination Gloves Powder Free (Orange, Purple) are Class I patient examination gloves bearing the product code Nitrile - LZA (21CFR880.6250). The gloves are made from acrylonitrile-butadiene copolymer dispersion. These gloves are available in Orange & Purple color and are powder free and are provided non-sterile. These gloves have a shelf life for 3 years.
E. INTENDED USE OF THE DEVICE:
JR MEDIC Nitrile Examination Gloves Powder Free is a disposable device intended for medical purpose that are worn on the examiner's hand to prevent contamination between patient and examiner.
| Characteristics | Standards | Device Performance | ComparisonAnalysis | ||
|---|---|---|---|---|---|
| PredicateK192333 | SubjectK222349 | ||||
| Name of device | - | Blue Nitrile ExaminationGloves Powder-free | JR MEDIC NitrileExamination Gloves PowderFree (Orange, Purple) | Similar | |
| Manufacturer(s) | - | JR Engineering & MedicalTechnologies(M) SDN.BHD. Malaysia. | JR Engineering & MedicalTechnologies(M) SDN.BHD. Malaysia. | Same | |
| Intended use | - | JR MEDIC Blue NitrileExamination Gloves Powder-freeis disposable devices intendedfor medical purpose that are wonon the examiner's hand toprevent contamination betweenpatient and examiner. | Nitrile Examination GlovesPowder free is a disposabledevice intended for medicalpurpose that are worn on theexaminer's hand to preventcontamination between patientand examiner. | Similar | |
| Color | - | Blue | Orange, Purple | Different | |
| Texture | - | Finger Texture | Finger texture | Same | |
| Size | ASTM D6319-2019 | Extra - Small, Small, Medium,Large, Extra - Large | Extra - Small, Small, Medium,Large, Extra - Large | Same | |
| Single Use | Medical GloveGuidance ManualLabeling | Single Use | Single Use | Same | |
| Shelf Life | Medical GloveGuidance ManualLabeling | 3 Years | 3 Years | Same | |
| Characteristics | Standards | Device Performance | Comparison | ||
| PredicateK192333 | SubjectK222349 | Analysis | |||
| Color | Blue | Orange, Purple | Different | ||
| Dimensions | ASTM D6319-2019 | Length min 220mm (XS, S)min 230 mm (M, L, XL)Width70 +/-10 mm (XS)80 +/-10 mm (S)95+/-10 mm (M)110+/-10 mm (L)120+/-10 mm (XL) | Length min 220mm (XS, S)min 230 mm (M, L, XL)70 +/-10 mm (XS)Width80 +/-10 mm (S)95+/-10 mm (M)110+/-10 mm (L)120+/-10 mm (XL) | Same | |
| PhysicalProperties | ASTM D6319-2019 | Before Aging TensileStrength min 14 MpaUltimate Elongation Min500%After Aging TensileStrength min 14 MpaUltimate Elongation Min400% | Before Aging TensileStrength min 14 MpaUltimate Elongation Min500%After Aging Tensile Strengthmin 14 Mpa UltimateElongation Min 400% | Same | |
| Thickness | ASTM D6319-2019 | Palm min 0.05 mmFinger min 0.05 mm | Palm min 0.05 mmFinger min 0.05 mm | Same | |
| Powder Residue | ASTM D6319-2019 | ≤2 mg/glove | ≤2 mg/glove | Same | |
| Watertight(1000 ml) | ASTM D5151-2019 | Passes AQL-1.5 | Passes AQL-2.5 | Similar | |
| Material | ASTM D6319-2019 | Nitrile | Nitrile | Same | |
| Biocompatibility | Primary SkinIrritation-ISO10993 - 10:2010(E) | Under the condition ofstudy not an irritant | Under the condition ofstudy not an irritant | Same | |
| DermalSensitization- ISO10993-10:2010 -(E) | Under the conditions of thestudy not a sensitizer | Under the conditions of thestudy not a sensitizer | Same | ||
| In vitro cytotoxicityISO10993-5:2009(E) | Under the conditions of thestudy, cytotoxic | Under the conditions of thestudy, cytotoxic | Same | ||
| Acute SystemicToxicity Test ISO10993-11:2017(E) | Under the conditions of study thedevice extracts do not pose asystemic toxicity concern | Under the conditions of studythe device extracts do not pose asystemic toxicity concern | Same | ||
| Test Method | Purpose | AcceptanceCriteria | Result | ||
| ASTM D6319-2019Standard Specification forNitrile Examination Gloves forMedical Application | To determine thelength of the gloves | Min 220mm (XS, S)Min 230 mm (M, L, XL) | X-Small:- 236 mmSmall:- 236 mmMedium:- 238 mmLarge:- 238 mmX-Large:- 240 mm | ||
| ASTM D6319-2019Standard Specification forNitrile Examination Gloves forMedical Application | To determine thewidth of the gloves | X-Small:- 70+/-10 mmSmall:- 80+/-10 mmMedium:- 95+/-10mmLarge:- 110+/-10 mmX-Large:- 120+/-10 mm | X-Small- 74 mmSmall:- 84 mmMedium:- 94 mmLarge:- 104 mmX-Large:- 114 mm | ||
| ASTM D6319-2019Standard Specification for NitrileExamination Gloves forMedical Application | To determine thethickness of thegloves | Palm 0.05 mm minFinger 0.05 mm minfor all sizes | SizeX-SmallSmallMediumLargeX-Large | Palm0.18mm0.18mm0.18mm0.18mm0.18mm | Finger0.20mm0.20mm0.20mm0.20mm0.20mm |
| ASTM D6319-2019Standard Specification forExamination Gloves forMedical Application | To determine thephysical properties -Tensile strength | Before Aging TensileStrength 14Mpa Minfor all sizesAfter AgingTensile Strength14Mpa Min for allsizes | SizeX-SmallSmallMediumLargeX-Large | BeforeAging22.77 Mpa22.80 Mpa24.46 Mpa24.51 Mpa24.59 Mpa | AfterAging20.50 Mpa20.69 Mpa21.28 Mpa21.34 Mpa21.36 Mpa |
| To determine thephysical properties -Ultimate Elongation | Before AgingUltimate Elongation500% Min for allsizesBefore AgingUltimate Elongation400% Min for allsizes | SizeX-SmallSmallMediumLargeX-Large | BeforeAging885%886%888%891%892% | AfterAging760%764%767%769%772% |
F. SUMMARY OF THE TECHNOLOGICAL CHARACTERISTICS OF THE DEVICE COMPARED TO THE PREDICATE DEVICE
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SUBMISSION OF PREMARKET NOTIFICATION (510k) FOR JR MEDIC NITRILE EXAMINATION GLOVES POWDER FREE (ORANGE, PURPLE)
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SUBMISSION OF PREMARKET NOTIFICATION (510k) FOR JR MEDIC NITRILE EXAMINATION GLOVES POWDER FREE (ORANGE, PURPLE)
There are no significant differences between the two products and are identical in terms of intended use, materials, design, manufacturing methods. Both devices meet the ASTM standard D6319-2019.
G.NON-CLINICAL TESTING SUMMARY OF JR MEDIC NITRILE EXAMINATION GLOVES POWDER FREE
PERFORMANCE DATA – ORANGE COLOR
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JR ENGINEERING & MEDICAL TECHNOLOGIES (M) SDN.BHD SUBMISSION OF PREMARKET NOTIFICATION (510k) FOR JR MEDIC NITRILE EXAMINATION GLOVES POWDER FREE (ORANGE, PURPLE)
| Test Method | Purpose | Acceptance Criteria | Result |
|---|---|---|---|
| ASTM D6319-2019Standard Specification forNitrile Examination Gloves forMedical Application | To determine thelength of the gloves | Min 220mm (XS, S)Min 230 mm (M, L, XL) | X-Small:- 245 mmSmall:- 245 mmMedium:- 246 mmLarge:- 248 mmX-Large:- 248 mm |
| ASTM D6319-2019Standard Specification forNitrile Examination Gloves forMedical Application | To determine thewidth of the gloves | X-Small:- 70+/-10 mmSmall:- 80+/-10 mmMedium:- 95+/-10mmLarge:- 110+/-10 mmX-Large:- 120+/-10 mm | X-Small:- 76 mmSmall:- 85 mmMedium:- 95 mmLarge:- 104 mmX-Large:- 115 mm |
| ASTM D6319-2019Standard Specification forNitrile Examination Glovesfor Medical Application | To determine thethickness of thegloves | Palm 0.05 mm minFinger 0.05 mm minfor all sizes | Size Palm FingerX-Small 0.18mm 0.21mmSmall 0.18mm 0.21mmMedium 0.18mm 0.21mmLarge 0.18mm 0.21mmX-Large 0.18mm 0.21mm |
| ASTM D6319-2019Standard Specification forNitrile Examination Glovesfor Medical Application | To determine thephysical properties-Tensile strength | Before AgingTensile Strength 14MpaMin for all sizesAfter AgingTensile Strength 14MpaMin for all sizes | Size Before Aging After AgeingX-Small 22.78 Mpa 20.48 MpaSmall 22.82 Mpa 20.67 MpaMedium 24.47 Mpa 21.30 MpaLarge 24.52 Mpa 21.35 MpaX-Large 24.58 Mpa 21.36 Mpa |
| To determine thePhysical properties-Ultimate Elongation | Before AgingUltimate Elongation500% Min for all sizesAfter AgingUltimate Elongation400% Min for all sizes | Size Before Aging After AgingX-Small 884% 759%Small 885% 763%Medium 887% 766%Large 892% 768%X-Large 893% 772% | |
| ASTM D5151-2019Standard Test Method forDetection of Holes in MedicalGloves | To determine the holesin the gloves | AQL 2.5 | Gloves Passes AQL 2.5 |
| ASTM D6124-06(Reapproved 2017) StandardTest Method for ResidualPowder on Medical Gloves | To determine theresidual powder inthe gloves | 2 Mg/Glove Max | Size Residual Powder ContentX-Small 0.16 mg/gloveSmall 0.16 mg/gloveMedium 0.16 mg/gloveLarge 0.16 mg/gloveX-Large 0.16 mg/glove |
PERFORMANCE DATA-PURPLE COLOR
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SUBMISSION OF PREMARKET NOTIFICATION (510k) FOR JR MEDIC NITRILE EXAMINATION GLOVES POWDER FREE (ORANGE, PURPLE)
BIOCOMPATIBILITY DATA
| Test Method | Purpose | AcceptanceCriteria | Result |
|---|---|---|---|
| ISO 10993-10Biological Evaluation ofMedical Devices Test forIrritation and Skin Sensitization.Test done for irritation. | To determine the potential ofthe material under test toproduce dermal irritation inRabbits | Under the conditionofstudynotanirritant | Under the condition ofstudy not an irritant |
| ISO 10993-10Biological Evaluation of MedicalDevices Test for Irritation andSkin Sensitization. Test done Skinsensitization. | Totheskindeterminesensitization potential of thematerial both in terms ofinduction and elicitation inGuinea Pig. | Under the conditionsof the study not asensitizer | Under the conditions ofthe study not a sensitizer |
| ISO 10993-5:2009Biological evaluation of medicaldevices - part 5, tests for in vitrocytotoxicity. | To evaluate the in vitrocytotoxic potential of the testitem (both inner and outersurface) Extracts in L-929fibroblastscellsmouseusing elution method. | Under the conditionsof study non cytotoxic | Under the conditions ofthe study, cytotoxic.Additional testing wasperformed to determineif this was a systemictoxicity concern. |
| ISO 10993-11:2017Biological evaluation of medicaldevices - part 11, tests forsystemic toxicity. | Todeterminetheacutesystemic toxicity potential ofthe test item extracts (bothinside and outer surfaces) inSwiss Albino mice. | Under the conditionsof study the deviceextracts do not pose asystemic toxicityconcern | Under the conditions ofstudy the deviceextracts do not pose asystemic toxicityconcern |
H. Clinical Testing Summary
Not applicable - Clinical data is not needed for gloves or for most devices cleared by the 510(k) process.
I. CONCLUSION
The conclusions drawn from the non-clinical test demonstrate that the subject device in 510(K) submission, JR MEDIC Nitrile Examination Gloves Powder Free (Orange, Purple) is as safe, as effective, and performs as well as or better than the legally marketed predicate device K192333.
§ 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.