(186 days)
Nitrile Medical Examination Gloves is disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.
Nitrile Examination Gloves Powder Free-Black 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 black in color and are powder free and non-sterile.
The provided text describes the regulatory clearance for "JR MEDIC Nitrile Examination Gloves Powder Free- Black" and includes performance data compared to a predicate device. However, it does not describe an AI/ML powered device or a study that evaluates its performance for diagnostic or predictive purposes. This information pertains to medical gloves, which are physical products with established performance standards.
Therefore, many of the requested categories related to AI/ML device testing (e.g., sample size for test set, data provenance, number of experts, adjudication method, MRMC studies, standalone performance, training set sample size, ground truth for training set) are not applicable to this document.
I will provide the available information from the text regarding the acceptance criteria and performance of the medical glove.
Acceptance Criteria and Device Performance for JR MEDIC Nitrile Examination Gloves Powder Free-Black
The device is a medical glove, and its performance is evaluated against established ASTM standards for physical properties and biocompatibility.
1. Table of Acceptance Criteria and Reported Device Performance
| Characteristic | Standard/Test Method | Acceptance Criteria | Reported Device Performance (JR MEDIC Nitrile Examination Gloves Powder Free-Black) |
|---|---|---|---|
| Dimensions | ASTM D6319-2019 | Length: Min 230 mm (all sizes) | X-Small: 483 mm, Small: 484 mm, Medium: 485 mm, Large: 486 mm, X-Large: 486 mm (All meet criteria) |
| Width: X-Small: 70+/-10 mm, Small: 80+/-10 mm, Medium: 95+/-10 mm, Large: 110+/-10 mm, X-Large: 120+/-10 mm | X-small: 74 mm, Small: 84 mm, Medium: 94 mm, Large: 104 mm, X-Large: 115 mm (All meet criteria) | ||
| Physical Properties (Before Aging) | ASTM D6319-2019 | Tensile Strength: Min 14 Mpa (all sizes) | X-Small: 18.44Mpa, Small: 18.49Mpa, Medium: 18.56Mpa, Large: 18.62Mpa, X-Large: 18.64Mpa (All meet criteria) |
| Ultimate Elongation: Min 500% (all sizes) | X-Small: 683%, Small: 687%, Medium: 692%, Large: 695%, X-Large: 698% (All meet criteria) | ||
| Physical Properties (After Aging) | ASTM D6319-2019 | Tensile Strength: Min 14 Mpa (all sizes) | X-Small: 17.49Mpa, Small: 17.53Mpa, Medium: 17.65Mpa, Large: 17.71Mpa, X-Large: 17.76Mpa (All meet criteria) |
| Ultimate Elongation: Min 400% (all sizes) | X-Small: 656%, Small: 660%, Medium: 663%, Large: 666%, X-Large: 669% (All meet criteria) | ||
| Thickness | ASTM D6319-2019 | Palm: 0.05 mm min (all sizes), Finger: 0.05 mm min (all sizes) | Palm: 0.19mm (all sizes), Finger: 0.21mm (all sizes) (All meet criteria) |
| Powder Residue | ASTM D6124-06 (Reapproved 2017) | ≤2 mg/glove | 0.16 mg/glove (for all sizes X-Small, Small, Medium, Large, X-Large) (Meets criteria) |
| Water Tight | ASTM D5151-2019 | Passes AQL-1.5 | Passes AQL 1.5 (Meets criteria) |
| Biocompatibility - Primary Skin Irritation | ISO 10993-10:2010(E) | Under the condition of study not an irritant | Under the condition of study not an irritant (Meets criteria) |
| Biocompatibility - Dermal Sensitization | ISO 10993-10:2010(E) | Under the conditions of the study not a sensitizer | Under the conditions of the study not a sensitizer (Meets criteria) |
| Biocompatibility - In vitro Cytotoxicity | ISO 10993-5:2009(E) | Under the conditions of study non cytotoxic | Under the conditions of the study cytotoxic (Note: This is a discrepancy. The acceptance criteria states "non cytotoxic," but the result is "cytotoxic." Further investigation would be needed on why this was deemed acceptable for clearance.) |
| Biocompatibility - Acute Systemic Toxicity | ISO 10993-11:2017(E) | 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 (Meets criteria) |
| Biocompatibility - Material Mediated Pyrogenicity | ISO 10993-11:2017(E) / USP 41<151> | Under the conditions of the study non pyrogenic | No data available in the table, but the predicate device met this criteria. In the summary table on page 4, it states "No data available" for the subject device but lists "Same" in remarks implying it aligns with the predicate which was "non pyrogenic". |
2. Sample size 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 for each test. However, tests like ASTM D6319-2019 and D5151-2019 involve specific sampling plans (e.g., AQL for water tightness) where a number of gloves are sampled from a lot.
- The data provenance is from Malyasia, as the applicant (JR Engineering & Medical Technologies (M) Sdn. Bhd.) is located there. The studies are non-clinical tests, likely conducted in a laboratory setting to evaluate the product's physical and biological properties.
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)
- Not applicable. This is for a medical glove, not an AI/ML diagnostic device. Ground truth is established by objective measurements against industry standards (ASTM, ISO).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. This is for a medical glove, not an AI/ML diagnostic device requiring expert review and adjudication.
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 for a medical glove, not an AI/ML device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is for a medical glove, not an AI/ML device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for the performance evaluation of the medical glove is based on established international and national standards (such as ASTM D6319-2019, ASTM D5151-2019, ASTM D6124-06, ISO 10993 series). These standards define objective pass/fail criteria for physical properties and biocompatibility.
8. The sample size for the training set
- Not applicable. This is not an AI/ML device requiring a training set.
9. How the ground truth for the training set was established
- Not applicable. This is not an AI/ML device requiring a training set.
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October 25, 2022 JR Engineering & Medical Technologies (M) SDN.BHD. % Manoj Zacharias Consultant Liberty Management Group Ltd. 75 Executive Drive, Ste 114 Aurora, Illinois 60504
Re: K221169
Trade/Device Name: JR MEDIC Nitrile Examination Gloves Powder Free- Black Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I, reserved Product Code: LZA Dated: October 20, 2022 Received: October 20, 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. In addition, there must not be any claim or documentation (now or in the future) indicating "extra protection" or "customer request".
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 and Part 809; medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4. Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Bifeng Qian, M.D., Ph.D. Assistant Director THT4B2: Personal Protective Equipment, Reprocessing & Disinfection Devices Team DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality CDRH | Food and Drug Administration
Enclosure
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Indications for Use
510(k) Number (if known) K221169
Device Name
JR MEDIC Nitrile Examination Gloves Powder Free- Black
Indications for Use (Describe)
Nitrile Medical Examination Gloves is 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)
X Over-The-Counter Use (21 CFR 801 Subpart C)
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510(K) SUMMARY As required by: 21CFR§807.92(c)
A. APPLICANTINFORMATION K221169
| 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 | 12 April 2022 |
B. DEVICE IDENTIFICATION
| Name of the device | Nitrile Examination Gloves Powder Free-Black |
|---|---|
| Product proprietary or trade name | JR Medic |
| Common or usual name | Exam Gloves |
| Classification name | Patient Examination Gloves |
| Device Classification | Class-1 |
| Product Code | LZA |
| Regulation Number | 21 CFR 880.6250 |
| Review Panel | General Hospital |
C. PREDICATE DEVICE
| Predicate Device | JR Engineering & Medical Technologies (M) SDN.BHD |
|---|---|
| 510(K) Number | K192333 |
| Regulatory Class | 1 |
| Product code | LZA |
D. DESCRIPTION OF THEDEVICE:
Nitrile Examination Gloves Powder Free-Black 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 black in color and are powder free and non-sterile.
E. INTENDED USE OF THE DEVICE:
Nitrile Examination Gloves Powder Free is a disposable devices intended for medical purpose that are worn on the examiner's hand to prevent contamination between patient and examiner.
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F. SUMMARY OF THE TECHNOLOGICAL CHARACTERISTICS OF THE DEVICE COMPARED TO THE PREDICATEDEVICE
| Characteristics | Standards | Device Performance | Remarks | |
|---|---|---|---|---|
| Predicate | Subject | |||
| 510(K) Number | K192333 | K221169 | ---- | |
| Name of device | JR MEDIC Blue Nitrile Examination Gloves Powder-free | Nitrile Examination Gloves Powder Free-Black | ---- | |
| Dimensions | ASTM D6319-2019 | Length Min 230 m Width Min 95+/-10 mm(for medium size) | Length Min 230 mm Width Min 95+/-10 mm(for medium size) | Same |
| Physical Properties | ASTM D6319-2019 | Before AgingTensile Strength min 14 MpaUltimate Elongation Min 500%After AgingTensile Strength min 14 MpaUltimate Elongation Min 400% | Before AgingTensile Strength min 14 MpaUltimate Elongation Min 500%After AgingTensile Strength min 14 MpaUltimate Elongation 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 |
| Biocompatibility | Primary Skin Irritation- ISO 10993-10:2010(E)Dermal Sensitization- ISO 10993-10:2010( E)In vitro cytotoxicity ISO10993-5 :2009(E)Acute Systemic Toxicity Test ISO 10993-11:2017(E)Material Mediated Pyrogenicity ISO 10993-11:2017(E) / USP 41<151> | Under the condition of study not an irritantUnder the conditions of the study not a sensitizerUnder the conditions of the study, cytotoxicUnder the conditions of study the device extracts do not pose a systemic toxicity concernUnder the conditions of the study non pyrogenic | Under the condition of study not an irritantUnder the conditions of the study not a sensitizerUnder the conditions of the study cytotoxicUnder the conditions of study the device extracts do not pose a systemic toxicity concernNo data available | Same |
| Characteristics | Standards | Device Performance | Remarks | |
| Predicate | Current | |||
| Water Tight (1000 ml) | ASTM D5151-2019 | Passes AQL-1.5 | Passes AQL-1.5 | Similar |
| Intended use | JR MEDIC Blue NitrileExamination GlovesPowder-free isdisposable devicesintended for medicalpurpose that are won onthe examiner's hand toprevent contaminationbetween patient andexaminer. | Nitrile ExaminationGloves Powder free isa disposable devicesintended for medicalpurpose that are wornon the examiner'shand to preventcontaminationbetween patient andexaminer. | Similar | |
| Material | ASTMD6319-2019 | Nitrile | Nitrile | Same |
| Color | - | Blue | Black | Different |
| Texture | - | Finger Texture | Finger texture | Same |
| Size | ASTMD6319-2019 | Extra Small, Small,Medium, Large, ExtraLarge | Extra Small, Small,Medium, Large, ExtraLarge | Same |
| Single Use | Medical GloveGuidance Manual- Labeling | Single Use | Single Use | Same |
| Manufacturer(s) | - | JR Engineering &MedicalTechnologies(M) SDN.BHD.Malaysia | JR Engineering &MedicalTechnologies(M) SDN.BHD.Malaysia | ------ |
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K221169
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.
NON-CLINICAL TESTING SUMMARY PERFORMANCE DATA Result Test Method Purpose Acceptance Criteria ASTM D6319-2019 Standard To determine the Min 230 mm for all sizes X-Small:- 483 mm Specification for Nitrile length of the gloves Small:-484 mm Examination Gloves for Medium:- 485 mm Medical Application Large:-486 mm X-Large:- 486 mm ASTM D6319-2019 Standard determine 70+/-10 mm To the X-small:- X-small-74 mm Specification for Nitrile width of the gloves Small:-80+/-10 mm Small:-84 mm Examination Gloves for Medium:- 95+/-10mm Medium:- 94 mm Medical Application Large:-110+/−10 mm Large:-104 mm X-Large:- 120+/-10 mm X-Large:- 115 mm
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| Test Method | Purpose | AcceptanceCriteria | 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 | SizeX-SmallSmallMediumLargeX-Large | Palm0.19mm0.19mm0.19mm0.19mm0.19mm | Finger0.21mm0.21mm0.21mm0.21mm0.21mm |
| ASTM D6319-2019 StandardSpecification for NitrileExamination Gloves forMedical Application | To Determine thephysical properties-Tensile strength | Before AgeingTensile Strength14Mpa Min for allsizesAfter AgeingTensile Strength14Mpa Min for allsizes | SizeX-SmallSmallMediumLargeX-Large | Beforeageing18.44Mpa18.49Mpa18.56Mpa18.62Mpa18.64Mpa | Afterageing17.49Mpa17.53Mpa17.65Mpa17.71Mpa17.76Mpa |
| ASTM D6319-2019 StandardSpecification for NitrileExamination Gloves forMedical Application | To Determine thephysical properties-Ultimate Elongation | Before AgeingUltimate Elongation500% Min for allsizesAfter AgeingUltimateElongation 400%Min for all sizes | SizeX-SmallSmallMediumLargeX-Large | Beforeageing683%687%692%695%698% | Afterageing656%660%663%666%669% |
| Test Method | Purpose | AcceptanceCriteria | Result |
|---|---|---|---|
| ASTM D5151-2019 StandardTest Method for Detection ofHoles in Medical Gloves | To determine theholes in the gloves | AQL 1.5 | 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 | SizeX-smallSmallMediumLargeX-LargeResidual PowderContent0.16 mg/glove0.16 mg/glove0.16 mg/glove0.16 mg/glove0.16 mg/glove |
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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 |
G. Clinical Testing Summary
Not applicable - Clinical data is not needed for gloves or for most devices cleared by the 510(K) process.
H. CONCLUSION
The conclusions drawn from the non clinical test demonstrate that the subject device in 510(K) submission, Nitrile Examination Gloves Powder Free-Black 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.