(90 days)
Blue Latex Examination Powder Free Gloves are disposable devices intended for medical purpose that are worn on the examiner's hand to prevent contamination between patient and examiner.
Blue Latex Examination Powder Free Gloves are manufactured to meet all the current specifications listed under the ASTM Specification D 3578-05 (Reapproved 2015), Standard Specification for Rubber Examination Gloves. They are made from Natural Rubber Latex. These gloves are blue in color and are powder free.
The document provided describes the acceptance criteria and the study results for the Blue Latex Examination Powder Free Gloves (K192329). This is a medical device, specifically examination gloves, and the studies evaluate physical properties and biocompatibility.
Here's the requested information:
1. A table of acceptance criteria and the reported device performance
| Characteristic / Test Method | Acceptance Criteria | Reported Device Performance (K192329) | Comparison with Predicate (K141042) |
|---|---|---|---|
| Dimensions - Length (ASTM D3578-05) | Min 230 mm for all sizes | Small: 304 mm, Medium: 304 mm, Large: 305 mm, X-Large: 305 mm, XX-Large: 305 mm | Similar |
| Dimensions - Width (ASTM D3578-05) | Small: 80+/-6 mm, Medium: 95+/-6mm, Large: 105+/-6 mm, X-Large: 114+/-6 mm, XX-Large: 120 +/-6 mm | Small: 84 mm, Medium: 94 mm, Large: 105 mm, X-Large: 114 mm, XX-Large: 123 mm | Similar |
| Thickness (ASTM D3578-05) | Palm: 0.08 mm min, Finger: 0.08 mm min for all sizes | Palm: 0.31mm (all sizes), Finger: 0.38mm (all sizes) | Similar |
| Physical Properties - Tensile Strength (ASTM D3578-05) | Before Ageing: 18 Mpa Min, After Ageing: 14 Mpa Min | Before Ageing: Small: 33.0 Mpa, Medium: 32.9 Mpa, Large: 32.2 Mpa, X-Large: 31.9 Mpa, XX-Large: 31.1 Mpa. After Ageing: Small: 30.0 Mpa, Medium: 30.6 Mpa, Large: 29.9 Mpa, X-Large: 29.7 Mpa, XX-Large: 28.2 Mpa | Similar |
| Physical Properties - Ultimate Elongation (ASTM D3578-05) | Before Ageing: 650% Min, After Ageing: 500% Min | Before Ageing: Small: 1322%, Medium: 1250%, Large: 1392%, X-Large: 1130%, XX-Large: 1149%. After Ageing: Small: 1046%, Medium: 1122%, Large: 1257%, X-Large: 1011%, XX-Large: 1110% | Similar |
| Physical Properties - Stress at 500% Elongation (ASTM D3578-05) | Before Ageing: 5.5 Mpa Max | Small: 5.1 Mpa, Medium: 5.2 Mpa, Large: 5.2 Mpa, X-Large: 5.1 Mpa, XX-Large: 5.2 Mpa | Not directly compared to predicate (N/A in predicate column) but meets the criteria |
| Water Tight (Holes) (ASTM D5151-06) | AQL 2.5 | Passes AQL 1.5 | Same |
| Powder Free Residue (ASTM D6124-06) | ≤ 2 mg/glove Max | Small: 0.20 mg/glove, Medium: 0.21 mg/glove, Large: 0.22 mg/glove, X-Large: 0.22 mg/glove, XX-Large: 0.23 mg/glove | Similar |
| Extractable Protein (ASTM D 5712-95) | 200 µg/dm² Max | Small: 45 µg/dm², Medium: 44 µg/dm², Large: 44 µg/dm², X-Large: 43 µg/dm², XX-Large: 45 µg/dm² | Not specified for predicate |
| Biocompatibility - Primary Skin Irritation (ISO 10993-10:2010(E)) | Not an irritant | Not an irritant | Same |
| Biocompatibility - Dermal Sensitization (ISO 10993-10:2010(E)) | Not a sensitizer | Not a sensitizer | Same |
| Biocompatibility - In vitro cytotoxicity (ISO10993-5:2009(E)) | Not explicitly stated in predicate, but implied (safe) | Cytotoxic, which is to be expected as latex is the positive control for this test. | Different (explained as expected) |
| Biocompatibility - Material mediated Pyrogenicity (ISO 10993-11:2017(E) / USP) | Data not available for predicate, implied non-pyrogenic if not listed. | Non-pyrogenic | Not available for predicate |
| Intended Use | For medical purposes to prevent contamination between patient and examiner. | Disposable devices intended for medical purpose that are worn on the examiner's hand to prevent contamination between patient and examiner. | Same |
| Material | Natural Latex | Natural Latex | Identical |
| Color | Blue | Blue | Identical |
| Texture | Finger Texture | Finger texture | Identical |
| Size (ASTM D3578-05) | Small, Medium, Large, X Large & XX Large | Small, Medium, Large, X Large & XX Large | Same |
| Single Use (Medical Glove Guidance Manual - Labeling) | Single Use | Single Use | Same |
| Sterile/non sterile | Non sterile | Non sterile | Same |
| Powder/Powder free | Powder free | Powder free | Same |
| Label and Labeling | Meets FDA's label and labeling requirements | Meets FDA's label and labeling requirements | Same |
2. Sample size used for the test set and the data provenance
The document provides specific values for various measurements (e.g., length, width, thickness, tensile strength, ultimate elongation, residual powder content, extractable protein content) across different glove sizes (Small, Medium, Large, X-Large, XX-Large). For tests like Water Tightness (AQL 1.5 achieved) and Biocompatibility testing (Primary Skin Irritation, Dermal Sensitization, In vitro cytotoxicity, Material mediated Pyrogenicity), the methodology implies testing on a statistically significant sample, but the exact sample sizes are not explicitly stated in the provided text for each test.
The data provenance is from non-clinical tests conducted by JR Engineering & Medical Technologies (M) SDN.BHD. in Malaysia. The study is a prospective assessment of the device's adherence to established ASTM standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable as the document describes non-clinical testing of physical and chemical properties of a medical device (gloves), not studies requiring expert interpretation of medical images or conditions to establish a ground truth. The "ground truth" here is defined by established engineering and medical device standards (e.g., ASTM, ISO).
4. Adjudication method for the test set
This is not applicable for the type of testing described (physical and chemical properties testing against standards). Adjudication methods like 2+1 or 3+1 are typically used in clinical studies for medical image interpretation or diagnostic accuracy assessments where human expert consensus is required.
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
This is not applicable. The document describes the performance of an examination glove, not an AI-powered diagnostic or assistive technology.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. This document evaluates a physical medical device (gloves), not a software algorithm.
7. The type of ground truth used
The ground truth used for these tests is based on established industry standards and specifications:
- ASTM D3578-05 (Reapproved 2015) Standard Specification for Rubber Examination Gloves
- ASTM D5151-06 (Reapproved 2015) Standard Test Method for Detection of Holes in Medical Gloves
- ASTM D6124-06 (Reapproved 2017) Standard Test Method for Residual Powder on Medical Gloves
- ASTM D 5712-95 (Reapproved 2010) Standard Test Method for the Analysis of Protein in Natural Rubber
- ISO 10993-10:2010(E) for Primary Skin Irritation and Dermal Sensitization
- ISO 10993-5:2009(E) for In vitro cytotoxicity
- ISO 10993-11:2017(E) / USP for Material mediated Pyrogenicity
8. The sample size for the training set
This is not applicable as this pertains to a physical product's performance validation, not a machine learning model.
9. How the ground truth for the training set was established
This is not applicable (see #8).
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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.
November 25, 2019
JR Engineering & Medical Technologies (M) SDN.BHD. % Manoj Zacharias Consultant Liberty Management Group Ltd. 75 Executive Dr. STE 114 Aurora, Illinois 60504
Re: K192329
Trade/Device Name: Blue Latex Examination Powder Free Gloves Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I, reserved Product Code: LYY Dated: August 24, 2019 Received: August 27, 2019
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.
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
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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 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,
For Elizabeth Claverie, M.S. Assistant Director for THT4B2 Acting Assistant Director for THT4B1 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
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Indications for Use
510(k) Number (if known) K192329
Device Name
Blue Latex Examination Powder Free Gloves
Indications for Use (Describe)
Blue Latex Examination Powder Free Gloves are disposable devices intended for medical purpose that are worn on the examiner's hand to prevent contamination between patient and examiner.
| Type of Use (Select one or both, as applicable) |
|---|
| Residential Use - Part of STR 30A Subarea Plan Owner - Time Construction with STR 30A Subarea Plan |
__ Prescription Use (Part 21 CFR 801 Subpart D)
|X | Over-The-Counter Use (21 CFR 801 Subpart C)
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510K SUMMARY K192329 as required by 21 CFR § 807.92
A. APPLICANT INFORMATION
| Applicant | JR Engineering & Medical Technologies (M) SDN.BHD. |
|---|---|
| Address | Lot 8 &10, Jalan Zurah 3, Lot 1 & 3, Jalan Zurah, 3A/1, PusatPerindustrian 2, 44200 Rasa, Selangor Darul 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 | November 24th 2019 |
B. DEVICE IDENTIFICATION
| Name of the device | Blue Latex Examination Powder Free Gloves |
|---|---|
| Product proprietary or trade name | Blue Latex Examination Powder Free Gloves |
| Common or usual name | Latex Examination Gloves Powder Free |
| Classification name | Patient Examination Glove |
| Device Classification | Class I |
| Product Code | LYY |
| Regulation Number | 21 CFR 880.6250 |
| Review Panel | General Hospital |
C. PREDICATE DEVICE
| Legally Marketed devices thatEquivalency is claimed | MCARE PF Powder-free Latex Examination Gloves |
|---|---|
| 510 (K) Number | K141042 |
| Regulatory Class | Class I |
| Product code | LYY |
D. DESCRIPTION OF THE DEVICE:
Blue Latex Examination Powder Free Gloves are manufactured to meet all the current specifications listed under the ASTM Specification D 3578-05 (Reapproved 2015), Standard Specification for Rubber Examination Gloves. They are made from Natural Rubber Latex. These gloves are blue in color and are powder free.
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E. INDICATIONS FOR USE/INTENDED USE OF THE DEVICE:
Blue Latex Examination Powder Free Gloves are disposable devices intended for medical purpose that are worn on the examiner's hand to prevent contamination between patient and examiner.
F. TECHNOLOGICAL CHARACTERISTICS
| CHARACTERSTICS | STANDARDS | DEVICE PERFORMANCE | Comparison | |||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| PREDICATE | SUBJECT | |||||||||||||||||||||||||||
| 510(k) Number | --- | K141042 | K192329 | --- | ||||||||||||||||||||||||
| Name of device | --- | MCARE PFPowder FreeLatexExaminationGloves | Blue Latex ExaminationPowder Free Gloves | --- | ||||||||||||||||||||||||
| Dimensions- Length | ASTMD3578-05(Reapproved2015) | Length > 230 mm | Length > 230 mmSize Average Small 304 Medium 304 Large 305 X-Large 305 XX-Large 305 | Similar | ||||||||||||||||||||||||
| CHARACTERSTICS | STANDARDS | DEVICE PERFORMANCE | Comparison | |||||||||||||||||||||||||
| 510(k) Number | K141042 K192329 | |||||||||||||||||||||||||||
| Physical Properties-Ultimate Elongation | ASTMD3578-05(Reapproved 2015) | Before AgeingUltimate Elongation> 650%After AgeingUltimate Elongation>500% | Before AgeingUltimate Elongation > 650%Size Actual value Small 1322 Medium 1250 Large 1392 X-Large 1130 XX-Large 1149After AgeingUltimate Elongation > 500%Size Actual value Small 1046 Medium 1122 Large 1257 X-Large 1011 XX-Large 1110 | Similar | ||||||||||||||||||||||||
| Dimensions- Width | ASTMD3578-05(Reapproved2015) | Width Min 95+/-10 mm (formedium size) | Width Min 95+/-10 mm(for medium size)Size Average Small 84 Medium 94 Large 105 X-Large 114 XX-Large 123 | Similar | ||||||||||||||||||||||||
| Physical Properties-Tensile Strength | ASTMD3578-05(Reapproved2015) | Before AgeingTensile Strength> 18 Mpa_After AgeingTensile Strength> 14 Mpa | Before AgeingTensile Strength > 18 MpaSize Actual value Small 33.0 Medium 32.9 Large 32.2 X-Large 31.9 XX-Large 31.1After AgeingTensile Strength > 14 Mpa Size Actual value Small 30.0 Medium 30.6 Large 29.9 X-Large 29.7 XX-Large 28.2 | Similar | ||||||||||||||||||||||||
| Thickness | ASTMD3578-05(Reapproved 2015) | Palm > 0.08 mmFinger > 0.08 mm | Palm > 0.08 mmFinger > 0.08 mmSize Palm(Actual value) Finger(Actual value) Small 0.31 0.38 Medium 0.31 0.38 Large 0.31 0.38 X-Large 0.31 0.38 XX-Large 0.31 0.38 | Similar | ||||||||||||||||||||||||
| Powder Free Residue | ASTMDD6319-10(Reapproved 2015) | $\leq$ 2 mg/glove | $\leq$ 2 mg/gloveSize Residualpowder content(mg/glove) Small 0.20 Medium 0.21 Large 0.22 X-Large 0.22 XX-Large 0.23 | Similar | ||||||||||||||||||||||||
| Biocompatibility | Primary SkinIrritation-ISO10993-10:2010(E) | Under the conditionof study, not anirritant | Under the condition of studynot an irritant | Same | ||||||||||||||||||||||||
| DermalSensitization-ISO10993-10:2010( E) | Under the conditionsof the study, not asensitizer | Under the conditions of thestudy, not a sensitizer | Same | |||||||||||||||||||||||||
| In vitrocytotoxicityISO10993-5:2009(E) | / | Under the conditions of thestudy, cytotoxic which is to beexpected as latex is the positivecontrol for this test. | Different | |||||||||||||||||||||||||
| Material mediatedPyrogenicityISO 10993-11:2017(E) / USP | Data Not available | Under the conditions of thestudy, non-pyrogenic | --- |
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| CHARACTERSTICS | STANDARDS | DEVICE PERFORMANCE | Comparison | |
|---|---|---|---|---|
| PREDICATE | CURRENT | |||
| 510(k) Number | K141042 | K192329 | ||
| Water Tight (1000 ml) | ASTM D5151-06(Reapproved 2015) | Passes | Passes AQL-2.5 | Same |
| Intended use | The mCare Powder Free LatexExamination BlueGlove is adisposable deviceintended formedical purposesthat is worn on theexaminer's hand orfinger to preventcontaminationbetween patientand examiner. | Blue Latex ExaminationPowder Free Gloves aredisposable devices intendedfor medical purpose that areworn on the examiner's handto prevent contaminationbetween patient and examiner. | Same | |
| Material | Natural Latex | Natural Latex | Identical | |
| Color | Blue | Blue | Identical | |
| Texture | Finger Texture | Finger texture | Identical | |
| Size | ASTMD 3578-5(Reapproved 2015) | Small, Medium,Large, X Large &XX Large | Small, Medium, Large, XLarge & XX Large | Same |
| Single Use | Medical GloveGuidance Manual- Labeling | Single Use | Single Use | Same |
| Sterile/non sterile | - | Non sterile | Non sterile | Same |
| Powder/Powder free | - | Powder free | Powder free | Same |
| Label and Labeling | FDA Labelrequirements | Meets FDA's labeland labelingrequirements | Meets FDA's label andlabeling requirements | Same |
| Manufacturer(s) | Mercator Medical(Thailand) LTD | JR Engineering & MedicalTechnologies (M) SDN.BHD.Malaysia | --- |
G. SUMMARY OF NON-CLINICAL PERFORMANCE DATA
| Test Method | Purpose | Acceptance Criteria | Result | |
|---|---|---|---|---|
| ASTM D3578-05 (Reapproved2015) Standard Specificationfor Rubber ExaminationGloves | To determine thelength of the gloves | Min 230 mm for all sizes | Small:-304 mmMedium:-304mmLarge:-305mmX-Large:-305mmXX-Large:-305 mm | |
| ASTM D3578-05 (Reapproved2015) Standard Specificationfor Rubber ExaminationGloves | To determine thewidth of the gloves | Small:-80+/-6 mmMedium:-95+/-6mmLarge:-105+/-6 mmX-Large:-114+/-6 mmXX-Large:-120 +/-6 mm | Small:-84 mmMedium:-94 mmLarge:-105 mmX-Large:-114 mmXX-Large:-123 mm | |
| Test Method | Purpose | Acceptance Criteria | Result | |
| ASTM D3578-05 (Reapproved 2015) Standard Specification for Rubber Examination Gloves | To determine the thickness of the gloves | Palm 0.08 mm minFinger 0.08 mm min for all sizes | SizeSmallMediumLargeX-LargeXX-Large | Palm Finger0.31mm 0.38mm0.31mm 0.38mm0.31mm 0.38mm0.31mm 0.38mm0.31mm 0.38mm |
| ASTM D3578-05 (Reapproved 2015) Standard Specification for Rubber Examination Gloves | To Determine the physical properties-Tensile strength | Before Ageing Tensile Strength 18Mpa Min for all sizesAfter Ageing Tensile Strength 14Mpa Min for all sizes | SizeSmallMediumLargeX-LargeXX-Large | Before ageing After ageing33Mpa 30Mpa32.9Mpa 30.6Mpa32.2Mpa 29.9Mpa31.9Mpa 29.7Mpa31.1Mpa 28.2Mpa |
| ASTM D3578-05 (Reapproved 2015) Standard Specification for Rubber Examination Gloves | To Determine the physical properties-Ultimate Elongation | Before Ageing Ultimate Elongation 650% Min for all sizesAfter Ageing Ultimate Elongation 500% Min for all sizes | SizeSmallMediumLargeX-LargeXX-Large | Before ageing After ageing1322% 1046%1250% 1122%1392% 1257%1130% 1011%1149% 1110% |
| To Determine the physical properties-stress at 500% Elongation | Before Ageing 5.5 Mpa Max for all sizes | SizeSmallMediumLargeX-LargeXX-Large | Before ageing NA5.1 Mpa5.2 Mpa5.2 Mpa5.1 Mpa5.2 Mpa | |
| ASTM D5151-06 (Reapproved 2015) 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 on Medical Gloves | To determine the residual powder in the gloves | 2 Mg/Glove Max | SizeSmallMediumLargeX-LargeXX-Large | Residual Powder Content0.20 mg/glove0.21 mg/glove0.22 mg/glove0.22 mg/glove0.23 mg/glove |
| ASTM D 5712-95 ( Re approved 2010) Standard Test Method for the Analysis of Protein in Natural Rubber | To determine the extractable protein in the gloves. | 200 µg/ dm² Max for all sizes | SizeSmallMediumLargeX-LargeXX-Large | Extractable Protein content45 µg/ dm²44 µg/ dm²44 µg/ dm²43 µg/ dm²45 µg/ dm² |
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The performance test data of the non-clinical tests meet following standards: ASTMD 3578-5 (Reapproved 2015) Standard Specification for Rubber Examination Gloves ASTM D5151-06 (Reapproved 2015) Standard Test Method for Detection of Holes in Medical Gloves ASTM D6124-06 (Reapproved 2017) Standard Test Method for Residual Powder on Medical Gloves ASTM D 5712-95 ( Re approved 2010) Standard Test Method for the Analysis of Protein in Natural Rubber
H.CONCLUSION
The conclusion drawn from the nonclinical tests demonstrates that the subject device in 510(K) submission K 192329, Blue Latex Examination Powder Free Gloves is as effective, and performs as well as or better than the legally marketed predicate device K141042.
§ 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.