(285 days)
Blue Nitrile Examination Gloves Powder Free is disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.
Blue Nitrile Examination Gloves Powder Free are Class I patient examination gloves bearing the product code Nitrile - LZA (21CFR880.6250). The gloves are made from acrylonitrilebutadiene copolymer dispersion. These gloves are blue in color and are powder free.
The provided text is a 510(k) summary for "Blue Nitrile Examination Gloves Powder Free". It details the device's characteristics, intended use, and a comparison to a predicate device. The document explicitly states that clinical testing is not applicable and that clinical data is not needed for gloves or for most devices cleared by the 510(K) process.
Therefore, there is no information in the provided text regarding a study that proves the device meets acceptance criteria related to AI or human-in-the-loop performance, as this is a physical medical device (examination gloves), not an AI-powered diagnostic or assistive tool.
However, I can extract the acceptance criteria and reported performance for the non-clinical tests conducted on the device, which are relevant for demonstrating its substantial equivalence to the predicate device.
1. Table of Acceptance Criteria and Reported Device Performance (Non-Clinical)
| Characteristic | Standard | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Dimensions | ASTM D6319-2019 | ||
| Length | Min 230 mm for all sizes | X-Small: 303 mmSmall: 304 mmMedium: 305mmLarge: 306mmX-Large: 307mm | |
| Width (for specific sizes) | 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: 115 mm | |
| Physical Properties | ASTM D6319-2019 | ||
| Before Aging: | |||
| Tensile Strength | 14 Mpa Min for all sizes | X-Small: 18.44 MpaSmall: 18.49 MpaMedium: 18.56 MpaLarge: 18.62 MpaX-Large: 18.64 Mpa | |
| Ultimate Elongation | 500% Min for all sizes | X-Small: 683%Small: 687%Medium: 692%Large: 695%X-Large: 698% | |
| After Aging: | |||
| Tensile Strength | 14 Mpa Min for all sizes | X-Small: 17.49 MpaSmall: 17.53 MpaMedium: 17.65 MpaLarge: 17.71 MpaX-Large: 17.76 Mpa | |
| Ultimate Elongation | 400% Min for all sizes | X-Small: 656%Small: 660%Medium: 663%Large: 666%X-Large: 669% | |
| Thickness | ASTM D6319-2019 | Palm 0.05 mm minFinger 0.05 mm min | Palm: 0.10 mm for all sizesFinger: 0.12 mm for all sizes |
| Water Tightness | ASTM D5151-2019 | AQL-1.5 | Passes AQL 1.5 |
| Powder Residue | ASTM D6124-06 (Reapproved 2017) | 2 mg/glove Max | X-Small: 0.21 mg/gloveSmall: 0.21 mg/gloveMedium: 0.22 mg/gloveLarge: 0.22 mg/gloveX-Large: 0.22 mg/glove |
| Biocompatibility | |||
| Primary Skin Irritation | ISO 10993-10 | Under the condition of study not an irritant | Under the condition of study not an irritant |
| Dermal Sensitization | ISO 10993-10 | 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 | Under the conditions of study non cytotoxic | Under the conditions of the study cytotoxic. |
| Acute Systemic Toxicity | ISO 10993-11:2017 | 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 |
| Material Mediated Pyrogenicity | ISO 10993-11:2017 / USP 41 <151> | Under the conditions of the study, the device did not demonstrate a material mediated pyrogenicity response. | Under the conditions of the study, the device did not demonstrate a material mediated pyrogenicity response. |
Regarding the other requested information (2-9), as a physical medical device (gloves) and not an AI/software device, these questions are not applicable to the context of the provided document.
- 2. Sample size used for the test set and the data provenance: Not applicable. (These are physical tests on glove samples, not a test set for AI performance).
- 3. Number of experts and qualifications: Not applicable. (These are standardized physical and biological tests).
- 4. Adjudication method: Not applicable. (These are standardized physical and biological tests).
- 5. Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable. This is for AI-assisted image interpretation or similar.
- 6. Standalone (algorithm only without human-in-the-loop performance): Not applicable. This is for AI algorithms.
- 7. Type of ground truth used: Not applicable in the AI sense. The "ground truth" for these tests comes from established industry standards (ASTM, ISO, USP) for physical and chemical properties and biological responses.
- 8. Sample size for the training set: Not applicable. Applies to AI/machine learning.
- 9. How the ground truth for the training set was established: Not applicable. Applies to AI/machine learning.
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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: a symbol on the left and the FDA name and title on the right. The symbol on the left is a stylized representation of a human figure, while the text on the right reads "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue letters.
May 28, 2022
Amazing Rubber Products Pvt Ltd % Manoj Zacharias Consultant Liberty Management Group Ltd. 75 Executive Dr. STE114 Aurora, Illinois 60504
Re: K212584
Trade/Device Name: Blue Nitrile Examination Gloves Powder Free Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I, reserved Product Code: LZA Dated: April 28, 2022 Received: May 2, 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.
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,
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
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Indications for Use
510(k) Number (if known) K212584
Device Name
Blue Nitrile Examination Gloves Powder Free
Indications for Use (Describe)
Blue Nitrile Examination Gloves Powder Free 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) |
|---|
| ------------------------------------------------- |
| Serve The Community (21 CFR 601 Subpart C) | X |
|---|---|
| Registration Use (Part 21 CFR 601 Subpart B) |
__ 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 K212584 As required by: 21CFR§807.92(c)
A. APPLICANTINFORMATION
| 510(K) Owner's Name | Amazing Rubber Products Pvt. Ltd. |
|---|---|
| Address | Plot No 14c, Cochin Special Economic Zone, Kakkanad,Cochin-682 037, Kerala- India |
| Phone | 9447053062 |
| Fax | ----- |
| info@amazingglove.com | |
| Contact Person | Mr. Jayasankar S |
| Designation | Executive Director |
| Contact Number | 9447053062 |
| Contact Email | info@amazingglove.com |
| Date Submitted | 12 August 2021 |
B. DEVICE IDENTIFICATION
| Name of the device | Blue Nitrile Examination Gloves Powder Free |
|---|---|
| Product proprietary or trade name | Amazing+ |
| 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 | I |
| Product code | LZA |
D. DESCRIPTION OF THEDEVICE:
Blue Nitrile Examination Gloves Powder Free are Class I patient examination gloves bearing the product code Nitrile - LZA (21CFR880.6250). The gloves are made from acrylonitrilebutadiene copolymer dispersion. These gloves are blue in color and are powder free.
E. INTENDED USE OF THE DEVICE:
Blue Nitrile Examination Gloves Powder Free is 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 | Comparison | |
|---|---|---|---|---|
| Predicate | Subject | |||
| 510(K) Number | K192333 | K212584 | ---- | |
| Name of device | JR MEDIC Blue NitrileExamination GlovesPowder-free | Blue NitrileExamination GlovesPowder Free | ---- | |
| Dimensions | ASTM D6319-2019 | Length Min 230 m WidthMin 95+/-10mm(for medium size) | Length Min 230 mmWidth Min 95+/-10mm(for medium size) | Same |
| Physical Properties | ASTM D6319-2019 | Before AgingTensile Strengthmin 14 MpaUltimate ElongationMin 500%After AgingTensile Strengthmin 14 MpaUltimate ElongationMin 400% | Before AgingTensile Strength min14 MpaUltimate ElongationMin 500%After AgingTensile Strengthmin 14 MpaUltimate ElongationMin 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 | $\le$ 2 mg/glove | $\le$ 2 mg/glove | Similar |
| Biocompatibility | Primary SkinIrritation-ISO 10993-10:2010(E) | Under the condition ofstudy not an irritant | Under the conditionof study not anirritant | Same |
| DermalSensitization- ISO10993-10:2010(E) | Under the conditions ofthe study not a sensitizer | Under the conditionsof the study not asensitizer | Same | |
| In vitro cytotoxicityISO10993-5:2009(E) | Under the conditions ofthe study, cytotoxic | Under the conditionsof the study cytotoxic | Same | |
| Acute SystemicToxicity Test ISO10993-11:2017(E) | Under the conditionsof study the deviceextracts do not pose asystemic toxicity concern | Under the conditionsof study the deviceextracts do not pose asystemic toxicityconcern | Same | |
| Material MediatedPyrogenicity ISO10993-11:2017(E) /USP 41<151> | Under the conditions ofthe study the deviceextract did not show amaterial mediatedpyrogenicity response. | Under the conditionsof the study thedevice extract didnot show a materialmediatedpyrogenicityresponse. | Same | |
| Characteristics | Standards | Device Performance | Comparison | |
| 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 is disposabledevices intended for medicalpurpose that are won onthe examiner's hand to preventcontamination between patientand examiner. | Blue NitrileExamination GlovesPowder free isdisposable devicesintended for medicalpurpose that are wornon the examiner's handto preventcontamination between patient andexaminer. | Similar | |
| Material | ASTMD6319-2019 | Nitrile | Nitrile | Same |
| Color | - | Blue | Blue | Same |
| 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 GloveGuidanceManual- Labeling | Single Use | Single Use | Same |
| Manufacturer(s) | - | JR Engineering &MedicalTechnologies(M) SDN.BHD.Malaysia | Amazing RubberProducts Pvt. Ltd. | ------ |
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NON-CLINICAL TESTING SUMMARY
PERFORMANCE DATA Result Test Method Acceptance Criteria Purpose ASTM D6319-2019 Standard To determine the Min 230 mm for all sizes X-Small:- 303 mm Specification for Nitrile length of the gloves Small:-304 mm Examination Gloves Medium:-305mm for Medical Application Large:-306mm X-Large:- 307mm ASTM D6319-2019 Standard To determine the X-small:-70+/-10 mm 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 | Palm0.10mm0.10mm0.10mm0.10mm0.10mm | Finger0.12mm0.12mm0.12mm0.12mm0.12mm |
| 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 PowderContent0.21mg/glove0.21mg/glove0.22 mg/glove0.22 mg/glove0.22 mg/glove |
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BIO-COMPATIBILITY DATA
| Test Method | Purpose | AcceptanceCriteria | 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. |
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 nonclinical test demonstrate that the subject device in 510(K) submission, Blue Nitrile Examination Gloves Powder Free is 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.