(185 days)
Sterile Nitrile Patient Examination Gloves Powder Free Blue Color is a disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.
Sterile Nitrile Patient Examination Gloves Powder Free Blue Color 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 blue in color and are powder free. Both Gamma & ETO sterilized gloves are available in X-Small, Small, Medium, Large & X-Large sizes.
The provided document is a 510(k) summary for a medical device: "Sterile Nitrile Patient Examination Gloves Powder Free Blue Color". This summary focuses on demonstrating substantial equivalence to a predicate device, rather than proving that the device meets acceptance criteria through a specific study with AI or human readers. Therefore, many of the requested items (2, 3, 4, 5, 6, 7, 8, 9) are not applicable or cannot be extracted from this document as it does not describe an AI/software study.
However, the document does contain "Acceptance Criteria" and "Result" for various non-clinical performance and biocompatibility tests.
Here's the information that can be extracted:
1. Table of Acceptance Criteria and Reported Device Performance
| Test Method (Characteristic) | Purpose | Acceptance Criteria | Reported Device Performance (Result) |
|---|---|---|---|
| ASTM D6319-2019 (Length) | To determine the length of the gloves | Min 220 mm for X-small and Small sizes; Min 230 mm for other sizes | X-Small: 303 mm; Small: 304 mm; Medium: 305mm; Large: 306mm; X-Large: 307mm |
| ASTM D6319-2019 (Width) | To determine the width of the gloves | 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 |
| ASTM D6319-2019 (Thickness) | To determine the thickness of the gloves | Palm 0.05 mm min; Finger 0.05 mm min for all sizes | All sizes: Palm 0.10mm; Finger 0.12mm |
| ASTM D6319-2019 (Tensile Strength - Before Ageing) | To Determine the physical properties- Tensile strength | Before Ageing Tensile Strength 14Mpa Min for all sizes | X-Small: 18.44Mpa; Small: 18.49Mpa; Medium: 18.56Mpa; Large: 18.62Mpa; X-Large: 18.64Mpa |
| ASTM D6319-2019 (Tensile Strength - After Ageing) | To Determine the physical properties- Tensile strength | After Ageing Tensile Strength 14Mpa Min for all sizes | X-Small: 17.49Mpa; Small: 17.53Mpa; Medium: 17.65Mpa; Large: 17.71Mpa; X-Large: 17.76Mpa |
| ASTM D6319-2019 (Ultimate Elongation - Before Ageing) | To Determine the physical properties- Ultimate Elongation | Before Ageing Ultimate Elongation 500% Min for all sizes | X-Small: 683%; Small: 687%; Medium: 692%; Large: 695%; X-Large: 698% |
| ASTM D6319-2019 (Ultimate Elongation - After Ageing) | To Determine the physical properties- Ultimate Elongation | After Ageing Ultimate Elongation 400% Min for all sizes | X-Small: 656%; Small: 660%; Medium: 663%; Large: 666%; X-Large: 669% |
| ASTM D5151-2019 (Water Tight / Holes) | To determine the holes in the gloves | AQL 2.5 | Passes AQL 1.5 |
| ASTM D6124-06 (Reapproved 2017) (Residual Powder) | To determine the residual powder in the gloves | 2 Mg/Glove Max | All sizes: 0.21mg/glove (X-small, Small), 0.22 mg/glove (Medium, Large, X-Large) |
| ISO 10993-10 (Skin Irritation) | To determine the potential of the material under test to produce dermal irritation in Rabbits | Under the condition of study not an irritant | Under the condition of study not an irritant |
| ISO 10993-10 (Skin Sensitization) | To determine the skin sensitization potential of the material both in terms of induction and elicitation in Guinea Pig. | Under the conditions of the study not a sensitizer | Under the conditions of the study not a sensitizer |
| ISO 10993-5:2009 (In vitro cytotoxicity) | To evaluate the in vitro cytotoxic potential of the test item (both inner and outer surface) Extracts in L-929 mouse fibroblasts cells using elution method. | Under the conditions of study non cytotoxic | Under the conditions of the study cytotoxic. (Note: This result does not meet the acceptance criteria. The document states "Under the conditions of the study cytotoxic" against an acceptance criteria of "Under the conditions of study non cytotoxic". This could be a typo in the provided text as later in the conclusion it says it performs "as well as or better than" in some cases. However, strictly based on the table, it appears unmet.) |
| ISO 10993-11:2017 (Acute Systemic Toxicity) | To determine the acute systemic toxicity potential of the test item extracts (both inside and outer surfaces) in Swiss Albino mice. | 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(E) / USP 41<151> | To determine the pyrogenic potential of the test item extract following intravenous injection in New Zealand white Rabbits. | 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. |
| Bacterial Endotoxin test USP 42<85> | To determine the bacterial Endotoxin limit in the glove | NMT 20 EU/pair of gloves | <20 EU/pair of gloves |
2. Sample size used for the test set and the data provenance: Not applicable. This document describes physical and biocompatibility testing, not an AI/software study with a test set of data. The "test sets" here would refer to the number of gloves tested per batch or samples for biocompatibility - which is not specified in detail.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" here is established through standardized laboratory testing methods (e.g., ASTM D6319, ISO 10993 series) and their respective criteria. For instance, for physical properties, it's objective measurements based on the standard. For biocompatibility, it's the observed biological response in animal models or in vitro assays compared to established acceptable limits.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.
Summary of the study that proves the device meets the acceptance criteria:
The device "Sterile Nitrile Patient Examination Gloves Powder Free Blue Color" underwent a series of non-clinical performance and biocompatibility tests according to recognized international and national standards (ASTM D6319, ASTM D5151, ASTM D6124, ISO 10993-10, ISO 10993-5, ISO 10993-11, USP 41<151>, USP 42<85>). The purpose of these tests was to demonstrate the device's physical properties (length, width, thickness, tensile strength, elongation), integrity (water tightness/holes), chemical residues (powder content), and biological safety (skin irritation, skin sensitization, cytotoxicity, systemic toxicity, pyrogenicity, bacterial endotoxin).
The results of these tests, as presented in the "Device Performance" columns, were compared against the "Acceptance Criteria" specified by the respective standards. The document states that the device met these criteria for most tests, demonstrating its safety and effectiveness. Notably, for "In vitro cytotoxicity," the device's result was "cytotoxic" while the acceptance criteria was "non cytotoxic." Despite this, the overall conclusion states that the device is "as safe, as effective, and performs as well as or better than the legally marketed predicate device K171093." This suggests either an interpretation allowing for some cytotoxicity in the context of the device's use and predicate equivalence, or a potential inconsistency in the provided information.
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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
February 17, 2022
Amazing Rubber Products Pvt Ltd % Manoj Zacharias Consultant Liberty Management Group Ltd 75 Executive Dr. STE 114 Aurora, Illinois 60504. USA
Re: K212586
Trade/Device Name: Sterile Nitrile Patient Examination Gloves Powder Free Blue Color Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I, reserved Product Code: LZA Dated: January 19, 2022 Received: January 19, 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 mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
For Clarence W. Murray III, 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) K212586
Device Name
Sterile Nitrile Patient Examination Gloves Powder Free Blue Color
Indications for Use (Describe)
Sterile Nitrile Patient Examination Gloves Powder Free Blue Color 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)
| Registration Use (Part 21 CFR 601 Subpart D) | |
|---|---|
| One-Time Stockpile Use (21 CFR 601 Subpart C) |
__ 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 K212586 As required by: 21CFR§807.92(c)
A. APPLICANT INFORMATION 510(K) Owner's Name Amazing Rubber Products Pvt. Ltd. Address Plot No 14c, Cochin Special Economic Zone , Kakkanad, Cochin-682 037, Kerala- India 9447053062 Phone ----------Fax E-mail info@aaazingglove.com Contact Person Mr. Jayasankar. S Designation Executive Director Contact Number 9447053062 Contact Email info@aaazingglove.com Date Submitted 14 January 2022
B. DEVICE IDENTIFICATION
| Name of the device | Sterile Nitrile Patient Examination Gloves Powder FreeBlue Color |
|---|---|
| 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 | Sancare Sterile Nitrile Patient ExaminationGloves, Powder free Blue Colour |
|---|---|
| 510(K) Number | K171093 |
| 510 (K) Owner | Sanrea Healthcare Products Pvt. Ltd. |
| Regulatory Class | 1 |
| Product code | LZA |
D. DESCRIPTION OF THEDEVICE:
Sterile Nitrile Patient Examination Gloves Powder Free Blue Color 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 blue in color and are powder free. Both Gamma & ETO sterilized gloves are available in X-Small, Small, Medium, Large & X-Large sizes.
E. INTENDED USE OF THE DEVICE:
Sterile Nitrile Patient Examination Gloves Powder Free Blue Color 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 | Remarks | |
|---|---|---|---|---|
| Predicate | Subject | |||
| 510(K) Number | K171093 | K212586 | --- | |
| Name of device | Sancare Sterile NitrilePatient ExaminationGloves, Powder freeBlue Colour | Sterile Nitrile PatientExamination GlovesPowder free BlueColor | Similar | |
| Dimensions | ASTM D6319- 2019 | Length Min 230 mWidth Min 95+/-10mm(for mediumsize) | 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 Mpa UltimateElongationMin 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 D6214 | ≤2 mg/glove | ≤2 mg/glove | Same |
| Primary SkinIrritation-ISO 10993-10:2010(E) | Under the condition ofstudy not an irritant | Under the conditionof study not anirritant | Same | |
| Biocompatibility | 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) | No data available | Under the conditionsof the study,cytotoxic | ---- | |
| Acute SystemicToxicity Test ISO10993-11:2017(E) | No data available | Under the conditionof study do not posea systemic toxicityconcern | ---- | |
| Material MediatedPyrogenicity ISO10993-11:2017(E) /USP 41<151> | No data available | Under the conditionsof the study nonpyrogenic | ---- | |
| Bacterial EndotoxintestUSP 42<85> | No data available | <20EU/pair of gloves | ---- | |
| Characteristics | Standards | Device Performance | Remarks | |
| PredicateK171093 | CurrentK212586 | |||
| Water Tight (1000 ml) | ASTM D5151-2019 | Passes AQL-1.5 | Passes AQL-1.5 | Similar |
| Intended use | The Sterile NitrilePatient Examinationgloves Powder free, Bluecolor, is a disposabledevice intended formedical purposes that isworn on the examiners'hand or finger to preventcontamination betweenPatient and examiner. | The Sterile NitrilePatient Examinationgloves Powder free, Bluecolor, is a disposabledevice intended formedical purposes that isworn on the examiners'hand or finger to preventcontamination betweenPatient and examiner. | Similar | |
| Material | ASTM D6319-2019 | Nitrile | Nitrile | Same |
| Color | Blue | Blue | Same | |
| Texture | Finger Texture | Finger texture | Same | |
| Size | ASTM D6319-2019 | Extra Small, Small, Medium, Large, ExtraLarge | Extra Small, Small, Medium, Large, ExtraLarge | Same |
| Single Use | Medical GloveGuidance Manual- Labeling | Single Use | Single Use | Same |
| Sterile/non sterile | Sterile- ETO/as well asRadiation,SAL- 10-6 | Sterile -ETO/as well asRadiation,SAL- 10-6 | Same | |
| Manufacturer(s) | Sanrea HealthcareProducts Pvt. Ltd. | Amazing RubberProducts Pvt. Ltd | ----- |
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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.
G. Non-Clinical Testing Summary
PERFORMANCE DATA
| Test Method | Purpose | Acceptance Criteria | Result |
|---|---|---|---|
| ASTM D6319-2019 StandardSpecification for NitrileExamination Gloves forMedical Application | To determine thelength of the gloves | Min 220 mm for X-smalland Small sizesMin 230 mm for othersizes | X-Small:- 303 mmSmall:- 304 mmMedium:- 305mmLarge:- 306mmX-Large:- 307mm |
| ASTM D6319-2019 StandardSpecification for NitrileExamination Gloves forMedical Application | To determine thewidth of the gloves | X-small:- $70\pm10$ mmSmall:- $80\pm10$ mmMedium:- $95\pm10$ mmLarge:- $110\pm10$ mmX-Large:- $120\pm10$ mm | X-small- 74 mmSmall:- 84 mmMedium:- 94 mmLarge:- 104 mmX-Large:- 115 mm |
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| Test Method | Purpose | Acceptance Criteria | Result | ||
|---|---|---|---|---|---|
| ASTM D6319-2019 Standard Specification for Nitrile Examination Gloves for Medical Application | To determine the thickness of the gloves | Palm 0.05 mm minFinger 0.05 mm min for all sizes | SizeX-SmallSmallMediumLargeX-Large | Palm0.10mm0.10mm0.10mm0.10mm0.10mm | Finger0.12mm0.12mm0.12mm0.12mm0.12mm |
| ASTM D6319-2019 Standard Specification for Nitrile Examination Gloves for Medical Application | To Determine the physical properties- Tensile strength | Before Ageing Tensile Strength 14Mpa Min for all sizesAfter Ageing Tensile Strength 14Mpa Min for all sizes | SizeX-SmallSmallMediumLargeX-Large | Before ageing18.44Mpa18.49Mpa18.56Mpa18.62Mpa18.64Mpa | After ageing17.49Mpa17.53Mpa17.65Mpa17.71Mpa17.76Mpa |
| To Determine the physical properties- Ultimate Elongation | Before Ageing Ultimate Elongation 500% Min for all sizesAfter Ageing Ultimate Elongation 400% Min for all sizes | SizeX-SmallSmallMediumLargeX-Large | Before ageing683%687%692%695%698% | After ageing656%660%663%666%669% |
| Test Method | Purpose | Acceptance Criteria | Result |
|---|---|---|---|
| ASTM D5151-2019 StandardTest Method for Detection ofHoles in Medical Gloves | To determine theholes in the gloves | AQL 2.5 | Gloves Passes AQL 1.5 |
| ASTM D6124-06 (Reapproved2017) Standard Test Methodfor Residual Powder onMedical Gloves | To determine theresidual powder inthe gloves | 2 Mg/Glove Max | 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 | Acceptance Criteria | Result |
|---|---|---|---|
| ISO 10993-10 BiologicalEvaluation of Medical DevicesTest for Skin Irritation andSkin Sensitization. Test donefor irritation. | 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. |
| Bacterial Endotoxin testUSP 42<85> | To determine the bacterialEndotoxin limit in the glove | NMT20 EU/pair ofgloves | <20 EU/pair of gloves |
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, Sterile Nitrile Patient Examination Gloves Powder Free Blue Color is as safe, as effective, and performs as well as or better than the legally marketed predicate device K171093.
§ 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.