(86 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 acrylonitrile-butadiene copolymer dispersion. These gloves are blue in color, powder free and non sterile. The device is available in Extra Small, Small, Medium, Large and Extra Large sizes.
The provided document details the acceptance criteria for "Blue Nitrile Examination Gloves Powder Free" and presents the results of non-clinical testing to demonstrate the device meets these criteria.
1. Table of Acceptance Criteria and Reported Device Performance
| Characteristic | Standard | Acceptance Criteria (Predicate / Subject Device) | Reported Device Performance (Subject Device) |
|---|---|---|---|
| Dimensions | |||
| Length | ASTM D6319-2019 | Min 230 mm for all sizes | X-Small: 245 mm, Small: 245 mm, Medium: 246 mm, Large: 248 mm, X-Large: 248 mm |
| Width | ASTM D6319-2019 | X-small: 70+/-10 mm, Small: 80+/-10 mm, Medium: 95+/-10 mm, Large: 110+/-10 mm, X-Large: 120+/-10 mm | X-small: 76 mm, Small: 84 mm, Medium: 94 mm, Large: 105 mm, X-Large: 115 mm |
| Physical Properties | |||
| Thickness | ASTM D6319-2019 | Palm min 0.05 mm, Finger min 0.05 mm for all sizes | Palm: 0.09 mm (all sizes), Finger: 0.15 mm (all sizes) |
| Tensile Strength (Before Aging) | ASTM D6319-2019 | Min 14 Mpa for all sizes | X-Small: 22.76 Mpa, Small: 22.77 Mpa, Medium: 24.46 Mpa, Large: 24.51 Mpa, X-Large: 24.59 Mpa |
| Tensile Strength (After Aging) | ASTM D6319-2019 | Min 14 Mpa for all sizes | X-Small: 20.50 Mpa, Small: 20.50 Mpa, Medium: 21.81 Mpa, Large: 21.95 Mpa, X-Large: 22.05 Mpa |
| Ultimate Elongation (Before Aging) | ASTM D6319-2019 | Min 500% for all sizes | X-Small: 884%, Small: 885%, Medium: 888%, Large: 891%, X-Large: 892% |
| Ultimate Elongation (After Aging) | ASTM D6319-2019 | Min 400% for all sizes | X-Small: 867%, Small: 868%, Medium: 870%, Large: 872%, X-Large: 875% |
| Water Tight (Detection of Holes) | ASTM D5151-2019 | Passes AQL-1.5 | Gloves Passes AQL 1.5 |
| Powder Residue | ASTM D6124-06 (Reapproved 2017) | ≤2 mg/glove | X-small: 0.16 mg/glove, Small: 0.16 mg/glove, Medium: 0.16 mg/glove, Large: 0.16 mg/glove, X-Large: 0.16 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 (Note: This result is listed as "cytotoxic" while the acceptance criteria is "non cytotoxic", which could be a typo or indicates further consideration is needed). |
| 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 |
From the table, the device performance meets or exceeds the acceptance criteria for all tested characteristics, with the exception of the "In vitro Cytotoxicity" test where the reported result is "cytotoxic" while the acceptance criteria is "non cytotoxic". This discrepancy needs clarification. However, in the "SUMMARY OF THE TECHNOLOGICAL CHARACTERISTICS", the predicate also states "cytotoxic" for in vitro cytotoxicity, implying it might be an acceptable characteristic for this type of device or a different interpretation of cytotoxicity specific to gloves.
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 specific sample sizes used for each test. For example, for "Water Tight (1000 ml)" test, it mentions "Passes AQL-1.5", which implies a sampling plan was used according to the ASTM standard, but the specific number of gloves tested is not provided. The data provenance (country of origin, retrospective/prospective) is also not specified, beyond the fact that the tests were conducted according to international standards (ASTM, ISO).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not applicable. The device under review is a medical glove, and the evaluation relies on adherence to established physical, chemical, and biological performance standards, not expert interpretation of medical images or cases. Ground truth for these tests is based on objective measurements and established test methodologies defined in the ASTM and ISO standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies involving interpretation of data (e.g., medical images) where expert consensus is required. The testing for this device involves objective, quantitative measurements against predefined standards.
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 information is not applicable. The device is a medical glove. MRMC studies are relevant for AI-powered diagnostic tools where human readers (e.g., radiologists) interpret images with or without AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable. The device is a medical glove, not an algorithm or AI system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth for this device's performance is based on the objective measurements and predefined thresholds within recognized international standards (ASTM D6319-2019, ASTM D5151-2019, ASTM D6124-06, ISO 10993-10, ISO 10993-5:2009, ISO 10993-11:2017, USP 41<151>). For example:
- Dimensions: Measured length and width against minimum/range requirements.
- Physical Properties: Measured tensile strength and elongation against minimum percentage requirements.
- Water Tightness: Statistical sampling and inspection against an Acceptable Quality Level (AQL).
- Biocompatibility: Observation of biological responses (e.g., irritation, sensitization) following standardized protocols, compared against criteria for "not an irritant" or "not a sensitizer".
8. The sample size for the training set
This information is not applicable. The device is a medical glove, not an AI or machine learning model that requires a training set.
9. How the ground truth for the training set was established
This information is not applicable, as there is no training set for this type of medical device.
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May 28, 2023
Latrile Gloves Private Limited % Manoj Zacharias Consultant Liberty Management Group Ltd. 75 Executive Dr. STE114 Aurora, Illinois 60504
Re: K230601
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: February 23, 2023 Received: March 3, 2023
Dear Manoi Zacharias:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about 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 -S
Bifeng Qian, M.D., Ph.D. Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K230601
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) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(K) SUMMARY K230601 As required by: 21CFR§807.92
A. APPLICANTINFORMATION
| 510(K) Owner's Name | Latrile Gloves Private Limited |
|---|---|
| Address | Plot No : B5 - Sipcot Induatrial Complex, 8th Main road,Pallapatti Village, Nilakottai Taluk, Dindigul Dist - 624201 |
| Phone | ----- |
| Fax | ----- |
| info@latrile.com | |
| Contact Person | Ragu. M |
| Designation | QMS - Head |
| Contact Number | 8754672072 |
| Contact Email | quality@latrile.com |
| Date Submitted | 22nd February 2023 |
B. DEVICE IDENTIFICATION
| Name of the device | Blue Nitrile Examination Gloves Powder Free |
|---|---|
| Product proprietary or trade name | Q-loves |
| Common or usual name | Exam Gloves |
| Classification name | Non-powdered patient examination glove |
| Device Classification | Class-1 |
| Product Code | LZA |
| Regulation Number | 21 CFR 880.6250 |
| Review Panel | General Hospital |
C. PREDICATE DEVICE
| Predicate Device | JR Engineering & Medical Technologies (M) SDN.BHD. |
|---|---|
| 510( K) Number | K192333 |
| Regulatory Class | 1 |
| 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 acrylonitrile-butadiene copolymer dispersion. These gloves are blue in color, powder free and non sterile. The device is available in Extra Small, Small, Medium, Large and Extra Large sizes.
E. INTENDED USE OF THE DEVICE:
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.
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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 | K230601 | ---- | |
| 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 mm WidthMin 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 | ≤2 mg/glove | ≤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 non pyrogenic | Under the conditionsof the study nonpyrogenic | 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. | Blue NitrileExamination GlovesPowder free isdisposable devicesintended for medicalpurpose that are wornon the examiner'shand to preventcontaminationbetween 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 GloveGuidance Manual- Labeling | Single Use | Single Use | Same |
| Manufacturer(s) | JR Engineering &MedicalTechnologies(M) SDN.BHD.Malaysia | Latrile Gloves PrivateLimited | ----- |
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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 D6319-2019.
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 230 mm for all sizes | X-Small:- 245 mmSmall:- 245 mmMedium:- 246mmLarge:- 248 mmX-Large:- 248 mm |
| ASTM D6319-2019 StandardSpecification for NitrileExamination Gloves forMedical Application | To determine thewidth of the gloves | X-small:- 70+/-10 mmSmall:- 80+/-10 mmMedium:- 95+/-10mmLarge:- 110+/-10 mmX-Large:- 120+/-10 mm | X-small:- 76 mmSmall:- 84 mmMedium:- 94 mmLarge:- 105 mmX-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 | Palm0.09mm0.09mm0.09mm0.09mm0.09mm | Finger0.15mm0.15mm0.15mm0.15mm0.15mm |
| 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 | Beforeageing22.76Mpa22.77Mpa24.46Mpa24.51Mpa24.59Mpa | Afterageing20.50Mpa20.50Mpa21.81Mpa21.95Mpa22.05Mpa |
| 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 | Beforeageing884%885%888%891%892% | Afterageing867%868%870%872%875% |
| Test Method | Purpose | Acceptance Criteria | 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-small 0.16mg/gloveSmall 0.16mg/gloveMedium 0.16 mg/gloveLarge 0.16 mg/gloveX-Large 0.16 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.
H. CONCLUSION
The conclusions drawn from the nonclinical tests demonstrate that the device is as safe, as effective, and performs as well as or better than the legally marketed device.
§ 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.