(166 days)
Tegamen Nitrile Patient Examination gloves, is a disposable device intended for medical purposes that is worn on the examiners' hand or finger to prevent contamination between patient and examiner.
The subject device in this 510(k) Notification is Tegamen Nitrile Examination Gloves, Powder Free. The subject device is a patient examination glove made from nitrile compound, blue color, powder free and non-sterile (Per 21 CFR 880.6250, Class I). The device meets the specifications in ASTM D6319-19 Standard Specification for Nitrile Examination Gloves for Medical Application.
This document describes the premarket notification for the "Tegamen Nitrile Examination Gloves" (K223102) and its substantial equivalence to a predicate device.
Here's an analysis of the acceptance criteria and study data:
1. Table of Acceptance Criteria and Reported Device Performance
| Test Method | Purpose | Acceptance Criteria (from D6319-19 and other ISO standards) | Reported Device Performance (Tegamen Nitrile Examination Gloves) |
|---|---|---|---|
| Physical Dimensions (ASMT D6319-19) | To determine the width, length, and thickness of the gloves | * Length: > 230 mm (240-400mm) | * Pass |
| * Width: 70±10 mm to 120±10 mm (sizes XS to XL) | * Length (mm) Mean Value: 239.45 | ||
| * Thickness: > 0.05 mm (palm & finger) | * Width (mm) Mean Value: 84.7 (small), 95.9 (medium), 105.8 (large), 115.5 (extra large) | ||
| * Thickness at finger (mm) Mean Value: 0.13 | |||
| * Thickness at Palm (mm) Mean Value: 0.065 | |||
| Physical Requirements (ASMT D6319-19) - Tensile Strength & Elongation | To determine the tensile strength and ultimate elongation before and after aging | * Before Acceleration Aging: | * Pass |
| * Tensile Strength: 14 Mpa min | * Tensile Strength (MPa) Mean Value before aging: 23.24 | ||
| * Ultimate Elongation: 500 % min | * Ultimate Elongation (Mean Value) before aging: 851.9 | ||
| * After Acceleration Aging: | * Tensile Strength (MPa) Mean Value after aging: 22.62 | ||
| * Tensile Strength: 14 Mpa min | * Ultimate Elongation (Mean Value) after aging: 808.7 | ||
| * Ultimate Elongation: 400 % min | |||
| Detection of Holes (ASTM D6319-19, ASTM D5151-11) | To determine the holes in the gloves | AQL (Acceptance Quality Limit) 2.5 | * Pass |
| * Total Defects: 01 (Holes found 1) | |||
| Residual Powder (ASMT D6319-19, ASTM D6124-11) | To determine the residual powder in the gloves | ≤ 2.0 mg/glove | * Pass |
| * Powder Content (mg/glove): 1.335 | |||
| Skin Irritation (ISO 10993-10) | To determine the potential of the material to produce skin irritation in rabbits | Under the condition of study not an irritant | * Under the condition of study not an irritant |
| Skin Sensitization (ISO 10993-10) | To determine the skin sensitization potential in guinea pigs | Under the conditions of the study not a sensitizer. | * Under the conditions of the study not a sensitizer. |
| In vitro Cytotoxicity (ISO 10993-5) | To evaluate the in vitro cytotoxic potential of the test item in L-929 mouse fibroblasts cells using elution method | Under the conditions of study cytotoxic | * Cytotoxic in undiluted extract, 1:2, 1:4, 1:8, and 1:16 dilutions. Non-cytotoxic to L-929 cells at 1:32 dilutions (This states the acceptance criteria as "cytotoxic" but then the result details the levels of cytotoxicity. This is a common phrasing where 'cytotoxic' isn't necessarily a 'fail' but rather describes the finding which then needs to be contextualized by the dilutions). |
| Acute Systemic Toxicity (ISO 10993-11:2017) | The test item was evaluated for acute systemic toxicity in Swiss Albino Mice | Under the conditions of the study no acute systemic toxicity | * Under the conditions of the study no acute systemic toxicity |
Summary of Device Performance: The Tegamen Nitrile Examination Gloves passed all physical and chemical performance tests specified by ASTM D6319-19 (including dimensions, tensile strength, ultimate elongation, freedom from holes, and residual powder). In biocompatibility testing, the gloves were found to be non-irritant, non-sensitizer, and showed no acute systemic toxicity. While the cytotoxicity test reported cytotoxicity at higher concentrations, it was non-cytotoxic at a 1:32 dilution, which is typical for some materials and needs to be evaluated in context of direct patient contact and exposure levels.
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the exact sample sizes for each specific test (e.g., number of gloves tested for holes, number of mice for toxicity, etc.). However, it refers to standard test methods (ASTM D6319-19, ASTM D5151-11, ASTM D6124-11, ISO 10993 series), which inherently prescribe statistical sampling plans for each test. For example, ASTM D5151-11 (Detection of Holes in Medical Gloves) would specify a sample size based on the lot size and AQL.
- Data Provenance: The device manufacturer, Tegamen Safety products Ltd, is located in Ghiloth Alwar, Rajasthan, India. Therefore, the testing was presumably conducted in India or a facility contracted by the manufacturer. The data is retrospective, generated specifically for this 510(k) submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable (N/A) to this type of device submission. This is a medical glove, a Class I device, and the testing involves objective physical, chemical, and biological tests based on established standards (ASTM, ISO). There is no "ground truth" established by human experts in the way it would be for an AI diagnostic device (e.g., expert radiologists evaluating images). The ground truth is defined by the measurable parameters and pass/fail criteria of the specified ASTM and ISO standards.
4. Adjudication Method for the Test Set
This information is not applicable (N/A) for the same reasons as point 3. Adjudication methods like 2+1 or 3+1 are used in studies where human experts disagree on a subjective assessment, typically in image interpretation or clinical diagnosis. The tests performed for this device are objective measurements against defined criteria.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, What was the Effect Size of How Much Human Readers Improve with AI vs without AI Assistance
This information is not applicable (N/A). This device is a nitrile examination glove, not an AI diagnostic tool. Therefore, MRMC studies and the concept of human reader improvement with AI assistance are irrelevant to this submission.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
This information is not applicable (N/A). This device is a physical medical glove, not an algorithm or AI system.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" in this context is defined by the objective, measurable standards and specifications set forth in:
- ASTM D6319-19 (Standard Specification for Nitrile Examination Gloves for Medical Application)
- ASTM D5151-11 (Standard Test Method for Detection of Holes in Medical Gloves)
- ASTM D6124-11 (Standard Test Method for Residual Powder on Medical Gloves)
- ISO 10993-5 (Biological evaluation of medical devices – Part 5: Tests for in vitro cytotoxicity)
- ISO 10993-10 (Biological evaluation of medical devices – Part 10: Tests for skin irritation and skin sensitization)
- ISO 10993-11:2017 (Biological evaluation of medical devices – Part 11: Tests for acute systemic toxicity)
The device's performance metrics are directly compared against the values and thresholds specified in these international standards.
8. The Sample Size for the Training Set
This information is not applicable (N/A). This device does not involve machine learning or AI, so there is no "training set." The product is manufactured and tested according to established quality control procedures and standards.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable (N/A) for the same reasons as point 8.
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March 15, 2023
M/S Tegamen Safety Products Private Limited % Avinash Arora Consultant Arora 297 Consultancy 229 Deer Ridge Dr Kitchener, ON N2P2k5 Canada
Re: K223102
Trade/Device Name: Tegamen Nitrile Examination Gloves Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I. reserved Product Code: LZA Dated: February 10, 2023 Received: February 10, 2023
Dear Avinash Arora:
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
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Indications for Use
Submission Number (if known)
Device Name
Tegamen Nitrile Examination Gloves
Indications for Use (Describe)
Tegamen Nitrile Patient Examination gloves, is a disposable device intended for medical purposes that is worn on the examiners' hand or finger to prevent contamination between patient and examiner.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary K223102
As required by 21CFR§807.92
1. 510(k) Submitter
Avinash K Arora Arora 297 Consultancy 229 Deer Ridge Dr Kitchener, ON Canada - N2P2k5 +1.5194985957 arora297consultancy@gmail.com
2. Manufacturer
Tegamen Safety products Ltd Sp7-52, Ricco Industrial Area Ghiloth Alwar, Rajasthan, 301705 India
3. Preparation Date: Mar 8, 2023
4. Device Identification
| Trade/Proprietary Name: | Tegamen Nitrile Examination Gloves |
|---|---|
| Common/Usual Name: | Nitrile Examination Gloves |
| Classification Name: | Patient Examination Gloves |
| Regulation Number: | 21 CFR 880.6250 |
| Product Code: | LZA |
| Device Class: | Class I |
| Classification Panel: | General Plastic Surgery/General Hospital |
5. Legally Marketed Predicate Device(s)
| Device name: | Nitrile Patient Examination gloves, Powderfree, Blue Color |
|---|---|
| 510(k) number: | K143477 |
| Manufacturer: | PRIMUS GLOVES PVT LIMITEDPLOT No: 14-A, COCHIN SPECIAL ECONOMIC ZONE,KAKKANADCOCHIN, IN 682037 |
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6. Indications for Use
Tegamen Nitrile Patient Examination Gloves, is a disposable device intended for medical purposes that is worn on the examiners' hand or finger to prevent contamination between patient and examiner.
7. Device Description
The subject device in this 510(k) Notification is Tegamen Nitrile Examination Gloves, Powder Free. The subject device is a patient examination glove made from nitrile compound, blue color, powder free and non-sterile (Per 21 CFR 880.6250, Class I). The device meets the specifications in ASTM D6319-19 Standard Specification for Nitrile Examination Gloves for Medical Application.
8. Substantial Equivalence Discussion
The following table compares the subject Tegamen Nitrile Examination Gloves to the selected predicate device. The comparisons include the following attributes which forms the basis for determining substantial equivalence:
- . Indications for use,
- . Technological characteristics, and
- . Device performance
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| Table 1: Comparison of Characteristics | ||
|---|---|---|
| -- | -- | ----------------------------------------- |
| Attribute | Tegamen Nitrile Examination Gloves | Nitrile Patient Examination gloves, Powderfree, Blue | Same / Similar / Different |
|---|---|---|---|
| K223102 | (K143477) | ||
| Manufacturer | Tegamen Safety Products Ltd | Primus Gloves Private Ltd | Different |
| Product Code | LZA | LZA | Same |
| Regulation Number | 21 CFR 880.6250 | 21 CFR 880.6250 | Same |
| Device Description | The subject device in this 510(k) Notification isTegamen Nitrile Examination Gloves, PowderFree. The subject device is a patientexamination glove made from nitrile compound,blue color, powder free and non-sterile (Per 21CFR 880.6250, Class I). The device meets thespecifications in ASTM D6319-19 StandardSpecification for Nitrile Examination Glovesfor Medical Application. | The subject device is a patient examinationglove made of synthetic nitrilelatex compound. It is non-sterile, powderfreeand is Blue in color. The device isambidextrous and can be worn on either theeft or right hand. The device meets ASTM06319-10: Standard specification for NitrileExamination Gloves for Medical Application.The device is for over-the counter single use. | Similar |
| Materials of Use | Nitrile compound | Nitrile compound | Same |
| Sterile | No | No | Same |
| Indications for Use | Tegamen Nitrile Patient Examination gloves isa disposable device intended for medicalpurposes that is worn on the examiners handor finger to prevent contamination betweenpatient and examiner. | The examination gloves is a disposable deviceintended for medical purposes that is worn onthe examiners hand or finger to preventcontamination between patient and examiner | Same |
| Attribute | Tegamen Nitrile Examination GlovesK223102 | Nitrile Patient Examination gloves, Powderfree, Blue Color(K143477) | Comparison |
| Color | Blue | Blue | Same |
| Size(ASTM D6319-19) | Small, Medium, Large,Extra Large | Extra Small, Small, Medium, Large, ExtraLarge | Similar |
| Freedom from Holes(ASTM D6319-19) | Passed AQL2.5 | Passed AQL2.5 | Similar |
| Single Use | Yes | Yes | Same |
| Ambidextrous | Yes | Yes | Same |
| PhysicalProperties(ASTMD6319-19) | Before Aging Tensile Strength Min 14 MpaUltimate Elongation Min 500After AgingTensile Strength Min 14 MpaUltimate Elongation Min 400 | Before Aging Tensile Strength Min 14 MpaUltimate Elongation Min 500After AgingTensile Strength Min 14 MpaUltimate Elongation Min 400 | Similar |
| Powder Free(ASTM D6319-19) | <2 mg/glove | <2 mg/glove | Similar |
| Dimensions(ASTM D6319-19) | Overall Length 239 min | Overall Length 240 min | Similar |
| Thickness(ASTM D6319-19) | Palm min 0.05 mmFinger min 0.05 mm | Palm min 0.05 mmFinger min 0.05 mm | Similar |
| Biocompatibility -Cytotoxicity | Under theconditions ofstudycytotoxic | NA | DifferentNot conducted onpredicate device |
| Biocompatibility -Acute systemictoxicity | Under the conditions of thestudy no acute systemictoxicity | NA | DifferentNot conducted onpredicate device. |
| Biocompatibility -SKINSENSITIZATION -ISO 10993-10:2010 (E) | Under theconditions ofstudy not a sensitizer | Under theconditions ofstudy not a sensitizer | Similar |
| Biocompatibility -SKINIRRITATION -ISO10993-10: 2010 (E) | Under theconditions ofstudy not an irritant | Under theconditions ofstudy not an irritant | Similar |
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9 . Non-Clinical Testing Summary PERFORMANCE DATA
| Test Method | Purpose | Acceptance Criteria | Result |
|---|---|---|---|
| ASMT D6319-19Standard Specificationfor Nitrile ExaminationGloves for MedicalApplication - PhysicalDimensions Test | To determine thewidth, length, andthickness of thegloves | Length > 230 mm (240-400mm)Width 70±10 mm to 120±10 mm (sizes XS to XL)Thickness > 0.05 mm(palm & finger) | PassLength (mm) MeanValue –239.45Width (mm) MeanValue –84.7 (small), 95.9(medium), 105.8(large), 115.5(extra large)Thickness at finger(mm)Mean Value – .13Thickness at Palm(mm)Mean Value –0.065 |
| ASMT D6319-19Standard Specificationfor Nitrile ExaminationGloves for MedicalApplication - PhysicalRequirements Test | To determine thetensile strengthand ultimateelongation beforeand afteracceleration aging | Before Acceleration Aging:Tensile Strength 14 Mpa min before agingUltimate Elongation 500 % min before agingAfter Acceleration Aging:Tensile Strength 14 Mpa min after aging UltimateElongation 400 % min after aging | PassMPa (Mean Value) - 23.24before agingMPa (Mean Value) –22.62after agingUltimate Elongation(MeanValue) 851.9 before agingUltimate Elongation(MeanValue) 808.7 after aging |
| ASTM D6319-19(ASTM D5151-11)Standard Test Methodfor Detection of Holes inMedical Gloves | To determine theholes in thegloves | AQL 2.5 | PassTotal Defects - 01(Holesfound 1) |
| ASMT D6319-19(ASTM D6124-11)Standard Test Methodfor Residual Powder onMedical Gloves | To determine theresidual powderin the gloves | ≤ 2.0 mg/glove | PassPowder Content(mg/glove)– 1.335 |
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BIO-COMPATIBILITY DATA
| TestMethod | Purpose | AcceptanceCriteria | Result |
|---|---|---|---|
| ISO 10993-10 Biologicalevaluation of medical devices –Part 10: Tests for skin irritationand skin sensitization | To determine the potential of thematerial under test to produceskin irritation in rabbits | Under theconditionof studynot anirritant | Under the condition ofstudy not an irritant |
| ISO 10993-10Biologicalevaluation of medical devices –Part 10: Tests for skin irritationand skin sensitization | To determine the skinsensitization potential ofthe material both in termsof induction and elicitationin guinea pigs. | Under theconditionsof thestudy not asensitizer. | Under the conditions of thestudy not a sensitizer. |
| ISO 10993-5 Biologicalevaluation of medical devices –Part 5: Tests for in vitrocytotoxicity | To evaluate the in vitro cytotoxicpotential of the test item (bothinner and outer surface) Extractsin L-929 mouse fibroblasts cellsusing elution method | Under theconditionsof studycytotoxic | Based upon the resultsobtained in this study and inline with ISO 10993-5:2009,it is concluded that the giventest item, Tegamen NitrileExamination, supplied byTegamen Safety ProductsPvt Ltd., is considered ascytotoxic in undilutedextract, 1:2, 1:4, 1:8, and1:16 dilutions. Non-cytotoxic to L-929 cells at1:32 dilutions |
| ISO 10993-11:2017 Biologicalevaluation of medical devices–Part 11: Tests for acute systemictoxicity | The test item was evaluated foracute systemic toxicity in SwissAlbino Mice | Under theconditionsof thestudy noacutesystemictoxicity | Under the conditions of thestudy no acute systemictoxicity |
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10. Clinical Testing summary
Not applicable - Clinical data is not needed for the subject gloves.
11. Conclusion
The conclusion drawn from the non-clinical test demonstrate that the subject device, Tegamen Nitrile Examination Glove, is as safe, as effective, and performs as well as or better than the legally marketed predicate 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.