(56 days)
First Glove Blue Nitrile Examination Gloves Powder Free is a disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.
First Glove Blue Nitrile Examination Gloves Powder Free are equivalent to Class I patient examination gloves bearing the product code LZA (21CFR880.6250). They meet all the current specifications listed under the ASTM D6319-19, Standard Specification for Nitrile Examination Gloves for Medical Application. They are made from Nitrile (NBR)100%. These gloves are blue in color and are powder free. The product is non-sterile, finger textured, ambidextrous with beaded cuff and single use only.
This document describes the acceptance criteria and performance of the "First Glove Blue Nitrile Examination Gloves Powder Free" based on non-clinical testing.
Here's the information requested:
1. Table of acceptance criteria and the reported device performance:
| Characteristic | Standard | Acceptance Criteria | Reported Device Performance (Subject Device K230958) |
|---|---|---|---|
| Dimensions - Length | ASTM D6319-19 | XS: ≥ 220 mm, S: ≥ 220 mm, M: ≥ 230 mm, L: ≥ 230 mm, XL: ≥ 230 mm, XXL: ≥ 230 mm | XS: 247.00 mm, S: 247.23 mm, M: 252.54 mm, L: 250.92 mm, XL: 245.54 mm, XXL: 251.00 mm |
| Dimensions - Width | ASTM D6319-19 | XS: 70±10 mm, S: 80±10 mm, M: 95±10 mm, L: 110±10 mm, XL: 120±10 mm, XXL: 130±10 mm | XS: 74.31 mm, S: 85.08 mm, M: 94.85 mm, L: 105.38 mm, XL: 110.77 mm, XXL: 121.31 mm |
| Thickness | ASTM D6319-19 | Palm: ≥ 0.05 mm, Finger: ≥ 0.05 mm (for all sizes) | Palm: XS 0.07, S 0.06, M 0.07, L 0.06, XL 0.07, XXL 0.07 (mm); Finger: XS 0.10, S 0.10, M 0.10, L 0.10, XL 0.11, XXL 0.10 (mm) |
| Physical Properties - Tensile Strength (Before Ageing) | ASTM D6319-19 | ≥ 14 MPa (for all sizes) | XS: 35.25 MPa, S: 29.47 MPa, M: 27.72 MPa, L: 30.12 MPa, XL: 36.26 MPa, XXL: 33.60 MPa |
| Physical Properties - Tensile Strength (After Ageing) | ASTM D6319-19 | ≥ 14 MPa (for all sizes) | XS: 35.75 MPa, S: 30.02 MPa, M: 28.75 MPa, L: 29.55 MPa, XL: 31.20 MPa, XXL: 35.66 MPa |
| Physical Properties - Ultimate Elongation (Before Ageing) | ASTM D6319-19 | ≥ 500% (for all sizes) | XS: 537%, S: 525%, M: 525%, L: 523%, XL: 528%, XXL: 533% |
| Physical Properties - Ultimate Elongation (After Ageing) | ASTM D6319-19 | ≥ 400% (for all sizes) | XS: 493%, S: 478%, M: 516%, L: 495%, XL: 485%, XXL: 502% |
| Freedom from Holes | ASTM D5151-19 | AQL 2.5 | Passes AQL 2.5 |
| Powder Free Residue | ASTM D6124-06 (Reapproved 2017) | ≤ 2 mg/glove | XS: 0.04 mg/glove, S: 0.28 mg/glove, M: 0.04 mg/glove, L: 0.04 mg/glove, XL: 0.26 mg/glove, XXL: 0.48 mg/glove |
| Biocompatibility - Primary Skin Irritation | ANSI AAMI ISO 10993-10:2010/(R)2014 | Not an irritant | Considered a non-irritant |
| Biocompatibility - Dermal Sensitization | ANSI AAMI ISO 10993-10:2010/(R)2014 | Not a sensitizer | Not considered to be a contact sensitizer |
| Biocompatibility - In vitro Cytotoxicity | ANSI AAMI ISO 10993-5:2009/(R)2014 | Non-cytotoxic | Cytotoxic at extract concentrations of 100%, 66.7%, 44.4%, 29.6% and 19.8%; non-cytotoxic at 13.2% |
| Biocompatibility - Acute Systemic Toxicity | ANSI AAMI ISO 10993-11:2017 | Device extracts do not pose a systemic toxicity concern | Did not induce any systemic toxicity |
2. Sample size used for the test set and the data provenance:
The document does not explicitly state the specific sample sizes used for each individual test (e.g., number of gloves tested for dimensions, tensile strength, etc.). However, it indicates the tests were conducted according to the specified ASTM and ISO standards, which typically include defined sampling plans.
The data provenance is from non-clinical bench testing. The country of origin of the data is not explicitly stated in the provided text, but the applicant's address is Malaysia (First Glove Sdn. Bhd.).
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 evaluation is based on non-clinical, objective laboratory tests against established international standards (ASTM and ISO). There were no human expert assessments of images or patient data to establish ground truth in this context.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
None. Adjudication methods are typically relevant for studies involving human interpretation or subjective assessments. This submission relies on objective physical, chemical, and biological tests.
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. This is a submission for medical gloves, which are physical devices. MRMC comparative effectiveness studies are used for AI-powered diagnostic or interpretive tools, not for devices like gloves.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
Not applicable. This is not an algorithm or AI-powered device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The "ground truth" for the non-clinical tests is based on the objective and quantifiable criteria defined by the relevant ASTM and ISO international standards. For example, for tensile strength, the ground truth is a specific numerical value (e.g., ≥ 14 MPa). For biocompatibility, it's defined by biological endpoints (e.g., "non-irritant," "non-sensitizer," "non-cytotoxic").
8. The sample size for the training set:
Not applicable. This is not an AI/machine learning device that requires a training set.
9. How the ground truth for the training set was established:
Not applicable. As mentioned above, there is no training set for this type of device.
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Image /page/0/Picture/0 description: The image contains 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.
May 30, 2023
First Glove Sdn. Bhd. % Manoj Zacharias Consultant Liberty Management Group Ltd. 75 Executive Dr. Ste 114 Aurora, Illinois 60504
Re: K230958
Trade/Device Name: First Glove 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: March 13, 2023 Received: April 4, 2023
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.
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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 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.
Bifeng Qian -S
Bifeng Oian, 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
510(k) Number (if known) K230958
Device Name
First Glove Blue Nitrile Examination Gloves Powder Free
Indications for Use (Describe)
First Glove Blue Nitrile Examination Gloves Powder Free 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) | |
|---|---|
| ☐ Prescription Use (Part 21 CFR 801 Subpart D) | ☑ Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(K) SUMMARY K230958 AS REQUIRED BY: 21CFR§807.92
A. APPLICANT INFORMATION
| 510(K) Owner's Name | FIRST GLOVE SDN. BHD. |
|---|---|
| Address | Unit 23-2, Level 23, Binjai 8, No. 2, Lorong Binjai,Kuala Lumpur, Wilayah Persekutuan, Malaysia50450. |
| Phone | +60 12-389 1644, +603 2181 8201 |
| Fax | +603 2181 7201 |
| dean@firstglove.com, | |
| Contact Person | Mr. Dean Segal |
| Designation | President |
| Contact Number | +60 12-389 1644 |
| Contact Email | dean@firstglove.com |
| Date Submitted | 13 March 2023 |
B. DEVICE IDENTIFICATION
| Name of the device | First Glove Blue Nitrile Examination Gloves PowderFree |
|---|---|
| Product proprietary or trade name | First Glove |
| Common or usual name | Blue Nitrile Examination Gloves Powder Free |
| 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 | Palm Care Blue Nitrile Examination Gloves Powder free |
|---|---|
| 510(k) Number | K202384 |
| Regulatory Class | Class 1 |
| Product code | LZA |
| Reference Device | Nitrile Patient Examination Gloves |
|---|---|
| 510(k) Number | K211351 |
| Regulatory Class | Class 1 |
| Product code | LZA |
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510(K) SUMMARY AS REQUIRED BY: 21CFR§807.92
D. DESCRIPTION OF THE DEVICE:
First Glove Blue Nitrile Examination Gloves Powder Free are equivalent to Class I patient examination gloves bearing the product code LZA (21CFR880.6250). They meet all the current specifications listed under the ASTM D6319-19, Standard Specification for Nitrile Examination Gloves for Medical Application. They are made from Nitrile (NBR)100%. These gloves are blue in color and are powder free. The product is non-sterile, finger textured, ambidextrous with beaded cuff and single use only.
First Glove Blue Nitrile Examination Gloves Powder Free with sizes Extra Small, Small, Medium, Large, Extra Large and Extra Extra Large are included in the submission.
E. INDICATIONS FOR USE OF THE DEVICE:
First Glove Blue Nitrile Examination Gloves Powder Free is a disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.
F.SUMMARY OF THE TECHNOLOGICAL CHARACTERISTICS OF THE DEVICE COMPARED TO THE PREDICATE DEVICE
| CHARACTERISTICS | STANDARDS | DEVICE PERFORMANCE | COMPARISON | ||
|---|---|---|---|---|---|
| PREDICATE | REFERENCE | SUBJECT | |||
| 510(k) Number | --- | K202384 | K211351 | K230958 | --- |
| Name of device | --- | Palm Care BlueNitrileExaminationGloves Powderfree | Nitrile PatientExaminationGloves | First Glove BlueNitrile ExaminationGloves PowderFree | --- |
| Product Code | --- | LZA | LZA | LZA | Same |
| Indications for Use | --- | Blue NitrileExaminationGloves PowderFree is disposabledevices intendedfor medicalpurpose that areworn on theexaminer's handto preventcontaminationbetween patientand examiner. | The NitrilePatientExaminationGloves are non-sterile disposabledevices intendedfor medical purposesthat are worn onthe examiner'shands or finger topreventcontaminationbetween patientand examiner. | First Glove BlueNitrileExaminationGloves PowderFree is a disposabledevice intended formedical purposethat is worn on theexaminer's hand topreventcontaminationbetween patientand examiner. | Same |
| Regulation Number | --- | 21 CFR 880.6250 | 21 CFR 880.6250 | 21 CFR 880.6250 | Same |
| Material | ASTMD6319-19 | Nitrile (NBR) | Nitrile | Nitrile (NBR) | Same |
| Color | --- | Blue | Blue | Blue | Same |
| Texture | --- | Finger Texture | --- | Finger Texture | Same aspredicatedevice |
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| CHARACTERISTICS | STANDARDS | DEVICE PERFORMANCE | COMPARISON | ||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| PREDICATE | REFERENCE | SUBJECT | |||||||||||||||||
| 510(k) Number | --- | K202384 | K211351 | K230958 | --- | ||||||||||||||
| Size | ASTMD6319-19 | Extra Small, Small, Medium, Large, Extra Large | XS, S, M, L, XL, XXL | XS, S, M, L, XL, XXL | Same as reference device | ||||||||||||||
| Design Feature | --- | Ambidextrous | Ambidextrous | Ambidextrous | Same | ||||||||||||||
| Single Use | Medical Glove Guidance Manual-Labeling | Single Use | Single Use | Single Use | Same | ||||||||||||||
| Sterile/non sterile | --- | Nonsterile | Non-Sterile | Nonsterile | Same | ||||||||||||||
| Powder/Powder free | --- | Powder free | Powder free | Powder free | Same | ||||||||||||||
| Dimensions- Length | ASTMD6319-19 | Length Min 230 mm(for medium size) | Length (mm):XS/S:≥220;M/L/XL/XXL:≥230 | Length (mm):XS/S:≥220;M/L/XL/XXL:≥230Size Average XS 247.00 S 247.23 M 252.54 L 250.92 XL 245.54 XXL 251.00 | Same as reference device | ||||||||||||||
| Dimensions- Width | ASTMD6319-19 | Width Min 95+/-10mm(for medium size) | Width (mm):XS:70±10;S:80±10;M:95±10;L:110±10;XL:120±10;XXL:130±10 | Width (mm):XS:70±10;S:80±10;M:95±10;L:110±10;XL:120±10;XXL:130±10Size Average XS 74.31 S 85.08 M 94.85 L 105.38 XL 110.77 XXL 121.31 | Same as reference device | ||||||||||||||
| Physical Properties-Tensile Strength | ASTMD6319-19 | Before AgeingTensile StrengthMin 14 MPa | Before AgeingTensileStrength14MPa, min | Before AgeingTensile StrengthMin 14 MPaSize Average XS 35.25 S 29.47 M 27.72 L 30.12 XL 36.26 | Same |
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| CHARACTERISTICS | STANDARDS | DEVICE PERFORMANCE | COMPARISON | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| PREDICATE | REFERENCE | SUBJECT | ||||||||||||||||||||||||
| 510(k) Number | K202384 | K211351 | K230958 | |||||||||||||||||||||||
| Physical Properties-Tensile Strength | ASTMD6319-19 | After AgeingTensile StrengthMin14 MPa | After AgeingTensileStrength14MPa, min | After AgeingTensile StrengthMin 14 MPaSize Average XS 35.75 S 30.02 M 28.75 L 29.55 XL 31.20 XXL 35.66 | Same | |||||||||||||||||||||
| Physical Properties-Ultimate Elongation | ASTMD6319-19 | Before AgeingUltimateElongationMin 500% | Before AgeingUltimateElongation500% min | Before AgeingUltimate ElongationMin 500%Size Average XS 537 S 525 M 525 L 523 XL 528 XXL 533 | Same | |||||||||||||||||||||
| Physical Properties-Ultimate Elongation | ASTMD6319-19 | After AgeingUltimateElongationMin 400% | After AgeingUltimateElongation400% min | After AgeingUltimate ElongationMin 400%Size Average XS 493 S 478 M 516 L 495 XL 485 XXL 502 | Same | |||||||||||||||||||||
| Thickness | ASTMD6319-19 | Palm Min0.05mmFinger Min0.05mm | Thickness(mm):Palm: ≥0.05Finger: ≥0.05 | Palm Min 0.05 mmFinger Min 0.05mmSize Palm(Avg)mm Finger(Avg)mm XS 0.07 0.10 S 0.06 0.10 M 0.07 0.10 L 0.06 0.10 XL 0.07 0.11 XXL 0.07 0.10 | Same | |||||||||||||||||||||
| Powder Free Residue | ASTMD6319-19 | ≤2 mg/glove | Meet therequirementsof ASTMD6124<2.0mg | ≤2 mg/gloveSize Average XS 0.04 mg/glove S 0.28 mg/glove M 0.04 mg/glove L 0.04 mg/glove XL 0.26 mg/glove XXL 0.48 mg/glove | Same |
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510(K) SUMMAR AS REQUIRED BY: 21CFR§807.92
| CHARACTERISTICS | STANDARDS | DEVICE PERFORMANCE | COMPARISON | ||
|---|---|---|---|---|---|
| PREDICATE | REFERENCE | SUBJECT | |||
| 510(k) Number | --- | K202384 | K211351 | K23958 | |
| Freedom fromHoles | ASTMD5151-19 | Passes AQL - 1.5 | Be free fromholes whentested inaccordancewith ASTMD5151AQL=2.5 | Passes AQL - 2.5 | Similar toreference device |
| Biocompatibility | Primary SkinIrritation- ANSIAAMI ISO10993-10:2010/(R)2014 | Under thecondition ofstudy, not anirritant | Under theconditions ofthe study, notan irritant or asensitizer. | Under thecondition of thestudy, the testarticle isconsidered a non-irritant. | Same |
| DermalSensitization-ANSI AAMIISO 10993-10:2010/(R)2014 | Under theconditions of thestudy, not asensitizer | Underconditions ofthe study, not asensitizer. | Under theconditions of thestudy, the testarticle is notconsidered to be acontact sensitizer. | Same | |
| In vitrocytotoxicity-ANSI AAMIISO 10993-5:2009/(R)2014 | Under theconditions of thestudy, non-cytotoxic | Underconditions ofthe study, didnot showpotentialtoxicity to L-929 cells. | Under theconditions of thestudy, the testarticle isconsideredcytotoxic at extractconcentrations of100%, 66.7%,44.4%, 29.6% and19.8% and did notproduce a cytotoxiceffect at 13.2%.Moreover, underthe conditions ofthe study, nonacute systemictoxic. | Similar | |
| Acute SystemicToxicity-ANSIAAMI ISO10993-11:2017 | Under theconditions ofstudy, the deviceextracts do notpose a systemictoxicity | --- | Under thecondition of study,the test article didnot induce anysystemic toxicity. | Same aspredicate device |
There are no significant differences between the products and are identical in terms of intended use materials, design and manufacturing methods. Devices meet the ASTM standard D6319-19.
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510(K) SUMMARY AS REQUIRED BY: 21CFR§807.92
G. SUMMARY OF NON-CLINICAL PERFORMANCE TESTING
| TEST METHOD | PURPOSE | ACCEPTANCECRITERIA | RESULT | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| ASTM D6319-19Standard Specificationfor Nitrile ExaminationGloves for MedicalApplication. | To determinethe length of thegloves | X-Small : 220 mm minSmall : 220 mm minMedium : 230 mm minLarge : 230 mm minX-Large : 230 mm minXX-Large : 230 mm min | XS: - 247.00 mmS: - 247.23 mmM: - 252.54 mmL: - 250.92 mmXL: - 245.54 mmXXL: - 251.00 mm | |||||||||||||||||||||
| ASTM D6319-19Standard Specificationfor Nitrile ExaminationGloves for MedicalApplication. | To determinethe width of thegloves | XS: 70+/-10 mmS: 80+/-10 mmM: 95+/-10 mmL: 110+/-10 mmXL: 120+/-10 mmXXL: 130+/-10 mm | XS: - 74.31 mmS: - 85.08 mmM: - 94.85 mmL: - 105.38 mmXL: - 110.77 mmXXL: - 121.31 mm | |||||||||||||||||||||
| ASTM D6319-19Standard Specificationfor Nitrile ExaminationGloves for MedicalApplication. | To determinethe thickness ofthe gloves | Palm0.05 mm min (for allsizes)Finger0.05 mm min (for allsizes) | Size Palm(mm) Finger(mm) XS 0.07 0.10 S 0.06 0.10 M 0.07 0.10 L 0.06 0.10 XL 0.07 0.11 XXL 0.07 0.10 | |||||||||||||||||||||
| ASTM D6319-19Standard Specificationfor Nitrile ExaminationGloves for MedicalApplication. | To determinethe physicalproperties-Tensile strength | Before AgeingTensile Strength 14MPaMin for all sizesAfter AgeingTensile Strength 14MPaMin for all sizes | Size BeforeAgeing Afterageing XS 35.25 MPa 35.75 MPa S 29.47 MPa 30.02 MPa M 27.72 MPa 28.75 MPa L 30.12 MPa 29.55 MPa XL 36.26 MPa 31.20 MPa XXL 33.60 MPa 35.66 MPa | |||||||||||||||||||||
| To determinethe physicalproperties-UltimateElongation | Before AgeingUltimate Elongation500% Min for all sizesAfter AgeingUltimate Elongation400% Min for all sizes | Size BeforeAgeing AfterAgeing XS 537 % 493 % S 525 % 478 % M 525 % 516 % L 523 % 495 % XL 528 % 485 % XXL 533 % 502 % | ||||||||||||||||||||||
| ASTM D5151-19Standard Test Methodfor Detection of Holesin Medical Gloves | To determine theholes in thegloves | AQL 2.5 | Gloves Passes AQL 2.5 | |||||||||||||||||||||
| ASTM D6124-06(Reapproved 2017)Standard Test Methodfor Residual Powder onMedical Gloves | To determine theresidual powderin the gloves | ≤ 2 mg/glove | XS: - 0.04 mg/gloveS: - 0.28 mg/gloveM: - 0.04 mg/gloveL: - 0.04 mg/gloveXL: - 0.26 mg/gloveXXL: - 0.48 mg/glove |
BENCH TEST DATA
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AS REQUIRED BY: 2
BIOCOMPATIBILITY DATA
| TEST METHOD | PURPOSE | ACCEPTANCECRITERIA | RESULT |
|---|---|---|---|
| ANSI AAMI ISO 10993-10:2010/(R)2014 - Biologicalevaluation of medical devices- Part 10: Tests for irritationand skin sensitizationTest done for irritation | To evaluate the test item,for skin irritation test inNew Zealand AlbinoRabbits. | Under the condition ofstudy not an irritant | Under the condition of thestudy, the test article isconsidered a non-irritant. |
| ANSI AAMI ISO 10993-10:2010/(R)2014 - Biologicalevaluation of medical devices- Part 10: Tests for irritationand skin sensitizationTest done for skin sensitization | To evaluate the test item,for the skin sensitizationin Guinea pigs bymaximization test. | Under the conditionsof the study, not asensitizer | Under the conditions of thestudy, the test article is notconsidered to be a contactsensitizer. |
| ANSI AAMI ISO 10993-5:2009/(R)2014 - Biologicalevaluation of medical devices-Part 5: Tests for in vitrocytotoxicity | To evaluate the test item,for its ability to inducecytotoxicity using mousecell line L929 by XTTDye Method. | Under the conditionsof the study, non-cytotoxic | Under the conditions of thestudy, the test article isconsidered cytotoxic atextract concentrations of100%, 66.7%, 44.4%,29.6% and 19.8% and didnot produce a cytotoxiceffect at 13.2%.Moreover, under theconditions of the study, nonacute systemic toxic. |
| ANSI AAMI ISO 10993-11:2017 - Biologicalevaluation of medical devices- Part 11: Tests for systemictoxicity | To evaluate the test item,for acute systemictoxicity in Albino CD-1Mouse. | Under the conditionsof study, the deviceextracts do not pose asystemic toxicityconcern | Under the condition ofstudy, the test article didnot induce any systemictoxicity. |
The performance test data of the non-clinical tests meet the following standards:
ASTM D6319-19 Standard Specification for Nitrile Examination Gloves for Medical Application.
ASTM D5151-19 Standard Test Method for Detection of Holes in Medical Gloves
ASTM D6124-06 (Reapproved 2017) Standard Test Method for Residual Powder on Medical Gloves
ANSI AAMI ISO 10993-10:2010/(R)2014 Biological Evaluation of Medical Devices - Part 10: Tests for Irritation and Skin Sensitization.
ANSI AAMI ISO 10993-5:2009/(R)2014 Biological Evaluation of Medical Devices - Part 5, Tests for In Vitro Cytotoxicity.
ANSI AAMI ISO 10993-11:2017 Biological Evaluation of Medical Devices - Part 11, Tests for Systemic Toxicity.
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510(K) SUMMARY AS REQUIRED BY: 21CFR§807.92
H. SUMMARY OF CLINICAL PERFORMANCE TESTING
Not applicable - Clinical data is not needed for gloves.
I. CONCLUSION
The conclusion drawn from the nonclinical tests demonstrates that the subject device in 510(k) submission, First Glove Blue Nitrile Examination Gloves Powder free is as effective, and performs as well as or better than the legally marketed predicate device K202384.
§ 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.