(127 days)
A Sterile Latex Surgical Gloves Powder Free is a device made of natural rubber intended to be worn by operating room personnel to protect a surgical wound from contamination.
The proposed device, Sterile Latex Surgical Gloves Powder Free is a sterile and disposable medical glove intended to be worn by operating room personnel to protect a surgical wound from contamination. The proposed device is made of natural rubber latex, as per standard ASTM D3577 -09(2015), Standard Specification for Rubber Surgical Gloves. The classification is: Type I - gloves compounded primarily from natural rubber latex. The proposed device is Sterile Latex Surgical Gloves Powder Free, and variants of different sizes. All variants share the same natural color (No color is added). The proposed device is sterilized using Gamma method to achieve the Sterility Assurance Level (SAL) of 10 and place in a sterility maintained package to ensure a shelf life of 3 years.
The provided document is a 510(k) Premarket Notification for a medical device: "Sterile Latex Surgical Gloves powder free." This document focuses on demonstrating substantial equivalence to an existing predicate device, rather than proving the device meets clinical acceptance criteria for an AI/ML medical device. Therefore, many of the requested points related to AI/ML study design (e.g., sample size for test set, number of experts, adjudication methods, MRMC studies, standalone performance, ground truth for training set) are not applicable to this type of submission.
However, the document does contain information about performance testing against established standards, which serve as the acceptance criteria for this specific device.
Here's an analysis of the provided information, addressing the relevant points and noting those that are not applicable:
Device Name: Sterile Latex Surgical Gloves powder free
Submission Type: 510(k) Premarket Notification (for substantial equivalence)
1. A table of acceptance criteria and the reported device performance
The document provides extensive tables comparing the subject device's performance to the predicate device and against the specifications outlined in relevant ASTM standards. These standards define the "acceptance criteria" for the physical and chemical properties of surgical gloves.
Summary Table of Acceptance Criteria and Reported Performance (Selected Key Parameters)
| Criteria Category | Performance Criterion Source (Standard/Section) | Acceptance Criteria | Reported Device Performance (K211478) | Proof of Meeting Criteria |
|---|---|---|---|---|
| Physical Dimensions | ASTM D3577-09 (Reapproved 2015) | Min 265mm (Length, all sizes) | 385mm - 396mm (All sizes) | Met |
| ASTM D3577-09 (Reapproved 2015) | Various +/- 6mm (Width, per size) | 74mm - 116mm (All sizes) | Met | |
| ASTM D3577-09 (Reapproved 2015) | Min 0.10mm (Finger Thickness, all sizes) | 0.20mm | Met | |
| ASTM D3577-09 (Reapproved 2015) | Min 0.10mm (Palm Thickness, all sizes) | 0.15mm | Met | |
| ASTM D3577-09 (Reapproved 2015) | Min 0.10mm (Cuff Thickness, all sizes) | 0.12mm | Met | |
| Physical Properties | ASTM D3577-09 (Reapproved 2015) | 24 Mpa minimum (Tensile Strength, Before Aging) | 27.2 Mpa - 29.7 Mpa | Met |
| ASTM D3577-09 (Reapproved 2015) | 18 Mpa minimum (Tensile Strength, After Aging) | 22.1 Mpa - 24.5 Mpa | Met | |
| ASTM D3577-09 (Reapproved 2015) | 750% minimum (Ultimate Elongation, Before Aging) | 864% - 874% | Met | |
| ASTM D3577-09 (Reapproved 2015) | 560% minimum (Ultimate Elongation, After Aging) | 727% - 734% | Met | |
| ASTM D3577-09 (Reapproved 2015) | 5.5 MPa Max (Stress at 500% before ageing) | 5.1 Mpa (Average Value) | Met | |
| Barrier Integrity | ASTM D3577-09 & ASTM D5151-06 | Max 1.5 AQL (Pinhole AQL, Before & After Aging) | 1.0 AQL (Gloves Passes) | Met |
| Chemical Residues | ASTM D6124-06 | $\le$ 2 mg/Glove (Powder Residue) | 0.26 mg/glove - 0.62 mg/glove (All sizes) | Met |
| ASTM D3577 & ASTM D5712-15 | $\le$ 50µg/dm² (Protein Content) | 38 µg/dm² | Met | |
| Biocompatibility | ISO 10993-10 | Non-irritant | Non-irritant | Met |
| ISO 10993-10 | Non-sensitizer | Non-sensitizer | Met | |
| ISO 10993-5:2009 | Non-cytotoxic | Cytotoxic | NOT Met (Qualified) | |
| ISO 10993-11:2017 | No systemic toxicity concern | No systemic toxicity concern | Met | |
| ISO 10993-11:2017 / USP 41<151> | No material mediated pyrogenicity response | No material mediated pyrogenicity response | Met | |
| USP 42<85> | NMT 20 EU/pair of gloves (Bacterial Endotoxin) | <20 EU/pair of gloves | Met |
Note on Biocompatibility (Cytotoxicity): The device reported "Cytotoxic" against an acceptance criteria of "non-cytotoxic." However, the comparison table in Section G.c notes that the predicate device (K192328) also tested "Cytotoxic" for this parameter. This indicates that while the specific test result might seem like a failure in isolation, in the context of demonstrating substantial equivalence to a legally marketed predicate, it is acceptable if the predicate device exhibits the same characteristic and is already on the market. The FDA would have cleared the predicate with this characteristic, implying it's acceptable for surgical gloves.
Study that proves the device meets the acceptance criteria:
The document describes non-clinical bench testing conducted to verify that the proposed device meets design specifications and acceptance criteria outlined in various industry standards (primarily ASTM and ISO).
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: The document does not explicitly state the sample size for each test performed. However, the tests are performed according to recognized international standards (ASTM, ISO, USP), which typically specify minimum sample sizes for reliable results. For example, ASTM D5151-06 (Detection of Holes in Medical Gloves) employs an Acceptable Quality Level (AQL) methodology, implying a statistically determined sample size tested for pinholes.
- Data Provenance: The tests were conducted to support a 510(k) submission for a manufacturer in Malaysia (Aspen Glove Sdn. Bhd.). The data itself is "bench test" data. It is not patient data, so "retrospective or prospective" does not apply in the typical sense of a clinical study.
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)
- Not Applicable. This is not a study involving expert readers or establishment of ground truth by human experts, as it is a physical device (surgical glove) and not an AI/ML diagnostic tool. The "ground truth" here is defined by the technical specifications and test methods within the referenced ASTM and ISO standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. This is a physical device performance study, not an imaging or diagnostic study requiring adjudication of expert opinions.
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 not an AI/ML device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is not an AI/ML device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" in this context is the established technical and performance specifications defined by international consensus standards (ASTM D3577-09, ASTM D5151-06, ASTM D6124-06, ISO 10993 series, USP). These standards outline the physical and chemical properties and safety requirements for such medical devices, and the tests verify compliance with these objective measures.
8. The sample size for the training set
- Not Applicable. This is not an AI/ML device and thus does not have a "training set."
9. How the ground truth for the training set was established
- Not Applicable. As there is no training set for this type of device, ground truth establishment for a training set is irrelevant.
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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.
September 16, 2021
Aspen Glove Sdn. Bhd. % Manoj Zacharias Consultant Liberty Management Group Ltd. 75 Executive Dr. STE 114 Aurora, Illinois 60504
Re: K211478
Trade/Device Name: Sterile Latex Surgical Gloves powder free Regulation Number: 21 CFR 878.4460 Regulation Name: Non-Powdered Surgeon's Glove Regulatory Class: Class I, reserved Product Code: KGO Dated: August 16, 2021 Received: August 16, 2021
Dear Manoj Zacharias:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal
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statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Clarence W. Murray III -S
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) K211478
Device Name
Sterile Latex Surgical Gloves powder free
Indications for Use (Describe)
A Sterile Latex Surgical Gloves Powder Free is a device made of natural rubber intended to be worn by operating room personnel to protect a surgical wound from contamination.
| 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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510K SUMMARY K211478 As required by: 21CFR § 807.92
A. APPLICANT INFORMATION
| 1. | Submitter Name | Aspen Glove Sdn. Bhd. |
|---|---|---|
| 2 | Date Submitted | 14 September 2021 |
| 3 | Address | Aspen House, 300, JLN Macalister,10450 Georgetown, Pulau Pinang, Malaysia |
| 4 | Phone | +604- 227 5000 |
| 5 | Fax | +604- 227 5000 |
| 6 | corporate@aspen.com.my | |
| 7 | Contact Person | Mr. Iskandar Basha bin Abdul Kadir |
| 8 | Designation | Managing Director |
| 9 | Contact Number | 017 -550 0577 |
| 10 | Contact Email | Iskandar@aspenglove.com.my |
B. US AGENT & CONTACT PERSON INFORMATION
| 11 | US agent &contact person name | Manoj Zacharias |
|---|---|---|
| 12 | Address | Liberty Management Group Ltd.75 Executive Dr. STE 114 Aurora, IL-60504, USA. |
| 13 | Phone | (630) 270-2921 |
| 14 | Fax | (815) 986-2632 |
| 15 | manoj@libertymanagement.us |
C. DEVICE IDENTIFICATION
| 16 | Common Name | Surgeon's Gloves |
|---|---|---|
| 17 | Device Name | Sterile Latex Surgical Gloves Powder Free |
| Product proprietary or trade name | AspenMed+S | |
| 18 | Classification name | Surgeon's Gloves |
| 19 | Device Classification | 1 |
| 20 | Product Code | KGO |
| 21 | Regulation Number | 21 CFR 878.4460 |
| 22 | Regulation Name | Non-Powdered Surgeon's Glove |
| 23 | Review Panel | Gen & Plastic Surgery |
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D. PREDICATE DEVICE INFORMATION
| Description | Name of device | 510kNumber | 510K Owner |
|---|---|---|---|
| Predicatedevice | JR Medic Latex Surgeon's GlovesSterile Powder Free with proteincontent labeling claim of 50 µg/dm² or less per glove ofextractable protein | K192328 | JR Engineering & MedicalTechnologies (M) SDN.BHD.Lot 8 &10, Jalan Zurah 3& Lot 1&3, Jalan Zurah3A/1, Pusat Perindustrian2, 44200 Rasa, HuluSelangor, Selangor DarulEhsan, Malaysia. |
E. DESCRIPTION OF THE DEVICE
The proposed device, Sterile Latex Surgical Gloves Powder Free is a sterile and disposable medical glove intended to be worn by operating room personnel to protect a surgical wound from contamination.
The proposed device is made of natural rubber latex, as per standard ASTM D3577 -09(2015), Standard Specification for Rubber Surgical Gloves.
The classification is: Type I - gloves compounded primarily from natural rubber latex.
The proposed device is Sterile Latex Surgical Gloves Powder Free, and variants of differentsizes.
All variants share the same natural color (No color is added).
The proposed device is sterilized using Gamma method to achieve the Sterility Assurance Level (SAL) of 10 and place in a sterility maintained package to ensure a shelf life of 3 years.
F. INDICATION FOR USE:
A Sterile Latex Surgical Gloves Powder Free is a device made of natural rubber intended to be worn by operating room personnel to protect a surgical wound from contamination.
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G. TECHNOLOGICAL CHARACTERISTIC COMPARISON TABLE
| Characteristic | Subject device | Predicate device | Comparison |
|---|---|---|---|
| K211478 | K192328 | ||
| Product Code | KGO | KGO | Same |
| Regulation No. | 21 CFR 878.4460 | 21 CFR 878.4460 | Same |
| Class | 1 | 1 | Same |
| Intended Use | A Sterile Latex SurgicalGloves Powder Free is adevice made of naturalrubber intended to be wornby operating roompersonnel to protect asurgical wound fromcontamination. | A latex surgeon's glove isa device made of naturalrubber intended to beworn by operating roompersonnel to protect asurgical wound fromcontamination. | Similar |
| Powdered or Powderfree | Powder free | Powder free | Same |
| Classification as perASTMD3577-09,StandardSpecification forRubber SurgicalGloves | Type I - glovescompounded primarilyfrom natural rubber latex | Type I - glovescompounded primarilyfrom natural rubber latex | Same |
| Sterilization | Radiation,SAL- 10-6 | Radiation,SAL- 10-6 | Same |
| Label and Labeling | Meet FDA's labelRequirements | Meet FDA's labelRequirements | Same |
| Special label claim | Protein content labelingclaim of 50µg/dm² or lessper glove of extractableprotein for Latex Surgeon'sGloves Powder Free. | Protein content labelingclaim of 50µg/dm² or lessper glove of extractableprotein for LatexSurgeon'sGlovesPowder Free. | Same |
| Type of use | Over the counter use | Over the counter use | Same |
a. General Characteristics Comparison
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b. Technological Characteristics Comparison
| SI.No | Criteria | Specification asper ASTMD3577-09,StandardSpecificationfor RubberSurgical Gloves | SubjectdeviceK211478 | PredicatedeviceK192328 | Comparison |
|---|---|---|---|---|---|
| 1 | |||||
| Length | |||||
| Size 6 | Min 265mm | 385mm | 306mm | SimilarMeets ASTM D3577-09(Reapproved 2015), StandardSpecification for RubberSurgical Gloves | |
| Size 6'/2 | Min 265mm | 386mm | 306mm | ||
| Size 7 | Min 265mm | 388mm | 305mm | ||
| Size 7'/2 | Min 265mm | 390mm | 305mm | ||
| Size 8 | Min 265mm | 392mm | 305mm | ||
| Size 8'/2 | Min 265mm | 394mm | 305mm | ||
| Size 9 | Min 265mm | 396mm | 305mm | ||
| 2 | |||||
| Width | |||||
| Size 6 | 76+/-6mm | 74mm | 78mm | SimilarMeets ASTM D3577-09(Reapproved 2015), StandardSpecification for RubberSurgical Gloves | |
| Size 6'/2 | 83+/-6mm | 86mm | 85mm | ||
| Size 7 | 89+/-6mm | 92mm | 88mm | ||
| Size 7'/2 | 95+/-6mm | 98mm | 97mm | ||
| Size 8 | 102+/-6mm | 103mm | 103mm | ||
| Size 8'/2 | 108+/-6mm | 110mm | 110mm | ||
| Size 9 | 114+/-6mm | 116mm | 116mm | ||
| 3 | FingerThickness(All sizes) | Min 0.10mm | 0.20mm | 0.21mm | SimilarMeets ASTM D3577-09(Reapproved 2015), StandardSpecification for RubberSurgical Gloves |
| 4 | PalmThickness(All sizes) | Min 0.10mm | 0.15mm | 0.18mm | |
| 5 | CuffThickness(All sizes) | Min 0.10mm | 0.12mm | 0.11mm | |
| SI.No | Criteria | Specification as per ASTMD3577-09, StandardSpecification for Rubber SurgicalGloves | Average Value ofSubject deviceK211478 | Average Value ofPredicate deviceK192328 | Comparison |
| 6 | Tensile Strength | ||||
| Before aging(All sizes) | 24 Mpa minimum | 28.55 Mpa | 26.00 Mpa | Similar Meets ASTMD3577-09(Reapproved 2015), StandardSpecification for RubberSurgical Gloves | |
| After aging@70°±2C for166±2 hr(All sizes) | 18 Mpa minimum | 23.48 Mpa | 22.00 Mpa | ||
| 7 | Ultimate Elongation | ||||
| Before aging(All sizes) | 750% minimum | 870% | 860% | ||
| After aging@70°±2C for166±2 hr(All sizes) | 560% minimum | 731% | 725% | Similar Meets ASTMD3577-09(Reapproved 2015), StandardSpecification for RubberSurgical Gloves | |
| 8 | Stress at500% beforeageing(All sizes) | 5.5 MPa Max | 5.1 Mpa | 2.7 Mpa | |
| 9 | Pinhole AQL | ||||
| Before aging(All sizes) | Max 1.5 | 1.0 | 1.0 | SimilarMeets ASTMD3577-09 (15) andASTM D5151-06,( Reapproved2015), Standard TestMethod for Detection ofHoles in Medical Gloves | |
| After aging@70°C for 7days(All sizes) | Max 1.5 | 1.0 | 1.0 | ||
| SI.No | Criteria | Specification asper ASTMD3577-09,StandardSpecification forRubber SurgicalGloves | AverageValue ofSubjectdeviceK211478 | AverageValue ofPredicatedeviceK192328 | Comparison |
| 10 | Powder Content | ||||
| Powderresidue forpowder freeglove(All sizes) | Powder content$\leq$ 2 mg/Glove | 0.40mg/Glove | 0.34mg/Glove | SimilarMeets ASTM D3577 andASTM D6124-06,(Reapproved 2017),Standard Test Method forResidual Powder onMedical Gloves | |
| 11 | Protein Content | ||||
| ProteinContent | $\leq$ 50 µg/ dm² | 38 µg/ dm² | 43 µg/ dm² | SimilarMeets ASTM D3577,ASTM D5712-15,Standard Test Method forthe Analysis of AqueousExtractable Protein inNaturalRubber |
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c. Biocompatibility Comparison
| Biocompatibility | Test Method | SubjectdeviceK211478 | Predicate deviceK192328 | Comparison |
|---|---|---|---|---|
| Skin Irritation &SkinSensitization | ISO 10993-10,Biologicalevaluation of medicaldevices - Part 10:Tests for irritation andskin sensitization | Non- irritantand Non-Sensitizer | Non- irritant andNon-Sensitizer | Same |
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| Biocompatibility | Test Method | Subject deviceK211478 | Predicate deviceK192328 | Comparison |
|---|---|---|---|---|
| In vitrocytotoxicity | ISO 10993-5:2009(E),BiologicalEvaluation of MedicalDevices - Part 5-Testsfor in vitroCytotoxicity | Cytotoxic | Cytotoxic | Same |
| MaterialMediatedpyrogenicity | ISO 10993-11:2017(E),Biological Evaluationof Medical Devices -Part 11, Tests forSystemic Toxicity andUSP 41<151>Pyrogen Test | Non pyrogenic | Non pyrogenic | Same |
| SystemicToxicity | ISO 10993-11:2017(E),Biological Evaluationof Medical Devices -Part 11, Tests forSystemic Toxicity | Under theconditionsof study thedevice extractsdo not pose asystemictoxicityconcern | No data available | ---- |
| BacterialEndotoxin | USP 42 <85> | <20EU/pair ofgloves | No data available | ---- |
H. NON-CLINICAL TESTING SUMMARY
Bench tests were conducted to verify that the proposed device met all design specifications and acceptance criteria in the standard or test methodology. The test results demonstrated that the proposed device complies with the following standards:
| Test Method | Purpose | Acceptance Criteria | Result |
|---|---|---|---|
| ASTM(Reapproved 2015), | To determine thelength of the gloves | Min 265 mm for allsizes | Size 6 385mmSize 6'/2 386mm |
PERFORMANCE DATA
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| Standard Specificationfor Rubber SurgicalGloves | Size | mm |
|---|---|---|
| Size 7 | 388mm | |
| Size 7'/2 | 390mm | |
| Size 8 | 392mm | |
| Size 8'/2 | 394mm | |
| Size 9 | 396mm |
| Test Method | Purpose | Acceptance Criteria | Result |
|---|---|---|---|
| ASTM D3577-09(Reapproved 2015),Standard Specificationfor Rubber SurgicalGloves | To determine the widthof the gloves | Size 676+/-6mm | 74mm |
| Size 6′/283+/-6mm | 86mm | ||
| Size 789+/-6mm | 92mm | ||
| Size 7′/295+/-6mm | 98mm | ||
| Size 8102+/-6mm | 103mm | ||
| Size 8′/2108+/-6mm | 110mm | ||
| Size 9114+/-6mm | 116mm |
| Test Method | Purpose | AcceptanceCriteria | Result | |||
|---|---|---|---|---|---|---|
| Size | Palm | Finger | ||||
| ASTM D3577-09(Reapproved 2015),Standard Specificationfor Rubber SurgicalGloves | To determine thethickness of thegloves | Palm 0.10 mmminFinger 0.10 mmminfor all sizes | 6 | 0.15mm | 0.20mm | |
| 6'/2 | 0.15mm | 0.20mm | ||||
| 7 | 0.15mm | 0.20mm | ||||
| 7'/2 | 0.15mm | 0.20mm | ||||
| 8 | 0.15mm | 0.20mm | ||||
| 8'/2 | 0.15mm | 0.20mm | ||||
| 9 | 0.15mm | 0.20mm | ||||
| Test Method | Purpose | AcceptanceCriteria | Result | |||
| ASTMD3577-09(Reapproved 2015),Standard Specificationfor Rubber SurgicalGloves | To Determine the physicalproperties-Tensile strength | BeforeAgeing24Mpa Minfor all sizesAfter Ageing18Mpa Min forall sizes | Size | BeforeAgeing | AfterAgeing | |
| 6 | 27.2Mpa | 22.1Mpa | ||||
| 6'/2 | 27.5Mpa | 22.6Mpa | ||||
| 7 | 28.3Mpa | 23.4Mpa | ||||
| 7'/2 | 28.5Mpa | 23.6Mpa | ||||
| 8 | 29.2Mpa | 23.9Mpa | ||||
| 8'/2 | 29.5Mpa | 24.3Mpa | ||||
| 9 | 29.7Mpa | 24.5Mpa | ||||
| To Determine the physicalproperties-UltimateElongation | BeforeAgeing750% Minfor all sizesAfter Ageing560% Minfor all sizes | Size | BeforeAgeing | After Ageing | ||
| 6 | 864% | 727% | ||||
| 6'/2 | 867% | 729% | ||||
| 7 | 869% | 730% | ||||
| 7'/2 | 871% | 731% | ||||
| 8 | 872% | 732% | ||||
| 8'/2 | 873% | 733% | ||||
| 9 | 874% | 734% | ||||
| Test Method | Purpose | AcceptanceCriteria | Result | |||
| ASTMD5151-06(Reapproved 2015)Standard Test Method forDetection of Holes inMedical Gloves | To determine theholes in the gloves | AQL 1.5 | Gloves Passes AQL 1.0 | |||
| ASTMD6124-06(Reapproved 2017)Standard Test Method forResidual Powder onMedical Gloves | To determine theresidual powder in thegloves | 2Mg/GloveMax | Size 6 | 0.26mg/glove | ||
| Size 6'/2 | 0.29mg/glove | |||||
| Size 7 | 0.32mg/glove | |||||
| Size 7'/2 | 0.38mg/glove | |||||
| Size 8 | 0.44mg/glove | |||||
| Size 8'/2 | 0.52mg/glove | |||||
| Size 9 | 0.62mg/glove |
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BIO-COMPATIBILITY DATA
| Test Method | Purpose | AcceptanceCriteria | Result |
|---|---|---|---|
| ISO10993-10Biological Evaluationof Medical DevicesTest for Irritation andSkin Sensitization.Test done for irritation. | To determine the potential ofthe material under test toproduce dermal irritation inRabbits | Undertheconditionofstudy not anirritant | Under the condition of studynot an irritant |
| ISO10993-10Biological Evaluationof Medical DevicesTest for Irritation andSkin Sensitization.Test done Skinsensitization. | To determine the skinsensitization potential of thematerial both in terms ofinduction and elicitation inGuinea Pig. | Undertheconditionsofthe study not asensitizer | Under theconditionsofstudy notsensitizer |
| ISO 10993-5:2009biological evaluation ofmedical 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. | Undertheconditionsofstudynoncytotoxic | Under theconditionsofstudy cytotoxic. |
| ISO 10993-11:2017biological evaluation ofmedical devices - part11, tests for systemictoxicity. | To determine the acutesystemic toxicity potentialof the test item extracts (bothinside and outer surfaces) inSwiss Albino mice. | Undertheconditionsofstudythedevice extractsdo not pose asystemictoxicityconcern | Under theconditionsof study the device extractsdo not pose a systemictoxicity concern |
| Material MediatedPyrogenicity ISO10993-11:2017(E) /USP 41<151> | To determine the pyrogenicpotential of the test itemextractfollowingintravenous injection in NewZealand white Rabbits. | Undertheconditions ofthe study, thedevice did notdemonstrate amaterialmediatedpyrogenicityresponse. | Under theconditions of the study,the device did notdemonstrate a materialmediatedpyrogenicity response. |
| Bacterial Endotoxintest USP 42<85> | To determine the BacterialEndotoxin limit in the glove | NMT 20EU/pair ofgloves | <20 EU/pair ofgloves |
Summary of clinical performance data.
Clinical data was not required for this submission.
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Conclusion
The conclusion drawn from the nonclinical tests demonstrates that the subject device in 510(K) submission Sterile Latex Surgical Gloves Powder Free is as safe, as effective, and performs as well as or better than the legally marketed predicated device K192328, JR MEDIC Latex Surgeon's Gloves Sterile Powder Free.
§ 878.4460 Non-powdered surgeon's glove.
(a)
Identification. A non-powdered surgeon's glove is a device intended to be worn on the hands of operating room personnel to protect a surgical wound from contamination. A non-powdered surgeon's 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).