(197 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 with protein content labeling claim of 50 µg/ dm² or less per glove of extractable protein 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 D3577-2019, 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 and ETO method to achieve the Sterility Assurance Level (SAL) of 10 and place in a sterility maintained package to ensure a shelf life of 5years.
The provided text describes the acceptance criteria and the study that proves the device meets those criteria for Sterile Latex Surgical Gloves Powder Free (K212596), intended to be worn in operating rooms. The study is a non-clinical performance (bench testing) study demonstrating substantial equivalence to a predicate device (K192328).
Here's the breakdown of the information requested, based on the provided document:
Acceptance Criteria and Device Performance Study for Sterile Latex Surgical Gloves Powder Free (K212596)
The study performed is a non-clinical performance (bench testing) study, as explicitly stated under "SUMMARY OF NONCLINICAL PERFORMANCE DATA" and "SUMMARY OF CLINICAL PERFORMANCE DATA: Clinical data was not required for this submission." This type of study focuses on technical and physical characteristics rather than performance in a clinical setting with human participants.
1. Table of Acceptance Criteria and the Reported Device Performance
The acceptance criteria are generally based on ASTM D3577-2019, Standard Specification for Rubber Surgical Gloves, and other specific standards for each test.
| Characteristic | Acceptance Criteria (Standard) | Reported Device Performance (Average Value of Subject Device) | Met Acceptance Criteria? |
|---|---|---|---|
| Dimensions | ASTM D3577-2019 | ||
| Length (All sizes) | Min 265 mm | Varies by size (e.g., Size 7: 486 mm, Size 9: 488 mm) | Yes |
| Width (e.g., Size 7) | 89 ± 6 mm | 91 mm | Yes |
| Finger Thickness (All sizes) | Min 0.10 mm | 0.33 mm | Yes |
| Palm Thickness (All sizes) | Min 0.10 mm | 0.21 mm | Yes |
| Cuff Thickness (All sizes) | Min 0.10 mm | 0.16 mm | Yes |
| Tensile Strength | ASTM D3577-2019 | ||
| Before aging (All sizes) | 24 MPa minimum | 28.61 MPa | Yes |
| After aging (All sizes) | 18 MPa minimum | 24.12 MPa | Yes |
| Ultimate Elongation | ASTM D3577-2019 | ||
| Before aging (All sizes) | 750% minimum | 871% | Yes |
| After aging (All sizes) | 560% minimum | 732% | Yes |
| Stress at 500% before aging | 5.5 MPa Max | 5.1 MPa | Yes |
| Pinhole AQL | ASTM D3577-2019, ASTM D5151-2019 | ||
| Before aging (All sizes) | Max 1.5 | 1.0 | Yes |
| After aging (All sizes) | Max 1.5 | 1.0 | Yes |
| Freedom from Holes AQL | AQL 1.0 (ASTM D3577-2019, ASTM D5151-2019) | 1.0 | Yes |
| Powder Residue | < 2 mg/Glove; (ASTM D3577-2019, ASTM D6124-06) | 0.38 mg/Glove | Yes |
| Protein Content | < 50 µg/dm² (ASTM D3577-2019, ASTM D5712-15) | 46.40 µg/dm² | Yes |
| Biocompatibility | |||
| Skin Irritation & Sensitization | Non-irritant and Non-Sensitizer (ISO 10993-10) | Non-irritant and Non-Sensitizer | Yes |
| In vitro Cytotoxicity | Non-cytotoxic (ISO 10993-5) | Cytotoxic (Note: While reported as 'cytotoxic', this appears to be a misstatement or misinterpretation in the table, as the comparison table above it shows 'non-cytotoxic' for the predicate. However, in the detailed table, it is reported as 'cytotoxic', matching what is written for the predicate. This requires clarification to understand why a 'cytotoxic' result is deemed acceptable if the acceptance criteria is 'non-cytotoxic'.) | Check with manufacturer/FDA guidance |
| Material Mediated Pyrogenicity | Non-pyrogenic (ISO 10993-11, USP 41 <151>) | Non-pyrogenic | Yes |
| Systemic Toxicity | Device extracts do not pose a systemic toxicity concern (ISO 10993-11) | Device extracts do not pose a systemic toxicity concern | Yes |
| Bacterial Endotoxin | <20 EU/pair of gloves (USP 42 <85>) | <20 EU/pair of gloves | Yes |
Note on Cytotoxicity: The specific call out for "in vitro cytotoxicity" in the detailed results table (page 9) states "Under the conditions of the study cytotoxic." However, the acceptance criteria listed immediately above it is "Under the conditions of study non cytotoxic." And in the "Technological Characteristics Comparison" table (page 7), both the subject and predicate devices are listed as "cytotoxic" with an acceptance criterion of "cytotoxic" but then the standard states "non-cytotoxic." This is a discrepancy that would typically require clarification in a regulatory submission. Assuming the manufacturer has demonstrated that this level of cytotoxicity is acceptable for the intended use and does not pose a safety risk, or that the "acceptance criteria" presented in the detailed result is actually just reporting the finding, it passed. However, simply stating "cytotoxic" when the standard implies "non-cytotoxic" needs careful review. For the purpose of this summary, it's listed as reported.
2. Sample size used for the test set and the data provenance
- Sample Size: The document does not explicitly state the exact sample sizes (number of gloves) used for each bench test. Standards like ASTM D3577 typically specify sampling plans (e.g., AQL levels for defect testing).
- Data Provenance: The tests were conducted internally by the manufacturer or by contracted labs. The manufacturer is Amazing Rubber Products Pvt. Ltd. located in Kerala, India. The data is retrospective in the sense that it was collected as part of the device development and verification process to support the 510(k) submission.
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 study is a bench test verification of physical and chemical properties against established industry standards (e.g., ASTM, ISO, USP). Ground truth in this context is defined by these measurable standards and the associated testing methodologies, not by expert interpretation of, for example, medical images.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- This information is not applicable as the study is a bench test verification. Adjudication methods are typically used in clinical studies, especially those involving human interpretation (e.g., radiology reads) to resolve discrepancies.
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
- No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic AI devices where human performance is being evaluated or improved with AI assistance. The device in question is a surgical glove, which is a physical product, not a diagnostic tool requiring human reader interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No, this is not applicable. The device is a physical product (surgical glove), not an algorithm or AI system. Its performance is assessed through bench testing against established performance standards.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- The "ground truth" for this device is defined by established international and national standards and specifications for surgical gloves (e.g., ASTM D3577-2019, ISO 10993 series, USP monographs). These standards specify the acceptable physical, chemical, and biological properties through defined test methods.
8. The sample size for the training set
- Not applicable. This question pertains to machine learning models. The device is a physical product, not an AI/ML model that requires training.
9. How the ground truth for the training set was established
- Not applicable. As above, this pertains to machine learning models.
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March 1, 2022
Amazing Rubber Products Pvt Ltd % Manoj Zacharias Consultant Liberty Management Group Ltd. 75 Executive Dr. STE 114 Aurora, Illinois 60504
Re: K212596
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: January 19, 2022 Received: January 19, 2022
Dear Manoj Zacharias:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal
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statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about 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, 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) K212596
Device Name
Sterile Latex Surgical Gloves Powder Free
Indications for Use (Describe)
A Sterile Latex Surgical Cloves 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 K212596 As required by: 21CFR § 807.92
A. APPLICANT INFORMATION
| 1. | Submitter Name | Amazing Rubber Products Pvt. Ltd. |
|---|---|---|
| 2 | Date Submitted | 14 January 2021 |
| 3 | Address | Plot No 14c, Cochin Special Economic Zone ,Kakkanad, Cochin-682 037,Kerala- India |
| 4 | Phone | 9447053062 |
| 5 | Fax | ----- |
| 6 | info@amazingglove.com | |
| 7 | Contact Person | Jayasankar S |
| 8 | Designation | Executive Director |
| 9 | Contact Number | 9447053062 |
| 10 | Contact Email | info@amazingglove.com |
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 | Surgical Gloves |
|---|---|---|
| 17 | Device Name | Sterile Latex Surgical Gloves Powder Free |
| Product proprietary ortrade name | Amazing+ | |
| 18 | Classification name | Surgeon's Gloves |
| 19 | Device Classification | 1 |
| 20 | Product Code | KGO |
| 21 | Regulation Number | 21 CFR 878.4460 |
| 22 | 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 with protein content labeling claim of 50 µg/ dm² or less per glove of extractable protein 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 D3577-2019, 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 and ETO method to achieve the Sterility Assurance Level (SAL) of 10 and place in a sterility maintained package to ensure a shelf life of 5years.
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 CHARACTERISTICS COMPARISON
a. General Characteristics Comparison
| Characteristic | Subject deviceK212596 | Predicate deviceK192328 | Comparison | Characteristics | Acceptance criteria of the standard | Comparison | |
|---|---|---|---|---|---|---|---|
| Product Code | KGO | KGO | Same | Subject deviceK212596 | Predicate deviceK192328 | ||
| Regulation No. | 21 CFR 878.4460 | 21 CFR 878.4460 | Same | DimensionsLength:- Min265 mm | 486 mm | 300 mm | SimilarMeets ASTM D3577-2019,Standard Specification for RubberSurgical Gloves |
| Class | 1 | 1 | Same | Size6.0 (76+/-6mm)6.5 (83+/-6mm)7.0 (89+/-6mm)7.5 (95+/-6mm)8.0 (102+/6mm)8.5 (108+/6mm)9.0 (114+/6mm) | 80mm87mm91mm97mm103mm110mm116mm | 78mm85mm88mm97mm103mm110mm116mm | SimilarMeets ASTM D3577-2019,Standard Specification for RubberSurgical Gloves |
| Intended Use | A Sterile Latex Surgical Gloves Powder Free is adevice made of naturalrubber intended to be wornby operating room personnelto protect a surgical woundfrom contamination. | A latex surgeon's glove is adevice made of naturalrubber intended to be wornby operating roompersonnel to protect asurgical wound fromcontamination. | Similar | Cuff, Palm,Finger Tip Min0.10 mm | Cuff-0.16mmPalm-0.21mmFinger Tip-0.33mm | Cuff-0.11mmPalm-0.18mmFinger Tip-0.21mm | SimilarMeets ASTM D3577-2019,Standard Specification for RubberSurgical Gloves |
| Powdered or Powderfree | Powder free | Powder free | Same | Tensile Strength24Mpa minimum | 28.61Mpa | 26.00Mpa | SimilarMeets ASTM D3577-2019,Standard Specification for RubberSurgical Gloves |
| Material | Natural Rubber | Natural Rubber | Same | UltimateElongation750% minimum | 871% | 860% | SimilarMeets ASTM D3577-2019,Standard Specification for RubberSurgical Gloves |
| Classification as perASTMD3577-09,Standard Specificationfor Rubber SurgicalGloves | Type I - glovescompounded primarilyfrom natural rubber latex | Type I - glovescompounded primarilyfrom natural rubber latex | Same | Stress at 500%5.5 MPa Max | 5.1Mpa | 2.7 Mpa | |
| Sterilization | ETO/as well as Radiation,SAL- 10-6 | ETO/as well as Radiation,SAL- 10-6 | Similar | Tensile Strength18Mpa minimum | 24.12Mpa | 22.0Mpa | SimilarMeets ASTM D3577-2019,Standard Specification for RubberSurgical Gloves |
| Label and Labeling | Meet FDA's labelRequirements | Meet FDA's labelRequirements | Same | UltimateElongation | 732% | 725% | |
| Special label claim | Protein content labelingclaim of 50µg/dm² or less perglove of extractable proteinfor Latex Surgeon's GlovesPowder Free. | Protein content labelingclaim of 50µg/dm² or lessper glove of extractableprotein for Latex Surgeon'sGloves Powder Free. | Same | ||||
| Type of use | Over the counter use | Over the counter use | Same |
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b. Technological Characteristics Comparison
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| Characteristics | Acceptance criteria of the standard | Predicate deviceK192328 | Subject deviceK212596 | Comparison |
|---|---|---|---|---|
| Freedom fromHolesAQL 1.5 | AQL 1.0 | AQL 1.0 | SimilarMeets ASTM D3577-2019 andASTM D5151-2019, Standard TestMethod for Detection of Holes inMedical Gloves | |
| Powder residuefor powder freeglove Powdercontent < 2mg/Glove | 0.38 mg/Glove | 0.34 mg/Glove | SimilarMeets ASTM D3577-2019 and ASTMD6124-06,( Reapproved 2017),Standard Test Method for ResidualPowder on Medical Gloves | |
| Protein Content< 50 µg/ dm² | 46.40µg/ dm² | 43µg/ dm² | SimilarMeets ASTM D3577-2019, ASTMD5712(15), Standard Test Method forthe Analysis of Aqueous ExtractableProtein in Natural Rubber and ItsProducts Using the Modified LowryMethod | |
| Characteristics | Acceptance criteria of the standard | Comparison | ||
| Biocompatibility | Subject deviceK212596 | Predicate deviceK192328 | ||
| Skin Irritation &Skin Sensitization | ISO 10993-10,Biologicalevaluation of medicaldevices - Part 10: Testsfor irritation and skinsensitization | Non- irritant andNon-Sensitizer | Non- irritant andNon-Sensitizer | Same |
| In vitrocytotoxicity | ISO 10993-5:2009(E),BiologicalEvaluation of MedicalDevices - Part 5-Testsfor in vitro Cytotoxicity | cytotoxic | cytotoxic | Same |
| Material Mediatedpyrogenicity | ISO 10993-11:2017(E),Biological Evaluation ofMedical Devices - Part11, Tests for SystemicToxicity and USP 41<151>Pyrogen Test | Non pyrogenic | Non pyrogenic | Same |
| Systemic Toxicity | ISO 10993-11:2017(E),Biological Evaluation ofMedical Devices - Part11, Tests for SystemicToxicity | Under theconditionsof study thedevice extracts donot pose asystemic toxicityconcern | No data available | ---- |
| BacterialEndotoxin | USP 42 < 85> | <20EU/pair ofgloves | No data available | ---- |
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There is no difference with predicate device.
H. SUMMARY OF NONCLINICAL PERFORMANCE DATA
Bench tests were conducted to verify that the proposed device met all design specifications was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards and table below:
ASTM D3577-2019:- Standard Specification for Rubber Surgical Gloves.
ASTM D5151-2019:- Standard Test Method for Detection of Holes in Medical Gloves.
ASTM D6124-06 (2017):- Standard Test Method for Residual Powder on Medical Gloves.
ASTM D5712-15:- Standard Test Method for the Analysis of Aqueous Extractable Protein in Natural Rubber and Its Products Using the Modified Lowry Method.
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ASTM F1929-2015:- Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration.
ISO 10993-10: 2010, Biological evaluation of medical devices - Part 10- Tests for irritation and skin sensitization.
ISO 10993-5:2009(E) Biological Evaluation of Medical Devices - Part 5-Tests for in vitro Cytotoxicity
ISO 10993-11:2017(E) Biological Evaluation of Medical Devices - Part 11- Tests for Systemic Toxicity and Biological Tests
USP 41 <151> Pyrogen Test
ISO 11137-1-2006/ (R) 2010 - validation of sterilization process
ISO 11137-2:2013, sterilization of health care products - radiation - part 2: Establishing the sterilization dose
USP 42 <85> Bacterial Endotoxin Test
| TestMethodology/Standard | Purpose | Acceptance Criteria | Results |
|---|---|---|---|
| ISO 10993-10Biological Evaluation ofMedical Devices Test forIrritation and SkinSensitization. Test donefor irritation. | To determine the potential ofthe material under test toproduce dermal irritation inRabbits | Under the conditionof study not anirritant | Under theconditionofstudy not anirritant |
| ISO 10993-10Biological Evaluation ofMedical Devices Test forIrritation and SkinSensitization. Test doneSkin sensitization. | Todeterminetheskinsensitization potential of thematerial both in termsofinductionand elicitation in GuineaPig. | Under the conditionsof the study not asensitizer | Under theconditionsofthe study not asensitizer |
| ISO 10993-5:2009biological evaluation ofmedical devices - part 5,tests for in vitrocytotoxicity. | To evaluate the in vitrocytotoxic potential of the testitem (both inner andoutersurface) Extracts in L-929mouse fibroblastscells using elution method. | Under the conditionsof study noncytotoxic | Under theconditionsofthe studycytotoxic. |
| USP 42 <85> | Bacterial EndotoxinTest | <20EU/pair ofgloves | <20EU/pair ofgloves |
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| TestMethodology/Standard | Purpose | Acceptance Criteria | Results |
|---|---|---|---|
| ISO 10993-11:2017biological evaluation ofmedical devices - part 11,tests for systemic toxicity. | To determine the acute systemictoxicity potential of the testitem extracts (both inside andoutersurfaces) in SwissAlbino mice. | Under the conditionsof study the deviceextracts do not pose asystemic toxicityconcern | Under theconditionsof study thedevice extractsdo not pose asystemictoxicity concern |
PRODUCT COMPARISON IN COMPLIANCE WITH ASTM D 3577-2019, STANDARD SPECIFICATION FOR RUBBER SURGICAL GLOVES SIZES AVAILABLE: - 6, 6'/2, 7, 7'/2, 8, 8'/2, 9
| Sl.No | Criteria | Specification as perASTM D3577-2019,StandardSpecification forRubber SurgicalGloves | Average value ofsubject device | Whether subjectdevice compliedwith the ASTMD3577-2019,StandardSpecification forRubber SurgicalGloves |
|---|---|---|---|---|
| 1 | Length | |||
| Size 6 | Min 265mm | 484mm | Yes | |
| Size 6'/2 | Min 265mm | 485mm | Yes | |
| Size 7 | Min 265mm | 486mm | Yes | |
| Size 7'/2 | Min 265mm | 486mm | Yes | |
| Size 8 | Min 265mm | 487mm | Yes | |
| Size 8'/2 | Min 265mm | 487mm | Yes | |
| Size 9 | Min 265mm | 488mm | Yes | |
| 2 | Width | |||
| Size 6 | 76+/-6mm | 80mm | Yes | |
| Size 6'/2 | 83+/-6mm | 87mm | Yes | |
| Size 7 | 89+/-6mm | 91mm | Yes | |
| Size 7'/2 | 95+/-6mm | 97mm | Yes | |
| Size 8 | 102+/-6mm | 103mm | Yes | |
| Size 8'/2 | 108+/-6mm | 110mm | Yes | |
| Size 9 | 114+/-6mm | 116mm | Yes | |
| 3 | Finger Thickness(All sizes) | Min 0.10mm | 0.33mm | Yes |
| 4 | Palm Thickness(All sizes) | Min 0.10mm | 0.21mm | Yes |
| 5 | Cuff Thickness(All sizes) | Min 0.10mm | 0.16mm | Yes |
| SL.NO | CRITERIA | Specification as perASTMD3577-2019StandardSpecification forRubber SurgicalGloves | Average Valueof SubjectDevice | Whether Subject DeviceComplied with theASTMD3577-2019Standard Specificationfor Rubber SurgicalGloves |
| 6 | Tensile Strength | |||
| Before aging(All sizes) | 24Mpa minimum | 28.61Mpa | Yes | |
| After aging@70°±2C for 166±2 hr(All sizes) | 18Mpa minimum | 24.12Mpa | Yes | |
| 7 | Ultimate Elongation | |||
| Before aging(All sizes) | 750% minimum | 871% | Yes | |
| After aging@70°±2C for 166±2 hr(All sizes) | 560% minimum | 732% | Yes | |
| 8 | Stress at 500%before ageing(All sizes) | 5.5 MPa Max | 5.1 Mpa | Yes |
| 9 | Pinhole AQL | |||
| Before aging(All sizes) | Max 1.5 | 1.0 | Yes | |
| After aging@70°C for 7 days(All sizes) | Max 1.5 | 1.0 | Yes |
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SUMMARY OF CLINICAL PERFORMANCE DATA
Clinical data was not required for this submission.
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).