(111 days)
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 Radiation 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 text describes the acceptance criteria and study results for "Sterile Latex Surgical Gloves Powder Free." Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
| Characteristic | Acceptance Criteria (Specification as per ASTM D3577-2019) | Reported Device Performance (Average value of subject device) | Complied with Standard? |
|---|---|---|---|
| Dimensions | |||
| Length (all sizes) | Min 265mm | 383mm (Size 6), 385mm (Size 6.5), 388mm (Size 7), 390mm (Size 7.5), 392mm (Size 8), 394mm (Size 8.5), 396mm (Size 9) | Yes |
| Width (Size 6) | 76+/-6mm | 74mm | Yes |
| Width (Size 6.5) | 83+/-6mm | 86mm | Yes |
| Width (Size 7) | 89+/-6mm | 92mm | Yes |
| Width (Size 7.5) | 95+/-6mm | 98mm | Yes |
| Width (Size 8) | 102+/-6mm | 105mm | Yes |
| Width (Size 8.5) | 108+/-6mm | 110mm | Yes |
| Width (Size 9) | 114+/-6mm | 116mm | Yes |
| Finger Thickness (all sizes) | Min 0.10mm | 0.21mm | Yes |
| Palm Thickness (all sizes) | Min 0.10mm | 0.16mm | Yes |
| Cuff Thickness (all sizes) | Min 0.10mm | 0.12mm | Yes |
| Tensile Strength | |||
| Before aging (all sizes) | 24Mpa minimum | 28.55Mpa | Yes |
| After aging @ 70°±2C for 166±2 hr (all sizes) | 18Mpa minimum | 23.48Mpa | Yes |
| Ultimate Elongation | |||
| Before aging (all sizes) | 750% minimum | 870% | Yes |
| After aging @ 70°±2C for 166±2 hr (all sizes) | 560% minimum | 731% | Yes |
| Stress at 500% | |||
| Before aging (all sizes) | 5.5 MPa Max | 5.1 Mpa | Yes |
| 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 |
| Powder Residue | < 2 mg/Glove | 0.40 mg/Glove | Yes (Implied, as 0.40 < 2) |
| Protein Content | ≤ 50 µg/ dm² | 50 µg/ dm² | Yes |
| Biocompatibility - Skin Irritation | Under the condition of study not an irritant | Under the condition of study not an irritant | Yes |
| Biocompatibility - Skin Sensitization | Under the conditions of the study not a sensitizer | Under the conditions of the study not a sensitizer | Yes |
| Biocompatibility - In vitro Cytotoxicity | Under the conditions of study non cytotoxic | Under the conditions of the study cytotoxic. | No (Did not meet "non cytotoxic" criteria, but similarity to predicate allowed) |
| Biocompatibility - Systemic Toxicity | Under the conditions of study the device extracts do not pose a systemic toxicity concern | Under the conditions of study the device extracts do not pose a systemic toxicity concern | Yes |
| Bacterial Endotoxin | <20EU/pair of gloves | <20EU/pair of gloves | Yes |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not explicitly state the sample sizes used for each specific test (e.g., how many gloves were tested for length, tensile strength, etc.). It refers to meeting the "acceptance criteria of the standard" (ASTM D3577-2019, ASTM D5151-2019, ASTM D6124-06, ASTM D5712-15) which would define the sampling plans.
The data provenance is not explicitly stated as "country of origin" for the testing or whether it was retrospective/prospective. However, the applicant is "Pentavest Holdings Sdn Bhd" located in Melaka, Malaysia, suggesting the testing was performed, or overseen, with connections to Malaysia. The testing, described as "Bench tests," typically refers to laboratory-based evaluations of the device itself rather than clinical data from human subjects.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This is not applicable to the submitted document. The "ground truth" for this medical device (Sterile Latex Surgical Gloves) is established through adherence to recognized international and national consensus standards (e.g., ASTM, ISO, USP) for physical, chemical, and biological properties, not by expert consensus in diagnostic imaging or clinical assessment. The standards themselves define the acceptable parameters.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This type of adjudication method is used in studies where human readers interpret data, such as medical images. For device performance testing against manufacturing and performance standards, the results are quantitative and compared directly to specified limits.
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 document pertains to the regulatory submission for surgical gloves, not an AI-powered diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This document is for surgical gloves, not an algorithm or AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the device's performance is based on established consensus standards (ASTM, ISO, USP). These standards define the acceptable physical, chemical, and biological properties and performance characteristics for rubber surgical gloves. Compliance with these standards serves as the evidence that the device is safe and effective for its intended use.
8. The sample size for the training set
Not applicable. This is not an AI or machine learning device; therefore, there is no "training set."
9. How the ground truth for the training set was established
Not applicable. As there is no training set, there is no ground truth for it to be established.
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December 27, 2021
Pentavest Holdings Sdn Bhd % Manoj Zacharias Consultant Liberty Management Group Ltd. 75 Executive Dr. STE114 Aurora, Illinois 60504
Re: K212848
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: September 1, 2021 Received: September 7, 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(@tda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Clarence W. Murray III -S
Clarence W. Murray, III, PhD 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) K212848
Device Name
Sterile Latex Surgical Gloves powder free
Indications for Use (Describe)
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) |
__ Prescription Use (Part 21 CFR 801 Subpart D)
|X Over-The-Counter Use (21 CFR 801 Subpart C)
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K212848 510K SUMMARY As required by: 21CFR § 807.92
A. APPLICANT INFORMATION
| 1. | Submitter Name | Pentavest Holdings Sdn Bhd |
|---|---|---|
| 2 | Date Submitted | 01 September 2021 |
| 3 | Address | No. 9574-9578, Jalan PTB 2 , Kawasan PerindustrianTangga, Batu , 76400 Melaka, Malaysia |
| 4 | Phone | +601 22332689 |
| 5 | Fax | ------- |
| 6 | bjteng@pentavest.com.my | |
| 7 | Contact Person | Teng Boon Joo |
| 8 | Designation | Managing Director |
| 9 | Contact Number | +601 22332689 |
| 10 | Contact Email | bjteng@pentavest.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 | Surgical Gloves |
|---|---|---|
| 17 | Device Name | Sterile Latex Surgical Gloves Powder Free |
| Product proprietary ortrade name | George Glove | |
| 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 Radiation 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
| Characteristic | Subject deviceK212848 | Predicate deviceK192328 | Remarks | |
|---|---|---|---|---|
| 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 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. | A latex surgeon's glove is a device made of natural rubber intended to be worn by operating room personnel to protect a surgical wound from contamination. | Similar | |
| Powdered or Powder free | Powder free | Powder free | Same | |
| Classification as perASTM D3577-2019,Standard Specificationfor Rubber SurgicalGloves | Type I - gloves compounded primarily from natural rubber latex | Type I - gloves compounded primarily from natural rubber latex | Same | |
| Sterilization | Radiation,SAL- 10-6 | ETO/as well as Radiation,SAL- 10-6 | Similar | |
| Label and Labeling | Meet FDA's labelRequirements | Meet FDA's labelRequirements | Same | |
| Special label claim | Protein content labeling claim of 50µg/dm² or less per glove of extractable protein for Latex Surgeon's Gloves Powder Free. | Protein content labeling claim of 50µg/dm² or less per glove of extractable protein for Latex Surgeon's Gloves Powder Free. | Same | |
| Type of use | Over the counter use | Over the counter use | Same | |
| Characteristics | Acceptance criteria of the standard | Remarks | ||
| Subject deviceK212848 | Predicate deviceK192328 | |||
| DimensionsLength:- Min265 mm | 380 mm | 300 mm | SimilarMeets ASTM D3577-2019,Standard Specification for RubberSurgical Gloves | |
| Size | ||||
| 6.0 (76+/-6mm) | 74mm | 78mm | SimilarMeets ASTM D3577-2019,Standard Specification for RubberSurgical Gloves | |
| 6.5 (83+/-6mm) | 86mm | 85mm | ||
| 7.0 (89+/-6mm) | 92mm | 88mm | Standard Specification for Rubber | |
| 7.5 (95+/-6mm) | 98mm | 97mm | Surgical Gloves | |
| 8.0 (102+/6mm) | 105mm | 103mm | ||
| 8.5 (108+/6mm) | 110mm | 110mm | ||
| 9.0 (114+/6mm) | 116mm | 116mm | ||
| Cuff, Palm,Finger Tip Min0.10 mm | Cuff-0.12mmPalm-0.16mmFinger Tip-0.21mm | Cuff-0.11mmPalm-0.18mmFinger Tip-0.21mm | SimilarMeets ASTM D3577-2019,Standard Specification for RubberSurgical Gloves | |
| Tensile Strength24Mpa minimum | 28.55Mpa | 26.0Mpa | SimilarMeets ASTM D3577-2019,Standard Specification for RubberSurgical Gloves | |
| UltimateElongation750% minimum | 870% | 860% | SimilarMeets ASTM D3577-2019,Standard Specification for RubberSurgical Gloves | |
| Stress at 500%5.5 MPa Max | 5.1Mpa | 2.7 Mpa | ||
| Tensile Strength18Mpa minimum | 23.48Mpa | 22.0Mpa | SimilarMeets ASTM D3577-2019,Standard Specification for RubberSurgical Gloves | |
| UltimateElongation560% minimum | 731% | 725% | ||
| Characteristics | Acceptance criteria of the standard | Remarks | ||
| SubjectdeviceK212848 | Predicate deviceK192328 | |||
| Freedom fromHolesAQL 1.5 | AQL 1.0 | AQL 1.0 | SimilarMeets ASTM D3577-2019 andASTM D5151-2019,Standard Test Method for Detectionof Holes in Medical Gloves | |
| Powder residuefor powder freeglove Powdercontent < 2mg/Glove | 0.40 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 | 50 µg/ 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 | Remarks | ||
| Biocompatibility | Subject deviceK212848 | 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-Tests forin 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 | ------ |
| 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 | ------ |
| 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 | 383mm | Yes | |
| Size 6'/2 | Min 265mm | 385mm | Yes | |
| Size 7 | Min 265mm | 388mm | Yes | |
| Size 7'/2 | Min 265mm | 390mm | Yes | |
| Size 8 | Min 265mm | 392mm | Yes | |
| Size 8'/2 | Min 265mm | 394mm | Yes | |
| Size 9 | Min 265mm | 396mm | Yes | |
| 2 | Width | |||
| Size 6 | 76+/-6mm | 74mm | Yes | |
| Size 6'/2 | 83+/-6mm | 86mm | Yes | |
| Size 7 | 89+/-6mm | 92mm | Yes | |
| Size 7'/2 | 95+/-6mm | 98mm | Yes | |
| Size 8 | 102+/-6mm | 105mm | Yes | |
| Size 8'/2 | 108+/-6mm | 110mm | Yes | |
| Size 9 | 114+/-6mm | 116mm | Yes | |
| 3 | FingerThickness(All sizes) | Min 0.10mm | 0.21mm | Yes |
| 4 | Palm Thickness(All sizes) | Min 0.10mm | 0.16mm | Yes |
| 5 | Cuff Thickness(All sizes) | Min 0.10mm | 0.12mm | Yes |
| SL.NO | CRITERIA | Specification as perASTM D3577-2019StandardSpecification forRubber SurgicalGloves | Average Valueof SubjectDevice | Whether SubjectDevice Complied withthe ASTM D3577 -2019 StandardSpecification forRubber SurgicalGloves |
| 6 | Tensile Strength | |||
| Before aging(All sizes) | 24Mpa minimum | 28.55Mpa | Yes | |
| After aging@70°±2C for166±2 hr(All sizes) | 18Mpa minimum | 23.48Mpa | Yes | |
| 7 | Ultimate Elongation | |||
| Before aging(All sizes) | 750% minimum | 870% | Yes | |
| After aging@70°±2C for166±2 hr(All sizes) | 560% minimum | 731% | 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 |
a. General Characteristics Comparison
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b. Technological Characteristics Comparison
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H. PRODUCT COMPARISON IN COMPLIANCE WITH ASTM D 3577-09,STANDARD SPECIFICATION FOR RUBBER SURGICAL GLOVES
SIZES AVAILABLE: - 6, 6'/2, 7, 7'/2, 8, 8'/2, 9
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I. NON-CLINICAL TEST CONCLUSION
Bench tests were conducted to verify that the proposed device met all design specifications and acceptance criteria found in the standards or test methodology. The test results demonstrated that the proposed device complies with the following standards:
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.
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
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
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| TestMethodology/Standard | Purpose | Acceptance Criteria | Results |
|---|---|---|---|
| ISO 10993-10Biological Evaluation ofMedical Devices Testfor Irritation and SkinSensitization. Test donefor irritation. | To determine thepotential of thematerial under test toproduce dermalirritation in Rabbits | Under the conditionof study not anirritant | Under the conditionof study not anirritant |
| ISO 10993-10Biological Evaluation ofMedical Devices Testfor Irritation and SkinSensitization. Test doneSkin sensitization. | To determine the skinsensitization potentialof the material both interms of inductionand elicitation inGuinea Pig. | Under the conditionsof the study not asensitizer | Under the conditionsof the study not asensitizer |
| ISO 10993-5:2009biological evaluation ofmedical devices - part 5,tests for in vitrocytotoxicity. | To evaluate the invitro cytotoxicpotential of the testitem (both inner andouter surface)Extracts in L-929mouse fibroblastscells using elutionmethod. | Under the conditionsof study noncytotoxic | Under the conditionsof the studycytotoxic. |
| ISO 10993-11:2017biological evaluation ofmedical devices - part11, tests for systemictoxicity. | To determine theacute systemictoxicity potential ofthe test item extracts(both inside and outersurfaces) in SwissAlbino mice. | Under the conditionsof study the deviceextracts do not pose asystemic toxicityconcern | Under the conditionsof study the deviceextracts do not pose asystemic toxicityconcern |
| USP 42 <85> | Bacterial EndotoxinTest | <20EU/pair ofgloves | <20EU/pair ofgloves |
J. SUMMARY OF CLINICAL TESTING
Clinical data was not required for this submission.
K. 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 effective, and performs as well as 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).