(97 days)
Latex Examination Powder Free Gloves are disposable devices intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.
Latex Examination Powder Free Gloves are manufactured to meet all the current specifications listed under the ASTM Specification D3578-19, Standard Specification for Rubber Examination Gloves. They are made from Natural Rubber Latex. These gloves are Natural in color (No color added) and are powder free, non-sterile, ambidextrous and single use only.
Latex Examination Powder Free Gloves with sizes X-Small, Medium, Large and X-Large are included in the submission.
The provided document, a 510(k) Premarket Notification from the FDA, describes the acceptance criteria and performance of a medical device: Latex Examination Powder Free Gloves.
This document is NOT related to an AI/ML device, a comparative effectiveness study, or a study involving human readers or expert ground truth adjudication. Therefore, many of the requested details, such as sample sizes for test/training sets, data provenance, number and qualifications of experts, adjudication methods, MRMC studies, standalone algorithm performance, and ground truth establishment for AI models, are not applicable to this document.
However, I can extract the acceptance criteria and reported device performance from the provided text for this specific device.
Acceptance Criteria and Device Performance for Latex Examination Powder Free Gloves
The study described here focuses on demonstrating the substantial equivalence of the "Latex Examination Powder Free Gloves" to legally marketed predicate devices by showing that they meet established performance standards (primarily ASTM and ISO standards for medical gloves) and are as safe and effective.
1. A table of acceptance criteria and the reported device performance
| Characteristic / Test Method | Acceptance Criteria | Reported Device Performance for Subject Device (K213073) |
|---|---|---|
| Dimensions - Length (ASTM D3578-19) | Min 230 mm for all sizes | X-Small: 245 mmSmall: 244 mmMedium: 247 mmLarge: 240 mmX-Large: 247 mm |
| Dimensions - Width (ASTM D3578-19) | X-Small: 70+/-10 mmSmall: 80+/-10 mmMedium: 95+/-10 mmLarge: 111+/-10 mmX Large: 120+/-10 mm | X-Small: 77 mmSmall: 80 mmMedium: 92 mmLarge: 101 mmX-Large: 110 mm |
| Thickness (ASTM D3578-19) | Palm: 0.08 mm min for all sizesFinger: 0.08 mm min for all sizes | Palm:X-Small: 0.115 mm, Small: 0.115 mm, Medium: 0.115 mm, Large: 0.121 mm, X-Large: 0.109 mmFinger:X-Small: 0.125 mm, Small: 0.128 mm, Medium: 0.132 mm, Large: 0.135 mm, X-Large: 0.122 mm |
| Physical Properties - Tensile Strength (Before Ageing) (ASTM D3578-19) | 18 MPa Min for all sizes | X-Small: 26.2 MPaSmall: 25.0 MPaMedium: 24.0 MPaLarge: 22.6 MPaX-Large: 24.2 MPa |
| Physical Properties - Tensile Strength (After Ageing) (ASTM D3578-19) | 14 MPa Min for all sizes | X-Small: 24.1 MPaSmall: 24.1 MPaMedium: 23.4 MPaLarge: 24.3 MPaX-Large: 22.5 MPa |
| Physical Properties - Ultimate Elongation (Before Ageing) (ASTM D3578-19) | 650% Min for all sizes | X-Small: 830%Small: 790%Medium: 810%Large: 800%X-Large: 800% |
| Physical Properties - Ultimate Elongation (After Ageing) (ASTM D3578-19) | 500% Min for all sizes | X-Small: 800%Small: 760%Medium: 830%Large: 810%X-Large: 780% |
| Water Tight (Detection of Holes) (ASTM D5151-19) | AQL 2.5 | Passes AQL 2.5 |
| Powder Free Residue (ASTM D6124-06) | $\le$ 2 mg/glove | X-Small: 0.60 mg/gloveSmall: 0.80 mg/gloveMedium: 1.46 mg/gloveLarge: 0.62 mg/gloveX-Large: 1.13 mg/glove |
| Aqueous Extractable Protein (ASTM D5712-15) | 200 $\mu$g/ dm² Max | Medium: 191.9 $\mu$g/ dm² |
| Biocompatibility - Primary Skin Irritation (ISO 10993-10:2010(E)) | Under the condition of study, not an irritant | Under the condition of study, not an irritant |
| Biocompatibility - Dermal Sensitization (ISO 10993-10:2010(E)) | Under the conditions of the study, not a sensitizer | Under the conditions of the study, not a sensitizer |
| Biocompatibility - In Vitro Cytotoxicity (ISO10993-5:2009(E)) | Under the conditions of the study, non-cytotoxic | Under the conditions of the study the device is "cytotoxic". (Note: The document states this is similar to the reference device and expected for latex as it's a "positive control" for this test, implying it's a known property of natural latex and deemed acceptable for the intended use of the glove). |
| Biocompatibility - Acute Systemic Toxicity Test (ISO 10993-11:2017(E)) | Under the conditions of study, the device extracts do not pose a systemic toxicity concern. | Under the conditions of study, the device extracts did not reveal any systemic toxicity. |
2. Sample sizes used for the test set and the data provenance
The document does not specify the exact sample sizes for each test (e.g., how many gloves were tested for length, width, etc.). It refers to meeting the standards (ASTM/ISO), which typically outline sampling plans.
The data provenance is based on bench tests conducted on the subject device, "Latex Examination Powder Free Gloves". The tests are non-clinical. The submitting company is THAI RUBBER GLOVES CO., LTD., located in THAILAND. Therefore, the data originates from tests performed by or for this manufacturer. The nature of the tests (bench tests, not patient data) means the retrospective/prospective distinction is not directly applicable in the same way it would be for clinical data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This is not an AI/ML device or a diagnostic study requiring expert interpretation or ground truth establishment in a clinical context. The "ground truth" for glove performance is defined by adherence to established industry standards and specifications (ASTM, ISO).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. As this is not a diagnostic study with human-interpreted results, no adjudication method was used.
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-assisted device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" is defined by adherence to established international and national standards and specifications for latex examination gloves, such as ASTM D3578-19, ASTM D5151-19, ASTM D6124-06, ASTM D5712-15, ISO 10993-10, ISO 10993-5, and ISO 10993-11. These standards define the acceptable physical, mechanical, and biological properties of the gloves.
8. The sample size for the training set
Not applicable. This is not a machine learning device; therefore, there is no training set.
9. How the ground truth for the training set was established
Not applicable. No training set exists for this 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.
December 29, 2021
Thai Rubber Gloves Co., Ltd % Manoj Zacharias Consultant Liberty Management Group Ltd. 75 Executive Dr. STE 114. Aurora, Illinois 60504, USA
Re: K213073
Trade/Device Name: Latex Examination Powder Free Gloves Regulation Number: 21 CFR 880.6250 Regulation Name: Latex Exmamination Powder Free Gloves Regulatory Class: Class I. reserved Product Code: LYY Dated: November 30, 2021 Received: November 30, 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.
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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
For Clarence 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) K213073
Device Name Latex Examination Powder Free Gloves
Indications for Use (Describe)
Latex Examination Powder Free Gloves are disposable devices 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)
X Over-The-Counter Use (21 CFR 801 Subpart C)
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510(K) SUMMARY K213073
AS REQUIRED BY: 21CFR§807.92
A. APPLICANT INFORMATION
| 510(K) Owner's Name | THAI RUBBER GLOVES CO., LTD. |
|---|---|
| Address | 680 MOO 2 BANBUENG – KLAENGRD., NONGYAI CHONBURI 20190THAILAND. |
| Phone | +66-2-1306356, +66-38-168613 |
| Fax | +66-2-1306357 |
| chalongkwan@thaitex.cominfo@thairubbergloves.com | |
| Contact Person | Miss Chalongkwan Wongsasuthikul |
| Designation | Managing Director |
| Contact Number | +66-2-1306356 |
| Contact Email | chalongkwan@thaitex.com |
| Date Submitted | 29 December 2021 |
B. DEVICE IDENTIFICATION
| Name of the device | Latex Examination Powder Free Gloves |
|---|---|
| Product proprietary or trade name | Goody Gloves / Wincare / TBG Gloves |
| Common or usual name | Latex examination powder free gloves |
| Classification name | Latex Patient Examination Glove |
| Device Classification | Class-1 |
| Product Code | LYY |
| Regulation Number | 21 CFR 880.6250 |
| Review Panel | General Hospital |
C. PREDICATE DEVICE
| Predicate Device | Hi-Care Thai Gloves Co. Ltd. |
|---|---|
| 510(k) Number | K202377 |
| Regulatory Class | Class 1 |
| Product code | LYY |
| Reference Device | JR Engineering & Medical Technologies (M)SDN.BHD. |
|---|---|
| 510(k) Number | K192329 |
| Regulatory Class | Class 1 |
| Product code | LYY |
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D. DESCRIPTION OF THE DEVICE:
Latex Examination Powder Free Gloves are manufactured to meet all the current specifications listed under the ASTM Specification D3578-19, Standard Specification for Rubber Examination Gloves. They are made from Natural Rubber Latex. These gloves are Natural in color (No color added) and are powder free, non-sterile, ambidextrous and single use only.
Latex Examination Powder Free Gloves with sizes X-Small, Medium, Large and X-Large are included in the submission.
E. INDICATIONS FOR USE OF THE DEVICE:
Latex Examination Powder Free Gloves are disposable devices 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
| CHARACTERSTICS | STANDARDS | DEVICE PERFORMANCE | Comparison | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| PREDICATE | REFERENCE | SUBJECT | |||||||||||||||
| 510(k) Number | --- | K202377 | K192329 | K213073 | --- | ||||||||||||
| Name of device | --- | Palm Care LatexExaminationPowder FreeGloves | Blue LatexExaminationPowder FreeGloves | Latex ExaminationPowder Free Gloves | --- | ||||||||||||
| Dimensions- Length | ASTM D3578-19 | Length > 230 mm | Length > 230 mm | Length > 230 mmSize Average X-Small 245 Small 244 Medium 247 Large 240 X-Large 247 | Similar | ||||||||||||
| CHARACTERSTICS | STANDARDS | DEVICE PERFORMANCE | Comparison | ||||||||||||||
| PREDICATE | REFERENCE | SUBJECT | |||||||||||||||
| 510(k) Number | K202377 | K192329 | K213073 | ||||||||||||||
| Physical Properties-Tensile Strength | ASTM D3578-19 | BeforeAgeingTensileStrength> 18 MPa | BeforeAgeingTensileStrength> 18 MPa | Before AgeingTensile Strength> 18 MPa | Similar | ||||||||||||
| Size Ac tualvalue X-Small 26.2 Small 25.0 Medium 24.0 Large 22.6 X-Large 24.2 | |||||||||||||||||
| Dimensions- Width | ASTM D3578-19 | Width Min95+/- 10 mm(for mediumsize) | Width Min95+/- 10 mm(for mediumsize) | Width 95+/-10 mm(for medium size)Size Average X-Small 77 Small 80 Medium 92 Large 101 X-Large 110 | Similar | ||||||||||||
| After AgeingTensileStrength> 14 MPa | After AgeingTensileStrength> 14 MPa | After AgeingTensile Strength> 14 MPa | Similar | ||||||||||||||
| Size Actualvalue X-Small 24.1 Small 24.1 Medium 23.4 Large 24.3 X-Large 22.5 | |||||||||||||||||
| Physical Properties-Ultimate Elongation | ASTM D3578-19 | BeforeAgeingUltimateElongation> 650% | BeforeA geingUltimateElongation> 650% | Before AgeingUltimate Elongation> 650% | Similar | ||||||||||||
| Size Actualvalue X-Small 830 Small 790 Medium 810 Large 800 X-Large 800 | |||||||||||||||||
| AfterAgeingUltimateElongation>500% | After AgeingUltimateElongation>500% | After AgeingUltimate Elongation> 500% | Similar | ||||||||||||||
| Size Actualvalue X-Small 800 Small 760 Medium 830 Large 810 X-Large 780 |
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| CHARACTERSTICS | STANDARDS | DEVICE PERFORMANCE | Comparison | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| PREDICATEK202377 | REFERENCEK192329 | SUBJECTK213073 | |||||||||||||||||||||
| 510(k) Number | |||||||||||||||||||||||
| Thickness | ASTM D3578-19 | Palm > 0.08 mmFinger > 0.08 mm | Palm > 0.08 mmFinger > 0.08 mm | Palm > 0.08 mmFinger > 0.08 mmSize Palm (Actual value) Finger (Actual value) X-Small 0.115 0.125 Small 0.115 0.128 Medium 0.115 0.132 Large 0.121 0.135 X-Large 0.109 0.122 | Similar | ||||||||||||||||||
| Powder Free Residue | ASTM D3578-19 | ≤2 mg/glove | ≤2 mg/glove | ≤2 mg/gloveSize Actual value X-Small 0.60 Small 0.80 Medium 1.46 Large 0.62 X-Large 1.13 | Similar | ||||||||||||||||||
| Biocompatibility | Primary SkinIrritation-ISO10993-10:2010(E) | Under the condition ofstudy, not anirritant | Under the condition ofstudy, not anirritant | Under the condition ofstudy, not an irritant | Same | ||||||||||||||||||
| DermalSensitization-ISO10993-10:2010(E) | Under theconditions ofthe study, not asensitizer | Under theconditions ofthe study, not asensitizer | Under the conditions ofthe study, not a sensitizer | Same | |||||||||||||||||||
| In vitro cytotoxicityISO10993-5:2009(E) | Under theconditionsof the study,non-cytotoxic | Under theconditions ofthe study,cytotoxicwhich is to beexpected aslatex is thepositivecontrol for thistest. | Under the conditions ofthe study, cytotoxic | Similar toreferencedevice | |||||||||||||||||||
| Acute SystemicToxicity Test ISO10993-11:2017(E) | Under theconditions ofstudy thedeviceextracts donot pose asystemictoxicityconcern | --- | Under the conditionsof study the deviceextracts did not revealany systemic toxicity | Similar |
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| CHARACTERSTICS | STANDARDS | DEVICE PERFORMANCE | Comparison | ||
|---|---|---|---|---|---|
| PREDICATE | REFERENCE | SUBJECT | |||
| 510(k) Number | K202377 | K192329 | K213073 | ||
| Water Tight (1000 ml) | ASTM D5151-19AQL-2.5 | Passes | Passes | Passes | Similar |
| Indication for Use | --- | LatexExaminationPowder FreeGloves aredisposabledevicesintended formedicalpurpose that areworn on theexaminer'shand to preventcontaminationbetweenpatient andexaminer. | Blue LatexExaminationPowder FreeGloves aredisposabledevices intendedfor medicalpurpose that areworn on theexaminer's handto preventcontaminationbetweenpatient andexaminer. | Latex ExaminationPowder Free Glovesare disposable devicesintended for medicalpurpose that is wornon the examiner'shand to preventcontaminationbetween patient andexaminer. | Similar |
| Material | --- | Natural Latex | Natural Latex | Natural Latex | Identical |
| Color | --- | Natural (Nocolor isadded) | Blue | Natural color (Nocolor is added) | Similar topredicatedevice |
| Size | ASTM D3578-19 | X Small,Small,Medium,Large | Small, Medium,Large, XLarge & XXLarge | X-Small, Small,Medium, Large, X-Large | Similar(compared topredicate andreferencedevices) |
| Single Use | Medical GloveGuidance Manual-Labeling | Single Use | Single Use | Single Use | Same |
| Sterile/nonsterile | --- | Nonsterile | Non sterile | Nonsterile | Similar |
| Powder/Powder free | --- | Powder free | Powder free | Powder free | Same |
| Label and Labeling | FDA Labelrequirements | Meets FDA'slabel andlabelingrequirements | Meets FDA'slabel andlabelingrequirements | Meets FDA's labeland labelingrequirements | Same |
| Manufacturer(s) | --- | Hi-Care ThaiGloves Co.Ltd. | JR Engineering& MedicalTechnologies(M)SDN BHD | THAI RUBBERGLOVES CO., LTD. | --- |
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 D3578-19.
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G.COMPARISON BASED ON AN ASSESSMENT OF NON-CLINICAL PERFORMANCE DATA
BENCH TEST DATA
| TEST METHOD | PURPOSE | ACCEPTANCECRITERIA | RESULT |
|---|---|---|---|
| ASTM D3578-19Standard Specification for RubberExamination Gloves | To determine thelength of the gloves | Min 230 mm for all sizes | X-Small : 245 mmSmall : 244 mmMedium : 247 mmLarge : 240 mmX-Large : 247 mm |
| ASTM D3578-19Standard Specification for RubberExamination Gloves | To determine thewidth of the gloves | X-Small : 70+/-10 mmSmall : 80+/-10 mmMedium : 95+/-10 mmLarge : 111+/-10 mmX Large : 120+/-10 mm | X-Small : 77 mmSmall : 80 mmMedium : 92 mmLarge : 101 mmX-Large : 110 mm |
| TESTMETHOD | PURPOSE | ACCEPTANCECRITERIA | RESULT | ||
|---|---|---|---|---|---|
| ASTM D3578-19StandardSpecification forRubberExamination Gloves | To determine thethickness of thegloves | Palm0.08 mm minfor all sizesFinger0.08 mm minfor all sizes | Size | Palm | Finger |
| X-Small | 0.115 mm | 0.125 mm | |||
| Small | 0.115 mm | 0.128 mm | |||
| Medium | 0.115 mm | 0.132 mm | |||
| Large | 0.121 mm | 0.135 mm | |||
| X Large | 0.109 mm | 0.122 mm | |||
| ASTM D3578-19StandardSpecification forRubberExamination Gloves | To determine thephysical properties-Tensile strength | Before AgeingTensile Strength18MPa Min for allsizesAfter AgeingTensile Strength14MPa Min for allsizes | Size | Before ageing | After ageing |
| X-Small | 26.2 MPa | 24.1 MPa | |||
| Small | 25.0 MPa | 24.1 MPa | |||
| Medium | 24.0 MPa | 23.4 MPa | |||
| Large | 22.6 MPa | 24.3 MPa | |||
| X Large | 24.2 MPa | 22.5 MPa | |||
| ASTM D3578-19StandardSpecification forRubberExamination Gloves | To determine thephysical properties-Ultimate Elongation | Before AgeingUltimateElongation 650%Min for all sizesAfter AgeingUltimateElongation 500%Min for all sizes | Size | Before ageing | After ageing |
| X-Small | 830% | 800% | |||
| Small | 790% | 760% | |||
| Medium | 810% | 830% | |||
| Large | 800% | 810% | |||
| X Large | 800% | 780% |
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| TEST METHOD | PURPOSE | ACCEPTANCECRITERIA | RESULT |
|---|---|---|---|
| ASTM D5151-19 StandardTest Method for Detectionof Holes in Medical Gloves | To determine the holesin the gloves | AQL 2.5 | Gloves Passes AQL 2.5 |
| ASTM D6124-06(Reapproved 2017) StandardTest Method for ResidualPowder on Medical Gloves | To determine theresidual powder in thegloves | $\leq$ 2 mg/glove | X-Small : 0.60 mg/gloveSmall : 0.80 mg/gloveMedium : 1.46 mg/gloveLarge : 0.62 mg/glove X-Large : 1.13 mg/glove |
| ASTM D5712-15(Reapproved 2020) StandardTest Method for Analysis ofAqueous Extractable Proteinin Latex, Natural Rubber, andElastomeric Products Usingthe Modified Lowry Method | To determine theextractable protein inthe gloves. | 200 $\mu$ g/ dm² Max | Medium : 191.9 $\mu$ g/ dm² |
BIOCOMPATIBILITY DATA
| TEST METHOD | PURPOSE | ACCEPTANCECRITERIA | RESULT |
|---|---|---|---|
| ISO 10993-10:2010(E)Biological Evaluation OfMedical Devices - Part 10,Tests for Irritation and SkinSensitization.Test done for irritation. | To evaluate the testitem, for skin irritationtest in New ZealandWhite rabbits. | Under the conditionof study, not anirritant | Under the condition ofstudy, not an irritant |
| ISO 10993 10:2010(E)Biological Evaluation ofMedical Devices - Part 10,Tests for Irritation and SkinSensitization.Test done for skin sensitization | To evaluate the testitem, for the skinsensitization in Guineapigs by maximizationtest. | Under the conditionsof the study, not asensitizer | Under the conditions ofthe study, not asensitizer |
| ISO10993-5:2009(E)Biological Evaluation ofMedical Devices - Part 5,Tests for In VitroCytotoxicity. | To evaluate the testitem, for its ability toinduce cytotoxicityusing L-929 mousefibroblast cells byElution Method. | Under the conditionsof the study, non-cytotoxic | Under the conditions ofthe study the device is"cytotoxic" |
| ISO 10993-11:2017(E)Biological Evaluation ofMedical Devices - Part 11,Tests for Systemic Toxicity. | To evaluate the testitem, for acute systemictoxicity in Swiss AlbinoMice. | Under the conditionsof study, the deviceextracts do not pose asystemic toxicityconcern | Under the conditionsof study, the deviceextracts did not revealany systemic toxicity |
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The performance test data of the non-clinical tests that support a determination of safety and equivalence is the same as mentioned above (ASTM Requirements).
The performance test data of the non-clinical tests meet following standards:
ASTM D3578-19 Standard Specification for Rubber Examination Gloves
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
ASTM D5712-15 (Reapproved 2020) Standard Test Method for Analysis of Aqueous Extractable Protein in Latex, Natural Rubber, and Elastomeric Products Using the Modified Lowry Method
ISO 10993-10:2010 (E) 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.
H. COMPARISON BASED ON ASSESSMENT OF CLINICAL PERFORMANCE
DATA
Not applicable - Clinical data is not needed for gloves or for most devices cleared by the 510(k) process.
I. CONCLUSION
The conclusion drawn from the nonclinical tests demonstrates that the subject devices in 510(K) submission, Latex Examination Powder Free Gloves, are as safe, as effective, and performs as well as or better than the legally marketed predicate device K202377.
§ 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.