(119 days)
Blue Nitrile Examination Gloves Powder Free are disposable devices intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.
Blue Nitrile Examination Gloves Powder Free are equivalent to the Class I patient examination gloves bearing the product code LZA (21CFR880.6250). They meet all the current specifications listed under the ASTM D6319-19, Standard Specification for Nitrile Examination Gloves for Medical Application. They are made from Nitrile (NBR)100%. These gloves are blue in color and are powder free. The product is non-sterile, ambidextrous and single use only.
Blue Nitrile Examination Gloves Powder Free with sizes X-Small, Medium, Large and X-Large are included in the submission.
Here's a breakdown of the acceptance criteria and study information for the Blue Nitrile Examination Gloves Powder Free, based on the provided FDA 510(k) summary:
1. Table of Acceptance Criteria and Reported Device Performance
| Characteristic / Test Method | Acceptance Criteria (Standard) | Reported Device Performance |
|---|---|---|
| Dimensions - Length (ASTM D6319-19) | Min 230 mm for all sizes | X-Small: 250 mm, Small: 241 mm, Medium: 240 mm, Large: 243 mm, X-Large: 240 mm (All > 230 mm) |
| Dimensions - Width (ASTM D6319-19) | X-Small: 70+/-10 mm, Small: 80+/-10 mm, Medium: 95+/-10 mm, Large: 110+/-10 mm, X-Large: 120+/-10 mm | X-Small: 80 mm, Small: 82 mm, Medium: 93 mm, Large: 103 mm, X-Large: 110 mm (All within specified ranges) |
| Physical Properties - Tensile Strength (Before Ageing) (ASTM D6319-19) | 14 MPa Min for all sizes | X-Small: 24.5 MPa, Small: 22.7 MPa, Medium: 25.3 MPa, Large: 26.4 MPa, X-Large: 25.5 MPa (All > 14 MPa) |
| Physical Properties - Tensile Strength (After Ageing) (ASTM D6319-19) | 14 MPa Min for all sizes | X-Small: 23.8 MPa, Small: 24.3 MPa, Medium: 31.9 MPa, Large: 30.3 MPa, X-Large: 27.4 MPa (All > 14 MPa) |
| Physical Properties - Ultimate Elongation (Before Ageing) (ASTM D6319-19) | 500% Min for all sizes | X-Small: 620%, Small: 580%, Medium: 530%, Large: 540%, X-Large: 540% (All > 500%) |
| Physical Properties - Ultimate Elongation (After Ageing) (ASTM D6319-19) | 400% Min for all sizes | X-Small: 590%, Small: 560%, Medium: 530%, Large: 540%, X-Large: 530% (All > 400%) |
| Thickness (Palm) (ASTM D6319-19) | 0.05 mm min for all sizes | X-Small: 0.101 mm, Small: 0.089 mm, Medium: 0.100 mm, Large: 0.098 mm, X-Large: 0.094 mm (All > 0.05 mm) |
| Thickness (Finger) (ASTM D6319-19) | 0.05 mm min for all sizes | X-Small: 0.121 mm, Small: 0.103 mm, Medium: 0.116 mm, Large: 0.121 mm, X-Large: 0.114 mm (All > 0.05 mm) |
| Powder Residue (ASTM D6124-06) | ≤ 2 mg/glove | X-Small: 1.07 mg/glove, Small: 1.49 mg/glove, Medium: 0.62 mg/glove, Large: 0.56 mg/glove, X-Large: 1.60 mg/glove (All ≤ 2 mg/glove) |
| Water Tight (ASTM D5151-19) | AQL 2.5 | Passes AQL 2.5 |
| Biocompatibility - Primary Skin Irritation (ISO 10993-10:2010) | Under the condition of study not an irritant | Under the condition of study, not an irritant |
| Biocompatibility - Dermal Sensitization (ISO 10993-10:2010) | Under the conditions of the study, not a sensitizer | Under the conditions of the study, not a sensitizer |
| Biocompatibility - In vitro Cytotoxicity (ISO 10993-5:2009) | Under the conditions of the study, non-cytotoxic | Under the conditions of the study, the device is cytotoxic. (Note: This is a discrepancy. The table in section F states "Similar" and describes it as "non-cytotoxic at 50%, 25%, 12.5% and 6.25% extracts." However, the table in section G, which details the bench test data, explicitly states "the device is cytotoxic." This is a significant finding that would typically require further explanation or clarification in a submission. Assuming the 'bench test data' result is the final documented finding for this specific test.) |
| Biocompatibility - Acute Systemic Toxicity Test (ISO 10993-11:2017) | 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 Size Used for the Test Set and Data Provenance
The document does not explicitly state the specific sample sizes for each test in the provided tables. However, it indicates that the tests were conducted according to established ASTM and ISO standards, which typically specify sample size requirements.
- Provenance: This is a non-clinical device (examination gloves). The data provenance refers to laboratory bench testing. The location of the testing is not explicitly stated, but the applicant's address is in Thailand. Given the nature of bench testing, the "country of origin of the data" is the laboratory where the tests were performed, which is not specified beyond being conducted according to international standards. The data is prospective in the sense that these tests were performed specifically for this submission to demonstrate compliance.
3. Number of Experts and Qualifications for Ground Truth
Not applicable. This device is a physical product (examination glove) and its performance is evaluated through standardized physical, chemical, and biocompatibility bench tests, not through expert interpretation of medical images or observations. Therefore, there is no "ground truth" established by medical experts in the traditional sense for an AI/medical imaging device.
4. Adjudication Method
Not applicable for this type of device and testing. Adjudication methods like 2+1 or 3+1 are used for human-in-the-loop evaluations, typically with medical image interpretation, to resolve discrepancies among experts.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. This is not an AI/medical imaging device that would involve human readers or AI assistance in interpretation. It's a non-clinical evaluation of a physical product's safety and performance characteristics.
6. Standalone Performance Study
Yes, a standalone performance study was done. The entire "BENCH TEST DATA" section (pages 7-8) and "BIOCOMPATIBILITY DATA" section (page 8) outline the algorithm/device-only performance against predefined acceptance criteria from international standards (ASTM and ISO). There is no "human-in-the-loop" component described for these tests.
7. Type of Ground Truth Used
The "ground truth" for this device's performance relies on established international standards and specifications:
- ASTM D6319-19 (Standard Specification for Nitrile Examination Gloves for Medical Application)
- ASTM D5151-19 (Standard Test Method for Detection of Holes in Medical Gloves)
- ASTM D6124-06 (Reapproved 2017) (Standard Test Method for Residual Powder on Medical Gloves)
- 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)
The device's physical and biological properties are measured and compared directly against the quantitative thresholds and qualitative outcomes specified in these standards.
8. Sample Size for the Training Set
Not applicable. This is not an AI device that requires a training set. The "device" here refers to the physical product (gloves).
9. How the Ground Truth for the Training Set was Established
Not applicable, as no training set is involved.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
January 20, 2022
Thai Rubber Gloves Co., Ltd. Manoj Zacharias Consultant Liberty Management Group Ltd. 75 Executive Dr. STE 114, Aurora, Illinois 60504
Re: K213075
Trade/Device Name: Blue Nitrile Examination Gloves Powder Free Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I, reserved Product Code: LZA Dated: December 20, 2021 Received: December 20, 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,
For 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) K213075
Device Name Blue Nitrile Examination Gloves Powder Free
Indications for Use (Describe)
Blue Nitrile Examination Gloves Powder Free 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) | ☐ |
|---|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) | ☑ |
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510(K) SUMMARY K213075
AS REQUIRED BY: 21CFR§807.92(C)
A. APPLICANT INFORMATION
| 510(K) Owner's Name | THAI RUBBER GLOVES CO., LTD. |
|---|---|
| Address | 680 MOO 2 BANBUENG – KLAENG RD.,NONGYAI CHONBURI 20190 THAILAND. |
| 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 | 13 September 2021 |
B. DEVICE IDENTIFICATION
| Name of the device | Blue Nitrile Examination Gloves Powder Free |
|---|---|
| Product proprietary or trade name | Goody Gloves / Wincare / TBG Gloves |
| Common or usual name | Blue Nitrile Examination Gloves Powder Free |
| Classification name | Polymer Patient Examination Glove |
| Device Classification | Class-1 |
| Product Code | LZA |
| Regulation Number | 21 CFR 880.6250 |
| Review Panel | General Hospital |
C. PREDICATE DEVICE
| Predicate Device | Hi-Care Thai Gloves Co. Ltd. |
|---|---|
| 510(k) Number | K202384 |
| Regulatory Class | Class 1 |
| Product code | LZA |
D. DESCRIPTION OF THE DEVICE:
Blue Nitrile Examination Gloves Powder Free are equivalent to the Class I patient examination gloves bearing the product code LZA (21CFR880.6250). They meet all the current specifications listed under the ASTM D6319-19, Standard Specification for Nitrile Examination Gloves for Medical Application. They are made from Nitrile (NBR)100%. These gloves are blue in color and are powder free. The product is non-sterile, ambidextrous and single use only.
Blue Nitrile Examination Gloves Powder Free with sizes X-Small, Medium, Large and X-Large are included in the submission.
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E. INDICATION FOR USE OF THE DEVICE:
Blue Nitrile Examination Gloves Powder Free 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 | SUBJECT | |||
| 510(K) Number | --- | K202384 | K213075 | |
| Name of device | --- | Palm Care Blue NitrileExamination GlovesPowder free | Blue NitrileExamination GlovesPowder free | --- |
| Dimensions - Length | ASTM D6319-19 | Length Min 230 mm | Length > 230 mm | Similar |
| SizeAverage | ||||
| X-Small250 | ||||
| Small241 | ||||
| Medium240 | ||||
| Large243 | ||||
| X-Large240 | ||||
| Dimensions - Width | ASTM D6319-19 | Width Min 95+/-10mm(for medium size) | Width 95+/-10mm(for medium size) | Similar |
| SizeAverage | ||||
| X-Small80 | ||||
| Small82 | ||||
| Medium93 | ||||
| Large103 | ||||
| X-Large110 | ||||
| Physical Properties-Tensile Strength | ASTM D6319-19 | Before AgeingTensile Strengthmin 14 MPa | Before AgeingTensile Strength > 14 MPa | Similar |
| SizeActualvalue | ||||
| X-Small24.5 | ||||
| Small22.7 | ||||
| Medium25.3 | ||||
| Large26.4 | ||||
| X-Large25.5 | ||||
| After AgeingTensile Strengthmin 14 MPa | After AgeingTensile Strength > 14 MPa | Similar | ||
| SizeActualvalue | ||||
| X-Small23.8 | ||||
| Small24.3 | ||||
| Medium31.9 | ||||
| Large30.3 | ||||
| X-Large27.4 |
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| CHARACTERSTICS | STANDARDS | DEVICE PERFORMANCE | Comparison | |||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| PREDICATE | SUBJECT | |||||||||||||||||||||
| 510(K) Number | K202384 | K213075 | ||||||||||||||||||||
| Physical Properties-Ultimate Elongation | ASTM D6319-19 | Before AgeingUltimate Elongation> 500% | Before AgeingUltimate Elongation > 500%Size Actual value X-Small 620 Small 580 Medium 530 Large 540 X-Large 540 | Similar | ||||||||||||||||||
| After AgeingUltimate Elongation> 400% | After AgeingUltimate Elongation > 400%Size Actual value X-Small 590 Small 560 Medium 530 Large 540 X-Large 530 | Similar | ||||||||||||||||||||
| Thickness | ASTM D6319-19 | Palm min 0.05 mmFinger min 0.05 mm | Palm > 0.05 mm Finger > 0.05 mmSize Palm(Actualvalue) Finger(Actualvalue) X-Small 0.101 0.121 Small 0.089 0.103 Medium 0.100 0.116 Large 0.098 0.121 X-Large 0.094 0.114 | Similar | ||||||||||||||||||
| Powder Residue | ASTM D6319-19 | <2 mg/glove | <2 mg/gloveSize Actual value X-Small 1.07 Small 1.49 Medium 0.62 Large 0.56 X-Large 1.60 | Similar | ||||||||||||||||||
| Biocompatibility | Primary SkinIrritation- ISO 10993-10:2010(E) | Under the conditionof study not anirritant | Under the condition of study notan irritant | Same | ||||||||||||||||||
| Dermal Sensitization-ISO 10993-10:2010(E) | Under theconditions of thestudy not asensitizer | Under the conditions of the studynot a sensitizer | Same | |||||||||||||||||||
| In vitro cytotoxicity-ISO 10993-5:2009(E) | Under theconditions of thestudy, noncytotoxic | Under the conditions of the study,"non-cytotoxic" at 50%, 25%,12.5% and 6.25% extracts | Similar | |||||||||||||||||||
| Acute SystemicToxicity Test- ISO10993-11:2017(E) | Under theconditions of study,the device extractsdo not pose asystemic toxicity | Under the conditions of study, thedevice extracts did not reveal anysystemic toxicity | Same |
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| CHARACTERSTICS | STANDARDS | DEVICE PERFORMANCE | Comparison | |
|---|---|---|---|---|
| PREDICATEK202384 | SUBJECTK213075 | |||
| 510(K) Number | --- | Similar | ||
| Water Tight(1000 ml) | ASTM D5151-19AQL 2.5 | Passes | Passes | Similar |
| Indication for Use | --- | Blue NitrileExamination GlovesPowder Free isdisposable devicesintended for medicalpurpose that are wornon the examiner'shand to preventcontaminationbetween patient andexaminer. | Blue Nitrile ExaminationGloves Powder Free aredisposable devices intendedfor medical purpose that isworn on the examiner's handto prevent contaminationbetween patient and examiner. | Similar |
| Material | ASTM D6319-19 | Nitrile (NBR) | Nitrile (NBR) | Same |
| Color | --- | Blue | Blue | Same |
| Size | ASTM D6319-19 | Extra Small, Small,Medium, Large, ExtraLarge | Extra Small, Small, Medium,Large, Extra Large | Same |
| Single Use | Medical GloveGuidanceManual- Labeling | Single Use | Single Use | Same |
| Sterile/non sterile | --- | Nonsterile | Nonsterile | Same |
| Powder/Powder free | --- | Powder free | Powder free | Same |
| Label and Labeling | Meets FDA'slabel andlabelingrequirements | Meets FDA's label andlabeling requirements | Meets FDA's label and labelingrequirements | Same |
| Manufacturer(s) | --- | Hi-Care Thai Gloves Co.Ltd. | THAI RUBBER GLOVES CO.,LTD.. | --- |
There are no significant differences between the two products and are identical in terms of intended use, materials, design and manufacturing methods. Both devices meet the ASTM standard D6319-19.
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G. COMPARISON BASED ON ASSESSMENT OF NON-CLINICAL PERFORMANCE DATA
BENCH TEST DATA
| TEST METHOD | PURPOSE | ACCEPTANCECRITERIA | RESULT |
|---|---|---|---|
| ASTM D6319-19Standard Specification for NitrileExamination Gloves for MedicalApplication. | To determine thelength of the gloves | Min 230 mm for allsizes | X-Small : 250 mmSmall : 241 mmMedium : 240 mmLarge : 243 mmX-Large : 240 mm |
| ASTM D6319-19Standard Specification for NitrileExamination Gloves for MedicalApplication. | To determine thewidth of the gloves | X-Small : 70+/-10 mmSmall : 80+/-10 mmMedium : 95+/-10 mmLarge : 110+/-10 mmX-Large : 120+/-10 mm | X-Small : 80 mmSmall : 82 mmMedium : 93 mmLarge : 103 mmX-Large : 110 mm |
| TESTMETHOD | PURPOSE | ACCEPTANCECRITERIA | RESULT | ||
|---|---|---|---|---|---|
| ASTM D6319-19StandardSpecification forNitrile ExaminationGloves for MedicalApplication. | To determine thethickness of thegloves | Palm0.05 mm minfor all sizesFinger0.05 mm minfor all sizes | Size | Palm | Finger |
| X-Small | 0.101 mm | 0.121 mm | |||
| Small | 0.089 mm | 0.103 mm | |||
| Medium | 0.100 mm | 0.116 mm | |||
| Large | 0.098 mm | 0.121 mm | |||
| X-Large | 0.094 mm | 0.114 mm | |||
| ASTM D6319-19StandardSpecification forNitrile ExaminationGloves for MedicalApplication. | To determine thephysical properties-Tensile strength | Before AgeingTensile Strength14MPa Min for allsizesAfter AgeingTensile Strength14MPa Min for allsizes | Size | Before ageing | After ageing |
| X-Small | 24.5 MPa | 23.8 MPa | |||
| Small | 22.7 MPa | 24.3 MPa | |||
| Medium | 25.3 MPa | 31.9 MPa | |||
| Large | 26.4 MPa | 30.3 MPa | |||
| X-Large | 25.5 MPa | 27.4 MPa | |||
| To determine thephysical properties-Ultimate Elongation | Before AgeingUltimateElongation500% Min for allsizesAfter AgeingUltimateElongation 400%Min for all sizes | Size | Before ageing | After ageing | |
| X-Small | 620% | 590% | |||
| Small | 580% | 560% | |||
| Medium | 530% | 530% | |||
| Large | 540% | 540% | |||
| X-Large | 540% | 530% |
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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 | ≤ 2 mg/glove | X-Small : 1.07 mg/gloveSmall : 1.49 mg/gloveMedium : 0.62 mg/gloveLarge : 0.56 mg/gloveX-Large : 1.60 mg/glove |
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 conditionsof the study, the deviceis 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 conditions ofstudy, the deviceextracts did not revealany systemic toxicity |
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 D6319-19 Standard Specification for Nitrile examination Gloves for Medical Application.
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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
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 conclusions drawn from the non-clinical test demonstrate that the subject devices in 510(K) submission, Goody Gloves / Wincare / TBG Gloves (Blue Nitrile Examination Gloves Powder Free) are as safe, as effective, and performs as well as or better than the legally marketed predicate device K202384.
§ 880.6250 Non-powdered patient examination glove.
(a)
Identification. A non-powdered patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. A non-powdered patient examination glove does not incorporate powder for purposes other than manufacturing. The final finished glove includes only residual powder from manufacturing.(b)
Classification. Class I (general controls). The device, when it is a finger cot, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 880.9.