(125 days)
Comfortpro latex examination powder free gloves is disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.
COMFORTPRO 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.
This is a 510(k) summary for a medical device, specifically, a latex examination glove. The document describes the device's characteristics and compares them against a predicate device and established performance standards.
Here's the breakdown of the acceptance criteria and the study that proves the device meets them, structured as requested:
1. Table of Acceptance Criteria and Reported Device Performance
| Characteristic | Standard | Acceptance Criteria (Predicate) | Device Performance (Current) | Comparison |
|---|---|---|---|---|
| Dimensions - Length | ASTM D3578-19 | Min 230 mm for all sizes | Overall: Length > 230 mm X-Small: 245 mm Small: 238 mm Medium: 233 mm Large: 240 mm | Similar |
| Dimensions - Width (Medium size) | ASTM D3578-19 | Min 95 +/- 10 mm (for medium size) | Overall: Min 95+/-10 mm (for medium size) X-Small: 77 mm Small: 81 mm Medium: 93 mm Large: 101 mm | Similar |
| Physical Properties - Tensile Strength | ASTM D3578-19 | Before Ageing: Tensile Strength > 18 MPa After Ageing: Tensile Strength > 14 MPa | Before Ageing: Tensile Strength > 18 MPa Actual values: X-Small: 29.6 MPa, Small: 25 MPa, Medium: 26 MPa, Large: 24.9 MPa After Ageing: Tensile Strength > 14 MPa Actual values: X-Small: 25.5 MPa, Small: 24.1 MPa, Medium: 22.2 MPa, Large: 24.4 MPa | Similar |
| Physical Properties - Ultimate Elongation | ASTM D3578-19 | Before Ageing: Ultimate Elongation > 650% After Ageing: Ultimate Elongation > 500% | Before Ageing: Ultimate Elongation > 650% Actual values: X-Small: 810%, Small: 760%, Medium: 680%, Large: 780% After Ageing: Ultimate Elongation > 500% Actual values: X-Small: 820%, Small: 760%, Medium: 650%, Large: 760% | Similar |
| Thickness | ASTM D3578-19 | Palm: > 0.08 mm Finger: > 0.08 mm | Palm: > 0.08 mm Actual values: X-Small: 0.102 mm, Small: 0.087 mm, Medium: 0.10 mm, Large: 0.108 mm Finger: > 0.08 mm Actual values: X-Small: 0.114 mm, Small: 0.109 mm, Medium: 0.122 mm, Large: 0.121 mm | Similar |
| Powder Free Residue | ASTM D3578-19 | $\leq$ 2 mg/glove | 0.68 mg/glove (for Medium) | Similar |
| Water Tight (1000 ml) | ASTM D5151-19 AQL-2.5 | Passes | Passes | Similar |
| Extractable Protein | ASTM D5712-15 | 200 µg/dm² Max | 187.1 µg/dm² (for Medium) | Meets criteria |
| 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 | Same |
| 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 | Same |
| Biocompatibility - In vitro Cytotoxicity | ISO 10993-5:2009(E) | Under the conditions of the study, non-cytotoxic | Under the conditions of the study cytotoxic for 100% (neat) test item extract. A follow-up acute systemic toxicity test demonstrated the extract did not present an acute systemic toxicity concern. | Meets criteria |
| Biocompatibility - Acute Systemic Toxicity | 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 do not pose a systemic toxicity concern | Same |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample sizes used for each specific test (e.g., how many gloves were tested for length or tensile strength). However, the tests are conducted according to ASTM D3578-19, ASTM D5151-19, ASTM D6124-06, and ASTM D5712-15, which describe the standard test methods and typically include specifications for sampling.
The data provenance is from non-clinical bench testing and biocompatibility studies of the "Comfortpro" device. The manufacturer is THAI RUBBER INDUSTRY COMPANY LIMITED, located in Thailand. The tests are therefore likely performed by the manufacturer or a third-party lab on behalf of the manufacturer, and the data is prospective as it's generated specifically for this 510(k) submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This type of device (patient examination glove) does not involve a "ground truth" established by human experts in the typical sense of medical image analysis or diagnostic studies. The performance is assessed against established international consensus standards (ASTM and ISO) for physical properties and biocompatibility. The "ground truth" is not based on expert interpretation but on the quantitative measurement and qualitative assessment defined by these standards.
4. Adjudication Method for the Test Set
Not applicable. As noted above, the performance is measured against objective standards, not subjective human assessment requiring adjudication.
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-powered diagnostic device or a device where human interpretation is a primary performance factor.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device (glove), not an algorithm or AI system.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" in this context is defined by international consensus standards (ASTM D3578-19, ASTM D5151-19, ASTM D6124-06, ASTM D5712-15, ISO 10993-10:2010(E), ISO 10993-5:2009(E), ISO 10993-11:2017(E)). These standards specify the test methods and the acceptable ranges for the physical and biological properties of the gloves.
8. The Sample Size for the Training Set
Not applicable. This is not a machine learning or AI device that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. There is no training set for this type of device.
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December 7, 2021
Thai Rubber Industry Company Limited % Manoj Zacharias Consultant Liberty Management Group Ltd. 75 Executive Dr. STE 114, Aurora, Illinois 60504
Re: K212438
Trade/Device Name: Comfortpro Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I, reserved Product Code: LYY Dated: November 4, 2021 Received: November 4, 2021
Dear Manoj Zacharias:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal
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statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Clarence W. Murray, III, 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) K212438
Device Name Comfortpro
Indications for Use (Describe)
Comfortpro latex examination powder free gloves is disposable device 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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A. APPLICANT INFORMATION
| 510(K) Owner's Name | THAI RUBBER INDUSTRY COMPANY LIMITED |
|---|---|
| Address | 738 MOO 5, MANAM KOO,PLUAKDAENGRAYONG 21140 THAILAND |
| Phone | +66-81-6298773, +66-85-6000373 |
| Fax | - |
| chawalit@thairubberindustry.com | |
| Contact Person | Mr. Chawalit Tiyadechachai |
| Designation | Owner and Managing Director |
| Contact Number | +66-81-6298773, +66-85-6000373 |
| Contact Email | chawalit@thairubberindustry.com,Chawalit.tiya@gmail.com |
| Date Submitted | July 15, 2021 |
B. DEVICE IDENTIFICATION
| Name of the device | COMFORTPRO |
|---|---|
| Product proprietary or trade name | COMFORTPRO |
| Common or usualname | 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 |
D. DESCRIPTION OF THE DEVICE:
COMFORTPRO 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.
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E. INDICATIONS FOR USE OF THE DEVICE:
COMFORTPRO latex examination powder free gloves is disposable device 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 | CURRENT | ||||
| 510(k) Number | -- | K202377 | K212438 | ||
| Name of device | -- | Palm Care LatexExamination PowderFree Gloves | ComfortPro latex ExaminationPowder Free Gloves | -- | |
| Dimensions- Length | ASTMD3578-19 | Length > 230 mm | Length > 230 mm | Similar | |
| Size | Average | ||||
| X-Small | 245 mm | ||||
| Small | 238 mm | ||||
| Medium | 233 mm | ||||
| Large | 240 mm | ||||
| Dimensions- Width | ASTMD3578-19 | Width Min 95+/- 10mm (for mediumsize) | Width Min 95+/-10mm (for medium size) | Similar | |
| Size | Average | ||||
| X-Small | 77 mm | ||||
| Small | 81 mm | ||||
| Medium | 93 mm | ||||
| Large | 101 mm | ||||
| Physical Properties-Tensile Strength | ASTMD3578-19 | Before AgeingTensile Strength> 18 Mpa AfterAgeing TensileStrength> 14 Mpa | Before AgeingTensile Strength > 18 Mpa | Similar | |
| Size | Actual value | ||||
| X-Small | 29.6 | ||||
| Small | 25 | ||||
| Medium | 26 | ||||
| Large | 24.9 | ||||
| After AgeingTensile Strength > 14 Mpa | Similar | ||||
| Size | Actualvalue | ||||
| X-Small | 25.5 | ||||
| Small | 24.1 | ||||
| Medium | 22.2 | ||||
| Large | 24.4 |
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| CHARACTERSTICS | STANDARDS | DEVICE PERFORMANCE | Comparison | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| PREDICATE | CURRENT | |||||||||||||||||||||||
| 510(k) Number | -- | K202377 | K212438 | |||||||||||||||||||||
| Physical Properties-Ultimate Elongation | ASTMD3578-19 | Before AgeingUltimateElongation> 650%After AgeingUltimateElongation>500% | Before AgeingUltimate Elongation > 650%Size Actual value X-Small 810 Small 760 Medium 680 Large 780After AgeingUltimate Elongation > 500% Size Actual value X-Small 820 Small 760 Medium 650 Large 760 | Similar | ||||||||||||||||||||
| Thickness | ASTMD3578-19 | Palm > 0.08 mmFinger > 0.08 mm | Palm > 0.08 mmFinger > 0.08 mm Size Palm (Actual value) Finger (Actual value) X-Small 0.102 mm. 0.114 mm. Small 0.087 mm. 0.109 mm. Medium 0.10 mm. 0.122 mm. Large 0.108 mm. 0.121 mm. | Similar | ||||||||||||||||||||
| Powder Free Residue | ASTMD3578-19 | $\leq$ 2 mg/glove | 0.68 mg/glove | Similar | ||||||||||||||||||||
| Biocompatibility | Primary SkinIrritation-ISO10993-10:2010(E) | Under thecondition ofstudy, not anirritant | Under the condition of studynot an irritant | Same | ||||||||||||||||||||
| DermalSensitization-ISO10993-10:2010(E) | Under theconditions of thestudy, not asensitizer | Under the conditions of thestudy, not a sensitizer | Same | |||||||||||||||||||||
| In vitrocytotoxicityISO10993-5:2009(E) | Under theconditionsof the study, non-cytotoxic | Under the conditions of thestudy, non-cytotoxic | Same | |||||||||||||||||||||
| Acute SystemicToxicity Test ISO10993-11:2017(E) | Under theconditions of studythe device extractsdo not pose asystemic toxicityconcern | Under the conditionsof study the device extractsdo not pose a systemictoxicity concern | same |
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| CHARACTERSTICS | STANDARDS | DEVICE PERFORMANCE | COMPARISONON | |
|---|---|---|---|---|
| PREDICATE | CURRENT | |||
| 510(k) Number | K202377 | K212438 | ||
| Water Tight (1000 ml) | ASTM D5151-19AQL-2.5 | Passes | Passes | Similar |
| Indication for Use | Latex ExaminationPowder Free Gloves aredisposable devices intendedfor medical purpose that areworn on the examiner'shand to preventcontamination betweenpatient and examiner. | ComfortPro latexexamination powder freegloves is disposabledevice intended formedical purpose that isworn on the examiner'shand to preventcontaminationbetween patient andexaminer. | Same | |
| Material | Natural Latex | Natural Latex | Identical | |
| Color | Natural (No color is added) | Natural color (No color isadded) | Similar | |
| Size | ASTMD3578-19 | X Small, Small, Medium,Large | X Small, Small,Medium, Large | Similar |
| Single Use | Medical GloveGuidanceManual-Labeling | Single Use | Single Use | Same |
| Sterile/nonsterile | Nonsterile | Nonsterile | Same | |
| Powder/Powderfree | Powder free | Powder free | Same | |
| Label andLabeling | FDA Labelrequirements | Meets FDA's label andlabeling requirements | Meets FDA'slabel and labelingrequirements | Same |
| Manufacturer(s) | Hi-Care Thai Gloves Co.Ltd. | THAI RUBBERINDUSTRY COMPANYLIMITED | --- |
Both devices meet the ASTM standard D3578.
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G. COMPARISON BASED ON AN ASSESSMENT OF NON-CLINICAL PERFORMANCE DATA
BENCH TEST DATA
| TEST METHOD | PURPOSE | ACCEPTANCE CRITERIA | RESULT | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| ASTM D3578-19StandardSpecification forRubber ExaminationGloves | To determine thelength of the gloves | Min 230 mm for allsizes | X-Small : 245 mmSmall : 238 mmMedium : 233 mmLarge : 240 mm | |||||||||||||||
| ASTM D3578-19StandardSpecification forRubber ExaminationGloves | To determine thewidth of the gloves | X-Small : 70+/-10 mmSmall : 80+/-10 mmMedium : 95+/-10 mmLarge : 111+/-10 mm | X-Small : 77 mmSmall : 81 mmMedium : 93 mmLarge : 101 mm | |||||||||||||||
| ASTM D3578-19StandardSpecification forRubber ExaminationGloves | To determine thethickness of thegloves | Palm0.08 mm min for allsizesFinger0.08 mm min for allsizes | Size Palm Finger X-Small 0.102 mm 0.114 mm Small 0.087 mm 0.109 mm Medium 0.10 mm 0.122 mm Large 0.108 mm 0.121 mm | |||||||||||||||
| ASTM D3578-19StandardSpecification forRubber ExaminationGloves | To determine thephysical properties-Tensile strength | Before AgeingTensile Strength18MPa Min for allsizesAfter AgeingTensile Strength14MPa Min for allsizes | Size Beforeageing Afterageing X-Small 29.6 MPa 25.5 MPa Small 25 MPa 24.1 MPa Medium 26 MPa 22.2 MPa Large 24.9 MPa 24.4 MPa | |||||||||||||||
| To determine thephysical properties-UltimateElongation | Before AgeingUltimate Elongation650% Min for all sizesAfter AgeingUltimate Elongation500% Min for all sizes | Size Beforeageing Afterageing X-Small 810% 820% Small 760% 760% Medium 680% 650% Large 780% 760% |
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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 | Medium : 0.68 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 µg/ dm² Max | Medium : 187.1 µg/ 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 of thestudy cytotoxic for 100%(neat) test item extract. Asa follow up, acutesystemic toxicity testingwas performed todemonstrate the extractdid not present an acutesystemic toxicity concern. |
| 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 do not pose asystemic toxicity concern |
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510(K) SUMMARY
AS REQUIRED BY: 21CFR§807.92(C)
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 Medica1Gloves
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 device in 510(K) submission ComfortPro Latex Examination Powder Free Gloves is 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.