(268 days)
The Nitrile Powder Free Examination Gloves Biodegradable (Green) is a medical glove which is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between examiner and patient.
Nitrile Powder Free Examination Gloves Biodegradable (Green) meet all the requirements of ASTM D6319-19 Standard Specification for Nitrile Examination Gloves for Medical Application. The gloves are single use, disposable, and non-sterile. The gloves are offered in five sizes: S, M, L, XL, XXL.
The provided document is a 510(k) Premarket Notification for Nitrile Powder Free Examination Gloves Biodegradable (Green). It describes the device, its intended use, and comparative testing against a predicate device to demonstrate substantial equivalence.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
Important Note: This document pertains to a medical device (examination gloves) that is a physical product, not an AI/software-based device. Therefore, several of the requested categories (e.g., number of experts for ground truth, MRMC study, training set ground truth) are not applicable in this context, as they relate specifically to the validation of AI/ML systems or diagnostic aids, not physical medical devices like gloves.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for these gloves are primarily based on established ASTM and ISO standards for medical examination gloves and biocompatibility.
| Characteristic | Test Methodology / Standard | Acceptance Criteria (Specification) | Reported Device Performance (Results) |
|---|---|---|---|
| Dimensions | ASTM D6319-19 | (S) Length: Min 230mm, Width: 80±10mm (M) Length: Min 230mm, Width: 95±10mm (L) Length: Min 230mm, Width: 105±5mm (XL) Length: Min 230mm, Width: 115±5mm (XXL) Length: Min 230mm, Width: >120mm | (S) Average: Length 246mm, Width 86mm (M) Average: Length 246mm, Width 99mm (L) Average: Length 246mm, Width 106mm (XL) Average: Length 250mm, Width 115mm (XXL) Average: Length 254mm, Width 125mm |
| Material Thickness | ASTM D6319-19 | Palm & Finger: Min 0.05mm | (S) Palm 0.13mm, Finger 0.19mm (M) Palm 0.13mm, Finger 0.19mm (L) Palm 0.13mm, Finger 0.18mm (XL) Palm 0.13mm, Finger 0.17mm (XXL) Palm 0.12mm, Finger 0.19mm |
| Physical Properties (Tensile Strength) | ASTM D6319-19 | Before Aging: ≥14MPa After Aging: ≥14MPa | M: Before Aging 29.95MPa, After Aging 29.66MPa (Only M size reported) |
| Physical Properties (Ultimate Elongation) | ASTM D6319-19 | Before Aging: ≥500% After Aging: ≥400% | M: Before Aging 561%, After Aging 496% (Only M size reported) |
| Hole Detection (Watertight) | ASTM D5151-19, 21 CFR 800.20 | AQL 1.5 | All sizes (S, M, L, XL, XXL) Pass AQL 1.5 |
| Residual Powder | ASTM D6124-06(2022) | Max - 2 mg/glove | 0.36 mg/glove |
| Biodegradation | ASTM D5511-18 | Tested (Specific % is not an 'acceptance criterion' but a 'result' of testing) | Adjusted Percent Biodegraded (%): 7.2 |
| Biocompatibility - Cytotoxicity | ISO 10993-5 | Not explicitly stated as a numeric criterion, but expectation of low/no reactivity | Mild cytotoxicity reactivity result (2) with the neat extract (100%). (This indicates a mild reaction but is often acceptable depending on the product and risk assessment) |
| Biocompatibility - Skin Sensitization | ISO 10993-10:2021 | Not explicitly stated, but expectation of non-sensitizing | Extracts are not sensitizing to the animal model. |
| Biocompatibility - Irritation | ISO 10993-23:2021 | Not explicitly stated, but expectation of non-irritating | Device is non-irritating, extracts are not irritating to the animal model. |
| Biocompatibility - Systemic Toxicity | ISO 10993-11:2017 | Not explicitly stated, but expectation of no acute toxic reaction | Did not demonstrate any acute toxic reaction. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the numerical sample size for each specific test (e.g., how many gloves were tested for dimensions, tensile strength, or holes). However, the tests are conducted according to recognized standards (ASTM, ISO), which inherently specify sampling plans and test methods (e.g., AQL 1.5 for hole detection typically implies a specific sampling size based on lot size).
- Data Provenance: The tests were conducted by the manufacturer, Comfort Rubber Gloves Industries Sdn. Bhd., located in Matang, Perak, Malaysia. The data appears to be prospective as it directly supports the 510(k) submission for this specific device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not Applicable. For a physical product like medical gloves, "ground truth" is established through standardized physical, chemical, and biological testing methods (e.g., measuring dimensions, tensile strength, or observing biological reactions in animal models), not through expert consensus on interpretations like with AI/imaging data. The standards themselves define the "ground truth" for compliance.
4. Adjudication Method for the Test Set
Not Applicable. Adjudication methods (e.g., 2+1, 3+1) are relevant for subjective human assessments, particularly in image interpretation or clinical diagnosis. For physical and chemical property testing of gloves, the results are typically objective measurements or observations by trained laboratory personnel following the specified test protocols.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of Human Reader Improvement
Not Applicable. MRMC studies are used to evaluate the diagnostic performance of a system (often AI-assisted) by comparing human reader performance with and without the system. This is not relevant for a physical product like examination gloves.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study Was Done
Not Applicable. "Standalone" performance refers to the diagnostic capability of an algorithm or AI without human interaction. This concept does not apply to a physical medical device. The device's performance is intrinsically linked to its physical and material properties.
7. The Type of Ground Truth Used
The "ground truth" for this device is based on objective measurements and observations derived from:
- Standardized Test Methods: Adherence to established and recognized international standards (e.g., ASTM D6319-19, ASTM D5151-19, ASTM D5511-18, ASTM D6124-06(2022), ISO 10993 series). These standards define the test procedures and acceptance criteria for various physical, chemical, and biological properties.
- Direct Physical and Chemical Analysis: Measurements of dimensions, tensile strength, elongation, residual powder, and observations of biodegradation and biocompatibility reactions.
- Biological Endpoints: For biocompatibility, the ground truth is based on the observed biological response (e.g., presence/absence of irritation, sensitization, or systemic toxicity) in established animal or in-vitro models as per ISO 10993.
8. The Sample Size for the Training Set
Not Applicable. The concept of a "training set" (for machine learning models) does not apply to the development or validation of a physical medical device like these gloves. The manufacturing process is controlled by quality management systems (e.g., 21 CFR Part 820 Quality System Regulation), and product performance is validated through testing of manufactured lots against specifications, not through machine learning.
9. How the Ground Truth for the Training Set Was Established
Not Applicable. As mentioned above, there is no "training set" in the context of this device. The physical and performance characteristics are inherent to the material and manufacturing process, validated through testing against pre-defined standards.
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Image /page/0/Picture/0 description: The image shows 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.
October 25, 2024
Comfort Rubber Gloves Industries Sdn. Bhd. Sumanthi D/O Saravana Sami RA Manager Lot 821 Matang, Perak 34750 Malaysia
Re: K240269
Trade/Device Name: Nitrile Powder Free Examination Gloves Biodegradable (Green) Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I, reserved Product Code: LZA Dated: April 2, 2024 Received: September 30, 2024
Dear Sumanthi D/O Saravana Sami:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
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(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rue"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 mediation-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).
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Sincerely,
Image /page/2/Picture/3 description: The image shows the name "Bifeng Qian -S" in a large, sans-serif font. The text is black and stands out against a white background. The name appears to be a person's name, with "Bifeng" as the first name and "Qian" as the last name. The "-S" at the end could be an initial or a designation.
Bifeng Qian, M.D., Ph.D. Assistant Director DHT4C: Division of Infection Control 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
Submission Number (if known)
Device Name
Nitrile Powder Free Examination Gloves Biodegradable (Green)
Indications for Use (Describe)
The Nitrile Powder Free Examination Gloves Biodegradable (Green) is a medical glove which is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between examiner and patient.
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 (K240269) Nitrile Powder Free Examination Gloves Biodegradable (Green)
1.0 Submitter:
| Name | : Comfort Rubber Gloves Industries Sdn. Bhd |
|---|---|
| Address | : Lot 821, Jalan Matang,34750 Matang, Perak, Malaysia.Malaysia. |
| Phone No. | : 605-847 2777 |
| Fax No. | : 605-847 9108 |
| Contact Person: | : Sumathi d/o Sararavan Sami (Miss.) |
Date of Preparation: January 8, 2024
2.0 Name of the Device
Nitrile Powder Free Examination Gloves Biodegradable (Green)
Common Name: Patient Examination Gloves
Classification Name: Non-powdered Patient Examination Gloves (21 CFR 880.6250 product code LZA)
3.0 Predicate Device
Device Name: Biodegradable Nitrile Examination Powder Free Glove, Green Company: Top Glove SDN BHD
510(K) No.: K192111
4.0 Description of the Device:
Nitrile Powder Free Examination Gloves Biodegradable (Green) meet all the requirements of ASTM D6319-19 Standard Specification for Nitrile Examination Gloves for Medical Application. The gloves are single use, disposable, and non-sterile. The gloves are offered in five sizes: S, M, L, XL, XXL.
5.0 Indication for Use of the Device
The Nitrile Powder Free Examination Gloves Biodegradable (Green) is a medical glove which is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between examiner and patient.
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Image /page/5/Picture/1 description: The image shows a green nitrile powder-free examination glove. The glove is biodegradable and is laid flat on a white surface. The text at the top of the image indicates the type of glove, and the text at the bottom indicates that it is page 1 of 1.
6.0 Photo and/or figure of Nitrile Powder Free Examination Gloves Biodegradable (Green)
7.0 Technological Characteristics Comparison Table:
| CHARACTERISTICS | STANDARDS | PREDICATE DEVICEK192111 | SUBJECT DEVICEK240269 | COMPARISON | EXPLANATION |
|---|---|---|---|---|---|
| Product Code | LZA | LZA | Same |
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| Device Name | Biodegradable NitrileExamination PowderFree Glove, Green | Nitrile Powder FreeExamination GlovesBiodegradable(Green) | Similar | Device names aredifferent, but bothserve the sameintended use asexamination gloves. | |
|---|---|---|---|---|---|
| Manufacturer(s) | Top Gloves Sdn. Bhd. | Comfort RubberGloves IndustriesSdn. Bhd | Different | Difference inmanufacturers.Manufacturersadhere to industrystandards andregulations,ensuring that theirproducts areequally safe andeffective | |
| Indication for Use | The BiodegradableNitrile ExaminationPowder Free Glove,Green is a non-steriledisposable deviceintended for medicalpurpose that is wornon examiner's hand toprevent contaminationbetween patient andexaminer. | The Nitrile PowderFree ExaminationGlovesBiodegradable(Green) is a medicalglove which is adisposable deviceintended for medicalpurposes that isworn on theexaminer's hand orfinger to preventcontaminationbetween examinerand patient. | Similar | The indications arecomparable,indicating that bothproducts serve thesame function andintended use withinclinical settings.This similarityreinforces the claimof substantialequivalence, asboth products aredesigned to meetthe same clinicalneeds and safetystandards | |
| Material | ASTM D6319-19 | Nitrile | Nitrile | Same | - |
| Color | Green | Green | Same | - | |
| Size | Medical GloveGuidance ManualLabeling | Small | Small | - | - |
| Medium | Medium | Same | - | ||
| Large | Large | ||||
| Extra Large | Extra Large | ||||
| Double Extra Large | Double Extra Large | ||||
| Single Use | Medical GloveGuidance Manual | Single Use | Single Use | Same | - |
| Shelf life | Medical GloveGuidance Manual | - | Accelerated 3 Years | Different | Does not impactsubstantialequivalencebecause the shelflife is determined byspecific stabilitytesting conductedunder relevantconditions |
| Sterile | Medical GloveGuidance Manual | Non-Sterile | Non-Sterile | Same | - |
| Dimension | ASTM D6319- 19 | Length-Min 230mmThickness palm andfinger- Min 0.05mm | Length-Min 230mmThickness palm andfinger-Min 0.05mmWidth -S - 80±10mmM - 95±10mmL - 105 ± 5mmXL - 115 ± 5mmXXL -> 120 mm | Similar | Slight variation inlength (240 mm vs.230 mm) does notimpact usability orsafety, as bothdimensions fallwithin acceptableranges forexamination gloves |
| Physical Properties | ASTM D6319- 19 | Before Aging | Similar | - | |
| Tensile Strength≥14MPaUltimateElongation≥500% | Tensile Strength≥14MPaUltimateElongation≥500% | ||||
| After Aging | The test resultreading might havevariance but meetsthe ASTM D6319requirement. | ||||
| Tensile Strength≥14MPaUltimateElongation≥400% | Tensile Strength≥14MPaUltimateElongation≥400% | ||||
| Thickness - Finger– Palm | ASTM D6319-19 | Min 0.05Min 0.05 | 0.16 mm - 0.20 mm0.12 mm - 0.14 mm | Similar | The test resultreading might havevariance but meetsthe ASTM D6319requirement. |
| Residual Powder | ASTM 6124-06 -2022 | Max - 2 mg/glove | Max - 2 mg/glove0.36 mg/glove | Same | |
| Biodegradable | ASTM D5511 | Tested | Tested | Similar | The test resultreading might havevariance but meetsthe ASTM D5511requirement. |
| ISO 10993-23:2021Biological evaluationof medical devicesPart 23:Tests forirritation | Under the conditionsof the study, thesubject device extractsare not irritating to theanimal model. | Under the conditionsof the study, thesubject device isnon-irritatingextracts are notirritating to theanimal model. | Same | -- | |
| Biocompatibility | ISO 10993- 10:2021Biological evaluationof medical devicesPart 10: Tests forskin sensitization | Under the conditionsof the study, thesubject device extractsare not sensitizing tothe animal model. | Under the conditionsof the study, thesubject deviceextracts are notsensitizing to theanimal model. | Same | -- |
| Cytotoxicity ISO10993-5:2009 -Biological evaluationof medical devices --Part 5: Tests for invitro cytotoxicity | Under the conditionsof the study, thesubject device extractexhibits mildcytotoxicity reactivityresult (2) with the neatextract (100%). | Under the conditionsof the study, thesubject deviceextract exhibits mildcytotoxicity reactivityresult (2) with theneat extract (100%). | Same | -- | |
| ISO 10993-11:2017Biological evaluationof medical devicesPart 11: Tests forsystemic toxicity | No test report wassubmitted for thepredicate. | Under the conditionsof the study, did notdemonstrate anyacute toxic reaction. | Different | The Acute systemictoxicity is additionaltest tested toevaluate thepotential forsystemic healtheffects resultingfrom exposure tothe materials usedin the gloves. | |
| Watertight (1000ml) | 21 CFR 800.20ASTM D5151 | Passes | Passes | Same | -- |
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Summary of Non-Clinical Performance Data 8.0
| Test Methodology | Purpose | Acceptance Criteria | Results | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| ASTM D6319-19Standard Specificationfor Nitrile ExaminationGloves for MedicalApplication | To determine thelength of the gloves | Min 230 for all sizes | Average:S – 246M – 246L – 246XL - 250XXL - 254 | ||||||||||||||||||
| To determine the widthof the gloves | S – 80±10mmM – 95±10mmL – 105 ± 5mmXL - 115 ± 5mmXXL - > 120 mm | Average:S – 86M – 99L – 106XL - 115XXL - 125 | |||||||||||||||||||
| To determine thethickness of the gloves | Thickness palm andfinger- Min 0.05mm | Average:Size Palm Finger S 0.13 0.19 M 0.13 0.19 L 0.13 0.18 XL 0.13 0.17 XXL 0.12 0.19 |
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| Test Methodology | Purpose | Acceptance Criteria | Results | ||
|---|---|---|---|---|---|
| ASTM D6319-19Standard Specificationfor Nitrile ExaminationGloves for MedicalApplication | To determine thePhysical properties –Tensile Strength | Before Aging – Min 14MPaAfter Aging - Min 14MPa | Size | BeforeAging | AfterAging |
| M | 29.95 | 29.66 | |||
| To determine thePhysical properties -Ultimate Elongation | Before Aging -Min.500After Aging - Min. 400 | Size | BeforeAging | AfterAging | |
| M | 561 | 496 | |||
| ASTM D5151-19Standard Test Methodfor Detection of Holesin Medical Gloves | To determine the holesin the gloves | AQL 1.5 | S – Pass AQL 1.5 | ||
| M – Pass AQL 1.5 | |||||
| L – Pass AQL 1.5 | |||||
| XL – Pass AQL 1.5 | |||||
| XXL – Pass AQL 1.5 | |||||
| ASTM D6124-06(2022)Standard Test Methodfor Residual Powder onMedical Gloves | To determine theamount of residualpowder on the gloves | Max - 2 mg/glove | 0.36mg | ||
| ASTM D5511-18Standard Test Methodfor DeterminingAnaerobicBiodegradation ofPlastic MaterialsUnder High-SolidsAnaerobic-DigestionCondition | Determination of thedegree and rate ofanaerobicbiodegradation ofplastic materials inhigh-solids anaerobicconditions | Tested | Adjusted PercentBiodegraded (%) – 7.2 | ||
| ISO 10993-5Biological evaluationof medical devices-Part 5 Tests for invitro cytotoxicity | To determine thebiological response ofmammalian cells invitro using appropriatebiological parameters | - | Under the conditions ofthe study, the subjectdevice extract exhibitsmild cytotoxicityreactivity result (2) withthe neat extract (100%). | ||
| ISO 10993-10:2021Biological evaluationof medical devicesPart 10: Tests forskin sensitization | Assessment of medicaldevices and theirconstituent materialswith regard to theirpotential to induce skinsensitization | - | Under the conditions ofthe study, the subjectdevice extracts are notsensitizing to the animalmodel. | ||
| ISO 10993-23:2021Biological evaluationof medical devicesPart 23: Tests forirritation | Assessment of medicaldevices and theirconstituent materialswith regard to theirpotential to produceirritation | - | Under the conditions ofthe study, the subjectdevice is non-irritatingextracts are not irritatingto the animal model. | ||
| ISO 10993-11:2017Biological evaluationof medical devicesPart 11: Tests forsystemic toxicity | Evaluation of thepotential for medicaldevice materials tocause adversesystemic reactions | - | Under the conditions ofthe study, did notdemonstrate anyacute toxic reaction. |
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Non-clinical tests were conducted to demonstrate that the proposed device met all design specifications. The test results demonstrated that the proposed device met the performance criteria with the following standards:
- 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 D5511-18 Standard Test Method for Determining Anaerobic Biodegradation of Plastic . Materials Under High-Solids Anaerobic-Digestion Condition
- . ASTM D6124-06(2022) Standard Test Method for Residual Powder on Medical Gloves
- ISO 2859 Sampling Procedures and Tables for Inspection by Attributes
- . ISO 10993-5 Biological evaluation of medical devices-Part 5 Tests for in vitro cytotoxicity
- . ISO 10993-10:2021 Biological evaluation of medical devices Part 10: Tests for skin sensitization
- ISO 10993-23:2021 Biological evaluation of medical devices Part 23: Tests for irritation ●
- ISO 10993-11:2017 Biological evaluation of medical devices Part 11: Tests for systemic toxicity .
9.0 Clinical Performance Data
Clinical data is not needed.
10.0 Conclusion
The conclusions drawn from the nonclinical tests demonstrate that the proposed device is as safe, as effective, and performs as well as or better than the legally marketed predicate device.
§ 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.