(94 days)
ComfortPro Blue Nitrile Examination Gloves Powder free is disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.
ComfortPro Blue Nitrile Examination Gloves Powder Free is Class I patient examination gloves bearing the product code LZA (21CFR880.6250). The gloves are made from Nitrile (NBR)100%. These gloves are blue in color, non-sterile, ambidextrous, powder free and single use only. Blue Nitrile Examination Gloves Powder Free are available in sizes X-small, Small, Medium, Large and X Large.
The provided document is a 510(k) summary for the ComfortPro Blue Nitrile Examination Gloves Powder Free. It describes the device, its intended use, and a comparison to a predicate device based on non-clinical performance data.
Here's the breakdown of the acceptance criteria and study information as requested:
1. A table of acceptance criteria and the reported device performance
| Test Method | Purpose | Acceptance Criteria (Predicate / Standard) | Reported Device Performance (Subject Device) |
|---|---|---|---|
| Bench Test Data | |||
| ASTM D6319-19 (Length) | To determine the length of the gloves | Min 230 mm for all sizes | X-Small: 250mm, Small: 241mm, Medium: 245mm, Large: 242mm, X-Large: 242mm |
| ASTM D6319-19 (Width) | To determine the width of the gloves | X-Small: 70+/-10 mm, Small: 80+/-10mm, Medium: 95+/-10 mm, Large: 110+/-10 mm, X Large: 120+/-10 mm | X-Small: 80 mm, Small: 82mm, Medium: 93mm, Large: 103mm, X-Large: 110mm |
| ASTM D6319-19 (Thickness) | To determine the thickness of the gloves | Palm: 0.05 mm min, Finger: 0.05 mm min (for all sizes) | Palm (mm): X-Small: 0.101, Small: 0.081, Medium: 0.091, Large: 0.092, X-Large: 0.091Finger (mm): X-Small: 0.121, Small: 0.097, Medium: 0.108, Large: 0.108, X-Large: 0.111 |
| ASTM D6319-19 (Tensile Strength) | To Determine the physical properties - Tensile strength | Before Ageing: Tensile Strength 14 Mpa Min for all sizesAfter Ageing: Tensile Strength 14 Mpa Min for all sizes | Before Ageing (Mpa): X-Small: 27.2, Small: 23.2, Medium: 24, Large: 26.2, X-Large: 27.4After Ageing (Mpa): X-Small: 24.2, Small: 23.8, Medium: 27.6, Large: 27.6, X-Large: 27.9 |
| ASTM D6319-19 (Ultimate Elongation) | To Determine the physical properties - Ultimate Elongation | Before Ageing: Ultimate Elongation 500% Min for all sizesAfter Ageing: Ultimate Elongation 400% Min for all sizes | Before Ageing (%): X-Small: 620, Small: 590, Medium: 570, Large: 570, X-Large: 550After Ageing (%): X-Small: 600, Small: 560, Medium: 540, Large: 540, X-Large: 550 |
| ASTM D5151-19 (Water Tight) | To determine the holes in the gloves | AQL 2.5 | Gloves Passes AQL 2.5 |
| ASTM D6124-06 (Residual Powder) | To determine the residual powder in the gloves | ≤2 Mg/Glove | 0.49 mg/glove |
| Biocompatibility Data | |||
| ISO 10993-10:2010 (Primary Skin Irritation) | To evaluate the test item, for skin irritation test in New Zealand White rabbits. | Under the condition of study not an irritant | Under the condition of study, not an irritant |
| ISO 10993-10:2010 (Dermal Sensitization) | To evaluate the test item, for the Skin Sensitization in Guinea pigs by maximization test. | Under the conditions of the study, not a sensitizer | Under the conditions of the study, not a sensitizer |
| ISO10993-5:2009 (In vitro cytotoxicity) | To evaluate the test item, for its ability to induce cytotoxicity using L-929 mouse fibroblast cells by Elution Method. | Under the conditions of the study, non-cytotoxic | Under the conditions of the study cytotoxic for 100% test item extract and non-cytotoxic at 50%, 25%, 12.5% and 6.25% test item extracts. Moreover, under the conditions of the study, non acute systemic toxic. |
| ISO 10993-11:2017 (Acute Systemic Toxicity Test) | To evaluate the test item, for Acute Systemic Toxicity in Swiss Albino Mice. | Under the conditions of study, the device extracts do not pose a systemic toxicity concern | Under the condition of study, the device extracts did not reveal any systemic toxicity. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- The document does not specify the exact sample sizes used for each test (e.g., how many gloves were tested for length, width, tensile strength, etc., or how many animals were used for biocompatibility tests). It only states they meet the relevant ASTM and ISO standards, which likely prescribe minimum sample sizes.
- Data Provenance: The document does not explicitly state the country of origin of the data or whether it was retrospective or prospective. Given that the manufacturer is "THAI RUBBER INDUSTRY COMPANY LIMITED" in Thailand, it is highly probable the testing was conducted in Thailand or by contractors on behalf of the Thai manufacturer. The nature of these tests (bench testing for physical properties and biocompatibility for materials) suggests they are prospective tests conducted on representative samples of the manufactured device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- This question is not applicable to this type of device (nitrile examination gloves) and the studies performed. The "ground truth" for these tests are objective, measurable physical and chemical properties and biological responses, determined by standardized test methods (ASTM, ISO), rather than expert interpretation or consensus.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- This question is not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies, particularly those involving interpretation of medical images or patient outcomes where subjective expert opinion is involved. The tests for these gloves are objective measurements against predefined standards.
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
- This question is not applicable. MRMC studies are specific to medical imaging devices, often involving AI, to assess the impact of AI assistance on human reader performance. Examination gloves do not involve "readers" or "AI assistance" in this context.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- This question is not applicable. This concept applies to AI-driven algorithms. The ComfortPro Blue Nitrile Examination Gloves are physical medical devices.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" is established by the defined specifications and test methods within the ASTM and ISO standards. For example, the "ground truth" for length is "Min 230 mm," and the test result is a direct measurement. Similarly, for biocompatibility, the "ground truth" is "not an irritant" or "non-cytotoxic," determined by specific biological assays.
- It's a combination of objective measurements compared against pre-defined normative standards.
8. The sample size for the training set
- This question is not applicable. The device is not an AI/ML algorithm that requires a "training set." The performance data is derived from testing physical samples of the manufactured gloves.
9. How the ground truth for the training set was established
- This question is not applicable for the same reason as point 8.
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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.
December 10, 2021
Thai Rubber Industry Company Limited % Manoj Zacharias Consultant Liberty Management Group Ltd. 75 Executive Dr. STE 114, Aurora, Illinois 60504
Re: K212850
Trade/Device Name: ComfortPro 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: August 13, 2021 Received: September 7, 2021
Dear Manoj Zacharias:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal
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statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@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 Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K212850
Device Name
ComfortPro Blue Nitrile Examination Gloves Powder free
Indications for Use (Describe)
ComfortPro Blue Nitrile Examination Gloves Powder free 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):
| Commercial | |
|---|---|
| Residential |
__ Prescription Use (Part 21 CFR 801 Subpart D)
|X | Over-The-Counter Use (21 CFR 801 Subpart C)
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K212850 510(K) SUMMARY AS REQUIRED BY: 21CFR§807.92(C)
A. APPLICANT INFORMATION
| 510(K) Owner's Name | THAI RUBBER INDUSTRY COMPANY LIMITED |
|---|---|
| Address | 738 MOO 5, MANAM KOO,PLUAKDAENGRAYONG 21140 THAILAND |
| Phone | +66-098-2520209 |
| Fax | - |
| vanida@thairubberindustry.com | |
| Contact Person | Ms. Supawadee Phoungthong |
| Designation | Managing Director |
| Contact Number | +66-098-2520209 |
| Contact Email | vanida@thairubberindustry.com |
| Date Submitted | December 9, 2021 |
B. DEVICE IDENTIFICATION
| Name of the device | ComfortPro Blue Nitrile Examination GlovesPowder Free |
|---|---|
| Product proprietary or trade name | ComfortPro |
| Common or usual name | Nitrile Examination Gloves |
| 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:
ComfortPro Blue Nitrile Examination Gloves Powder Free is Class I patient examination gloves bearing the product code LZA (21CFR880.6250). The gloves are made from Nitrile (NBR)100%. These gloves are blue in color, non-sterile, ambidextrous, powder free and single use only. Blue Nitrile Examination Gloves Powder Free are available in sizes X-small, Small, Medium, Large and X Large.
E. INDICATION FOR USE OF THE DEVICE:
ComfortPro Blue Nitrile Examination Gloves Powder Free is disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.
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510(K) SUMMARY AS REQUIRED BY: 21CFR§807.92(C)
F. SUMMARY OF THE TECHNOLOGICAL CHARACTERISTICS OF THE DEVICE COMPARED TO THE PREDICATE DEVICE
| CHARACTERSTICS | STANDARDS | DEVICE PERFORMANCE | REMARKS | ||
|---|---|---|---|---|---|
| PREDICATE | SUBJECT | ||||
| 510(K) Number | K202384 | K212850 | |||
| Name of device | -- | Palm Care Blue Nitrile | ComfortPro Blue Nitrile | ||
| Examination Gloves | Examination Gloves | ---- | |||
| Powder free | Powder Free | ||||
| Dimensions- Length | ASTMD 6319-19 | Length Min 230 mm | Length > 230 mm | Similar | |
| Size | Average | ||||
| X-Small | 250 | ||||
| Small | 241 | ||||
| Medium | 245 | ||||
| Large | 242 | ||||
| X- Large | 242 | ||||
| Dimensions- Width | ASTMD 6319-19 | Width Min 95+/-10mm | Width Min 95+/-10mm | Similar | |
| (for medium size) | (for medium size) | ||||
| Size | Average | ||||
| X-Small | 80 | ||||
| Small | 82 | ||||
| Medium | 93 | ||||
| Large | 103 | ||||
| X- Large | 110 | ||||
| Physical Properties- | ASTMD 6319-19 | Before Ageing | Before Ageing | ||
| Tensile Strength | Tensile Strength | Tensile Strength > | |||
| min 14 MpaAfter Ageing | 14 MpaSize | Average | |||
| Tensile Strength | Similar | ||||
| min 14 Mpa | X-Small | 27.2 | |||
| SmallMedium | 23.2 | ||||
| 24 | |||||
| Large | 26.2 | ||||
| X- Large | 27.4 | ||||
| After Ageing | |||||
| Tensile Strength > | |||||
| 14 Mpa | |||||
| Size | Average | ||||
| X-SmallSmall | 24.223.8 | ||||
| Medium | 27.6 | ||||
| Large | 27.6 | ||||
| X- Large | 27.9 | ||||
| Physical Properties- | ASTMD 6319-19 | Before Ageing | Similar | ||
| Ultimate Elongation | Ultimate Elongation | Before AgeingUltimate Elongation >500% | |||
| > 500% | |||||
| X-Small | 620 | ||||
| Small | 290 | ||||
| Medium | 570 | ||||
| Large | 570 | ||||
| X- Large | રરા | ||||
| CHARACTERSTICS | STANDARDS | DEVICE PERFORMANCE | REMARKS | ||
| PREDICATE | SUBJECT | ||||
| ASTMD 6319-19 | After AgeingUltimateElongation >400% | After AgeingUltimate Elongation > 400%X-Small 600Small 560Medium 540Large 540X- Large 550 | Similar | ||
| Thickness | ASTMD 6319-19 | Palm min 0.05 mmFinger min 0.05 mm | Palm > 0.05 mm Finger > 0.05 mmSize Palm (Actual value) mm Finger (Actual value) mmX-Small 0.101 0.121Small 0.081 0.097Medium 0.091 0.108Large 0.092 0.108X- Large 0.091 0.111 | Similar | |
| Powder Residue | ASTMD 6319-19 | <2 mg/glove | <2 mg/gloveActual value :0.49 mg/glove | Similar | |
| Biocompatibility | Primary Skin Irritation-ISO 10993-10:2010(E) | Under thecondition of studynot an irritant | Under the condition of study notan irritant | Same | |
| Dermal Sensitization-ISO 10993-10:2010(E) | Under the conditionsof the study not asensitizer | Under the conditions of thestudy not a sensitizer | Same | ||
| In vitro cytotoxicityISO10993-5 2009(E) | Under the conditionsof the study,noncytotoxic | Under the conditions of the studycytotoxic for 100% test item extractand non-cytotoxic at 50%, 25%,12.5% and 6.25% test item extracts.Moreover, under the conditions ofthe study, non acute systemic toxic. | Similar | ||
| Acute SystemicToxicity Test ISO10993-11:2017(E) | Under theconditions of study,the device extractsdo not pose asystemic toxicityconcern. | Under the condition of study, thedevice extracts did not reveal anysystemic toxicity. | Same | ||
| Water Tight(1000 ml) | ASTM D 5151-19AQL 2.5 | Passes | Passes | Similar | |
| Indication for Use | -- | Blue NitrileExamination GlovesPowder Free isdisposable devicesintended for medicalpurpose that areworn on theexaminer's hand toprevent contaminatiobetween patient andexaminer. | ComfortPro Blue NitrileExamination Gloves PowderFree is disposable deviceintended for medical purposethat is worn on the examiner'shand to prevent contaminationbetween patient and examiner. | Similar | |
| CHARACTERSTICS | STANDARDS | DEVICE PERFORMANCE | REMARKS | ||
| PREDICATE | SUBJECT | ||||
| Material | ASTMD 6319-19 | Nitrile (NBR) | Nitrile (NBR) | Same | |
| Color | -- | Blue | Blue | Same | |
| Size | ASTMD 6319-19 | Extra Small, Small,Medium, Large, ExtraLarge | Extra Small, Small,Medium, Large, ExtraLarge | Same | |
| Single Use | Medical GloveGuidance Manual- 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's labeland labelingrequirements | Meets FDA's label andlabeling requirements | Meets FDA's label andlabeling requirements | Same | |
| Manufacturer(s) | -- | Hi-Care Thai Gloves Co.Ltd. Thailand. | THAI RUBBERINDUSTRY CO., LTD.. | ----- |
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510(K) SUMMARY
AS REQUIRED BY: 21CFR§807.92(C)
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510(K) SUMMARY AS REQUIRED BY: 21CFR§807.92(C)
There are no significant differences between the two products and are identical in terms of intended use, materials, design, manufacturing methods. Both devices meet the ASTM standard D 6319-19.
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: 250mmSmall:- 241mmMedium: - 245 mmLarge:- 242 mmX-Large- 242 mm |
| ASTM D6319-19Standard Specification for nitrileexamination gloves for medicalApplication. | To determine thewidth of the gloves | X-Small:-70+/-10 mmSmall:-80+/-10mmMedium:-95+/-10 mmLarge:-110+/-10 mmX Large:- 120+/-10 mm | X-Small:- 80 mmSmall:- 82mmMedium:-93mmLarge:- 103mmX-Large-110mm |
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510(K) SUMMARY AS REQUIRED BY: 21CFR§807.92(C)
| TESTMETHOD | PURPOSE | ACCEPTANCECRITERIA | RESULT | ||
|---|---|---|---|---|---|
| ASTM D6319-19StandardSpecification fornitrile examinationgloves for medicalApplication. | To determine thethickness of thegloves | Palm0.05 mm minFinger0.05 mm minfor all sizes | Size | Palm | Finger |
| X-Small | 0.101 mm | 0.121 mm | |||
| Small | 0.081mm | 0.097mm | |||
| Medium | 0.091 mm | 0.108mm | |||
| Large | 0.092mm | 0.108mm | |||
| X Large | 0.091 mm | 0.111mm | |||
| ASTM D6319-19StandardSpecification fornitrile examinationgloves for medicalApplication. | To Determine thephysical properties-Tensile strength | Before AgeingTensile Strength 14Mpa Min for allsizesAfter AgeingTensile Strength14Mpa Min for allsizes | Size | Before ageing | After ageing |
| X-Small | 27.2 Mpa | 24.2 Mpa | |||
| Small | 23.2 Mpa | 23.8 Mpa | |||
| Medium | 24 Mpa | 27.6 Mpa | |||
| Large | 26.2 Mpa | 27.6 Mpa | |||
| X Large | 27.4 Mpa | 27.9 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% | 600% | |||
| Small | 590% | 560% | |||
| Medium | 570% | 540% | |||
| Large | 570% | 540% | |||
| X Large | 550% | 550% | |||
| ASTMD 5151-19Standard TestMethod forDetection ofHoles in MedicalGloves | To determine theholes in the gloves | AQL 2.5 | Gloves Passes AQL 2.5 | ||
| ASTM D6124-06(Reapproved2017) StandardTest Method forResidual Powderon MedicalGloves | To determine theresidual powder inthe gloves | ≤2 Mg/Glove | 0.49 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 test item,for skin irritation test inNew Zealand Whiterabbits. | Under the conditionof study not anirritant | Under the condition ofstudy, not an irritant |
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510(K) SUMMARY AS REQUIRED BY: 21CFR8807.92(C)
| TEST METHOD | PURPOSE | ACCEPTANCECRITERIA | RESULT |
|---|---|---|---|
| ISO 10993 10:2010(E)Biological Evaluation ofMedical Devices - Part 10:Tests for Irritation and SkinSensitization.Test done for skin sensitization | To evaluate the test item,for the Skin Sensitizationin Guinea pigs bymaximization test. | Under the conditionsof the study, not asensitizer | Under the conditions of thestudy, not a sensitizer |
| ISO10993-5:2009(E)Biological evaluation ofmedical devices - part 5, testsfor In vitro cytotoxicity. | To evaluate the test item,for its ability to inducecytotoxicity using L-929mouse fibroblast cells byElution Method. | Under the conditionsof the study, non-cytotoxic | Under the conditions of thestudy cytotoxic for 100% testitem extract and non-cytotoxic at 50%, 25%,12.5% and 6.25% test itemextracts. Moreover, under theconditions of the study, nonacute systemic toxic. |
| ISO 10993-11:2017(E)Biological evaluation ofmedical devices - part 11, testsfor systemic toxicity. | To evaluate the test item,for Acute SystemicToxicity in Swiss AlbinoMice. | Under the conditionsof study, the deviceextracts do not posea systemic toxicityconcern | Under the condition ofstudy, the device extractsdid not reveal anysystemic toxicity. |
The performance test data of the non-clinical tests demonstrates that the subject device meet the acceptance criteria and the specifications found in the standards and test methodology.
The performance test data of the non-clinical tests meet following standards:
ASTMD 6319-19 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 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 tests demonstrate that the subject device in 510(K) submission, ComfortPro Blue Nitrile Examination Gloves Powder Free is 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.