(83 days)
A nitrile patient examination glove is a disposable device made of nitrile rubber intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
Black Nitrile Powder Free Patient Examination Glove, Non Sterile is manufactured from nitrile rubber. Inner surface of gloves undergoes a surface treatment process to produce a smooth surface that assists the user in donning the gloves without using any lubricant such as powder or silicone on the glove surface. The glove is ambidextrous, i.e., can be worn on right or left hand.
This document describes the premarket notification (510(k)) for a medical device, specifically "Black Nitrile Powder Free Patient Examination Glove, Non Sterile". It is not an AI/ML medical device submission. Therefore, the questions related to AI/ML specific studies, such as MRMC studies, ground truth establishment by experts, and training/test set sample sizes for AI/ML models, are not applicable.
The acceptance criteria for this device are based on demonstrating substantial equivalence to a predicate device (K190942) by meeting established performance standards for patient examination gloves.
Here's a breakdown based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance & Comparison Analysis
The document provides a detailed comparison in "Table 1" and further test results in section "7.0 Summary of Non-Clinical Testing".
| CHARACTERISTICS | STANDARDS / Acceptance Criteria | Predicate Performance (K190942) | Subject Device Performance (K233740) | Comparison Analysis (Outcome) |
|---|---|---|---|---|
| Physical Properties | ASTM D6319-19 | |||
| Before Aging: | ||||
| - Tensile Strength | Min 14.0 MPa (Acceptance) | 14 Mpa, min | 15.7 – 39.8 Mpa (XS-XXL range) | Different but within the ASTM standard |
| - Ultimate Elongation | Min 500% (Acceptance) | 500% min | 550 - 620% (XS-XXL range) | Different but within the ASTM standard |
| After Aging: | ||||
| - Tensile Strength | Min 14.0 MPa (Acceptance) | 14 Mpa, min | 17.0 – 40.6 Mpa (XS-XXL range) | Different but within the ASTM standard |
| - Ultimate Elongation | Min 400% (Acceptance) | 400% min | 460 - 600% (XS-XXL range) | Different but within the ASTM standard |
| Dimensions | ASTM D6319-19 | |||
| Length | 230 mm min | 230 mm min | Min 240 mm | Different but within the ASTM standard |
| Thickness (Finger) | 0.05mm min | 0.05mm min | Min 0.13mm (XS-XXL) | Different but within the ASTM standard |
| Thickness (Palm) | 0.05mm min | 0.05mm min | Min 0.09mm (XS-XXL) | Different but within the ASTM standard |
| Powder Free | ASTM D6124 | < 2mg per glove | Below 2mg of residual powder | Similar |
| Watertight | ASTM D5151:2019 | Acc. to ASTM D6319-10 & D5151-06 (Reapproved 2011), G-1, AQL 2.5 | Tested per ASTM D5151 (Reapproved 2019) with AQL 2.5 (Minor leaks within acceptance for some sizes) | Similar |
| Biocompatibility | ISO 10993-10:2021 (E) | Passes | ||
| - Primary Skin Irritation | Observation of skin reaction for erythema and oedema | Passes | Induced negligible irritation in rabbit skin single-exposure test. | Same |
| - Dermal Sensitization | Observation of skin sites for erythema and oedema as per Magnusson and Klingman Grading | Passes | Did not produce a skin sensitization effect in guinea pigs. | Same |
| - Cytotoxicity | ISO 10993-5: 2009 | Passes | Conducted as alternative | Different - but an additional test of Acute Systemic Toxicity is conducted and passed |
| - Acute Systemic Toxicity | ISO 10993-11:2017 (E) | Not Tested | No acute systemic toxicity reaction in mice. | Different. The subject glove was tested, predicate was not. |
| General | ||||
| Material | ASTM D6319-19 | Nitrile | Nitrile | Same |
| Sterility | - | Non-Sterile | Non-Sterile | Same |
| Handedness | - | Ambidextrous | Ambidextrous | Same |
| Intended Use | - | Similar description | Similar description | Similar |
| Size | Medical Glove Guidance Manual - Labeling | Extra Small, Small, Medium, Large, X Large | Extra Small, Small, Medium, Large, Extra Large, Extra Extra Large | Similar, with addition of size Extra Extra Large |
| Single Use | Medical Glove Guidance Manual - Labeling | Single Use | Single Use | Same |
2. Sample sizes used for the test set and data provenance:
- Physical Properties (Tensile Strength, Elongation): Not explicitly stated as a "test set" in the context of AI/ML, but performance data is provided for various glove sizes (XS, S, M, L, XL, XXL). The test method ASTM D412 typically involves testing multiple specimens from a sample.
- Dimension: Various sizes (X-Small, Small, Medium, Large) are listed with their measured dimensions. The number of samples for measurement is not explicitly given, but it is expected to be a representative sample for each size.
- Watertight:
- Sample Size: 200 pieces for each size (XS, S, M, L, XL, XXL).
- Data Provenance: The standard is ASTM D5151. Based on the context of a 510(k) submission, this data would be generated from prospective testing of the manufactured device lots under controlled conditions, likely at the manufacturer's facility or a contracted lab. The country of origin for the manufacturing is Thailand.
- Residual Powder:
- Sample Size: 5 pieces.
- Data Provenance: Standard is ASTM D6124. This is also prospective testing.
- Biocompatibility (Primary Skin Irritation, Dermal Sensitization, Acute Systemic Toxicity):
- Sample Size: Not explicitly stated as a number of devices, but the studies describe using rabbit skin and guinea pigs (for sensitization) and mice (for systemic toxicity). Typical animal study protocols would define the sample size of animals.
- Data Provenance: Standards are ISO 10993-10 and ISO 10993-11. These are prospective animal studies conducted in a lab environment.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. This is a traditional medical device (glove) clearance, not an AI/ML device relying on expert labeling for ground truth. The "ground truth" is established by adherence to recognized international and national consensus standards (ASTM, ISO) for physical, chemical, and biological properties, which are quantitatively measured.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. This is not an AI/ML study design that would require human expert adjudication of ambiguous cases. Performance is based on objective measurements against established standard criteria.
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/ML diagnostic or assistive device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is not an AI/ML device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
The ground truth for device performance is based on established national and international consensus standards (ASTM D6319, ASTM D5151, ASTM D6124, ISO 10993 series) that define the test methods and acceptance criteria for patient examination gloves. These are objective, measurable parameters (e.g., tensile strength in MPa, elongation in %, presence/absence of holes, residual powder in mg, biological responses in animal models).
8. The sample size for the training set:
Not applicable. This is not an AI/ML device, so there is no "training set."
9. How the ground truth for the training set was established:
Not applicable. There is no training set.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
February 13, 2024
W.A. Rubbermate Co., Ltd. Prachai Kongwaree President 4 Ramkhamhaeng 19 (Chareonploy) Huamark Bangkok, 10240 Thailand
Re: K233740
Trade/Device Name: Black Nitrile Powder Free Patient Examination Glove, Non Sterile Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I, reserved Product Code: LZA Dated: November 15, 2023 Received: November 22, 2023
Dear Prachai Kongwaree:
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.
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 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.
Allan Guan-S
For Bifeng Qian, M.D., Ph.D. Assistant Director DHT4B: Division of Infection Control and Plastic and Reconstructive Surgery Devices
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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
Black Nitrile Powder Free Patient Examination Glove, Non Sterile
Indications for Use (Describe)
A nitrile patient examination glove is a disposable device made of nitrile rubber intended for medical purposes that is worn on the examiner's hand or finger 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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510k Summary (K233740)
(As Required by 21 CFR 807.92)
1.0 Submitter:
| Name | Prachai Kongwaree, President, W.A. RubbermateCO., LTD.W.A. RUBBERMATE CO., LTD. |
|---|---|
| Address | 4 Ramkhamhaeng 19 (Chareonploy)Huamark,Bangkok, Thailand 10240 |
| Phone No. | 66-2-3189442 |
| Date of Summary Prepared | 13 February 2024 |
2.0 ldentification of the subject device:
| Trade Name: | : Black Nitrile Powder Free Patient Examination Glove, NonSterile |
|---|---|
| Common Name: | : Patient Examination Gloves |
| Classification Name : | : Non-powdered patient examination glove |
| Device Classification | : I |
| Regulation Number : | : 21 CFR 880.6250 |
| Product Code | : LZA |
3.0 Predicate Device:
K190942
Trade Name : Disposable Powder Free Nitrile Examination Glove, Black Color Company: Ever Growth (Vietnam) Co., Ltd
4.0 Description of The Subject Device:
Black Nitrile Powder Free Patient Examination Glove, Non Sterile is manufactured from nitrile rubber. Inner surface of gloves undergoes a surface treatment process to produce a smooth surface that assists the user in donning the gloves without using any lubricant such as powder or silicone on the glove surface. The glove is ambidextrous, i.e., can be worn on right or left hand.
5.0 Indication for use:
A nitrile patient examination glove is a disposable device made of nitrile rubber intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
6.0 Comparison of the Technological Characteristics of the Device:
The Black Nitrile Powder Free Patient Examination Gloves, Non Sterile are summarized with the following technological characteristics compared to ASTM D6319 as shown in Table 1
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| CHARACTERISTICS | STANDARDS | PREDICATE | DEVICE PERFORMANCE | CURRENT | COMPARISON ANALYSIS |
|---|---|---|---|---|---|
| 510(k) Number | - | K190942 | K233740 | Different | |
| Manufacturer(s) | - | Ever Growth (Vietnam) Co., Ltd | W.A. Rubbermate CO., LTD. | Same | |
| Material | ASTM D6319-19 | Nitrile | Nitrile | Same | |
| Color | - | Black | Black | Same | |
| Sterility | - | Non-Sterile | Non-Sterile | Same | |
| Handedness | - | Ambidextrous | Ambidextrous | Same | |
| Physical Properties | ASTM D6319-19 | ||||
| Before AgingTensile Strength:Ultimate Elongation: | 14Mpa, min500% min | 15.7 – 39.8 Mpa550 - 620% | Different but within the ASTM standard | ||
| After Aging TensileStrength:Ultimate Elongation: | 14Mpa, min400% min | 17.0 – 40.6 Mpa460 - 600% | Different but within the ASTM standard | ||
| Length | ASTM D6319-19 | 230 mm min | Min 240 | Different but within the ASTM standard | |
| Thickness:- Finger- Palm | ASTM D6319-19 | 0.05mm min0.05mm min | Min 0.13mm for (XS, S, M, L, XL, XXL)Min 0.09mm for (XS, S, M, L, XL, XXL) | Different but within the ASTM standard | |
| Powder Free | ASTM D6124 | < 2mg per glove | Below 2mg of residual powder | Similar | |
| CHARACTERISTICS | STANDARDS | DEVICE PERFORMANCE | |||
| PREDICATE | CURRENT | COMPARISON ANALYSIS | |||
| BLACK | BLACK | ||||
| Primary Skin Irritation- ISO 10993-10:2021 (E) | Passes | Under the conditions of this study, the test material induced negligible irritation in a rabbit skin single-exposure test. | Same | ||
| Biocompatibility | Dermal Sensitization-ISO 10993-10: 2010 (E) | Passes | Under the conditions of this study, the frequency of positive challenge results in sample extract and Negative control animals are 0%, the Positive control is 100%, where the test material did not produce a skin sensitization effect in the guinea pigs. | Same | |
| Cytotoxicity - MEMElution, ISO 10993-5: 2009 | Passes | The study was conducted as the alternative to the cytotoxic test | Different - but an additional test of Acute Systemic Toxicity is conducted and passed | ||
| Acute SystemicToxicity, ISO 10993-11:2017 (E) | Not Tested | Under the conditions of this study, the test item did not induce any acute systemic toxicity reaction in mice. | Different. The subject glove was tested using a systemic toxicity test and passed, but the Predicate did not have the test performed | ||
| CHARACTERISTICS | STANDARDS | DEVICE PERFORMANCE | COMPARISON ANALYSIS | ||
| PREDICATEBLACK | CURRENTBLACK | ||||
| Watertight (1000ml) | ASTM D5151:2019 | In accordance with ASTM D6319-10and ASTM D5151-06 (Reapproved2011), G-1, AQL 2.5 | Tested in accordance with ASTMD5151 (Reapproved 2019) withacceptable results at an AQL 2.5 | Similar | |
| Intended use | - | The Nitrile Powder Free Patientexamination glove is a non-steriledisposable device intended formedical purpose that is worn onthe examiners hands or finger toprevent contamination betweenpatient and examiner. | A nitrile patient examination gloveis a disposable device made ofnitrile rubber intended for medicalpurposes that is worn on theexaminer's hand or finger toprevent contamination betweenpatient and examiner. | Similar | |
| Size | Medical GloveGuidance Manual -Labeling | Extra SmallSmallMediumLargeX Large | Extra SmallSmallMediumLargeExtra LargeExtra Extra Large | Similar, with andaddition of size ExtraExtra Large | |
| Single use | Medical GloveGuidance Manual -Labeling | Single Use | Single Use | Same |
Table 1
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Summary of Non-Clinical Testing 7.0
The performance test data of the non-clinical tests for this powder free nitrile examination glove is summarized as per below
| TestMethod | Standard | Purpose of Testing | Acceptance Criteria | Results | Status | |||
|---|---|---|---|---|---|---|---|---|
| Beforeaging | Afteraging | Before aging | After aging | |||||
| PhysicalProperties | ASTM D412(Standard Test Methodfor Vulcanized Rubberand ThermoplasticElastomers-Tension) | To evaluate thetensile (tension)properties of theglove. | Tensilestrength | Min 14.0 MPa | Min 14.0 MPa | XS - 22.3S – 15.7M - 27.1L – 24.8XL-30.1XXL – 23.3 | XS - 21.2S – 17.0M - 30.7L - 24.2XL – 23.3XXL - 23.5 | Pass |
| Ultimateelongation | Min500% | Min400% | XS - 560S - 540M - 540L - 540XL - 560XXL - 540 | XS - 560S - 500M - 500L - 520XL - 460XXL - 520 | Pass |
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| Test Method | Standard | Purpose of Testing | Glove Size | Acceptance Criteria | Results | Status | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Dimension | ASTM D3767 Standard Practice for Rubber—Measurementof Dimensions | To measure the length, width and thickness ofglove | X-Small | Length | Min 220 mm | Width | 70 ± 10 mm | Length | 240 mm | Width | 76.0 mm | Pass |
| Thickness | Finger - min 0.05mm | Palm - min 0.05mm | Thickness | 0.13 mm | Pass | |||||||
| Small | Length | Min 220 mm | Width | 80 ± 10 mm | Length | 241 mm | Width | 83.0 mm | Pass | |||
| Thickness | Finger - min 0.05mm | Palm - min 0.05mm | Thickness | 0.14 mm | Pass | |||||||
| Medium | Length | Min 230 mm | Width | 95 ± 10 mm | Length | 241 mm | Width | 95.0 mm | Pass | |||
| Thickness | Finger - min 0.05mm | Palm - min 0.05mm | Thickness | 0.13 mm | Pass | |||||||
| Large | Length | Min 230 mm | Width | 110 ± 10 mm | Length | 241 mm | Width | 105 mm | Pass | |||
| Thickness | Finger - min 0.05mm | Palm - min 0.05mm | Thickness | 0.09 mm | Pass |
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| Thickness | Length | Width | Thickness | Length | Width | Thickness | |
|---|---|---|---|---|---|---|---|
| Pass | Pass | Pass | Pass | Pass | Pass | Pass | |
| 0.13 mm | 240 mm | 110 mm | 0.14 mm | 240 mm | 121 mm | 0.13 mm | |
| X-Large | Finger - min 0.05mmPalm - min 0.05mm | Min 230 mm | $120 \pm 10$ mm | Finger - min 0.05mmPalm - min 0.05mm | Min 230 mm | $130 \pm 10$ mm | Finger - min 0.05mmPalm - min 0.05mm |
| XX-Large |
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| TestMethod | Standard | Purpose ofTesting | Acceptance Criteria | Results | Status |
|---|---|---|---|---|---|
| Watertight | ASTM D5151(Standard TestMethod forDetection of HolesinMedical Gloves) | To detect holesthat leak water andtherebycompromise theusefulness of theglove. | Sample size: 200 pcsAQL: 2.5, Acceptance No. 10The batch size for this samplingis 35,001 to 150,000. Hence,according to the singlesampling plan GI, thesample to be drawn isunder code L equivalent to200 pieces with accept 10and reject 11 to beaccepted under AQL 2.5 | For Size XS, during the test, 1piece was found with leaks.Hence it falls within theacceptance criteria.For Size S, during the test, 0piece was found with leaks.Hence it falls within theacceptance criteria.For Size M, during the test, 0piece was found with leaks.Hence it falls within theacceptance criteria.For Size L, during the test, 1piece was found with leaks.Hence it falls within theacceptance criteria.For Size XL, during the test, 1piece was found with leaks.Hence it falls within theacceptance criteria.For Size XXL, during the test, 3piece was found with leaks.Hence it falls within theacceptance criteria | Pass |
| Test Method | Standard | Purpose of Testing | Acceptance Criteria | Results | Status |
| ResidualPowder | ASTM D6124(Standard Test Methodfor Residual Powder onMedical Gloves) | To determine theamount of residualand non-powdersolids found ongloves | Less than 2 mg per glove | Sample size : 5 pcsResult XS :0.26mg/gloveResult S :0.50mg/gloveResult M :0.16mg/gloveResult L :0.52mg/gloveResult XL :0.46mg/gloveResult XXL :0.48mg/glove | Pass |
| compatibility | Primary SkinIrritation - ISO10993-10:2021(E) | Evaluate thepossibility of skinirritation after singletopical applicationsof the test sampleextracts on the skinof test subjects. | Observation of skin reaction forerythema and oedema on testsubject | Under the conditions of this study,the test material inducednegligible irritation in a rabbit skinsingle-exposure test. | Pass |
| Dermal SensitizationISO 10993-10: 2010(E) | To evaluatesensitization(maximization test)to evaluatepossibility of skinsensitization aftertopical applicationsof the test sampleextracts on the testsubjects | Observation of skin sites forerythema and oedema on test andcontrol test subjects as perMagnusson and KlingmanGrading. | Under the conditions of this study,the frequency of positivechallenge results in sampleextract and Negative controlanimals are 0%, the Positivecontrol is 100%, where the testmaterial did not produce a skinsensitization effect in the guineapigs | Pass | |
| Acute SystemicToxicity, ISO 10993-11:2017 (Ε) | Evaluate the acutesystemic adversereactions after beinginjected into testsubjects | No toxicity indication or death inthe animal subjected to study. | Under the conditions of this study,the test item did not induce anyacute systemic toxicity reaction inmice. | Pass |
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The following standards were followed to carry out the above testing:
- ASTM D412 Test Methods for Vulcanized Rubber and Thermoplastic Elastomers-O Tension
- ASTM D573 Test Method for Rubber-Deterioration in an Air Oven x ASTM D3578 O Specification for Rubber Examination Gloves
- ASTM D6319 Standard Specification for Nitrile Examination Gloves for Medical o Application
- ASTM D5151 Test Method for Detection of Holes in Medical Gloves O
- O ASTM D6124 Test Method for Residual Powder on Medical Gloves
- ISO 2859 Sampling Procedures and Tables for Inspection by Attributes Test results show O that under the conditions of the testing, there is no difference inphysical attributes between the proposed device and the predicate device.
- Biocompatibility Testing utilizing: ISO 10993 Biological Evaluation of Medical Devices: O
- . ISO 10993 - Part 10: Tests for Irritation and Sensitization. Both Skin Irritation and Dermal Magnuson/Kligman Sensitization performed.
- . ISO 10993 - Part 11: Tests for assessment of Systemic Toxicity
8.0 Summary of Clinical Testing:
No clinical studies are included in this submission.
Conclusion
The conclusion drawn from the non-clinical tests demonstrates that the subject "Black Nitrile Powder-Free Patient Examination Glove, Non-Sterile" is as safe, as effective, and performs as well as, or better than, the legally marketed predicate device K190942.
§ 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.