(129 days)
A 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.
Powder Free Nitrile Examination Glove - Black, Non-Sterile meet all requirements of ASTM standard D6319 and FDA 21 CFR 880.6250. The powder free nitrile examination glove is manufactured from Nitrile rubber. Inner surface of gloves undergoes surface treatment process to produce a smooth surface that assists the user in donning the qloves without using any lubricant such as powder on the glove surface. The glove is ambidextrous, i.e., can be worn on right hand or left hand and it is a single use device.
The document describes the non-clinical testing of a "Powder Free Nitrile Examination Glove - Black, Non Sterile" to demonstrate its substantial equivalence to a predicate device (K190942).
Here's the breakdown of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance:
| Test Method | Standard | Purpose of Testing | Acceptance Criteria | Reported Device Performance | Status |
|---|---|---|---|---|---|
| Physical Properties | ASTM D412 (Standard Test Method for Vulcanized Rubber and Thermoplastic Elastomers-Tension) | To evaluate the tensile (tension) properties of glove. | Before aging: Tensile strength Min 14.0 MPa; Ultimate elongation Min 500% | Before aging: Tensile strength 29.7 Mpa; Ultimate elongation 585% | Pass |
| After aging: Tensile strength Min 14.0 MPa; Ultimate elongation Min 400% | After aging: Tensile strength 33.1 Mpa; Ultimate elongation 554% | Pass | |||
| Dimension | ASTM D3767 (Standard Practice for Rubber—Measurement of Dimensions) | To measure the length, width and thickness of glove. | X-Small: Length Min 240 mm, Width 70 ± 10 mm, Thickness Finger - min 0.05mm, Palm - min 0.05mm | Length 250 mm, Width 78.0 mm, Thickness Finger - 0.10 mm, Palm - 0.07 mm | Pass |
| Small: Length Min 240 mm, Width 80 ± 10 mm, Thickness Finger - min 0.05mm, Palm - min 0.05mm | Length 250 mm, Width 88.0 mm, Thickness Finger - 0.10 mm, Palm - 0.07 mm | Pass | |||
| Medium: Length Min 240 mm, Width 95 ± 10 mm, Thickness Finger - min 0.05mm, Palm - min 0.05mm | Length 250 mm, Width 98.0 mm, Thickness Finger - 0.10 mm, Palm - 0.07 mm | Pass | |||
| Large: Length Min 240 mm, Width 110 ± 10 mm, Thickness Finger – min 0.05mm, Palm - min 0.05mm | Length 249 mm, Width 108 mm, Thickness Finger – 0.10 mm, Palm - 0.07 mm | Pass | |||
| X-Large: Length Min 240 mm, Width 120 ± 10 mm, Thickness Finger – min 0.05mm, Palm - min 0.05mm | Length 250 mm, Width 118 mm, Thickness Finger – 0.10 mm, Palm - 0.07 mm | Pass | |||
| Watertight | ASTM D5151 (Standard Test Method for Detection of Holes in Medical Gloves) | To detect holes that leak water and thereby compromise the usefulness of the glove. | Sample size: 500 pcs, Inspection level: G1, AQL: 1.5, Acceptance No. 10 | Batch size: 150,001 to 500,000. Sample drawn (code M): 315 pieces. 0 pieces found with leaks. Within acceptance criteria. | Pass |
| Residual Powder | ASTM D6124 (Standard Test Method for Residual Powder on Medical Gloves) | To determine the amount of residual powder and non-powder solids found on gloves. | Less than 2 mg per glove | Sample size: 5 pcs. Requirement: <2mg/glove. Result: 0.20 mg/glove. | Pass |
| Biocompatibility - Primary Skin Irritation | ISO 10993-10:2010 | To assess the potential of the material producing skin irritation. | Non-Irritant | The test material did not cause an irritant response. The Primary Irritant Response Category is deemed 'Negligible'. | Pass |
| Biocompatibility - Dermal Sensitization | ISO 10993-10:2010 | To assess the potential of the material producing skin sensitization. | Non-Irritant | The test material did not produce a skin sensitization effect in the guinea pigs. | Pass |
| Biocompatibility - Cytotoxicity | ISO 10993-5: 2009 (E) | To assess the in vitro cytotoxicity of the material. | Non-Toxicity | The test material demonstrated a cytotoxic effect under the condition of this study. Additional test i.e. Acute Systemic Toxicity was tested. (Initial test result was a "Fail" due to observed cytotoxic effect, leading to the additional test.) | Fail* |
| Biocompatibility - Acute Systemic Toxicity | ISO 10993-11:2017 (E) | To assess the potential of material to cause adverse systemic reactions. | Non-Toxicity | The test item did not induce any systemic toxicity in Swiss albino mice. (This was performed as an additional test after the cytotoxicity test showed a cytotoxic effect, bringing the overall biocompatibility evaluation to a "Pass" for systemic effects). | Pass |
Note on Cytotoxicity: While the initial cytotoxicity test resulted in a "Fail" due to the observed cytotoxic effect in vitro, an additional in vivo Acute Systemic Toxicity test was conducted, which passed. The conclusion states that the device is "as safe, as effective, and performs as well as or better than the legally marketed predicate devices K190942," implying that the comprehensive biocompatibility assessment led to an acceptable safety profile.
2. Sample Size Used for the Test Set and the Data Provenance:
- Physical Properties (Tensile Strength & Elongation): Specific sample size not explicitly stated, but tests were conducted according to ASTM D412, which defines sampling procedures.
- Dimensions: Not specified. ASTM D3767 is referenced, implying adherence to its sampling guidelines.
- Watertight (Hole Detection): A sample size of 315 pieces was drawn from a batch size of 150,001 to 500,000.
- Residual Powder: A sample size of 5 pcs was used.
- Biocompatibility (Primary Skin Irritation, Dermal Sensitization): Not explicitly stated, but typically involves a certain number of animal subjects (e.g., guinea pigs as mentioned for dermal sensitization). Testing was done according to ISO 10993-10.
- Biocompatibility (Cytotoxicity - MEM Elution): Not explicitly stated, but tested according to ISO 10993-5. In vitro test.
- Biocompatibility (Acute Systemic Toxicity): Not explicitly stated, but involved Swiss albino mice, tested according to ISO 10993-11.
Data Provenance: The document does not explicitly state the country of origin of the data. It appears to be generated from non-clinical laboratory testing performed by or for the manufacturer, Hong Seng Gloves Sdn Bhd, which is based in Malaysia. The studies are prospective in nature, as they involve testing the subject device to evaluate its performance against established standards.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts:
This information is not applicable as the document describes non-clinical laboratory testing of a medical device (gloves), not studies that rely on expert interpretation of medical images or diagnoses. The "ground truth" for these tests is defined by established performance standards (e.g., ASTM, ISO) and laboratory measurements.
4. Adjudication Method for the Test Set:
This information is not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies involving human readers or expert consensus on medical findings. Here, the assessment is based on objective laboratory 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 information is not applicable. This document pertains to the regulatory submission for a medical device (examination gloves) and describes non-clinical performance testing. It does not involve AI or human readers for diagnostic interpretation.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
This information is not applicable. This document describes the performance of a physical medical device (examination gloves), not a software algorithm.
7. The Type of Ground Truth Used:
The ground truth for this device's performance is established by international and national standards (e.g., ASTM D6319, ASTM D412, ASTM D3767, ASTM D5151, ASTM D6124, ISO 10993 series) and their defined acceptance criteria. These standards provide objective, measurable parameters (e.g., minimum tensile strength, maximum powder residue, AQL for watertightness, non-toxic response) that the device must meet.
8. The Sample Size for the Training Set:
This information is not applicable. This document describes the testing of a manufactured product against specified standards, not the development or training of a machine learning model. There is no "training set" in this context.
9. How the Ground Truth for the Training Set Was Established:
This information is not applicable for the same reason as point 8. There is no training set for this type of device submission.
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Image /page/0/Picture/0 description: The image shows the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
January 9, 2022
Hong Seng Gloves Sdn Bhd % Michael Van Der Woude U.S. Agent Emergo Global Representative LLC 2500 Bee Cave Road, Building 1 Suite 300 Austin, Texas 78746
Re: K212801
Trade/Device Name: Powder free nitrile examination glove- black, non sterile Regulation Number: 21 CFR 880.6250 Regulation Name: Non-powdered patient examination glove Regulatory Class: Class I, reserved Product Code: LZA Dated: December 2, 2021 Received: December 7, 2021
Dear Michael Van Der Woude:
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, Ph.D. 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) K212801
Device Name POWDER FREE NITRILE EXAMINATION GLOVE - BLACK, NON STERILE
Indications for Use (Describe)
A 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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1.0 Sponsor:
2.0
| Company Name: | Hong Seng Gloves Sdn Bhd |
|---|---|
| Company Address: | Lot 97, Jalan 10, Kawasan Perusahaan Bakar Arang, 08000Sungai Petani, Kedah, Malaysia. |
| Submitter: | |
| Contact Person: | Mr. Ho Chia Yao |
| Company Name: | Hong Seng Gloves Sdn Bhd |
| Company Address: | Lot 97, Jalan 10, Kawasan Perusahaan Bakar Arang, 08000Sungai Petani, Kedah, Malaysia. |
| Phone No.: | +604-4211555 |
| Fax No.: | +604-4211555 |
Date of Summary Prepared: 20th July 2021 (revised on 8th January 2022)
3.0 Identification of the subject device:
| Trade Name | : Powder Free Nitrile Examination Glove - Black, Non- Sterile |
|---|---|
| Common Name | : Patient Examination Gloves |
| Classification Name | : Patient Examination Gloves |
| Device Classification | : 1 |
| Regulation Number | : 21 CFR 880.6250 |
| Product Code | : LZA. |
3.0 Predicate Device:
K190942
Disposable Powder Free Nitrile Examination Glove, Black Color Company: Ever Growth (Vietnam) Co. Ltd.
4.0 Description of The Device:
Powder Free Nitrile Examination Glove - Black, Non-Sterile meet all requirements of ASTM standard D6319 and FDA 21 CFR 880.6250.
The powder free nitrile examination glove is manufactured from Nitrile rubber. Inner surface of gloves undergoes surface treatment process to produce a smooth surface that assists the user in donning the qloves without using any lubricant such as powder on the glove surface. The glove is ambidextrous, i.e., can be worn on right hand or left hand and it is a single use device.
| Design | : Ambidextrous (i.e., fit either hand) |
|---|---|
| Finish | : Texture Finger |
| Performance | : See Section 7 Summary of Non-Clinical Testing. |
Storage:
The product is kept away from direct sun and fluorescent lighting and stored in an environment with temperature not exceeding 40-degree C.
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Information For "Powder Free" Claim:
The finished powder free gloves meet ASTM D6319 requirements and are tested in according to ASTM D6124 method for powder measurement (less than 2mg per glove).
Glove Size and dimension:
Measurement is done as per ASTM D6319. Length is measured from the tip of the middle finger to the outside edge of the cuff. Width is measured at a level between the base of the index finger and the base of the thumb.
| Size | Palm Width (mm) | Length (mm) |
|---|---|---|
| X-Small | 70±10 | Minimum 230 |
| Small | 80±10 | Minimum 230 |
| Medium | 95±10 | Minimum 230 |
| Large | 110±10 | Minimum 230 |
| X-Large | 120±10 | Minimum 230 |
5.0 Indication for use:
A 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 Technological Characteristics Comparison of the Device:
Provided below is the technological comparison of the subject device vs the predicate device as shown in Table 1.
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Table 1
| DEVICE PERFORMANCE | ||||
|---|---|---|---|---|
| CHARACTERISTICS | STANDARDS | PREDICATE | SUBJECT DEVICE | COMPARISONANALYSIS |
| BLACK | BLACK | |||
| 510(k) Number | - | K190942 | K212801 | |
| Manufacturer(s) | - | Ever Growth EnterpriseCorporation | Hong Seng Gloves Sdn Bhd | Same |
| Material | ASTM D6319 | Nitrile | Nitrile | Same |
| Color | - | Black | Black | Same |
| PhysicalProperties | ASTM D6319 | |||
| Before AgingTensile Strength:UltimateElongation: | 14Mpa, min500% min | 29.7Mpa585% | Different butwithin the ASTMstandard | |
| After AgingTensile Strength:UltimateElongation: | 14Mpa, min400% min | 33.1Mpa554% | Different butwithin the ASTMstandard | |
| PhysicalDimensions: | ||||
| Glove Length: | Complies with ASTM D6319 -230mm minimum | Complies with ASTM D 6319 -230mm minimum. | Similar | |
| GloveThickness:- Finger- Palm | ASTM D6319 | 0.05mm min0.05mm min | 0.10mm0.07mm | Different butwithin the ASTMstandard |
| Glove PalmWidth:X-SmallSmallMediumLargeX-Large | Complies with ASTM D6319 | Complies with ASTM D6319 | Similar | |
| Powder Free | ASTM D6124 | < 2mg per glove | 0.20 mg/glove | Different butwithin the ASTMstandard |
| Primary SkinIrritation - ISO10993-10:2010 (E)& Consumer ProductSafety CommissionTitle 16. Chapter II,Part 1500 | Passes | The test material did not cause anirritant response. The PrimaryIrritant Response Category isdeemed 'Negligible' | Similar | |
| Biocompatibility | DermalSensitization- ISO10993-10: 2010 (E)& Consumer ProductSafety Commission,Title 16, Chapter II,Part 1500.3 (c) (4) | Passes | The test material did not producea skin sensitization effect in theguinea pigs. | Similar |
| Cytotoxicity - MEMElution, ISO 10993-5: 2009 (E) | Passes | The test material demonstrated acytotoxic effect under thecondition of this study. Additionaltest i.e. Acute Systemic Toxicitywas tested. | Different - butadditional test ofAcute SystemicToxicity isconducted. | |
| DEVICE PERFORMANCE | ||||
| CHARACTERISTICS | STANDARDS | PREDICATE | SUBJECT DEVICE | COMPARISONANALYSIS |
| BLACK | BLACK | |||
| Biocompatibility | Acute SystemicToxicity, ISO 10993-11:2017 (E) | Not Applicable | The test item did not induceany systemic toxicity in Swissalbino mice. | Different. |
| Watertight (1000ml) | ASTM D5151:2019 | In accordance with ASTMD6319-10 and ASTM D5151-06(reapproved 2011), G-1, AQL2.5 | Gloves passed AQL 1.5 | Different, butwithin the ASTMstandard. |
| Indication for use | - | The Nitrile Powder Free patientexamination glove is a non-sterile disposable deviceintended for medical purposethat is worn on the examiner'shands or finger to preventcontamination between patientand examiner. | A patient examination glove is adisposable device made ofnitrile rubber intended formedical purposes that is wornon the examiner's hand orfinger to prevent contaminationbetween patient and examiner. | Same |
| Size | Medical GloveGuidance Manual -Labeling | X SmallSmallMediumLargeX Large | Extra SmallSmallMediumLargeExtra Large | Same |
| Single use | Medical GloveGuidance Manual -Labeling | Yes | Single Use | Same |
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There are no significant differences between the two products and they are the same or similar in terms of intended use, materials design, physical properties, thickness and biocompatibility test.
7.0 Summary of Non-Clinical Testing
The performance test data of the non-clinical test for this powder free nitrile examination glove is summarized as per below.
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| TestMethod | Standard | Purpose of Testing | Acceptance Criteria | Results | Status | ||
|---|---|---|---|---|---|---|---|
| Before aging | After aging | Before aging | After aging | ||||
| Physical Properties | ASTM D412(Standard TestMethod forVulcanized Rubberand ThermoplasticElastomers-Tension) | To evaluate thetensile (tension)properties of glove. | Tensile strengthMin 14.0 MPa | Min 14.0 MPa | 29.7Mpa | 33.1Mpa | Pass |
| Ultimate elongationMin 500% | Min 400% | 585% | 554% | Pass |
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| TestMethod | Standard | Purpose ofTesting | GloveSize | Acceptance Criteria | Results | Status | |
|---|---|---|---|---|---|---|---|
| To measure thelength, width andthicknessofglove | X-Small | LengthMin 240 mm | Length250 mm | Pass | |||
| Width$70 \pm 10$ mm | Width78.0 mm | Pass | |||||
| ThicknessFinger - min 0.05mm | Thickness0.10 mm | Pass | |||||
| Palm - min 0.05mm | 0.07 mm | Pass | |||||
| ASTM D3767StandardPractice forRubber—Measurementof Dimensions | To measure thelength, width andthicknessofglove | Small | LengthMin 240 mm | Length250 mm | Pass | ||
| Width$80 \pm 10$ mm | Width88.0 mm | ||||||
| Dimension | ThicknessFinger - min 0.05mm | Thickness0.10 mm | |||||
| Palm - min 0.05mm | |||||||
| To measure thelength, width andthicknessofglove | Medium | LengthMin 240 mm | Length250 mm | ||||
| Width$95 \pm 10$ mm | Width98.0 mm | ||||||
| ThicknessFinger - min 0.05mm | Thickness0.10 mm | ||||||
| Palm - min 0.05mm | 0.07 mm | ||||||
| To measure thelength, width andthicknessofglove | Large | LengthMin 240 mm | Length249 mm | ||||
| Width$110 \pm 10$ mm | Width108 mm | ||||||
| Thickness | Finger – min 0.05mm | Thickness | 0.10 mm | Pass | |||
| Palm - min 0.05mm | 0.07 mm | ||||||
| Length | Min 240 mm | Length | 250 mm | Pass | |||
| X-Large | Width | $120 \pm 10$ mm | Width | 118 mm | Pass | ||
| Thickness | Finger – min 0.05mm | Thickness | 0.10 mm | Pass | |||
| Palm - min 0.05mm | 0.07 mm |
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| TestMethod | Standard | Purpose ofTesting | Acceptance Criteria | Results | Status |
|---|---|---|---|---|---|
| Watertight | ASTM D5151(Standard TestMethod forDetection of Holesin Medical Gloves) | To detect holesthat leak waterand therebycompromise theusefulness of theglove. | Sample size: 500 pcsInspection level: G1AQL: 1.5, Acceptance No. 10 | The batch size for thissampling is 150,001 to500,000. Hence,according to the singlesampling plan GI, thesample to be drawn isunder code Mequivalent to 315pieces with accept 10and reject 11 to beaccepted under AQL1.5. During the test, 0piece was found withleaks. Hence it fallswithin the acceptancecriteria. | Pass |
| TestMethod | Standard | Purpose ofTesting | Acceptance Criteria | Results | Status |
|---|---|---|---|---|---|
| ResidualPowder | ASTM D6124(Standard TestMethod for ResidualPowder on MedicalGloves) | To determine theamount ofresidual powderand non-powdersolids found ongloves. | Less than 2 mg per glove | Sample size : 5 pcsRequirement : <2mg/gloveResult :0.20mg/glove | Pass |
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| Test Method | Standard | Purpose ofTesting | Acceptance Criteria | Results | Status |
|---|---|---|---|---|---|
| Biocompatibility | Primary Skin Irritation - ISO 10993-10:2010 | To assess the potential of the material producing skin | Non-Irritant | The test material did not cause an irritant response. The Primary Irritant Response Category is deemed 'Negligible' | Pass |
| Dermal Sensitization- ISO 10993-10: 2010 | irritation and skin sensitization | Non-Irritant | The test material did not produce a skin sensitization effect in the guinea pigs. | Pass | |
| Cytotoxicity - MEM Elution, ISO 10993-5: 2009 (E) | To assess the in vitro cytotoxicity of the material | Non-Toxicity | The test material demonstrated a cytotoxic effect under the condition of this study. Additional test i.e. Acute Systemic Toxicity was tested. | Fail | |
| Acute Systemic Toxicity, ISO 10993-11:2017 (E) | To assess the potential of material to cause adverse systemic reactions | Non-Toxicity | The test item did not induce any systemic toxicity in Swiss albino mice. | Pass |
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8.0 Summary of Clinical Testing:
No clinical study is included in this submission.
9.0 Conclusion
The conclusion drawn from the non-clinical tests demonstrate that the subject Powder Free Nitrile Examination Glove - Black, Non-Sterile is as safe, as effective, and performs as well as or better than the legally marketed predicate devices 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.