(141 days)
A patient examination glove is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner
Nitrile Powder Free Blue Examination Gloves, Non-Sterile are Class I patient examination gloves bearing the product code Nitrile - LZA (21CFR880.6250).
The gloves are made from acrylonitrile-butadiene copolymer dispersion. Inner surface of gloves undergoes surface treatment process to produce a smooth surface that assists the user in donning the gloves without using any lubricant such as powder on the glove surface.
These gloves are blue in color and are powder free. The gloves are ambidextrous single use disposable devices that come in six sizes (XS, S, M, L, XL and XXL). The physical properties of glove, i.e., tensile strength meet ASTM D 6319-19.
The document describes the acceptance criteria and the results of non-clinical testing for the Nitrile Powder Free Blue Patient Examination Gloves, Non-Sterile (K221378).
Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
| Characteristics and Parameters | Standard | Acceptance Criteria | Proposed Device Performance (Result) |
|---|---|---|---|
| Residual Powder Content | ASTM D6124-06 (Reapproved 2017) | Less than 2mg / glove | XS: 0.36 mg/glove, S: 0.32 mg/glove, M: 0.36 mg/glove, L: 0.30 mg/glove, XL: 0.32 mg/glove, XXL: 0.30 mg/glove |
| Freedom of Holes | ASTM D5151-19 | Inspection level, G-I AQL 2.5 (In accordance with ASTM D6319-19) | Passed G-I, AQL 1.5 |
| Overall Length | ASTM D6319-19 | XS: 220mm min, S: 220mm min, M: 230mm min, L: 230mm min, XL: 230mm min | XS: 246–250mm, S: 248–252mm, M: 250–252mm, L: 248–251mm, XL: 245–248mm, XXL: 245–248mm |
| Width (Palm) | ASTM D6319-19 | XS: 70 ± 10mm, S: 80 ± 10mm, M: 95 ± 10mm, L: 110 ± 10mm, XL: 120 ± 10mm, XXL: 130 ± 10mm | XS: 77–78mm, S: 83–85mm, M: 94–96mm, L: 107–108mm, XL: 117–118mm, XXL: 124–125mm |
| Thickness (Palm) | ASTM D6319-19 | Measured in single wall at approximate center of palm area: 0.06mm min | XS: 0.06–0.07 mm, S: 0.06–0.07 mm, M: 0.06–0.07 mm, L: 0.06–0.07 mm, XL: 0.06–0.07 mm, XXL: 0.06–0.07 mm |
| Thickness (Finger) | ASTM D6319-19 | Measured in single wall at 13±3mm from the tip of middle finger region: 0.07mm min | XS: 0.08–0.09 mm, S: 0.08–0.09 mm, M: 0.08–0.10 mm, L: 0.08–0.10 mm, XL: 0.08–0.10 mm, XXL: 0.08–0.11 mm |
| Tensile Strength (Before Ageing) | ASTM D6319-19 | 14 MPa, for all sizes | XS: 21.67 MPa, S: 21.67 MPa, M: 22.14 MPa, L: 22.61 MPa, XL: 22.99 MPa, XXL: 22.35 MPa (average) |
| Tensile Strength (After Accelerated Ageing) | ASTM D6319-19 | 14 MPa, for all sizes | XS: 30.67 MPa, S: 27.80 MPa, M: 26.73 MPa, L: 22.44 MPa, XL: 23.15 MPa, XXL: 27.98 MPa (average) |
| Ultimate Elongation (Before Ageing) | ASTM D6319-19 | 500%, min for all sizes | XS: 547%, S: 529%, M: 533%, L: 523%, XL: 524%, XXL: 540% (average) |
| Ultimate Elongation (After Accelerated Ageing) | ASTM D6319-19 | 400%, min for all sizes | XS: 453%, S: 463%, M: 448%, L: 519%, XL: 516%, XXL: 458% (average) |
| Animal Irritation Test | ISO 10993-10 | Under the condition of study not an irritant. | Passed. No observable irreversible alteration on the skin; Primary Irritation Index (PII) was "0"; "negligible" irritation. |
| Dermal Sensitization Assay Test | ISO 10993-10 | Under the condition of the study not a sensitizer. | Passed. No sensitization induced. |
| Acute Systemic Toxicity | ISO 10993-11 | Not induce systemic toxicity. | Passed. No adverse toxic reaction demonstrated. |
2. Sample Size Used for the Test Set and the Data Provenance
The document does not explicitly state the exact sample sizes used for each specific non-clinical test. However, it implicitly indicates that various sizes of gloves (XS, S, M, L, XL, XXL) were tested for several parameters (e.g., residual powder, length, width, thickness, tensile strength, ultimate elongation), meaning multiple samples were drawn for each size.
- Data Provenance: The tests were performed by Tec Gloves Industry (M) Sdn. Bhd. for their "Nitrile Powder Free Blue Patient Examination Gloves, Non-Sterile". This suggests the data provenance is from the manufacturer's internal testing. The country of origin of the manufacturer is Malaysia. The data is prospective as it was generated to demonstrate compliance for this specific device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
Not applicable. The tests performed are non-clinical, objective measurements based on specified ASTM and ISO standards, not subjective expert evaluation of medical images or conditions.
4. Adjudication Method for the Test Set
Not applicable. This is not a human-in-the-loop study requiring adjudication of expert opinions. The performance criteria are defined by established international standards (ASTM, ISO).
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 a 510(k) submission for patient examination gloves, which are physical medical devices, not an AI/software device that would involve human readers or cases.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. The device is a physical glove, not an algorithm.
7. The Type of Ground Truth Used
The ground truth used for these non-clinical tests is based on predefined acceptance criteria specified by international standards (ASTM D6124-06, ASTM D5151-19, ASTM D6319-19, ISO 10993-10, ISO 10993-11). The results are quantitative measurements or qualitative observations (e.g., "not an irritant") against these established standard requirements. For example, for "Residual Powder Content," the ground truth is "Less than 2mg/glove."
8. The Sample Size for the Training Set
Not applicable. This device does not involve machine learning or AI, so there is no concept of a "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable. As there is no training set for this device.
{0}------------------------------------------------
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.
September 30, 2022
Tec Gloves Industry (M) Sdn.Bhd. Eunice Arumugam Regulatory Manager Lot 35793, Jalan Sungai Batu 31/KU6, Kawasan Perindustrian Klang Utama Klang, Selangor 42100 Malaysia
Re: K221378
Trade/Device Name: Nitrile Powder Free Blue Patient Examination Gloves, Non-Sterile Regulation Number: 21 CFR 880.6250 Regulation Name: Non-powdered patient examination glove Regulatory Class: Class I, reserved Product Code: LZA Dated: July 11, 2022 Received: July 11, 2022
Dear Eunice Arumugam:
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
{1}------------------------------------------------
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 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).
Sincerely,
Bifeng Oian, M.D., 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 Ouality Center for Devices and Radiological Health
Enclosure
{2}------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.
510(k) Number (if known) K221378
Device Name Nitrile Powder Free Blue Patient Examination Gloves, Non-Sterile
Indications for Use (Describe)
A patient examination glove is a disposable device intended for medical purpose 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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
{3}------------------------------------------------
Image /page/3/Picture/1 description: The image shows the logo for TEC Gloves. The logo features the text "TEC GLOVES" in a stylized font, with "TEC" in red and "GLOVES" in blue. To the left of the text is a semi-circular design made of blue and red dots. There is a trademark symbol to the right of the word "GLOVES".
LOT 35793 JALAN SUNGAI BATU 31/KU6 KAWASAN PERINDUSTRIAN KLANG UTAMA 42100 KLANG - MALAYSIA
+60 11-5725 2513 ए www.tecgloves.com
Premarket Notification [510(k)] No: K221378
510 (K) SUMMARY
1.0 Device Name:
Nitrile Powder Free Blue Patient Examination Gloves, Non-Sterile.
2.0 Submitter name / Contact details
TEC GLOVES INDUSTRY (M) SDN. BHD.
Lot 35793, Jalan Sungai Batu 31/KU6, Kawasan Perindustrian Klang Utama, 42100 Klang, Selangor. MALAYSIA
Contact Person Details: Eunice Varaletchumi Arumugam (Ms) E-mail: regulation@tecglovesusa.com Tel: +60-1-93121218 Fax: Nil
3.0 Summary Preparation Date:
April 28, 2022
4.0 Device Name & Classification:
Trade Name: Nitrile Powder Free Blue Patient Examination Gloves, Non-sterile Common Name: Nitrile Powder Free Patient Examination Glove Device Name: Polymer Patient Examination Gloves Device Classification: Class I Requlation Number: 21 CFR 880.6250 Panel: General Hospital Product Code: LZA
5.0 Identification of The Legally Marketed Device:
Predicate Device Name: Nitrile Powder Free Blue Patient Examination Gloves, Non-sterile Predicate 510(K) Number: K210369 Manufacture's Name: Pastel Glove Sdn Bhd
{4}------------------------------------------------
Image /page/4/Picture/1 description: The image shows the logo for TEC Gloves. The logo features the text "TEC GLOVES" in a stylized font. The word "TEC" is in red, while the word "GLOVES" is in blue. To the left of the text is a semi-circular design made up of blue and red dots. The letters in the logo are blocky and modern.
LOT 35793 JALAN SUNGAI BATU 31/KU6 KAWASAN PERINDUSTRIAN KLANG UTAMA 42100 KLANG - MALAYSIA +60 11-5725 2513 ए www.tecgloves.com
6.0 Description of Device
Nitrile Powder Free Blue Examination Gloves, Non-Sterile are Class I patient examination gloves bearing the product code Nitrile - LZA (21CFR880.6250).
The gloves are made from acrylonitrile-butadiene copolymer dispersion. Inner surface of gloves undergoes surface treatment process to produce a smooth surface that assists the user in donning the gloves without using any lubricant such as powder on the glove surface.
These gloves are blue in color and are powder free. The gloves are ambidextrous single use disposable devices that come in six sizes (XS, S, M, L, XL and XXL). The physical properties of glove, i.e., tensile strength meet ASTM D 6319-19.
7.0 Indications for Use:
A patient examination glove is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
8.0 Summary of the Technological Characteristic of the Device
Image /page/4/Picture/10 description: The image shows a crescent shape made of light blue and pink circles. The circles vary in size, with some being larger and some being smaller. The circles are arranged in a curved pattern, with the larger circles at the bottom and the smaller circles at the top. The background is white.
{5}------------------------------------------------
Image /page/5/Picture/1 description: The image shows the logo for TEC Gloves. The word "TEC" is in red, and the word "GLOVES" is in blue. To the left of the word "TEC" is a semi-circle made of red and blue dots. The letters are blocky and modern.
LOT 35793 JALAN SUNGAI BATU 31/KU6 KAWASAN PERINDUSTRIAN KLANG UTAMA 42100 KLANG - MALAYSIA
+60 11-5725 2513 ए www.tecgloves.com ക
| able- | 1 |
|---|---|
| ----------- | --- |
| Characteristics andParameters | Standard | Proposed Device | Predicate device | ComparisonAnalysis |
|---|---|---|---|---|
| 510(k) Number | - | K221378 | K210369 | - |
| Name of device | - | Nitrile Powder FreeBlue PatientExamination Gloves,Non-Sterile | Powder Free NitrileExamination GlovesNon-Sterile | Similar |
| Device ClassificationName/RegulationNumber | Patient ExaminationGlove,21 CFR Part880.6250 | Patient ExaminationGlove,21 CFR Part 880.6250 | Patient ExaminationGlove,21 CFR Part 880.6250 | Similar |
| Product Code | - | LZA | LZA | Similar |
| Intended Use | - | A patient examinationglove is a disposabledevice intended formedical purpose thatis worn on theexaminer's hand orfinger to preventcontaminationbetween patient andexaminer | A patient examinationglove is a disposabledevice intended formedical purpose thatis worn on theexaminer's hand orfinger to preventcontaminationbetween patient andexaminer. | Same intendeduse |
| Classification | - | Class 1 | Class 1 | Same Class |
| Raw Rubber Material | ASTM D 6319-19 | Nitrile (Acrylonitrile-butadiene) | Nitrile (Acrylonitrile-butadiene) | Same syntheticrubber material |
| Design, Color andSurface Appearance | - | 1. Ambidextrous2. Blue3. Powder Free4. Finger Textured | 1. Ambidextrous2. Blue3. Powder Free4. Finger Textured | Same,ambidextrousdesign, samecolor,same featuresand sametextured area |
| Overall Length(Minimum 230mm) | ASTM D 6319-19 | Average 245mm,all sizes | Average: 242 mm | Similar |
| Palm (mm)XS: 60 - 80mmS: 75 — 95mmM: 85 — 105mmL: 100 — 120mmXL: 110 — 130mmXXL: 120 - 140mm | ASTM D 6319-19 | XS : 77 – 78mmS : 83 — 85mmM : 94 - 96mmL : 107 — 108mmXL: 117 — 118mmXXL: 124 — 125mm | XS: NAS: 84mmM: 94mmL: 103mmXL: NAXXL: NA | Similar, subjectdevice meetrequirement ofASTM D6319 |
| Palm Thickness(Minimum 0.05mm) | ASTM D 6319-19 | Average 0.06mm,all sizes | Average: 0.06mm | Similar |
| Finger Thickness(Minimum 0.05mm) | ASTM D 6319-19 | Average 0.09mm,all sizes | Average: 0.08mm | Similar |
| Characteristics andParameters | Standard | Proposed Device | Predicate device | ComparisonAnalysis |
| Tensile Strength(Before aging)Minimum 14 MPa | ASTM D 6319-19 | Average: 22.24 MPa | Average: 17.75 MPa | Similar |
| Tensile Strength(After accelerated agingMinimum 14 MPa | ASTM D 6319-19 | Average: 26.46 MPa | Average: 16.07MPa | Similar |
| Ultimate Elongation(before aging)Minimum 500% | ASTM D 6319-19 | Average: 533 % | Average: 560 % | Similar |
| Ultimate Elongation(after accelerated agingMinimum 400% | ASTM D 6319-19 | Average: 476 % | Average:510 % | Similar |
| Freedom of Holes MeetAQL 2.5 at G1 | ASTM D 5151-19 | Meet AQL 1.5 with G1 | Meet AQL 1.5 with G1 | Similar |
| Residual powder test (Lthan 2mg/glove) | ASTM D 6124-06 | Average powder residuefor each size.XS : 0.36 mg/gloveS : 0.32 mg /gloveM : 0.36 mg /gloveL : 0.30 mg /gloveXL : 0.32 mg/gloveXXL: 0.30 mg/glove | Average powderresidue for each sizeXS : NilS : 0.45 mg/gloveM : 0.43 mg/gloveL : 0.27 mg/gloveXL : NilXXL: Nil | Similar |
| Animal Irritation Test | ISO 10993-10Biological evaluationof medical devices -Part 10: Tests forirritation and skinSensitization | Passed.Under the conditions ofstudy, not an irritant | Passed.Under the conditionsof study, not anirritant | Similar |
| Dermal Sensitization | ISO 10993-10Biological evaluationof medical devices -Part 10: Tests forirritation and skinsensitization | Passed.Under the conditions ofstudy, not a sensitizer | Passed.Under the conditionsof study, not asensitizer | Similar |
| Acute Systemic Toxicity | ISO 10993-11Biological evaluationof medical devices –Part 11: Tests forsystemic toxicity | Not induce systemictoxicity | Not induce systemictoxicity. | Similar |
| Expiration Date | ASTM D 7160-16Standard Practice forDetermination ofExpiration Dating forMedical Gloves | 3 years from date ofmanufactured | Predicate devicehas not stated. | - |
| Manufacturer | - | Tec Gloves Industry (M)Sdn. Bhd. | Pastel Glove Sdn Bhd | - |
{6}------------------------------------------------
Image /page/6/Picture/1 description: The image shows the logo for TEC Gloves. The logo features the text "TEC GLOVES" in a stylized font. The word "TEC" is in red, and the word "GLOVES" is in blue. To the left of the text is a semi-circular design made up of red and blue dots. The letters TM are in the upper right corner of the word "GLOVES".
LOT 35793 JALAN SUNGAI BATU 31/KU6 KAWASAN PERINDUSTRIAN KLANG UTAMA 42100 KLANG - MALAYSIA
+60 11-5725 2513 ए www.tecgloves.com
{7}------------------------------------------------
Section 006 Page 5 of 8
Image /page/7/Picture/1 description: The image shows the logo for TEC Gloves. The word "TEC" is in red, and the word "GLOVES" is in blue. To the left of the word "TEC" is a semi-circle made of red and blue dots. The letters "TM" are in the upper right corner of the image.
LOT 35793 JALAN SUNGAI BATU 31/KU6 KAWASAN PERINDUSTRIAN KLANG UTAMA 42100 KLANG - MALAYSIA
+60 11-5725 2513 ए www.tecgloves.com
9.0 Summary of Non-Clinical Testing
Table 2 -Performance Testing
| Non-Clinical Testing | |||
|---|---|---|---|
| Test Method | Purpose | Acceptance Criteria | Result |
| ASTM D6124-06(Reapproved 2017)Standard TestMethod for ResidualPowder on MedicalGloves. | To determine theresidual powder in thegloves | Less than 2mg / glove | Size XS 0.36mg/gloveSize S 0.32mg/gloveSize M 0.36mg/gloveSize L 0.30mg/gloveSize XL 0.32mg/gloveSize XXL 0.30 mg/glove |
| ASTM D5151-19Standard Test Methodfor Detection of Holes inMedical Gloves. | To determine the holesin the gloves | Inspection level, G-I AQL 2.5(In accordance with ASTMD6319-19) | Passed G-I, AQL 1.5 |
| ASTM D6319-19Standard Specification forNitrile Examination Glovesfor Medical Application. | To determine the lengthof the gloves | Size XS 220mm, minSize S 220mm, minSize M 230mm, minSize L 230mm, minSize XL 230mm, min | Size XS 246 – 250mmSize S 248 – 252mmSize M 250 – 252mmSize L 248 – 251mmSize XL 245 – 248mmSize XXL 245 – 248mm |
| ASTM D6319-19Standard Specificationfor Nitrile ExaminationGloves for MedicalApplication. | To determine the widthof the gloves | Size XS 70 ± 10mmSize S 80 ± 10mmSize M 95 ± 10mmSize L 110 ± 10mmSize XL 120 ± 10mmSize XXL 130 ± 10mm | Size XS XS: 77 - 78mmSize S S: 83 – 85mmSize M M: 94 – 96mmSize L L: 107 – 108mmSize XL XL: 117 – 118mmSize XXL XXL:124 – 125mm |
| Non-Clinical Testing (Cont'd) | |||
| Test Method | Purpose | Acceptance Criteria | Result |
| ASTM D6319-19StandardSpecification forNitrile ExaminationGloves for MedicalApplication. | To determine thethickness of thegloves | Measured in single wall at approximate center of palm areaPalm 0.06mm, min | Size XS 0.06 – 0.07 mmSize S 0.06 – 0.07 mmSize M 0.06 – 0.07 mmSize L 0.06 – 0.07 mmSize XL 0.06 – 0.07 mmSize XXL 0.06 – 0.07 mm |
| Measured in single wall at 13±3mm from the tip of middle finger regionFinger 0.07mm, min | Size XS 0.08 – 0.09 mmSize S 0.08 – 0.09 mmSize M 0.08 – 0.10 mmSize L 0.08 – 0.10 mmSize XL 0.08 – 0.10 mmSize XXL 0.08 – 0.11 mm | ||
| ASTM D6319-19StandardSpecification forNitrile ExaminationGloves for MedicalApplication. | To determine thephysical properties-Tensile strength | Before AgeingTensile Strength 14Mpa,for all sizes | Size XS 21.67 MPa, averageSize S 21.67 MPa, averageSize M 22.14 MPa, averageSize L 22.61 MPa, averageSize XL 22.99 MPa, averageSize XXL 22.35 MPa, average |
| After AgeingTensile Strength 14Mpa,for all sizes | Size XS 30.67 MPa, averageSize S 27.80 MPa, averageSize M 26.73 MPa, averageSize L 22.44 MPa, averageSize XL 23.15 MPa, averageSize XXL 27.98 MPa, average | ||
| To determine thephysical properties-Ultimate Elongation | Before Ageing UltimateElongation 500%, min forsizes | Size XS 547%, averageSize S 529%, averageSize M 533%, averageSize L 523%, averageSize XL 524%, averageSize XXL 540%, average | |
| After AgeingUltimate Elongation 400%,min for all sizes | Size XS 453%, averageSize S 463%, averageSize M 448%, averageSize L 519%, averageSize XL 516%, averageSize XXL 458%, average |
{8}------------------------------------------------
Section 006 Page 6 of 8
Image /page/8/Picture/1 description: The image shows the logo for TEC Gloves. The logo consists of the words "TEC GLOVES" in a stylized font. The word "TEC" is in red, and the word "GLOVES" is in blue. To the left of the words is a circular design made up of blue and red dots. The letters TM are in the upper right corner of the logo.
LOT 35793 JALAN SUNGAI BATU 31/KU6 KAWASAN PERINDUSTRIAN KLANG UTAMA 42100 KLANG - MALAYSIA
+60 11-5725 2513 ए www.tecgloves.com
{9}------------------------------------------------
Section 006 Page 7 of 8
Image /page/9/Picture/1 description: The image shows the logo for TEC Gloves. The logo has the word "TEC" in red and the word "GLOVES" in blue. There are blue and red dots arranged in a semi-circle around the word "TEC". The letters are in a sans-serif font.
LOT 35793 JALAN SUNGAI BATU 31/KU6 KAWASAN PERINDUSTRIAN KLANG UTAMA 42100 KLANG - MALAYSIA
+60 11-5725 2513 www.tecgloves.com
| Biocompatibility Testing | |||
|---|---|---|---|
| Test Method | Purpose | Acceptance Criteria | Result |
| ISO 10993-10Biological evaluationof medical devices -Part 10: Tests forirritation and skinsensitization(Animal IrritationTest) | To determine thepotential of thematerial undertest to producedermal irritationin Rabbits | Under the condition ofstudy not an irritant. | There was no observableirreversible alteration on theskin at the sites of contact withthe test material. The PrimaryIrritation Index (PII) was "0".The test material was notirritant, and the PrimaryIrritation Response Category istherefore "negligible", thereofmet the requirement. |
| ISO 10993-10Biological evaluationof medical devices -Part 10: Tests forirritation and skinsensitization(DermalSensitizationAssay Test) | To determine theskin sensitizationpotential of thematerial both interms of inductionand elicitation inGuinea pig | Under the condition ofthe study not asensitizer. | There was no sensitizationinduced by the application ofthe test material on the albinoguinea pigs under the conditionof this test, thereof met therequirement. |
| ISO 10993-11Biological evaluationof medical devices -Part 11: Tests forsystemic toxicity(Acute SystemicToxicity) | To provideinformation onhealth hazardslikely to arise froma short-termexposure to theextracts of testmaterial byintravenous andintraperitonealinjection in mice | Not induce systemictoxicity | Under the condition of thisstudy, the single dose acutesystemic toxicity of extractsfrom test material using bothnormal saline and sesame oil,did not demonstrate anyadverse toxic reaction, thereofmet the requirement. |
Non-Clinical tests were carried out to demonstrate product performance conformity with standards referenced.
The following bench tests were performed:
Non-clinical tests
- Residual Powder Content A
- ハ Physical Properties
-
Physical Dimension
-
Freedom from Holes
Biocompatibility Testing
-
Animal Irritation Test
-
Dermal Sensitization Assay
-
Acute Systemic Toxicity
The results from these performance evaluations demonstrated that the Nitrile Powder Free Blue Patient Examination Gloves, Non-Sterile, met the acceptance criteria defined in standards referenced.
{10}------------------------------------------------
Section 006 Page 8 of 8
Image /page/10/Picture/1 description: The image shows the logo for TEC Gloves. The word "TEC" is in red, and the word "GLOVES" is in blue. To the left of the word "TEC" is a semi-circle made of blue and red dots. To the right of the word "GLOVES" is the trademark symbol.
LOT 35793 JALAN SUNGAI BATU 31/KU6 KAWASAN PERINDUSTRIAN KLANG UTAMA 42100 KLANG - MALAYSIA
+60 11-5725 2513 ए www.tecgloves.com
10.0 Summary of Clinical Testing:
Clinical Testing is not needed for this device.
11.0 Conclusion
The conclusion drawn from the non-clinical test demonstrate that the subject device is as safe, as effective, and performs as well as or better than the legally marketed predicate device K2210369.
Image /page/10/Picture/8 description: The image shows a crescent shape made of light blue and pink circles. The circles vary in size, with the larger circles at the bottom and the smaller circles at the top. The crescent shape is open on the right side. The background is white.
§ 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.