(162 days)
Siam NTD+ NITRILE POWDER-FREE EXAMINATION GLOVES 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.
Siam NTD* NITRILE POWDER-FREE EXAMINATION GLOVES is a glove made from nitrile butadiene rubber Latex that covers the hand up to the wrist. It is cuffed and equally wearable on either hand, free from differentiation between the left hand and the right. It has 4 sizes, i.e. small, medium, large and extra large. All variations share the same blue color. The glove is non-sterile and is for single use only, to be discarded after each examination is performed. It acts as a barrier between the examiner and the subject being examined in order to prevent contamination between them.
The document describes the non-clinical performance data for the Siam NTD+ NITRILE POWDER-FREE EXAMINATION GLOVES.
Here's the information requested based on the provided text:
1. A table of acceptance criteria and the reported device performance:
| Test Method | Purpose | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| ASMT D6319-19 (Dimensions) | To determine the width, length, and thickness of the gloves | Width: Small: $80\pm10$ mm, Medium: $95\pm10$ mm, Large: $110\pm10$ mm, X-Large: $120\pm10$ mm Length: Small: 220 mm, Medium: 230mm, Large: 230 mm, X-Large: 230 mm Thickness: Finger: 0.05 mm min for all sizes, Palm: 0.05 mm min for all sizes | Width: Small: 84 mm, Medium: 95 mm, Large: 104 mm, X-Large: 114 mm Length: Small: 247 mm, Medium: 248 mm, Large: 247 mm, X-Large: 248 mm Thickness: Finger: Small: 0.11 mm, Medium: 0.10 mm, Large: 0.10 mm, X-Large: 0.10 mm; Palm: Small: 0.07 mm, Medium: 0.07 mm, Large: 0.07 mm, X-Large: 0.07 mm; Cuff: Small: 0.06 mm, Medium: 0.05 mm, Large: 0.05 mm, X-Large: 0.06 mm |
| ASMT D6319-19 (Physical Properties - Before Aging) | To determine the tensile strength and ultimate elongation | Tensile Strength Min 14 Mpa Ultimate Elongation Min 500% | Tensile Strength (Mpa): Small: 27.2, Medium: 27.6, Large: 26.6, X-Large: 27.8 Ultimate Elongation (%): Small: 540, Medium: 575, Large: 580, X-Large: 561 |
| ASMT D6319-19 (Physical Properties - After Acceleration Aging) | To determine the tensile strength and ultimate elongation | Tensile Strength (MPa): 14 (Min) for all sizes Ultimate Elongation (%): 400 (Min) for all sizes | Tensile Strength: Small: 14.6 Mpa, Medium: 15.5 Mpa, Large: 15.4 Mpa, X-Large: 14.9 Mpa Ultimate Elongation: Small: 413%, Medium: 424%, Large: 446%, X-Large: 442% |
| ASTM D6319-19 (ASTM D5151-11) (Freedom from Holes) | To determine the holes in the gloves | AQL 2.5 | Gloves Passed AQL 1.5 |
| ASMT D6319-19 (ASTM D6124-11) (Residual Powder) | To determine the residual powder in the gloves | ≤2.0 mg/glove | Small: 0.48 mg/glove, Medium: 0.35 mg/glove, Large: 0.38 mg/glove, X-Large: 0.18 mg/glove |
| ISO 10993-10 (Skin Irritation) | To determine the potential for skin irritation | Under the condition of study not an irritant | Under the condition of study not an irritant |
| ISO 10993-10 (Skin Sensitization) | To determine the skin sensitization potential | Under the conditions of the study not a sensitizer. | Under the conditions of the study not a sensitizer. |
| ISO 10993-5 (In Vitro Cytotoxicity) | To evaluate the in vitro cytotoxic potential | Under the conditions of study non cytotoxic | Under the conditions of the study, concentration of extract, 100%, 66%, 44%, 30%, 20% was cytotoxic., 13%, 9%, 6% are not cytotoxic |
| ISO 10993-11:2017 (Acute Systemic Toxicity) | To determine the acute systemic toxicity potential | Under the conditions of the study no systemic toxicity | Under the conditions of the study did not reveal any systemic toxicity. |
2. Sample size used for the test set and the data provenance:
- Sample size: The document does not explicitly state the sample size (number of gloves or individual test items) used for each specific test. It provides results per size (Small, Medium, Large, X-Large) for some tests, but not the 'n' for each.
- Data provenance: The tests were conducted to comply with international standards (ASTM and ISO). The manufacturing company is Siam NTD Corporation Co., Ltd. located in Pathum Thani, Thailand, and the manufacturing entity for the device is TOP GLOVE MEDICAL (THAILAND) CO., LTD. This suggests the tests were likely conducted in Thailand or by a laboratory recognized in Thailand. The data is retrospective, as it's submitted for a 510(k) clearance after the tests have been completed.
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 technical performance test of a physical device (gloves) against established engineering and biocompatibility standards, not a diagnostic or interpretative AI device where expert ground truth is typically required. The "ground truth" here is defined by the technical specifications and methods of the ASTM and ISO standards.
4. Adjudication method for the test set:
- Not applicable. As noted above, this is not an interpretation task requiring adjudication. The results are quantitative measurements or qualitative assessments (e.g., "passed") against objective 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 document pertains to the technical performance validation of a physical medical device (examination gloves), not an AI/ML-powered diagnostic tool. Clinical studies with human readers or AI assistance are not relevant to this type of device submission.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This document is for examination gloves, which do not involve algorithms or human-in-the-loop performance.
7. The type of ground truth used:
- Engineering and Biocompatibility Standards: The "ground truth" for the device's performance is defined by the acceptance criteria set forth in recognized international standards:
- ASTM D6319-19 (Standard Specification for Nitrile Examination Gloves for Medical Application)
- ASTM D5151-11 (Standard Test Method for Detection of Holes in Medical Gloves)
- ASTM D6124-11 (Standard Test Method for Residual Powder on Medical Gloves)
- ISO 10993-10 (Biological evaluation of medical devices - Tests for skin irritation and skin sensitization)
- ISO 10993-5 (Biological evaluation of medical devices - Tests for in vitro cytotoxicity)
- ISO 10993-11:2017 (Biological evaluation of medical devices - Tests for acute systemic toxicity)
8. The sample size for the training set:
- Not applicable. This is not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established:
- Not applicable. There is no training set for this device.
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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 USA seal. To the right of the seal is the FDA logo in blue, with the words "U.S. FOOD & DRUG" stacked on top of the word "ADMINISTRATION".
December 11, 2021
Siam NTD Corporation Co., Ltd. Taweesak Waideemaneetrakoon Manufacturer Manager Third Party Review Group 120/259 Moo1, Bueng Yitho Sub-district, Thanyaburi Pathum Thani. Thailand
Re: K212085
Trade/Device Name: Siam NTD+ Nitrile Powder-Free Examination gloves Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I, reserved Product Code: LZA Dated: November 17, 2021 Received: November 19, 2021
Dear Taweesak Waideemaneetrakoon:
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.
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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 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.
For 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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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)
Device Name
Siam NTD+ NITRILE POWDER-FREE EXAMINATION GLOVES
Indications for Use (Describe)
Siam NTD+ NITRILE POWDER-FREE EXAMINATION GLOVES 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.
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.
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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Image /page/3/Picture/2 description: The image shows a logo for Siam NTD+. The logo features a globe with blue continents and white oceans, held by two blue hands. The text "Siam NTD+" is written in red, with "Siam" above the globe and "NTD+" to the right of the globe. The logo is likely for a company or organization related to Siam NTD+.
Siam NTD Corporation Co., LTD. 120/259 Moo 1, Bueng Yitho Sub-district, Thanyaburi District Pathum Thani Thailand 12130 Telephone: +66909097731, +66863257731
510(k) Summary
The following 510(k) summary has been prepared pursuant to requirements specified in 21 CFR 807.92.
Date Summary Prepared: November 23, 2021
1. Submitter
| Company name : | Siam NTD Corporation Co., Ltd. |
|---|---|
| Company address : | 120/259 Moo1, Bueng Yitho Sub-district, Thanyaburi DistrictPathum Thani Thailand 12130 |
| Telephone: | +66863257731 |
| Contact Person : | Mr. Taweesak Waideemaneetrakoon,Manufacturer Manager |
| Phone number : | +66899268831 |
| E-mil : | taweesak8831@gmail.com |
2. Name of the Device:
| Proprietary Name: | Siam NTD+ NITRILE POWDER-FREE EXAMINATION GLOVES |
|---|---|
| Common Name: | Siam NTD+ NITRILE POWDER-FREE EXAMINATION GLOVES |
| Classification Name: | POLYMER PATIENT EXAMINATION GLOVE |
| Regulatory Class: | I |
| Product Code: | LZA |
| Regulation Number: | 21 CFR 880.6250 |
| Review Panel: | General Hospital |
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Image /page/4/Picture/1 description: The image shows a logo for Siam NTD+. The logo features a globe with blue continents and white landmasses. Two blue hands are cupping the globe from below. The text "Siam NTD+" is written in red and blue above the globe. The plus sign is slightly raised and smaller than the other letters.
D Corporation Co., LTD. 1, Bueng Yitho Sub-district, Thanyaburi District ani Thailand 12130 Telephone: +66909097731, +66863257731
3. IDENTIFICATION OF THE LEGALLY MARKETED DEVICE
K192333, JR MEDIC, JR Engineering & Medical Technologies (M) SDN.BHD. Predicate: Device Name: Blue Nitrile Examination Gloves Powder Free Device Classification Name: Polymer Patient Examination Glove Device Classification Number: 21 CFR 880.6250 Device Class: Class I Product Code: LZA Review Panel: General Hospital
4. DEVICE DESCRIPTION
Siam NTD* NITRILE POWDER-FREE EXAMINATION GLOVES is a glove made from nitrile butadiene rubber Latex that covers the hand up to the wrist. It is cuffed and equally wearable on either hand, free from differentiation between the left hand and the right. It has 4 sizes, i.e. small, medium, large and extra large. All variations share the same blue color. The glove is non-sterile and is for single use only, to be discarded after each examination is performed. It acts as a barrier between the examiner and the subject being examined in order to prevent contamination between them.
5. INDICATIONS FOR USE.
Siam NTD* NITRILE POWDER-FREE EXAMINATION GLOVES is a disposable device intended for medical purposes that is worn on the examiner's hand or fingers to prevent contamination between patient and examiner.
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Image /page/5/Picture/1 description: The image shows a logo with the text "Siam NTD+" in red and blue, superimposed on a globe. The globe is blue and white, with the continents outlined in white. Two blue hands are cupping the globe from below. The logo appears to represent a global organization or company named Siam NTD+.
Siam NTD Corporation Co., LTD. 120/259 Moo 1, Bueng Yitho Sub-district, Thanyaburi District Pathum Thani Thailand 12130 Telephone: +66909097731, +66863257731
6. TECHNOLOGICAL CHARACTERISTIC COMPARISON FOR THE PROPOSED AND PREDICATE
DEVICES
| DEVICE PERFORMANCE | |||
|---|---|---|---|
| CHARACTERISTICS | PREDICATE | SUBJECT | REMARKS |
| 510(K) Numbers | K192333 | K212085 | |
| Device Name | JR MEDIC BlueNitrile Examination GlovesPowder Free | Siam NTD+ NITRILEPOWDER-FREEEXAMINATION GLOVES | |
| Product Code | LZA | LZA | Same |
| Intended Use | JR MEDIC Blue NitrileExamination Gloves PowderFree is a disposable deviceintended for medicalpurposes that is worn on theexaminer's hand or fingers toprevent contaminationbetween patient andexaminer. | Siam NTD+ NITRILEPOWDER-FREEEXAMINATION GLOVES isa disposable device intendedfor medical purposes that isworn on the examiner's handor fingers to preventcontamination between patientand examiner. | Same |
| Material of Use(ASTM D6910/D6910M-19) | Nitrile Compound | Nitrile Compound | Same |
| Color | Blue | Blue | Same |
| Texture | Finger Textured | Finger Textured | Same |
| Size (ASTM D6319-19) | Small, Medium, Large, ExtraLarge | Small, Medium, Large, ExtraLarge | Same |
| Sterilization | Non-Sterile | Non-Sterile | Same |
| Usage | Single Usage | Single Usage | Same |
| Dimensions(ASTMD6319-19) | Length Min. 230 min, WidthMin 95+/-10 mm (formedium size) | Length Min. 230 min,Width Min 95+/-10 mm(for medium size) | Same |
| Physical Properties(ASTM D6319-19) | Before AgingTensile Strength Min 14 MpaUltimate Elongation Min500%After AgingTensile Strength Min 14 MpaUltimate Elongation Min400% | Before AgingTensile Strength Min 14 MpaUltimate Elongation Min500%After AgingTensile Strength Min 14 MpaUltimate Elongation Min400% | Same |
| Thickness(ASTM D6319-19) | Palm Min 0.05 mmFinger Min 0.05 mm | Palm Min 0.05 mmFinger Min 0.05 mm | Same |
| Powder-Free(ASTM D6319-19) | ≤2 mg/glove | ≤2 mg/glove | Same |
| Freedom from Holes(Water Tight-1000 ml) -ASTM D6319-19 (CrossReference D5151) | Passed | Passed | Same |
| Biocompatibility-SKINSENSITIZATION - ISO10993-10:2010 (E) | Under the conditions ofstudy not a sensitizer | Under the conditions of studynot a sensitizer | Same |
| Biocompatibility-SKINIRRITATION – ISO10993-10:2010 (E) | Under the conditions ofstudy not an irritant | Under the conditions of studynot an irritant | Same |
| Biocompatibility – INVITROCYTOTOXICITY – ISO10993-5:2009(E) | Under the conditions of thestudy, cytotoxic. Additionaltesting was performed todetermine if this was asystemic toxicity concern. | Under the conditions of thestudy, concentration ofextract, 100%, 66%, 44%,30%, 20% was cytotoxic.,13%, 9%, 6% are notcytotoxic and therefore thedevice extracts were evaluatedby ISO 10993-11 - Test forAcute Systemic Toxicity. | Same |
| Biocompatibility -ACUTE SYSTEMICTOXICITY – ISO10993-11:2017(E) | Under the conditions of thestudy the device extracts donot pose a systemic toxicityconcern | Under the conditions of thestudy did not reveal anysystemic toxicity. | Same |
| Manufacturer(s) | JR Engineering & MedicalTechnologies (M)SDN.BHD | TOP GLOVE MEDICAL(THAILAND) CO., LTD |
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Image /page/6/Picture/1 description: The image shows a logo with the words "Siam NTD+" in red letters. The letters are positioned in front of a globe with blue hands underneath it. The globe is showing the continents of North and South America. The logo appears to be for a company or organization called Siam NTD+.
120/259 Moo 1, Bueng Yitho Sub-district, Thanyaburi District Pathum Thani Thailand 12130 Telephone: +66909097731, +66863257731
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Image /page/7/Picture/1 description: The image shows a logo with the text "Siam NTD+" in red and blue letters. The text is positioned above a blue globe with white continents. Two blue hands are cupping the globe from below. The logo appears to represent a global organization or initiative, possibly related to technology or development, given the "NTD" abbreviation.
120/259 Moo 1, Bueng Yitho Sub-district, Thanyaburi District Pathum Thani Thailand 12130 Telephone: +66909097731, +66863257731
There are no significant differences between the three products and are identical in terms of intended use, materials, design, manufacturing methods. Both devices meet the ASTM standard D6319-19.
7. NON-CLINICAL TESTING SUMMARY
PERFORMANCE DATA
| Test Method | Purpose | Acceptance Criteria | Result |
|---|---|---|---|
| ASMT D6319-19 | To determine thewidth, length, andthickness of thegloves | Width:Small: $80\pm10$ mmMedium: $95\pm10$ mmLarge: $110\pm10$ mm | Width:Small: 84 mmMedium: 95 mmLarge: 104 mm |
| Standard Specificationfor Nitrile ExaminationGloves for Medical | |||
| Application - PhysicalDimensions Test | To determine thetensile strengthand ultimateelongation beforeand after | X-Large: 120±10 mmLength:Small: 220 mmMedium: 230mmLarge: 230 mmX-Large: 230 mmThickness:Finger: 0.05 mm minfor all sizesPalm: 0.05 mm minfor all sizes | X-Large: 114 mmLength:Small: 247 mmMedium: 248 mmLarge: 247 mmX-Large: 248 mmThickness:Finger:Small: 0.11 mmMedium: 0.10 mmLarge: 0.10 mmX-Large: 0.10 mmPalm:Small: 0.07 mmMedium: 0.07 mmLarge: 0.07 mmX-Large: 0.07 mmCuff:Small: 0.06 mmMedium: 0.05 mmLarge: 0.05 mmX-Large: 0.06 mm |
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Image /page/8/Picture/1 description: The image shows a logo for Siam NTD+. The logo features a globe with blue hands holding it up. The text "Siam" is in red, and "NTD+" is in blue. The globe shows the continents of the world.
120/259 Moo 1, Bueng Yitho Sub-district, Thanyaburi District Pathum Thani Thailand 12130 Telephone: +66909097731, +66863257731
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r
Image /page/9/Picture/1 description: The image shows a logo for Siam NTD+. The logo features a globe with the Americas prominently displayed, cradled by two blue hands. Above the globe, the words "Siam NTD+" are written, with "Siam" in red and "NTD+" in blue. The overall design suggests a global reach or international focus for the organization.
Siam NTD Corporation Co., LTD.
120/259 Moo 1, Bueng Yitho Sub-district, Thanyaburi District Pathum Thani Thailand 12130 Telephone: +66909097731, +66863257731
| Requirements Test | acceleration aging | After Acceleration | |
|---|---|---|---|
| Aging: TensileStrength (MPa): | X-Large: 27.8 Mpa | ||
| 14 (Min) for all sizes | Ultimate Elongation: | ||
| Ultimate Elongation (%): | Small: 540% | ||
| 400 (Min) for all sizes | Medium: 575% | ||
| Large: 580% | |||
| X-Large: 561% | |||
| After AccelerationAging: | |||
| Tensile Strength: | |||
| Small: 14.6 Mpa | |||
| Medium: 15.5 Mpa | |||
| Large: 15.4 Mpa | |||
| X-Large: 14.9 Mpa | |||
| Ultimate Elongation: | |||
| Small: 413% | |||
| Medium: 424% | |||
| Large: 446% | |||
| X-Large: 442% | |||
| ASTM D6319-19(ASTM D5151-11)Standard Test Methodfor Detection of Holes inMedical Gloves | To determine theholes in thegloves | AQL 2.5 | Gloves Passed AQL 1.5 |
| ASMT D6319-19(ASTM D6124-11)Standard Test Methodfor Residual Powder on | To determine theresidual powderin the gloves | ≤2.0 mg/glove | Small: 0.48 mg/glove |
| Medium: 0.35 mg/glove | |||
| Large: 0.38 mg/glove | |||
| X-Large: 0.18 mg/glove |
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Image /page/10/Picture/1 description: The image shows a logo for Siam NTD+. The logo features the words "Siam NTD+" in red letters above a globe. The globe is blue and white, and it is being held by two blue hands. The logo is likely for a company or organization that is involved in international trade or development.
120/259 Moo 1, Bueng Yitho Sub-district, Thanyaburi District Pathum Thani Thailand 12130 Telephone: +66909097731, +66863257731
BIO-COMPATIBILITY DATA
| Test Method | Purpose | AcceptanceCriteria | Result |
|---|---|---|---|
| ISO 10993-10 Biologicalevaluationof medical devices - Part10: Testsfor skin irritation and skinsensitization | To determine the potentialof thematerial under test toproduceskin irritation in rabbits | Under thecondition ofstudy not anirritant | Under the condition ofstudy not an irritant |
| ISO 10993-10 Biologicalevaluationof medical devices - Part10: Testsfor skin irritation and skinsensitization | To determine the skinsensitization potential ofthematerial both in terms ofinduction and elicitationinguinea pigs. | Under theconditions of thestudy not asensitizer. | Under the conditions ofthe study not asensitizer. |
| ISO 10993-5 Biologicalevaluationof medical devices — Part5: Testsfor in vitro cytotoxicity | To evaluate the in vitrocytotoxic potential of thetest item (both inner andouter surface) Extractsin L-929 mousefibroblasts cells usingelution method | Under the conditions ofstudy non cytotoxic | Under the conditions ofthe study, concentrationof extract,100%, 66%, 44%, 30%,20% was cytotoxic.,13%, 9%, 6% are notcytotoxic |
| ISO 10993-11:2017 | To determine the acute | Under the | Under the conditions of |
| Biological evaluation ofmedical devices - Part 11:Tests for acute systemictoxicity | systemic toxicitypotential of the test itemextracts (both inside andouter surface) in SwissAlbino Mice | conditions of thestudy no systemictoxicity | the study did not revealany systemic toxicity. |
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Image /page/11/Picture/1 description: The image shows a logo with the words "Siam NTD+" in red and blue letters. The letters are placed above a blue globe with white continents. Two blue hands are cupping the globe from below. The logo appears to represent a global organization or initiative, possibly related to health or development, given the imagery of care and the world.
120/259 Moo 1, Bueng Yitho Sub-district, Thanyaburi District Pathum Thani Thailand 12130 Telephone: +66909097731, +66863257731
8. CLINICAL TESTING SUMMARY
Not applicable - Clinical data is not needed for gloves or for most devices cleared by the 510(k) process.
9. CONCLUSION
The conclusions drawn from the non-clinical test demonstrate that the subject device in 510(k) submission, the Siam NTD+ NITRILE POWDER-FREE EXAMINATION GLOVES is as safe, as effective, and performs as well as the legally marketed predicate device K192333
§ 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.