(112 days)
TMG nitrile powder free examination glove is a disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.
TMG Nitrile Examination Gloves Powder Free are Class I patient examination gloves bearing the product code Nitrile - LZA (21CFR880.6250). The gloves are made from acrylonitrile-butadiene copolymer dispersion. These gloves are blue in color and are powder free.
Here's a summary of the acceptance criteria and the study that proves the device meets them, based on the provided text:
This document describes the premarket notification (510(k)) for the TMG Nitrile Powder Free Examination Glove, a Class I medical device. The submission aims to demonstrate substantial equivalence to a predicate device, K202384.
The "study" refers to non-clinical performance data testing, as clinical data was deemed not needed for this type of device.
1. Table of Acceptance Criteria and Reported Device Performance
| Characteristic | Standard / Test Method | Acceptance Criteria | Device Performance (Reported Result) | Status |
|---|---|---|---|---|
| Dimension | ASTM D6319-19 | |||
| - Length | ASTM D6319-19 | Min 230 mm for all sizes | Small: 243 mm, Medium: 240 mm, Large: 240 mm, Extra Large: 240 mm | Pass |
| - Width | ASTM D6319-19 | Small: 80 ± 10 mm, Medium: 95 ± 10 mm, Large: 110 ± 10 mm, Extra Large: 120 ± 10 mm | Small: 85 mm, Medium: 93 mm, Large: 105 mm, Extra Large: 115 mm | Pass |
| - Thickness | ASTM D6319-19 | Palm 0.05 mm min, Finger 0.05 mm min for all sizes | Small: Palm 0.09 mm, Finger: 0.13 mmMedium: Palm: 0.06 mm, Finger: 0.08 mmLarge: Palm 0.09 mm, Finger: 0.12 mmExtra Large: Palm 0.09 mm, Finger: 0.12 mm | Pass |
| Watertight test | ASTM D5151-19 | Sample size: 200 pcs, Inspection level: GI, AQL 1.5, Acceptance Number 7, Rejection Number 8 | Small: 0 (Zero), Medium: 0 (Zero), Large: 0 (Zero), Extra Large: 0 (Zero) | Pass |
| Residual Powder | ASTM D6124-06 (Reapproved 2017) | 2 mg per glove or less | Small: 1.42 mg/glove, Medium: 0.50 mg/glove, Large: 1.34 mg/glove, Extra Large: 1.36 mg/glove | Pass |
| Physical Properties | ASTM D6319-19 | |||
| - Tensile Strength | Before Ageing: 14 MPa min for all sizes | Before Ageing: Small: 18.37 MPa, Medium: 30.62 MPa, Large: 18.30 MPa, Extra Large: 18.20 MPa | Pass | |
| After Ageing: 14 MPa min for all sizes | After ageing: Small: 14.08 MPa, Medium: 31.89 MPa, Large: 14.00 MPa, Extra Large: 14.00 MPa | Pass | ||
| - Ultimate Elongation | Before Ageing: 500% Min for all sizes | Before Ageing: Small: 612%, Medium: 500 %, Large: 620%, Extra Large: 587% | Pass | |
| After Ageing: 400% Min for all sizes | After ageing: Small: 408%, Medium: 499%, Large: 403%, Extra Large: 416% | Pass | ||
| Biocompatibility | ISO 10993-10 (Primary Skin Irritation) | Not an irritant | Under the conditions of the study, not an irritant | Same (as predicate) |
| ISO 10993-10 (Dermal Sensitization) | Not a sensitizer | Under the conditions of the study, not a sensitizer | Same (as predicate) | |
| ISO10993-5:2009(E) (In vitro cytotoxicity) | Not cytotoxic | Cytotoxic for undiluted, 1:2 and 1:4 dilutions but noncytotoxic for 1:8, 1:16 and 1:32 dilutions. | Different (from predicate, further qualified as "non acute systemic toxic") | |
| ISO10993-11:2017(E) (Acute Systemic Toxicity) | No systemic toxicity concern | Under the conditions of the study, did not induce any systemic toxicity. | Same (as predicate) |
2. Sample Size Used for the Test Set and Data Provenance
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Dimension: Not explicitly stated for each dimension test, but implied to be sufficient for ASTM D6319-19 compliance. Each result listed (Small, Medium, Large, Extra Large) likely represents an average or single measurement for that size.
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Watertight Test: Sample size of 200 pieces per batch from a batch size of 35,001-150,000 gloves.
-
Residual Powder: Sample size of 5 pieces (per size, assumed).
-
Physical Properties (Tensile Strength, Ultimate Elongation): Not explicitly stated, but implied to be sufficient for ASTM D6319-19 compliance. Each result listed likely represents an average of multiple samples.
-
Biocompatibility: Sample sizes for ISO 10993 tests are not specified for this report, but would be standard for such tests.
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Data Provenance: The data is from the manufacturer's testing (THAI MEDICAL GLOVE CO., LTD.) of their current device (TMG Nitrile Powder Free Examination Glove). This is prospective testing conducted to demonstrate equivalence for their new device. The country of origin is Thailand.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. This device is a physical product (gloves) and the "ground truth" is established by adhering to recognized international and national consensus standards (e.g., ASTM, ISO) for physical and chemical properties, rather than expert interpretation of medical images or clinical outcomes. The tests are objective measurements.
4. Adjudication Method for the Test Set
Not applicable. The tests are objective measurements against predefined criteria in standards. There is no subjective assessment requiring adjudication.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices where human readers interpret results (e.g., radiologists reviewing images with or without AI assistance). This is a physical product where performance is measured objectively.
6. If a Standalone Study (i.e., algorithm only without human-in-the-loop performance) was done
Yes, in a sense, a "standalone" performance evaluation was done. The performance of the glove itself was tested against the acceptance criteria, without human interaction influencing the fundamental measurement of its physical and chemical properties. This is an "algorithm only" equivalent in that the device's intrinsic properties are being evaluated.
7. The Type of Ground Truth Used
The ground truth used for performance evaluation is based on established industry and regulatory standards:
- ASTM D6319-19 (Standard Specification for Nitrile Examination Gloves for Medical Application)
- ASTM D5151-19 (Standard Test Method for Detection of Holes in Medical Gloves)
- ASTM D6124-06 (Reapproved 2017) (Standard Test Method for Residual Powder on Medical Gloves)
- ISO 10993-10 (Biological evaluation of medical devices – Part 10: Tests for irritation and skin sensitization)
- ISO10993-5:2009(E) (Biological evaluation of medical devices – Part 5: Tests for in vitro cytotoxicity)
- ISO10993-11:2017(E) (Biological evaluation of medical devices – Part 11: Tests for systemic toxicity)
These standards define the methodologies and acceptable ranges for the glove's characteristics.
8. The Sample Size for the Training Set
Not applicable. This device does not use machine learning or AI, and therefore does not have a "training set" in the context of AI model development.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set.
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Image /page/0/Picture/0 description: The image contains two logos. On the left is the Department of Health & Human Services logo. On the right is the FDA logo, which includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
February 21, 2022
Thai Medical Glove Co., Ltd. Noppadol Polbundit Operation Director 363/2 Moo 8, Tambol Bangphra Sriracha. Chonburi 20110 Thailand
Re: K213500
Trade/Device Name: TMG Nitrile Powder Free Examination Glove Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I, reserved Product Code: LZA Dated: October 14, 2021 Received: November 1, 2021
Dear Noppadol Polbundit:
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 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
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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Clarence W. Murray, III, PhD Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
K213500
Device Name
TMG NITRILE POWDER FREE EXAMINATION GLOVE
Indications for Use (Describe)
TMG nitrile powder free examination glove is a disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpant D)
Over-The-Counter Use (21 CFR 801 Subpart C) -
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Image /page/3/Picture/1 description: The image is a logo for Thai Medical Glove. The logo is a circle with the words "THAI MEDICAL GLOVE" in the center. The word "THAI" is in blue, and the words "MEDICAL GLOVE" are in gray. The circle is blue and yellow, with the blue on the left and the yellow on the right. There are also blue lines at the bottom of the circle.
K213500 510(k) SUMMARY Nitrile Powder Free Examination Gloves
1.0 Appliance Information
| Applicant: | THAI MEDICAL GLOVE CO., LTD |
|---|---|
| Address: | 363/2 Moo 8, Tambol Bangphra, Sriracha, ChonburiTHAILAND 20110 |
| Phone Number: | +6638-198-102 |
| Fax Number: | N/A |
| Email: | info@thaimedicalglove.co.th |
| Name of Contact Person: | Noppadol Polbundit (Mr) |
| Designation: | Operation Director |
| Contact Number: | 66 96 445 3256 |
| Contact Email: | Noppadol.p@thaimedicalglove.co.th |
| Date 510(k) summary prepared: | February 07, 2022 |
2.0 Identification of the subject device
| Trade/Proprietary Name(s): | TMG NITRILE POWDER FREE EXAMINATION GLOVE |
|---|---|
| Common Name: | Nitrile Powder Free Examination Gloves |
| Classification Name: | Patient Examination Gloves |
| Device Class: | I |
| product code | LZA |
| Regulation Number: | 21 CFR 880.6250 |
| Review Panel: | General Hospital |
3.0 Predicate Device
| Device Name: | Palm Care Blue Nitrile Examination Gloves Powder Free |
|---|---|
| 510(k): | K202384 |
| Common Name: | Patient Examination Gloves |
| Classification Name: | Patient Examination Gloves |
| Device Classification | I |
| Product Code: | LZA |
| Regulation Number: | 21 CFR 880.6250 |
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Image /page/4/Picture/1 description: The image is a logo for Thai Medical Glove. The logo is a circle with the words "THAI MEDICAL GLOVE" in the upper half of the circle. The word "THAI" is in blue, and the words "MEDICAL GLOVE" are in gray. The lower half of the circle contains a blue hand with four fingers. The top right of the circle is yellow, and the rest of the circle is blue.
4.0 Description of the Device
TMG Nitrile Examination Gloves Powder Free are Class I patient examination gloves bearing the product code Nitrile - LZA (21CFR880.6250). The gloves are made from acrylonitrile-butadiene copolymer dispersion. These gloves are blue in color and are powder free.
5.0 Indication for Use of the Device
TMG nitrile powder free examination glove is a disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.
| Characteristics | Standards | Device performance | Comparison | ||
|---|---|---|---|---|---|
| Predicate | Current | ||||
| 510(k) Number | - | K202384 | K213500 | --- | |
| Manufacturer(s) | - | Hi-Care Thai Gloves Co. Ltd | THAI MEDICAL GLOVE CO., LTD. | --- | |
| Name of device | - | Blue Nitrile Examination Gloves Powder free | Blue Nitrile Examination Gloves Powder free | --- | |
| Indication for Use | Medical Gloves Guidance Manual - Issued on January 22, 2008 | Blue Nitrile Examination Gloves Powder-free is disposable devices intended for medical purpose that are won on the examiner's hand to prevent contamination between patient and examiner | TMG nitrile powder free examination glove is a disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner. | Similar | |
| Material | ASTM D6319-19 | Nitrile (NBR) | Nitrile (NBR) | Same | |
| Color | - | Blue | Blue | Same | |
| Texture | - | Textured Fingers | Textured Fingers | Same | |
| Size | ASTM D6319-19 | Extra SmallSmallMediumLargeExtra Large | SmallMediumLargeExtra Large | Different |
6.0 Summary of Technological Characteristics of the Device Compared to the Predicate Device
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Image /page/5/Picture/1 description: The image is a logo for Thai Medical Glove. The logo is a circle with a blue and yellow border. The words "THAI MEDICAL GLOVE" are in the center of the circle, with "THAI" in blue and "MEDICAL GLOVE" in gray. Below the text are five blue lines that are angled.
| Characteristics | Standards | Device performance | Comparison | |
|---|---|---|---|---|
| Predicate | Current | |||
| Single Use | Medical GlovesGuidance Manual -Issued on January22, 2008-Labeling | Single use | Single use | Same |
| Dimension | ASTM D6319-19 | Meet ASTM D6319-19Length 230 mm min.Width 95 ± 10 mm min(for Medium size) | Meet ASTM D6319-19Length 230 mm min.Width 95 ± 10 mm min(for Medium size) | Same |
| Thickness | ASTM D6319-19 | Meet ASTM D6319-19Finger: 0.05 mm minPalm: 0.05 mm min | Meet ASTM D6319-19Finger: 0.05 mm minPalm: 0.05 mm min | Same |
| PhysicalProperties | ASTM D6319-19 | Meet ASTM D6319-19Before agingTensile Strength:14 MPa minUltimate Elongation:500% minAfter agingTensile Strength14 MPa minUltimate Elongation:400% min | Meet ASTM D6319-19Before agingTensile Strength:14 MPa minUltimate Elongation:500% minAfter agingTensile Strength14 MPa minUltimate Elongation:400% min | Same |
| Watertight test(1000 ml) | ASTM D5151-19 | Pass AQL 1.5 | Pass AQL 1.5 | Similar |
| Powder Residue | ASTM D6124-06(Reapproved 2017) | Meet≤ 2.0 mg/glove | Meet≤ 2.0 mg/glove | Similar |
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Image /page/6/Picture/1 description: The image is a logo for Thai Medical Glove. The logo is a circle with the top half of the circle being yellow and the bottom half being blue. Inside the circle, the word "THAI" is in blue, the word "MEDICAL" is in gray, and the word "GLOVE" is in gray. Below the words are five blue lines that are meant to represent fingers.
| Characteristics | Standards | Device performance | Comparison | |
|---|---|---|---|---|
| Predicate | Current | |||
| Biocompatibility | Primary SkinIrritation –ISO 10993-10 ThirdEdition 2010-08-01 | Under the conditionsof the study, not anirritant | Under the conditionsof the study, not anirritant | Same |
| DermalSensitization –ISO 10993-10 ThirdEdition 2010-08-01 | Under the conditionsof the study, not asensitizer | Under the conditionsof the study, not asensitizer | Same | |
| In vitro cytotoxicityISO10993-5:2009(E) | Under the conditionsof the study, noncytotoxic | Under the conditions of thestudy cytotoxic for undiluted,1:2 and 1:4 dilutions butnoncytotoxic for 1:8, 1:16and 1:32 dilutions. Moreover,under the conditions of thestudy, non acute systemictoxic. | Different | |
| Acute SystemicToxicity ISO10993-11:2017(E) | Under the conditions ofstudy, the device extracts donot pose a systemic toxicityconcern | Under the conditions of thestudy, did not induce anysystemic toxicity. | Same |
There are no significant differences between the two products and are identical in terms of intended use, materials, design, manufacturing methods. Both devices meet the ASTM standards.
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Attachment 17
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Image /page/7/Picture/2 description: The image is a logo for Thai Medical Glove. The logo is a circle with the words "THAI MEDICAL GLOVE" stacked on top of each other in the center. The word "THAI" is in blue, and the words "MEDICAL GLOVE" are in gray. The circle is blue on the left side and yellow on the right side. There are three blue lines in the bottom right corner of the circle.
7.0 Non-clinical testing summary
Performance Data
| Test Method | Standard | Purpose of testing | Acceptance Criteria | Result | Status |
|---|---|---|---|---|---|
| Dimension | ASTM D6319-19Standard Specification for NitrileExamination Gloves for MedicalApplication | To determine the lengthof the gloves | Min 230 mm for all sizes | Small: 243 mmMedium: 240 mmLarge: 240 mmExtra Large: 240 mm | Pass |
| ASTM D6319-19Standard Specification for NitrileExamination Gloves for MedicalApplication | To determine the widthof the gloves | Small: 80 ± 10 mmMedium: 95 ± 10 mmLarge: 110 ± 10 mmExtra Large: 120 ± 10 mm | Small: 85 mmMedium: 93 mmLarge: 105 mmExtra Large: 115 mm | Pass | |
| ASTM D6319-19Standard Specification for NitrileExamination Gloves for MedicalApplication | To determine thethickness of the gloves | Palm 0.05 mm minFinger 0.05 mm min for all sizes | Small: Palm 0.09 mm, Finger: 0.13 mmMedium: Palm: 0.06 mm, Finger: 0.08 mmLarge: Palm 0.09 mm, Finger: 0.12 mmExtra Large: Palm 0.09 mm, Finger: 0.12mm | Pass | |
| Watertight test | ASTM D5151-19Standard Test Method for Detectionof Holes in MedicalGloves | To determine the holes inthe gloves | Sample size: 200 pcsInspection level : GIAQL 1.5Acceptance Number 7Rejection Number 8 | The batch size for this sampling is 35,001-150,000. Hence, according to the singlesampling plan GI, the sample to be drawnis under code L equivalent to 200 pcs withaccept 7 and reject 8 to be accept underAQL 1.5...Small: 0 (Zero)Medium: 0 (Zero)Large:0 (Zero)Extra Large:0 (Zero). | Pass |
| Test Method | Standard | Purpose of testing | Acceptance Criteria | Result | Status |
| Residualpowder | ASTM D6124-06 (Reapproved 2017)Standard Test Method for ResidualPowder on Medical Gloves | To determine the residualpowder in the gloves | 2 mg per glove or less | Sample size : 5 pcsRequirement: 2 mg per glove or lessResult:Small:1.42 mg/gloveMedium: 0.50 mg/gloveLarge: 1.34 mg/gloveExtra Large:1.36 mg/glove | Pass |
| PhysicalProperties | ASTM D6319-19Standard Specification for NitrileExamination Gloves for MedicalApplication | To Determine thephysical properties-Tensile strength | Before AgeingTensile Strength 14MpaMinimal for all sizesAfter Ageing TensileStrength 14MpaMinimal for all sizes | Before AgeingSmall: 18.37 MPaMedium: 30.62 MPaLarge: 18.30 MPaExtra Large: 18.20 MPaAfter ageing:Small: 14.08 MPaMedium: 31.89 MPaLarge: 14.00 MPaExtra Large: 14.00 MPa | Pass |
| To Determine thephysical properties-Ultimate Elongation | Before AgeingUltimate Elongation500% Min for all sizesAfter Ageing UltimateElongation 400% Minfor all sizes | Before Ageing:Small: 612%Medium: 500 %Large:620%Extra Large:587%After ageing:Small:408%Medium: 499%Large:403%Extra Large:416% | Pass |
THAI MEDICAL GLOVE CO., LTD. (BANG PHRA FACTORY)
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Attachment 17
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Image /page/8/Picture/2 description: The image is a logo for Thai Medical Glove. The logo is a circle with the words "THAI MEDICAL GLOVE" in the center. The word "THAI" is in blue, and the words "MEDICAL GLOVE" are in gray. The circle is blue on the left side and yellow on the right side. There are four blue lines at the bottom of the circle.
THAI MEDICAL GLOVE CO., LTD. (BANG PHRA FACTORY)
363/2 Moo 8, Tambol Bangphra, Sriracha, Chonburi, THAILAND 20110
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Image /page/9/Picture/1 description: The image is a logo for Thai Medical Glove. The logo is a circle with the top half being blue and the bottom half being yellow. Inside the circle, the words "THAI MEDICAL GLOVE" are stacked on top of each other, with "THAI" being in blue and "MEDICAL GLOVE" being in gray. Below the words, there are five blue lines that are slanted to the right.
8.0 Clinical Testing Summary
Not applicable - Clinical data is not needed for gloves or for most devices cleared by the 510(k) process.
9.0 Conclusion
The conclusions drawn from the non-clinical test demonstrate that the subject device TMG Nitrile Powder Free Examination Glove is as safe, as effective, and performs as well as or better than the legally marketed predicate device K202384.
§ 880.6250 Non-powdered patient examination glove.
(a)
Identification. A non-powdered patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. A non-powdered patient examination glove does not incorporate powder for purposes other than manufacturing. The final finished glove includes only residual powder from manufacturing.(b)
Classification. Class I (general controls). The device, when it is a finger cot, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 880.9.