(112 days)
Not Found
No
The 510(k) summary describes a standard examination glove and makes no mention of AI or ML technology.
No
The device, an examination glove, is intended to prevent contamination and is not designed to treat or alleviate a medical condition.
No
The device is described as an "examination glove" intended to "prevent contamination between patient and examiner," which is a protective barrier function, not a diagnostic one. There is no mention of it being used to identify or analyze diseases or conditions.
No
The device is a physical examination glove, not a software application. The description clearly outlines a hardware product made of acrylonitrile-butadiene copolymer dispersion.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's a glove worn on the examiner's hand to prevent contamination. This is a barrier device for physical protection, not a device used to examine specimens derived from the human body for the purpose of providing information for diagnosis, monitoring, or treatment.
- Device Description: The description confirms it's a Class I patient examination glove, which falls under a different regulatory category than IVDs.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in those samples
- Providing diagnostic information
Therefore, this device is a medical device, specifically a Class I examination glove, but it does not meet the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
LZA
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
examiner's hand
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical testing was performed for the following:
- Dimension (length, width, thickness) according to ASTM D6319-19.
- Watertight test according to ASTM D5151-19. Sample size: 200 pcs. Acceptance criteria: AQL 1.5, Acceptance Number 7, Rejection Number 8. Results for Small, Medium, Large, Extra Large sizes were 0 (Zero) failures.
- Residual powder according to ASTM D6124-06 (Reapproved 2017). Sample size: 5 pcs. Acceptance criteria: 2 mg per glove or less. Results for Small, Medium, Large, Extra Large sizes ranged from 0.50 mg/glove to 1.42 mg/glove.
- Physical Properties (Tensile strength and Ultimate Elongation) according to ASTM D6319-19.
- Biocompatibility (Primary Skin Irritation, Dermal Sensitization, In vitro cytotoxicity, Acute Systemic Toxicity) according to ISO 10993-10, ISO 10993-5, and ISO 10993-11.
Clinical data is not needed for gloves or for most devices cleared by the 510(k) process.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
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
1
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
2
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, Chonburi |
| THAILAND 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 |
4
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 Small | |||
| Small | |||||
| Medium | |||||
| Large | |||||
| Extra Large | Small | ||||
| Medium | |||||
| Large | |||||
| Extra Large | Different |
6.0 Summary of Technological Characteristics of the Device Compared to the Predicate Device
5
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 Gloves | |||
| Guidance Manual - | ||||
| Issued on January | ||||
| 22, 2008 | ||||
| -Labeling | Single use | Single use | Same | |
| Dimension | ASTM D6319-19 | Meet ASTM D6319-19 | ||
| Length 230 mm min. | ||||
| Width 95 ± 10 mm min | ||||
| (for Medium size) | Meet ASTM D6319-19 | |||
| Length 230 mm min. | ||||
| Width 95 ± 10 mm min | ||||
| (for Medium size) | Same | |||
| Thickness | ASTM D6319-19 | Meet ASTM D6319-19 | ||
| Finger: 0.05 mm min | ||||
| Palm: 0.05 mm min | Meet ASTM D6319-19 | |||
| Finger: 0.05 mm min | ||||
| Palm: 0.05 mm min | Same | |||
| Physical | ||||
| Properties | ASTM D6319-19 | Meet ASTM D6319-19 | ||
| Before aging | ||||
| Tensile Strength: | ||||
| 14 MPa min | ||||
| Ultimate Elongation: | ||||
| 500% min | ||||
| After aging | ||||
| Tensile Strength | ||||
| 14 MPa min | ||||
| Ultimate Elongation: | ||||
| 400% min | Meet ASTM D6319-19 | |||
| Before aging | ||||
| Tensile Strength: | ||||
| 14 MPa min | ||||
| Ultimate Elongation: | ||||
| 500% min | ||||
| After aging | ||||
| Tensile Strength | ||||
| 14 MPa min | ||||
| Ultimate 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 Skin | |||
| Irritation – | ||||
| ISO 10993-10 Third | ||||
| Edition 2010-08-01 | Under the conditions | |||
| of the study, not an | ||||
| irritant | Under the conditions | |||
| of the study, not an | ||||
| irritant | Same | |||
| Dermal | ||||
| Sensitization – | ||||
| ISO 10993-10 Third | ||||
| Edition 2010-08-01 | Under the conditions | |||
| of the study, not a | ||||
| sensitizer | Under the conditions | |||
| of the study, not a | ||||
| sensitizer | Same | |||
| In vitro cytotoxicity | ||||
| ISO10993-5 | ||||
| :2009(E) | Under the conditions | |||
| of the study, noncytotoxic | Under the conditions of the | |||
| study cytotoxic for undiluted, | ||||
| 1:2 and 1:4 dilutions but | ||||
| noncytotoxic for 1:8, 1:16 | ||||
| and 1:32 dilutions. Moreover, | ||||
| under the conditions of the | ||||
| study, non acute systemic | ||||
| toxic. | Different | |||
| Acute Systemic | ||||
| Toxicity ISO10993- | ||||
| 11:2017(E) | Under the conditions of | |||
| study, the device extracts do | ||||
| not pose a systemic toxicity | ||||
| concern | Under the conditions of the | |||
| study, did not induce any | ||||
| systemic 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.
7
Attachment 17
Page 5 of 7
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 D6319-19 | ||||
| Standard Specification for Nitrile | |||||
| Examination Gloves for Medical | |||||
| Application | To determine the length | ||||
| of the gloves | Min 230 mm for all sizes | Small: 243 mm | |||
| Medium: 240 mm | |||||
| Large: 240 mm | |||||
| Extra Large: 240 mm | Pass | ||||
| ASTM D6319-19 | |||||
| Standard Specification for Nitrile | |||||
| Examination Gloves for Medical | |||||
| Application | To determine the width | ||||
| of the gloves | 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 | ||||
| ASTM D6319-19 | |||||
| Standard Specification for Nitrile | |||||
| Examination Gloves for Medical | |||||
| Application | To determine the | ||||
| thickness of the gloves | Palm 0.05 mm min | ||||
| Finger 0.05 mm min for all sizes | Small: Palm 0.09 mm, Finger: 0.13 mm | ||||
| Medium: Palm: 0.06 mm, Finger: 0.08 mm | |||||
| Large: Palm 0.09 mm, Finger: 0.12 mm | |||||
| Extra Large: Palm 0.09 mm, Finger: 0.12 | |||||
| mm | Pass | ||||
| Watertight test | ASTM D5151-19 | ||||
| Standard Test Method for Detection | |||||
| of Holes in Medical | |||||
| Gloves | To determine the holes in | ||||
| the gloves | Sample size: 200 pcs | ||||
| Inspection level : GI | |||||
| AQL 1.5 | |||||
| Acceptance Number 7 | |||||
| Rejection Number 8 | The batch size for this sampling is 35,001- | ||||
| 150,000. Hence, according to the single | |||||
| sampling plan GI, the sample to be drawn | |||||
| is under code L equivalent to 200 pcs with | |||||
| accept 7 and reject 8 to be accept under | |||||
| AQL 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 |
| Residual
powder | ASTM D6124-06 (Reapproved 2017)
Standard Test Method for Residual
Powder on Medical Gloves | To determine the residual
powder in the gloves | 2 mg per glove or less | Sample size : 5 pcs
Requirement: 2 mg per glove or less
Result
:
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
Standard Specification for Nitrile
Examination Gloves for Medical
Application | To Determine the
physical properties-
Tensile strength | Before Ageing
Tensile Strength 14Mpa
Minimal for all sizes
After Ageing Tensile
Strength 14Mpa
Minimal for all sizes | Before Ageing
Small: 18.37 MPa
Medium: 30.62 MPa
Large: 18.30 MPa
Extra Large: 18.20 MPa
After ageing:
Small: 14.08 MPa
Medium: 31.89 MPa
Large: 14.00 MPa
Extra Large: 14.00 MPa | Pass |
| | | To Determine the
physical properties-
Ultimate Elongation | Before Ageing
Ultimate Elongation
500% Min for all sizes
After Ageing Ultimate
Elongation 400% Min
for 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)
8
Attachment 17
Page 6 of 7
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
9
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.