(52 days)
No
The device is a simple examination glove and the description contains no mention of AI or ML.
No
The device, TC Gloves, is described as an examination glove intended to prevent contamination between patient and examiner, not to treat or diagnose any medical condition.
No
Explanation: The device is an examination glove, used to prevent contamination, not to diagnose a condition.
No
The device is a physical product (examination gloves) and not software. The description details material composition, physical properties, and performance tests related to a tangible item.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the gloves are "worn on the examiner's hand to prevent contamination between patient and examiner." This is a barrier function, not a diagnostic function.
- Device Description: The description focuses on the material, specifications, and physical properties of the gloves. There is no mention of any components or processes that would be used to test samples from the human body (which is the core of IVD).
- Lack of Diagnostic Elements: There are no mentions of analyzing samples, detecting substances, or providing diagnostic information.
- Performance Studies: The performance studies focus on the physical and barrier properties of the gloves (holes, powder residue, biocompatibility), not on diagnostic accuracy or performance.
In summary, the device is a barrier device intended for infection control, not for performing diagnostic tests on in vitro samples.
N/A
Intended Use / Indications for Use
TC Gloves- Powder Free Nitrile Examination Gloves 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
LZA
Device Description
TC Gloves- Powder Free Nitrile Examination Gloves is a Class I device bearing the product code LZA (21CFR 880.6250). They meet all the current specifications listed under the ASTM D6319 -19, Standard Specification for Nitrile Examination Gloves for Medical Application. They are made from acrylonitrilebutadiene copolymer dispersion. These gloves are blue in color having Finger Texture, Ambidextrous, Single use and are powder free. The product is non-sterile. Sizes available - S, M, L and XL.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
hand
Indicated Patient Age Range
Not Found
Intended User / Care Setting
examiner
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)
Performance Tests:
- Dimension: Tested according to ASTM D6319-19 for Length, Width, and Thickness for sizes S, M, L, XL. Data presented for each size and compared against acceptance criteria.
- Physical property: Tensile strength and Ultimate Elongation tested according to ASTM D6319-19 for sizes S, M, L, XL, both before and after aging. Data presented for each size and compared against acceptance criteria.
- Barrier property tests- Detection of Holes in Medical Gloves: Tested according to ASTM D6319-19 / ASTM D5151-19 for sizes S, M, L, XL. Result showed AQL 2.5, matching acceptance criteria.
- Powder Free Residue: Tested according to ASTM D6124-06 (Reapproved 2017) for sizes S, M, L, XL. Results ranged from 0.23 mg to 0.57 mg, meeting the
§ 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.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name on the right. The symbol on the left is a stylized image of a human figure, while the FDA name on the right is written in blue letters. The words "U.S. FOOD & DRUG ADMINISTRATION" are written in a clear, sans-serif font.
June 16, 2022
Thanh Cong Pharmaceutical and Trading Company Limited % Manoj Zacharias US Agent Liberty Management Group Limited 75 Executive Drive, Suite 114 Aurora, Illinois 60504
Re: K221186
Trade/Device Name: TC Gloves - Powder Free Nitrile Examination Gloves Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I, reserved Product Code: LZA Dated: March 29, 2022 Received: April 25, 2022
Dear Manoj Zacharias:
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 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,
Bifeng Qian, M.D., Ph.D. Acting 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
Indications for Use
510(k) Number (if known) K221186
Device Name
TC Gloves- Powder Free Nitrile Examination Gloves
Indications for Use (Describe)
TC Gloves- Powder Free Nitrile Examination Gloves 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 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/3/Picture/0 description: The image shows the logo for TC Pharma. The logo features the text "TC Pharma" in green, with a stylized image of three green leaves above the text. The leaves are arranged in a cluster, with the central leaf slightly taller than the two flanking leaves. A curved, green line partially encircles the leaves and text, creating a sense of enclosure and unity.
510(k) SUMMARY (K221186)
[AS REQUIRED BY 21CFR807.92]
SUBMITTER DETAILS I.
| 510(k) Owner's Name | THANH CONG PHARMACEUTICAL AND TRADING COMPANY
LIMITED |
|--------------------------|---------------------------------------------------------------------------------------|
| Address | KM 6+ 200 National Road No.38, Hap Linh, Bac Ninh City, Bac
Ninh province, Vietnam |
| Contact person | Ms. Nguyễn Thi Tú Anh |
| Contact Designation | Director of Production |
| Contact Phone Number | 098 171 2992 |
| Contact Email | tuanhnquyentcpharma@gmail.com |
| Date of Summary Prepared | 15-06-2022 |
DEVICE DETAILS II.
| Brand Name | TC Gloves |
|---|---|
| Device Common Name | Powder Free Nitrile Examination Gloves |
| Device Classification name | Non-powdered patient examination glove |
| Regulation Number | 21 CFR 880.6250 |
| Class | I |
| Product Code | LZA |
III. PREDICATE DEVICE DETAILS
| Predicate Device Name | Jr Medic Blue Nitrile Examination Gloves Powder Free |
|---|---|
| 510(k) Number | K192333 |
| Regulation Number | 21 CFR 880.6250 |
| Class | I |
| Product Code | LZA |
Image /page/3/Picture/9 description: The image shows the word "Manufacturer:" in green font. To the left of the word is a green icon of a factory. Below the word "Manufacturer:" is the word "THANH CONG PHARMACEUTICAL" in green font.
THANH CONG PHARMACEUTICAL AND TRADING CO., LTD Km 6 + 200 National Road No.38, Hap Linh, Bac Ninh City, Bac Ninh province, Vietnam Tel: (+84) 222 3720031, (+84) 24 38563948 Email: support@tcpharma.vn * Website: http://www.tcpharma.vn
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Image /page/4/Picture/0 description: The image shows the logo for TC Pharma. The logo features a green plant with three leaves at the top, symbolizing nature and growth. Below the plant, the text "TC Pharma" is written in a bold, green font, indicating the company's name and its association with pharmaceuticals.
IV. DEVICE DESCRIPTION
TC Gloves- Powder Free Nitrile Examination Gloves is a Class I device bearing the product code LZA (21CFR 880.6250). They meet all the current specifications listed under the ASTM D6319 -19, Standard Specification for Nitrile Examination Gloves for Medical Application. They are made from acrylonitrilebutadiene copolymer dispersion. These gloves are blue in color having Finger Texture, Ambidextrous, Single use and are powder free. The product is non-sterile. Sizes available - S, M, L and XL.
V. INDICATION FOR USE
TC Gloves- Powder Free Nitrile Examination Gloves is a disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.
VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
| SI.
| No | Features compared | Proposed Device | Predicate Device | Result | ||
|---|---|---|---|---|---|---|
| General Information | ||||||
| 1. | 510(k) Number | K221186 | K192333 | - | ||
| 2. | Manufacturer | Thanh Cong Pharmaceutical And | ||||
| Trading Company Limited | JR Engineering & Medical | |||||
| Technologies | - | |||||
| 3. | Classification | I | I | Same | ||
| 4. | Regulation number | 21 CFR 880.6250 | 21 CFR 880.6250 | Same | ||
| 5. | Product Code | LZA | LZA | Same | ||
| 6. | Indication For Use | TC Gloves-Powder Free Nitrile | ||||
| Examination Gloves is a | ||||||
| disposable device intended for | ||||||
| medical purpose that is worn on | ||||||
| the examiner's hand to prevent | ||||||
| contamination between patient | ||||||
| and examiner. | Jr Medic Blue Nitrile Examination | |||||
| Gloves Powder Free are intended | ||||||
| for medical purposes that is worn | ||||||
| on the examiner's hands to | ||||||
| prevent contamination between | ||||||
| patient and examiner. | Same | |||||
| 7. | Material | Nitrile | Nitrile | Same | ||
| 8. | Color | Blue | Blue | Same | ||
| 9. | Texture | Finger Texture | Finger texture | Same | ||
| 10. | Ambidextrous | Yes | Yes | Same | ||
| 11. | Size | S, M, L, XL | XS, S, M, L, XL | Similar-1 | ||
| SI. | ||||||
| No | Features compared | Proposed Device | Predicate Device | Result | ||
| 12. | OTC Use | Yes | Yes | Same | ||
| 13. | Reusability | Single use | Single use | Same | ||
| 14. | Sterility | Non- sterile | Non- sterile | Same | ||
| 15. | Shelf Life | 3 years | Data Not available | - | ||
| 16. | Dimensions | Length Min 230 mm | ||||
| Width Min 95+/-10 mm (for | ||||||
| medium size) | Length Min 230 mm | |||||
| Width Min 95±10 mm | ||||||
| (for medium size) | Same | |||||
| 17. | Thickness | Palm min 0.05 mm | ||||
| Finger min 0.05 mm | Palm min 0.05 mm | |||||
| Finger min 0.05 mm | Same | |||||
| 18. | ||||||
| Physical Properties | Before Aging | |||||
| Tensile Strength min 14 Mpa | ||||||
| Ultimate Elongation Min 500% | ||||||
| After Aging | ||||||
| Tensile Strength min 14 Mpa | ||||||
| Ultimate Elongation Min 400% | Before Aging | |||||
| Tensile Strength min 14 Mpa | ||||||
| Ultimate Elongation Min 500% | ||||||
| After Aging | ||||||
| Tensile Strength min 14 Mpa | ||||||
| Ultimate Elongation Min 400% | Same | |||||
| 19. | Detection of Holes | Passes AQL 2.5 | Passes AQL 1.5 | Different-1 | ||
| 20. | Powder Free Residue | ≤2 mg/glove | ≤2 mg/glove | Same | ||
| 21. | Biocompatibility Study | In Vitro Cytotoxicity | Under the conditions of the | |||
| study, cytotoxic to L-929 cells. | ||||||
| Additional Testing was performed | ||||||
| to determine if this was a | ||||||
| systemic toxicity concern. | Under the conditions of the | |||||
| study, cytotoxic to L-929 cells. | ||||||
| Additional Testing was performed | ||||||
| to determine if this was a | ||||||
| systemic toxicity concern. | Same | |||||
| Skin Sensitization | Under the conditions of the study | |||||
| not a sensitizer | Under the conditions of the study | |||||
| not a sensitizer | Same | |||||
| Skin Irritation | Under the condition of study not | |||||
| an irritant | Under the condition of study not | |||||
| an irritant | Same | |||||
| Material mediated | ||||||
| pyrogenicity | Under the conditions of the | |||||
| study, the device did not | ||||||
| demonstrate a material mediated | ||||||
| Pyrogenicity response. | Under the conditions of the | |||||
| study, the device did not | ||||||
| demonstrate a material mediated | ||||||
| Pyrogenicity response. | Same | |||||
| Acute systemic | ||||||
| toxicity | Under the condition of study, the | |||||
| device extracts do not pose a | ||||||
| systemic toxicity. | Under the condition of study, the | |||||
| device extracts do not pose a | ||||||
| systemic toxicity. | Same |
Table 1: General Comparison
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Image /page/5/Picture/0 description: The image shows the logo for TC Pharma. The logo features the text "TC Pharma" in a bold, green sans-serif font. Above the text is a stylized green plant with three leaves, and the plant is encircled by two curved green lines, creating a sense of growth and nature.
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Image /page/6/Picture/0 description: The image shows the logo for TC Pharma. The logo features the text "TC Pharma" in a stylized font, with the "TC" in a darker green and "Pharma" in a lighter green. Above the text is a graphic of three green leaves, arranged in a cluster. The entire logo is encircled by a curved, light green line, giving it a natural and organic feel.
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 standard D6319-19.
PERFORMANCE DATA VII.
- A. Non- Clinical Data
Performance Tests
TC Gloves- Powder Free Nitrile Examination Gloves is subjected to the following performance tests according to the requirements of Guidance for Industry and FDA Staff - Medical Glove Guidance Manual and found to be safe and efficient with respect to its intended use:
- . Dimension
- . Physical property
- Barrier property tests- Detection of Holes in Medical Gloves .
- Powder Free Residue
Table 2: Performance Testing Summary
| SI
| No. | Tests | Proposed Device actual Data | Acceptance Criteria | ||||
|---|---|---|---|---|---|---|---|
| Size | Length | Width | Size | Length | Width | ||
| 1. | Dimension | ||||||
| Length, Width and | |||||||
| Thickness | |||||||
| ASTM D6319-19 | |||||||
| Standard | |||||||
| Specification for | |||||||
| Nitrile Examination | |||||||
| Gloves for Medical | |||||||
| Application | S | 241.4 mm | 86.6 mm | S | 230mm min | 80 mm±10 | |
| M | 240.6 mm | 96.5 mm | M | 95 mm ±10 | |||
| L | 243.2 mm | 106.4 mm | L | 110 mm ±10 | |||
| XL | 242.7 mm | 113.8 mm | XL | 120 mm ±10 | |||
| Thickness | Thickness | ||||||
| Size | Palm | Finger | Size | Palm | Finger | ||
| S | 0.14 mm | 0.16 mm | S | 0.05 mm min | 0.05 mm min | ||
| M | 0.14 mm | 0.15 mm | M | ||||
| L | 0.14 mm | 0.15 mm | L | ||||
| XL | 0.13 mm | 0.16 mm | XL | ||||
| Tensile strength | Tensile strength | ||||||
| Size | Before ageing | After ageing | Size | Before ageing | After ageing | ||
| 2. | Physical property | ||||||
| Tensile strength | |||||||
| and Ultimate | |||||||
| Elongation | |||||||
| ASTM D6319-19 | |||||||
| Standard | |||||||
| Specification for | |||||||
| Nitrile Examination | |||||||
| Gloves for Medical | |||||||
| Application | S | 15.7 MPa | 15.0 MPa | S | 14 MPa Min for all | ||
| sizes | 14 MPa Min for all | ||||||
| sizes | |||||||
| M | 15.5 MPa | 15.3 MPa | M | ||||
| L | 15.4 MPa | 14.9 MPa | L | ||||
| XL | 15.2 MPa | 15.3 MPa | XL | ||||
| Ultimate elongation | Ultimate elongation | ||||||
| Size | Before ageing | After ageing | Size | Before ageing | After ageing | ||
| S | 515.8% | 469.2% | S | ||||
| M | 514% | 510% | M | 500% Min for all | |||
| sizes | 400%Min for all | ||||||
| sizes | |||||||
| L | 512% | 510% | L |
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Image /page/7/Picture/0 description: The image shows the logo for TC Pharma. The logo features the text "TC Pharma" in a stylized, green font. Above the text, there are three green leaves arranged in a cluster, suggesting a connection to nature or plant-based products. The leaves and text are encircled by a curved, green line, creating a sense of unity and completeness.
| SI No. | Tests | Proposed Device actual Data | Acceptance Criteria | ||
|---|---|---|---|---|---|
| Detection of Holes | |||||
| in Medical Gloves | Size | Size | |||
| 3. | ASTM D6319-19 | ||||
| /ASTM D5151-19 | |||||
| Standard Test | |||||
| Method for | |||||
| Detection of Holes | |||||
| in Medical Gloves | S | AQL 2.5 | S | AQL 2.5 | |
| M | M | ||||
| L | L | ||||
| XL | XL | ||||
| Powder Free | |||||
| Residue | Size | Residual powder content | Size | Residual powder content | |
| 4. | ASTM D6124-06 | ||||
| (Reapproved 2017) | |||||
| Standard Test | |||||
| Method for Residual | |||||
| Powder on Medical | |||||
| Gloves | S | 0.41 mg | S | ||
| M | 0.23 mg | M |