← Product Code [LZA](/productcode/LZA) · K221186 # TC Gloves (K221186) _Thanh Cong Pharmaceutical and Trading Company Limited · LZA · Jun 16, 2022 · General Hospital · SESE_ **Canonical URL:** https://fda-staging.innolitics.com/device/K221186 ## Device Facts - **Applicant:** Thanh Cong Pharmaceutical and Trading Company Limited - **Product Code:** [LZA](/productcode/LZA.md) - **Decision Date:** Jun 16, 2022 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 880.6250 - **Device Class:** Class 1 - **Review Panel:** General Hospital ## 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. ## Device Story TC Gloves are disposable, non-sterile, powder-free nitrile examination gloves. Manufactured from acrylonitrile-butadiene copolymer dispersion. Features include blue color, finger texture, and ambidextrous design. Available in sizes S, M, L, and XL. Used by clinicians in medical settings to provide a barrier against contamination between the examiner and the patient. Device is single-use. Performance verified against ASTM D6319-19 standards for physical properties, dimensions, and barrier integrity. ## Clinical Evidence No clinical data. Bench testing only. Performance verified via ASTM D6319-19 (dimensions, physical properties), ASTM D5151-19 (barrier/hole detection), and ASTM D6124-06 (residual powder). Biocompatibility testing performed per ISO 10993-1:2018, including cytotoxicity, skin sensitization, skin irritation, acute systemic toxicity, and material-mediated pyrogenicity. ## Technological Characteristics Material: Acrylonitrile-butadiene copolymer. Standards: ASTM D6319-19, ASTM D5151-19, ASTM D6124-06, ISO 10993-1:2018. Form factor: Ambidextrous, finger-textured, powder-free, non-sterile. Dimensions: Length min 230mm, palm thickness min 0.05mm. Physical properties: Tensile strength min 14 MPa (before/after aging), ultimate elongation min 500% (before) and 400% (after). ## Regulatory 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. ## Predicate Devices - Jr Medic Blue Nitrile Examination Gloves Powder Free ([K192333](/device/K192333.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ 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) ## CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. ## *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ Image /page/3/Picture/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 {4}------------------------------------------------ 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 {5}------------------------------------------------ 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. {6}------------------------------------------------ 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 | | | | {7}------------------------------------------------ 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 | <= 2 mg/Glove Max | | | | L | 0.57 mg | L | | | | | XL | 0.37 mg | XL | | ### Biocompatibility B. The materials used in the TC Gloves- Powder Free Nitrile Examination Gloves are biocompatible based on the biocompatibility tests mentioned in the Guidance for Industry and FDA Staff - Medical Glove Guidance Manual: - . Invitro Cytotoxicity - . Skin Sensitization - . Skin Irritation - Acute Systemic Toxicity ● - . Material-Mediated Pyrogenicity These tests are performed according to ISO 10993-1:2018, Biological Evaluation of Medical Devices - Part 1, Evaluation and Testing within a Risk Management Process. ## Table 3: Biocompatibility Test Summary | SI.
No | Test Performed | Proposed Device | Acceptance Criteria | Result | |-----------|-----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------|--------| | 1. | 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, not cytotoxic. | - | | 2. | Skin Sensitization | Under the conditions of the
study not a sensitizer | Under the conditions of the
study not a sensitizer | Pass | | 3. | Skin Irritation | Under the condition of study not
an irritant | Under the condition of study not
an irritant | Pass | {8}------------------------------------------------ Image /page/8/Picture/0 description: The image shows a logo for TC Pharma. The logo is green and features a stylized plant with three leaves sprouting from a central point. The text "TC Pharma" is written in a bold, sans-serif font below the plant. The plant is encircled by a curved line. | 4. | Acute Systemic Toxicity | Under the conditions of the
study, the device extracts do not
pose a systemic toxicity concern | Under the conditions of the
study, the device extracts do not
pose a systemic toxicity concern | Pass | |----|-----------------------------------|-----------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------|------| | 5. | 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. | Pass | ### C. Shelf Life Study Expiration Date: Three years from the date of Manufacture A provisional expiration date of three years from the date of manufacturing is provided based on the shelf life study conducted as per ASTM D7160-16 Standard Practice for Determination of Expiration Dating for Medical Gloves. #### D. Clinical Test Data The clinical study was not conducted as clinical data is not needed for TC Gloves- Powder Free Nitrile Examination Gloves. ## VIII. CONCLUSION The conclusion drawn from the non-clinical tests demonstrates that the subject device, TC Gloves-Powder Free Nitrile Examination Gloves are as safe, as effective and perform as well as or better than legally marketed predicate device in K192333. --- **Source:** [https://fda-staging.innolitics.com/device/K221186](https://fda-staging.innolitics.com/device/K221186) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com