(58 days)
Not Found
No
The device is a simple examination glove and the summary contains no mention of AI or ML.
No
The device, TC Gloves, is described as a disposable glove intended to prevent contamination between patient and examiner. Its purpose is protective, not therapeutic (treating or alleviating a disease or condition).
No
The device is described as a disposable glove intended to prevent contamination, not to diagnose a medical condition.
No
The device is described as physical examination gloves made of latex, which are a hardware product, not software.
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 performed in vitro (outside the body).
- Device Description: The description details the physical characteristics and standards met by the gloves. There is no mention of any components or processes related to analyzing samples or diagnosing conditions.
- Lack of IVD Indicators: 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 specific substances (analytes)
- Providing information for diagnosis, monitoring, or prognosis of a disease or condition.
- Device Classification: The device is classified as Class I with product code LYY (21CFR 880.6250), which is for examination gloves, not IVD devices.
In summary, the purpose of these gloves is to provide a physical barrier during medical examinations, which is a different function than an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
TC Gloves Powder Free Latex 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 (comma separated list FDA assigned to the subject device)
LYY
Device Description
TC Gloves Powder Free Latex Examination Gloves is a Class I device bearing the product code LYY (21CFR 880.6250). They meet all the current specifications listed under the ASTM D3578 - 19, Standard Specification for Rubber Examination Gloves. They are made from natural rubber latex. These gloves are white in color having Finger Texture / Ambidextrous and are powder free. The product is non-sterile.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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 Data
Performance Tests:
- Dimension (Length, Width and Thickness)
- Physical property (Tensile strength and Ultimate Elongation)
- Barrier property tests (Detection of Holes in Medical Gloves)
- Powder Free Residue
- Extractable protein testing
Key results: All performance tests met the acceptance criteria according to ASTM D3578-19, ASTM D5151-19, ASTM D6124-06 (Reapproved 2017), and ASTM D5712-15.
Biocompatibility:
- Invitro Cytotoxicity: Under the conditions of the study, non-cytotoxic.
- Skin Sensitization: Under the conditions of the study not a sensitizer.
- Skin Irritation: Under the condition of study not an irritant.
- Acute Systemic Toxicity: Under the condition of study, the device extracts do not pose a systemic toxicity.
- Material-Mediated Pyrogenicity: Under the conditions of the study, the device did not demonstrate a material mediated Pyrogenicity response.
All biocompatibility tests were performed according to ISO 10993-1:2018 and met the acceptance criteria.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Acceptance Criteria for Performance Tests:
- Dimension: Min Length 230mm, Width (S: 80mm ±10, M: 95mm ±10, L: 111mm ±10, XL: 120mm ±10), Thickness (Palm: 0.08 mm min, Finger: 0.08 mm min)
- Physical property: Before Aging (Tensile Strength min 18 Mpa for all sizes, Ultimate Elongation 650% Min for all sizes), After Aging (Tensile Strength min 14 Mpa for all sizes, Ultimate Elongation 500% Min for all sizes)
- Detection of Holes: AQL 2.5
- Powder Free Residue: ≤2 mg/Glove Max
- Extractable Protein Testing: 200 µg/ dm² max
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.
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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: the Department of Health & Human Services logo on the left and the FDA acronym and full name on the right. The FDA part of the logo is in blue, with the acronym in a square and the full name, "U.S. Food & Drug Administration," written out next to it.
June 22, 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: K221185
Trade/Device Name: TC Gloves Powder Free Latex Examination Gloves Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I. reserved Product Code: LYY 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.
1
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about 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) K221185
Device Name
TC Gloves Powder Free Latex Examination Gloves
Indications for Use (Describe)
TC Gloves Powder Free Latex 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)
X 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 three green leaves sprouting upwards, symbolizing growth and nature. The text "TC Pharma" is written in green, with "TC" stacked above "Pharma", and the entire logo is encircled by two curved green lines, creating a sense of completeness and harmony.
510(k) SUMMARY K221185
[AS REQUIRED BY 21CFR807.92]
I. SUBMITTER DETAILS
| 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 Thị Tú Anh |
| Contact Designation | Director of Production |
| Contact Phone Number | 098 171 2992 |
| Contact Email | tuanhnquyentcpharma@gmail.com |
| Date of Summary Prepared | 07-04-2022 |
II. DEVICE DETAILS
| Brand Name | TC Gloves |
|---|---|
| Device Common Name | Powder-Free Latex Examination Gloves |
| Device Classification name | Non-powdered patient examination glove |
| Regulation Number | 21 CFR 880.6250 |
| Class | I |
| Product Code | LYY |
III. PREDICATE DEVICE DETAILS
| Predicate Device Name | Palm Care Latex Examination Powder Free Gloves |
|---|---|
| 510(k) Number | K202377 |
| Regulation Number | 21 CFR 880.6250 |
| Class | I |
| Product Code | LYY |
Manufacturer:
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 two green leaves above the text "TC Pharma" in green font. The logo is surrounded by a gray, curved shape.
IV. DEVICE DESCRIPTION
TC Gloves Powder Free Latex Examination Gloves is a Class I device bearing the product code LYY (21CFR 880.6250). They meet all the current specifications listed under the ASTM D3578 - 19, Standard Specification for Rubber Examination Gloves. They are made from natural rubber latex. These gloves are white in color having Finger Texture / Ambidextrous and are powder free. The product is non-sterile.
V. INDICATION FOR USE
TC Gloves Powder-Free Latex 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 | K221185 | K202377 | - | ||
| 2. | Manufacturer | Thanh Cong Pharmaceutical And | ||||
| Trading Company Limited | Hi-Care Thai Gloves Co. Ltd. | - | ||||
| 3. | Classification | I | I | Same | ||
| 4. | Regulation number | 21 CFR 880.6250 | 21 CFR 880.6250 | Same | ||
| 5. | Product Code | LYY | LYY | Same | ||
| 6. | Indication For Use | TC Gloves Powder-Free Latex | ||||
| Examination | ||||||
| Gloves are | ||||||
| disposable devices intended for | ||||||
| medical purpose that are worn on | ||||||
| the examiner's hand to prevent | ||||||
| contamination between patient | ||||||
| and examiner. | Palm Care Latex Examination | |||||
| Powder Free Gloves are | ||||||
| disposable devices intended for | ||||||
| medical purpose that are worn on | ||||||
| the examiner's hand to prevent | ||||||
| contamination between patient | ||||||
| and examiner. | Same | |||||
| 7. | Material | Latex | Latex | Same | ||
| 8. | Color | White | Natural (No color is added) | Different-1 | ||
| 9. | Texture | Finger Texture | Finger texture | Same | ||
| 10. | Ambidextrous | Yes | Yes | Same | ||
| 11. | Size | S, M, L, XL | XS, S, M, L | 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. | 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 | |||||
| 16. | Thickness | Palm min 0.08 mm | ||||
| Finger min 0.08 mm | Palm min 0.08 mm | |||||
| Finger min 0.08 mm | Same | |||||
| 17. | Physical Properties | Before Aging | ||||
| Tensile Strength min 18 Mpa | ||||||
| Ultimate Elongation Min 650% | ||||||
| After Aging | ||||||
| Tensile Strength min 14 Mpa | ||||||
| Ultimate Elongation Min 500% | Before Aging | |||||
| Tensile Strength min 18 Mpa | ||||||
| Ultimate Elongation Min 650% | ||||||
| After Aging | ||||||
| Tensile Strength min 14 Mpa | ||||||
| Ultimate Elongation Min 500% | Same | |||||
| 18. | Detection of Holes | Passes AQL 2.5 | Passes AQL 1.5 | Different-2 | ||
| 19. | Powder Free Residue | ≤2 mg/glove | ≤2 mg/glove | same | ||
| 20. | Extractable Protein | |||||
| Testing | 200 μg/ dm² max | 200 μg/ dm² max | same | |||
| 21. | Biocompatibility Study | Invitro 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, non-cytotoxic. | Different-3 | |
| 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 | |||
| 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 | |||
| 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 |
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 two green leaves above the text "TC Pharma" in green font. A grey swoosh design is behind the leaves and text.
There are no significant differences between the two products and are identical in terms of intended use, materials, design, manufacturing methods. Both devices met the performance standards.
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Image /page/6/Picture/0 description: The image shows the logo for TC Pharma. The logo features two green leaves above the text "TC Pharma" in green font. The leaves are positioned in the center of the logo, and the text is placed below the leaves. A gray curved line surrounds the leaves and text, creating a circular shape.
VII. PERFORMANCE DATA
Non- Clinical Data A.
Performance Tests
TC Gloves Powder-Free Latex 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
- A Detection of Holes in Medical Gloves
- . Powder Free Residue
- Extractable protein testing ●
Table 2: Performance Testing Summary
| SI
| No. | Tests | Proposed Device actual Data | Acceptance Criteria | Result | ||||
|---|---|---|---|---|---|---|---|---|
| 1. | Dimension | |||||||
| Length, Width and | ||||||||
| Thickness | ||||||||
| ASTM D3578 - 19, | ||||||||
| Standard Specification | ||||||||
| for Rubber Examination | ||||||||
| Gloves | Size | Length | Width | Size | Length | Width | Pass | |
| S | 240.9mm | 85mm | S | 230mm min | 80mm ±10 | |||
| M | 240.6mm | 95.8mm | M | 95mm ±10 | ||||
| L | 240.7mm | 104.5mm | L | 111mm ±10 | ||||
| XL | 240.3mm | 113.5mm | XL | 120mm ±10 | ||||
| Thickness | Thickness | |||||||
| Size | Palm | Finger | Size | Palm | Finger | |||
| S | 0.13mm | 0.15mm | S | 0.08 mm min | 0.08 mm | |||
| min | ||||||||
| M | 0.14mm | 0.15mm | M | |||||
| L | 0.14mm | 0.15mm | L | |||||
| XL | 0.13mm | 0.15mm | XL | |||||
| 2. | Tensile strength | Tensile strength | Pass | |||||
| Physical property | ||||||||
| Tensile strength | ||||||||
| and Ultimate | ||||||||
| Elongation | ||||||||
| ASTM D3578 - 19, | ||||||||
| Standard Specification | ||||||||
| for Rubber Examination | ||||||||
| Gloves | Size | Before | ||||||
| ageing | After | |||||||
| ageing | Size | Before | ||||||
| ageing | After | |||||||
| ageing | ||||||||
| S | 19.9 Mpa | 19.4 Mpa | S | 18 Mpa Min | ||||
| for all sizes | 14 Mpa Min | |||||||
| for all sizes | ||||||||
| M | 19.8 Mpa | 19.4 Mpa | M | |||||
| L | 20.0 Mpa | 19.3 Mpa | L | |||||
| XL | 20.0 Mpa | 19.2 Mpa | XL | |||||
| Ultimate elongation | Ultimate elongation |
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Image /page/7/Picture/0 description: The image shows the logo for TC Pharma. The logo features two green leaves above the text "TC Pharma" in green font. There are two gray curved lines that surround the leaves and text.
| SI
| No. | Tests | Proposed Device actual Data | Acceptance Criteria | Result | ||||
|---|---|---|---|---|---|---|---|---|
| Size | Before | |||||||
| ageing | After | |||||||
| ageing | Size | Before | ||||||
| ageing | After | |||||||
| ageing | ||||||||
| S | 805.5% | 790.5% | S | |||||
| M | 803.1% | 794.9% | M | 650% Min for | ||||
| all sizes | 500% Min for | |||||||
| all sizes | ||||||||
| L | 804.6% | 791% | L | |||||
| XL | 800.9% | 794.7% | XL | |||||
| 3. | Detection of Holes | |||||||
| in Medical Gloves | ||||||||
| ASTM D5151-19, | ||||||||
| Standard Test Method | ||||||||
| for Detection of Holes | ||||||||
| in Medical Gloves | Size | AQL 2.5 | Size | AQL 2.5 | Pass | |||
| S | S | |||||||
| M | M | |||||||
| L | L | |||||||
| XL | XL | |||||||
| 4. | Powder Free | |||||||
| Residue | ||||||||
| ASTM D6124-06 | ||||||||
| (Reapproved 2017) | ||||||||
| Standard Test Method | ||||||||
| for Residual Powder on | ||||||||
| Medical Gloves | Size | Residual powder content | Size | Residual powder content | ||||
| S | 0.31 mg | S | ≤2 mg/Glove Max | |||||
| M | 0.42 mg | M | Pass | |||||
| L | 0.57 mg | L | ||||||
| XL | 0.40 mg | XL | ||||||
| 5. | Extractable | |||||||
| Protein Testing | ||||||||
| ASTM D5712-15 | ||||||||
| Standard Test Method | ||||||||
| for Analysis of Aqueous | ||||||||
| Extractable Protein in | ||||||||
| Latex, Natural Rubber, | ||||||||
| and Elastomeric | ||||||||
| Products Using the | ||||||||
| Modified Lowry Method | Size | Extractable protein | ||||||
| content | Size | Extractable protein | ||||||
| content | ||||||||
| S | 47.96 (µg/dm²) | S | ||||||
| M | 50.0 (µg/dm²) | M | ||||||
| L | 34.82 (µg/dm²) | L | 200 µg/ dm² max | Pass | ||||
| XL | 49.27 (µg/dm²) | XL |
B. Biocompatibility
The materials used in the TC Gloves Powder-Free Latex 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.
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Image /page/8/Picture/0 description: The image shows the logo for TC Pharma. The logo features two green leaves above the text "TC Pharma". The leaves are arranged in a V-shape, with one leaf slightly overlapping the other. The text "TC Pharma" is in a bold, sans-serif font. The logo is surrounded by two curved, gray lines that form a partial oval shape.
| SI.
| No | Test Performed | Proposed Device | Acceptance Criteria | Result |
|---|---|---|---|---|
| 1. | Invitro 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, non-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 | |||
| 4. | 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. | 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 |
Table 3: Biocompatibility Test Summary
C. Clinical Test Data
Clinical study was not conducted as clinical data is not needed for TC Gloves Powder-Free Latex Examination Gloves.
VIII. CONCLUSION
The conclusion drawn from the non-clinical tests demonstrate that the subject device, TC Gloves Powder-Free Latex Examination Gloves are as safe, as effective and perform as well as or better than legally marketed predicated device in K202377.