(58 days)
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.
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.
This document is a 510(k) Premarket Notification for a medical device: "TC Gloves Powder Free Latex Examination Gloves." As such, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" refer to compliance with performance standards for the gloves, not an AI/algorithm-based diagnostic device. The request asks about AI-related aspects (e.g., number of experts, MRMC studies, training set), which are not applicable to the clearance of examination gloves.
Therefore, the response will focus on the performance criteria for the gloves as outlined in the document.
Acceptance Criteria and Device Performance for "TC Gloves Powder Free Latex Examination Gloves"
The acceptance criteria for the "TC Gloves Powder Free Latex Examination Gloves" are based on recognized standards for medical gloves, primarily ASTM D3578-19 and ASTM D5151-19, ASTM D6124-06, and ASTM D5712-15 for performance, and ISO 10993-1:2018 for biocompatibility.
1. Table of Acceptance Criteria and Reported Device Performance
| Feature/Test | Acceptance Criteria | Proposed Device Actual Data | Result |
|---|---|---|---|
| Dimensions | ASTM D3578-19 | ||
| Length | 230 mm min (all sizes) | 240.3mm - 240.9mm (all sizes) | Pass |
| Width (S) | 80 mm ± 10 | 85mm | Pass |
| Width (M) | 95 mm ± 10 | 95.8mm | Pass |
| Width (L) | 111 mm ± 10 | 104.5mm | Pass |
| Width (XL) | 120 mm ± 10 | 113.5mm | Pass |
| Thickness (Palm) | 0.08 mm min (all sizes) | 0.13mm - 0.14mm (all sizes) | Pass |
| Thickness (Finger) | 0.08 mm min (all sizes) | 0.15mm (all sizes) | Pass |
| Physical Property (ASTM D3578-19) | |||
| Tensile Strength (Before Aging) | 18 Mpa Min (all sizes) | 19.8 Mpa - 20.0 Mpa | Pass |
| Tensile Strength (After Aging) | 14 Mpa Min (all sizes) | 19.2 Mpa - 19.4 Mpa | Pass |
| Ultimate Elongation (Before Aging) | 650% Min (all sizes) | 800.9% - 805.5% | Pass |
| Ultimate Elongation (After Aging) | 500% Min (all sizes) | 790.5% - 794.9% | Pass |
| Barrier Property (ASTM D5151-19) | |||
| Detection of Holes | AQL 2.5 | AQL 2.5 | Pass |
| Powder-Free Residue (ASTM D6124-06) | |||
| Residual Powder Content | ≤ 2 mg/Glove Max (all sizes) | 0.31 mg - 0.57 mg | Pass |
| Extractable Protein (ASTM D5712-15) | |||
| Extractable Protein Content | 200 µg/dm² max (all sizes) | 34.82 µg/dm² - 50.0 µg/dm² | Pass |
| Biocompatibility (ISO 10993-1:2018) | |||
| Invitro Cytotoxicity | Non-cytotoxic | Non-cytotoxic | Pass |
| Skin Sensitization | Not a sensitizer | Not a sensitizer | Pass |
| Skin Irritation | Not an irritant | Not an irritant | Pass |
| Acute Systemic Toxicity | Device extracts do not pose a systemic toxicity. | Device extracts do not pose a systemic toxicity. | Pass |
| Material-Mediated Pyrogenicity | Device did not demonstrate a material-mediated Pyrogenicity response. | Device did not demonstrate a material-mediated Pyrogenicity response. | Pass |
2. Sample size used for the test set and the data provenance:
The document summarizes the results but does not specify the exact sample sizes (number of gloves) for each test. The tests were conducted according to the referenced ASTM and ISO standards, which typically specify sampling plans.
The data provenance is from the manufacturer, Thanh Cong Pharmaceutical and Trading Company Limited, located in Bac Ninh province, Vietnam. The tests are "Non-Clinical Data," implying laboratory testing of the product. The document does not specify if the testing was retrospective or prospective in relation to the submission date, but it represents data collected specifically to support this 510(k) submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This question is not applicable. This is not an AI/algorithm-based diagnostic device. The "ground truth" for glove performance is established by the specified ASTM and ISO standards, which define the testing methodologies and acceptance criteria. Experts in materials testing and quality control would perform and interpret these tests, but a panel of "experts" to establish "ground truth" in the way it's used for AI validation is not relevant here.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. This is not for an AI/algorithm-based diagnostic device requiring human adjudication.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
Not applicable. This is not an AI-assisted device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is not an AI/algorithm device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
The ground truth is based on established, quantitative, and objective international and national standards for medical device performance, specifically for examination gloves. This includes:
- ASTM International Standards: These define specific methodologies for testing physical properties (dimensions, tensile strength, elongation), barrier properties (detection of holes), chemical properties (powder residue, extractable protein).
- ISO International Standards (e.g., ISO 10993-1): These define methodologies for evaluating the biological safety (biocompatibility) of medical devices.
The "ground truth" is defined by the objective measurements obtained through these standardized tests compared against the predefined quantitative acceptance limits within those standards.
8. The sample size for the training set:
Not applicable. There is no training set as this is not an AI/machine learning product.
9. How the ground truth for the training set was established:
Not applicable. There is no training set for this type of medical device clearance.
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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.
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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
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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 COMPANYLIMITED |
|---|---|
| Address | KM 6+ 200 National Road No.38, Hap Linh, Bac Ninh City, BacNinh 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 AndTrading 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 LatexExaminationGloves aredisposable devices intended formedical purpose that are worn onthe examiner's hand to preventcontamination between patientand examiner. | Palm Care Latex ExaminationPowder Free Gloves aredisposable devices intended formedical purpose that are worn onthe examiner's hand to preventcontamination between patientand 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 mmWidth Min 95+/-10 mm (formedium size) | Length Min 230 mmWidth Min 95+/-10 mm (for medium size) | Same | ||
| 16. | Thickness | Palm min 0.08 mmFinger min 0.08 mm | Palm min 0.08 mmFinger min 0.08 mm | Same | ||
| 17. | Physical Properties | Before AgingTensile Strength min 18 MpaUltimate Elongation Min 650%After AgingTensile Strength min 14 MpaUltimate Elongation Min 500% | Before AgingTensile Strength min 18 MpaUltimate Elongation Min 650%After AgingTensile Strength min 14 MpaUltimate 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 ProteinTesting | 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 SystemicToxicity | 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 MediatedPyrogenicity | 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
| SINo. | Tests | Proposed Device actual Data | Acceptance Criteria | Result | ||||
|---|---|---|---|---|---|---|---|---|
| 1. | DimensionLength, Width andThicknessASTM D3578 - 19,Standard Specificationfor Rubber ExaminationGloves | 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 mmmin | |||
| 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 propertyTensile strengthand UltimateElongationASTM D3578 - 19,Standard Specificationfor Rubber ExaminationGloves | Size | Beforeageing | Afterageing | Size | Beforeageing | Afterageing | ||
| S | 19.9 Mpa | 19.4 Mpa | S | 18 Mpa Minfor all sizes | 14 Mpa Minfor 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.
| SINo. | Tests | Proposed Device actual Data | Acceptance Criteria | Result | ||||
|---|---|---|---|---|---|---|---|---|
| Size | Beforeageing | Afterageing | Size | Beforeageing | Afterageing | |||
| S | 805.5% | 790.5% | S | |||||
| M | 803.1% | 794.9% | M | 650% Min forall sizes | 500% Min forall sizes | |||
| L | 804.6% | 791% | L | |||||
| XL | 800.9% | 794.7% | XL | |||||
| 3. | Detection of Holesin Medical GlovesASTM D5151-19,Standard Test Methodfor Detection of Holesin Medical Gloves | Size | AQL 2.5 | Size | AQL 2.5 | Pass | ||
| S | S | |||||||
| M | M | |||||||
| L | L | |||||||
| XL | XL | |||||||
| 4. | Powder FreeResidueASTM D6124-06(Reapproved 2017)Standard Test Methodfor Residual Powder onMedical 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. | ExtractableProtein TestingASTM D5712-15Standard Test Methodfor Analysis of AqueousExtractable Protein inLatex, Natural Rubber,and ElastomericProducts Using theModified Lowry Method | Size | Extractable proteincontent | Size | Extractable proteincontent | |||
| 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. AdditionalTesting was performed todetermine if this was a systemictoxicity concern | Under the conditions of thestudy, non-cytotoxic. | - |
| 2. | Skin Sensitization | Under the conditions of the studynot a sensitizer | Under the conditions of the studynot a sensitizer | Pass |
| 3. | Skin Irritation | Under the condition of study notan irritant | Under the condition of study notan irritant | Pass |
| 4. | Acute Systemic Toxicity | Under the condition of study, thedevice extracts do not pose asystemic toxicity. | Under the condition of study, thedevice extracts do not pose asystemic toxicity. | Pass |
| 5. | Material-MediatedPyrogenicity | Under the conditions of the study,the device did not demonstrate amaterial mediated Pyrogenicityresponse. | Under the conditions of thestudy, the device did notdemonstrate a materialmediated Pyrogenicityresponse. | 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.
§ 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.