(52 days)
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.
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.
The provided document is a 510(k) Summary for TC Gloves - Powder Free Nitrile Examination Gloves. It focuses on demonstrating substantial equivalence to a predicate device, rather than detailed performance proof for a novel AI/software medical device. Therefore, the requested information, which is highly specific to the acceptance criteria and study design for AI-based medical devices, cannot be fully extracted from this document.
However, I can provide the acceptance criteria and reported device performance for the physical and biological characteristics of the gloves as detailed in the document, which serves as the "acceptance criteria" against which the device's performance is measured for this type of medical device (physical examination gloves).
Here's an attempt to answer the questions based on the provided document, acknowledging the limitations due to the nature of the device:
1. A table of acceptance criteria and the reported device performance
For a physical medical device like examination gloves, the "acceptance criteria" are defined by relevant ASTM standards and the "performance" is the actual test data.
| SI No. | Test Performed & Acceptance Criteria (ASTM D6319-19 unless specified) | Reported Device Performance (Actual Data) |
|---|---|---|
| Dimension | ||
| 1. | Length: 230mm min (all sizes) | S: 241.4 mm, M: 240.6 mm, L: 243.2 mm, XL: 242.7 mm |
| Width: S: 80 mm±10, M: 95 mm ±10, L: 110 mm ±10, XL: 120 mm ±10 | S: 86.6 mm, M: 96.5 mm, L: 106.4 mm, XL: 113.8 mm | |
| Thickness (Palm): 0.05 mm min (all sizes) | S: 0.14 mm, M: 0.14 mm, L: 0.14 mm, XL: 0.13 mm | |
| Thickness (Finger): 0.05 mm min (all sizes) | S: 0.16 mm, M: 0.15 mm, L: 0.15 mm, XL: 0.16 mm | |
| Physical Property | ||
| 2. | Tensile Strength (Before Aging): 14 MPa Min for all sizes | S: 15.7 MPa, M: 15.5 MPa, L: 15.4 MPa, XL: 15.2 MPa |
| Tensile Strength (After Aging): 14 MPa Min for all sizes | S: 15.0 MPa, M: 15.3 MPa, L: 14.9 MPa, XL: 15.3 MPa | |
| Ultimate Elongation (Before Aging): 500% Min for all sizes | S: 515.8%, M: 514%, L: 512%, XL: 511.2% | |
| Ultimate Elongation (After Aging): 400% Min for all sizes | S: 469.2%, M: 510%, L: 510%, XL: 468.9% | |
| Barrier Property | ||
| 3. | Detection of Holes (ASTM D6319-19 / ASTM D5151-19): Passes AQL 2.5 | S: AQL 2.5, M: AQL 2.5, L: AQL 2.5, XL: AQL 2.5 |
| Powder Free Residue | ||
| 4. | Residual Powder Content (ASTM D6124-06): ≤2 mg/Glove Max | S: 0.41 mg, M: 0.23 mg, L: 0.57 mg, XL: 0.37 mg |
| Biocompatibility | ||
| 1. | In Vitro Cytotoxicity (ISO 10993-1:2018): Under the conditions of the study, not cytotoxic. | Under the conditions of the study, cytotoxic to L-929 cells. Additional Testing was performed to determine if this was a systemic toxicity concern. |
| 2. | Skin Sensitization (ISO 10993-1:2018): Under the conditions of the study not a sensitizer. | Under the conditions of the study not a sensitizer. (Pass) |
| 3. | Skin Irritation (ISO 10993-1:2018): Under the condition of study not an irritant. | Under the condition of study not an irritant. (Pass) |
| 4. | Acute Systemic Toxicity (ISO 10993-1:2018): 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 (ISO 10993-1:2018): 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) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify the exact sample sizes used for each of the performance tests (Dimension, Physical Property, Detection of Holes, Powder Free Residue, Biocompatibility). The testing is standard for manufacturing quality control of examination gloves and would typically involve sampling from production batches.
- Sample Size: Not specified in the document.
- Data Provenance: The tests were conducted by the manufacturer, Thanh Cong Pharmaceutical And Trading Company Limited, located in Bac Ninh province, Vietnam. The tests are non-clinical, likely prospective (testing newly manufactured gloves), and carried out to demonstrate compliance with ASTM standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This is not applicable to the evaluation of medical examination gloves. The "ground truth" for the performance of these gloves is established through physical and chemical testing against recognized national and international standards (e.g., ASTM, ISO), not through expert consensus on medical images or clinical outcomes.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This concept (adjudication for ground truth establishment) is relevant for clinical studies, particularly in image interpretation or diagnostic performance, not for the physical and chemical testing of medical gloves.
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 a physical medical device (examination gloves), not an AI/software device. No MRMC study was performed as it is not relevant to the device's function or regulatory requirements.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device. The "performance" is inherent to the glove's material properties and manufacturing.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device is the defined specifications within universally recognized standards like ASTM D6319-19 and ISO 10993-1:2018. Compliance with these physical, chemical, and biological properties serves as the benchmark for safety and effectiveness for examination gloves.
8. The sample size for the training set
Not applicable. There is no "training set" as this is not an AI/machine learning device.
9. How the ground truth for the training set was established
Not applicable. There is no "ground truth for a training set." The regulatory pathway for this device relies on demonstrated compliance with established performance standards and substantial equivalence to a predicate device.
{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 COMPANYLIMITED |
|---|---|
| Address | KM 6+ 200 National Road No.38, Hap Linh, Bac Ninh City, BacNinh 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 AndTrading Company Limited | JR Engineering & MedicalTechnologies | - | ||
| 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 NitrileExamination Gloves is adisposable device intended formedical purpose that is worn onthe examiner's hand to preventcontamination between patientand examiner. | Jr Medic Blue Nitrile ExaminationGloves Powder Free are intendedfor medical purposes that is wornon the examiner's hands toprevent contamination betweenpatient 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 mmWidth Min 95+/-10 mm (formedium size) | Length Min 230 mmWidth Min 95±10 mm(for medium size) | Same | ||
| 17. | Thickness | Palm min 0.05 mmFinger min 0.05 mm | Palm min 0.05 mmFinger min 0.05 mm | Same | ||
| 18.Physical Properties | Before AgingTensile Strength min 14 MpaUltimate Elongation Min 500%After AgingTensile Strength min 14 MpaUltimate Elongation Min 400% | Before AgingTensile Strength min 14 MpaUltimate Elongation Min 500%After AgingTensile Strength min 14 MpaUltimate 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 thestudy, cytotoxic to L-929 cells.Additional Testing was performedto determine if this was asystemic toxicity concern. | Under the conditions of thestudy, cytotoxic to L-929 cells.Additional Testing was performedto determine if this was asystemic toxicity concern. | Same | |
| Skin Sensitization | Under the conditions of the studynot a sensitizer | Under the conditions of the studynot a sensitizer | Same | |||
| Skin Irritation | Under the condition of study notan irritant | Under the condition of study notan irritant | Same | |||
| Material mediatedpyrogenicity | Under the conditions of thestudy, the device did notdemonstrate a material mediatedPyrogenicity response. | Under the conditions of thestudy, the device did notdemonstrate a material mediatedPyrogenicity response. | Same | |||
| Acute systemictoxicity | Under the condition of study, thedevice extracts do not pose asystemic toxicity. | Under the condition of study, thedevice extracts do not pose asystemic 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
| SINo. | Tests | Proposed Device actual Data | Acceptance Criteria | ||||
|---|---|---|---|---|---|---|---|
| Size | Length | Width | Size | Length | Width | ||
| 1. | DimensionLength, Width andThicknessASTM D6319-19StandardSpecification forNitrile ExaminationGloves for MedicalApplication | 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 propertyTensile strengthand UltimateElongationASTM D6319-19StandardSpecification forNitrile ExaminationGloves for MedicalApplication | S | 15.7 MPa | 15.0 MPa | S | 14 MPa Min for allsizes | 14 MPa Min for allsizes |
| 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 allsizes | 400%Min for allsizes | ||
| 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 Holesin Medical Gloves | Size | Size | |||
| 3. | ASTM D6319-19/ASTM D5151-19Standard TestMethod forDetection of Holesin Medical Gloves | S | AQL 2.5 | S | AQL 2.5 |
| M | M | ||||
| L | L | ||||
| XL | XL | ||||
| Powder FreeResidue | Size | Residual powder content | Size | Residual powder content | |
| 4. | ASTM D6124-06(Reapproved 2017)Standard TestMethod for ResidualPowder on MedicalGloves | 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 thestudy, cytotoxic to L-929 cells.Additional Testing wasperformed to determine if thiswas a systemic toxicity concern | Under the conditions of thestudy, not cytotoxic. | - |
| 2. | Skin Sensitization | Under the conditions of thestudy not a sensitizer | Under the conditions of thestudy not a sensitizer | Pass |
| 3. | Skin Irritation | Under the condition of study notan irritant | Under the condition of study notan 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 thestudy, the device extracts do notpose a systemic toxicity concern | Under the conditions of thestudy, the device extracts do notpose a systemic toxicity concern | 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 amaterialmediated 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.
§ 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.