(224 days)
The Powder Free Nitrile Gloves is intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner. This device is a disposable product, provided non-sterile.
The Powder Free Nitrile Gloves are non-sterile disposable patient examination gloves. The gloves are blue and powder free. The Powder Free Nitrile Gloves come in four sizes: Small, Medium, Large, X Large. The Powder Free Nitrile Gloves act as a barrier to prevent contamination between patient and examiner. The device meets all requirements of ASTM D6319-19.
The provided document is a 510(k) Premarket Notification for Powder Free Nitrile Gloves. This document describes the substantial equivalence of the subject device to a predicate device, primarily through non-clinical testing. It does not describe a study involving an AI/software as a medical device (SaMD) or any comparative effectiveness study with human readers improving with AI assistance.
Therefore, many of the requested points related to AI/SaMD performance, ground truth establishment for AI training/testing, MRMC studies, expert adjudication, and effect sizes are not applicable within the context of this document.
This document focuses on proving the physical and chemical properties of a medical glove meet established ASTM and ISO standards for safety and effectiveness, similar to a legally marketed predicate device.
Here's the information that can be extracted from the provided text:
1. A table of acceptance criteria and the reported device performance
The document provides a comprehensive table outlining the acceptance criteria (standards) and the reported performance of the Powder Free Nitrile Gloves.
| Characteristic | Standard/Acceptance Criteria (ASTM/ISO) | Reported Device Performance |
|---|---|---|
| Dimension (Small) | ASTM D6319-19 | |
| Length | $\geq$220mm | 246mm |
| Width | 80$\pm$10mm | 86.4mm |
| Thickness Finger | $\geq$0.05mm | 0.11mm |
| Thickness Palm | $\geq$0.05mm | 0.08mm |
| Dimension (Medium) | ASTM D6319-19 | |
| Length | $\geq$230mm | 243mm |
| Width | 95$\pm$10mm | 96.9mm |
| Thickness Finger | $\geq$0.05mm | 0.12mm |
| Thickness Palm | $\geq$0.05mm | 0.09mm |
| Dimension (Large) | ASTM D6319-19 | |
| Length | $\geq$230mm | 255mm |
| Width | 110$\pm$10mm | 106mm |
| Thickness Finger | $\geq$0.05mm | 0.12mm |
| Thickness Palm | $\geq$0.05mm | 0.09mm |
| Dimension (X-Large) | ASTM D6319-19 | |
| Length | $\geq$230mm | 251mm |
| Width | 120$\pm$10mm | 116mm |
| Thickness Finger | $\geq$0.05mm | 0.12mm |
| Thickness Palm | $\geq$0.05mm | 0.08mm |
| Physical Properties | ASTM D6319-19 | |
| Before Aging: Tensile Strength | $\geq$14MPa | 34.56MPa |
| Before Aging: Ultimate Elongation | $\geq$500% | 556% |
| After Aging: Tensile Strength | $\geq$14MPa | 36.34MPa |
| After Aging: Ultimate Elongation | $\geq$400% | 485% |
| Freedom from Pinholes | ASTM D5151-19, Inspection level: G-1, AQL=2.5 | Pass, no water leakage, Passed Standard Acceptance Criteria |
| Residual Powder | ASTM D6319-19 and ASTM D6124-06 (Reapproved 2017) | Meets < 2.0 mg/glove (Reported: 0.3mg/glove) |
| Biocompatibility | ||
| In vitro cytotoxicity | ISO 10993-5:2009 | Cytotoxic (requires additional testing) |
| Acute Systemic Toxicity | ISO 10993-11:2017 | Pass (no evidence of systemic toxicity) |
| Skin Irritation | ISO 10993-10:2010 | Pass (negligible response) |
| Skin Sensitization | ISO 10993-10:2010 | Pass (no significant evidence of sensitization) |
| Shelf-life | ASTM D7160-16 | Pass and met 3 years of shelf-life |
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 explicitly state the specific sample sizes for each non-clinical test (e.g., how many gloves were tested for dimensions, tensile strength, pinholes, etc.). It refers to meeting the requirements of standards like ASTM and ISO, which would inherently include specified sample sizes for their respective tests. The provenance of the data is not specified beyond being part of a 510(k) submission from "ST FUTURE INTERNATIONAL LIMITED" (Hong Kong) through a consultant in China. The testing itself is non-clinical/laboratory-based.
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)
Not applicable. This is not an AI/SaMD study requiring expert interpretation or ground truth establishment in a clinical context. The "ground truth" for the device's properties is established by the methods and criteria defined in the referenced ASTM and ISO standards for physical and chemical testing.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable. This is not an AI/SaMD study involving human reader interpretation or 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/SaMD study.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI/SaMD study. The "device performance" refers to the intrinsic physical and chemical properties of the glove.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device is based on objective measurements and laboratory testing results against established industry standards (ASTM, ISO and their specific test methods). For example:
- Physical dimensions are measured.
- Tensile strength and elongation are measured using standardized equipment.
- Pinholes are detected via water leakage tests per ASTM D5151-19.
- Residual powder is measured gravimetrically.
- Biocompatibility tests (cytotoxicity, systemic toxicity, irritation, sensitization) are conducted following ISO standards using biological models (in vitro cell cultures, guinea pigs).
8. The sample size for the training set
Not applicable. This is not an AI/SaMD device that requires a "training set."
9. How the ground truth for the training set was established
Not applicable. This is not an AI/SaMD device.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
June 6, 2022
St Future International Limited % Bing Huang Registration Engineer Feiying Drug & Medical Consulting Technical Service Group Rm 2401 Zhenye International Business Center, No. 3101-90, Qianhai Road ShenZhen, GuangDong 518100 China
Re: K213448
Trade/Device Name: Powder Free Nitrile Gloves Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I, reserved Product Code: LZA Dated: April 28, 2022 Received: May 5, 2022
Dear Bing Huang:
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 mediation-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 Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K213448
Device Name Powder Free Nitrile Gloves
Indications for Use (Describe)
The Powder Free Nitrile Gloves is intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner.
This device is a disposable product, provided non-sterile.
| 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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510 (k) Summary
This "510(k) Summary" of 510(k) safety and effectiveness information is submitted in accordance with requirements of Title 21, CFR Section 807.92.
K213448
(1) Applicant information:
| 510(k) owner's name: | ST FUTURE INTERNATIONAL LIMITED |
|---|---|
| Address: | FLAT/RM 08 9/F CHEVALIER COMMERCIAL CENTRE 8WANG HOT ROAD KOWLOON BAY HK |
| Contact person: | Ivan Tan |
| Phone number: | +86-13416165207 |
| Email: | qa01@st-future.com |
| Date of summary prepared: | 2022-6-2 |
(2) Proprietary name of the device
| Trade name/model: | Powder Free Nitrile Gloves |
|---|---|
| Common name: | Polymer Patient Examination Glove |
| Regulation number: | 21 CFR 880.6250 |
| Product code: | LZA |
| Review panel: | General Hospital |
| Regulation class: | Class I |
(3) Predicate device
| Predicate device | |
|---|---|
| Sponsor | Onetexx Sdn Bhd |
| Device Name and Model | Blue Nitrile Powder Free Patient Examination Glove, Non Sterile |
| 510(k) Number | K210366 |
| Product Code | LZA |
| Regulation Number | 21 CFR 880.6250 |
| Regulation Class | Class I |
(4) Description/ Design of device:
The Powder Free Nitrile Gloves are non-sterile disposable patient examination gloves. The gloves are blue and powder free. The Powder Free Nitrile Gloves come in four sizes: Small, Medium, Large, X Large.
The Powder Free Nitrile Gloves act as a barrier to prevent contamination between patient and
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examiner. The device meets all requirements of ASTM D6319-19.
(5) Indications for use:
The Powder Free Nitrile Gloves is intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner.
This device is a disposable product, provided non-sterile.
(6) Materials
| Product name | Material of product | Color additives | Body contract category | Contact duration |
|---|---|---|---|---|
| Powder FreeNitrile Gloves | Nitrile | Blue | Surface and externalcommunicating device | Less than 24 hours |
(7) Technological Characteristic Comparison Table
| Item | Subject device | Predicate device | Remark |
|---|---|---|---|
| Company | ST FUTURE | Onetexx Sdn Bhd | / |
| INTERNATIONAL | |||
| LIMITED | |||
| Trade name | Powder Free Nitrile Gloves | Blue Nitrile Powder Free | / |
| Patient Examination Glove, | |||
| Non Sterile | |||
| 510 (k) number | K213448 | K210366 | / |
| Regulation number | 21CFR 880.6250 | 21 CFR 880.6250 | Same |
| Product code | LZA | LZA | Same |
| Size | S/ M/ L/ XL | Extra Small/ Small/ Medium/ | Same |
| Large/ Extra Large | |||
| Class | I | I | Same |
| Indications for use/Intended use | The Powder Free NitrileGloves is intended for | A patient examination gloveis a disposable device made | Similar,onlywordingdifference |
| medical purposes that is | of synthetic rubber latex | ||
| worn on the examiner's | intended for medical purposes | ||
| hands to prevent | that is worn on the examiner's | ||
| contamination between | hand or finger to prevent | ||
| patient and examiner. | contamination between | ||
| This device is a disposable | patient and examiner. | ||
| product, provided | |||
| non-sterile. | |||
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ST FUTURE INTERNATIONAL LIMITED
510(k)s – Section 1. 510 (k) Summary
| Dimensions: | |||||
|---|---|---|---|---|---|
| S | Length | 246mm | 249mm | Differentbut within the ASTM D6319 | |
| Width | 86.4mm | 87.0mm | |||
| Thic | Finger | 0.11mm | 0.10mm | ||
| kness | Palm | 0.08mm | 0.07mm | ||
| M | Length | 243mm | 249mm | ||
| Width | 96.9mm | 98.0mm | |||
| Thic | Finger | 0.12mm | 0.10mm | ||
| kness | Palm | 0.09mm | 0.07mm | ||
| L | Length | 255mm | 248mm | ||
| Width | 106mm | 107mm | |||
| Thic | Finger | 0.12mm | 0.10mm | ||
| kness | Palm | 0.09mm | 0.07mm | ||
| XL | Length | 251mm | 250mm | ||
| Width | 116mm | 117mm | |||
| Thic | Finger | 0.12mm | 0.10mm | ||
| kness | Palm | 0.08mm | 0.07mm | ||
| Physical Properties: | |||||
| Differentbut within the ASTM D6319 | |||||
| Before AgingTensile strength | 34.56MPa | 32.35MPa | |||
| Ultimate elongation | 556% | 568% | |||
| After AgingTensile strength | 36.34MPa | 36.10MPa | |||
| Ultimate elongation | 485% | 551% | |||
| Freedom fromPinholes Holes | In accordance with ASTMD5151-19 | In accordance with ASTMD5151-19 | Same | ||
| Inspection level: G-1AQL=2.5 | Inspection level: G-1AQL=2.5 | ||||
| Residual Powder | 0.3mg/glove | 0.24mg/glove | Differentbut within the ASTM D6124 | ||
| Materials used tofabricate the devices | Nitrile | Nitrile | Same | ||
| Color | Blue | Blue | Same |
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| Compareperformance datasupportingsubstantialequivalence | Meets ASTM D5151-19ASTM D6319-19ASTM D6124-06(Reapproved 2017) | Meets ASTM D5151-19ASTM D6319-19ASTM D6124-06(Reapproved 2017) | Same | |
|---|---|---|---|---|
| Single Use | Single Use | Single Use | Same | |
| Biocompatibility | Under the conditions of thisstudy, the test article extractshowed no significantevidence of causing skinsensitization in the guineapig. Complies with ISO10993-10:2010. | The test material did notproduce a skin sensitizationeffect in the guinea pigs.Complies with ISO10993-10:2010. | Same | |
| The test result showed thatthe irritant response of thetest article extract wascategorized as negligibleunder the test condition.Complies with ISO10993-10:2010. | The test material did notcause an irritant response.The Primary IrritantResponse Category is deemed'Negligible'. Complies withISO 10993-10:2010. | Same | ||
| According to ISO 10993-5:2009, the test materialdemonstrated a cytotoxiceffect under the condition ofthis study. Additional testi.e. Acute Systemic Toxicitywas tested. | According to ISO 10993-5:2009, the test materialdemonstrated a cytotoxiceffect under the condition ofthis study. Additional test i.e.Acute Systemic Toxicity wastested. | Same | ||
| Under the conditions of thisstudy, there was noevidence of systemictoxicity from the extract.Complies with ISO10993-11:2017 | The test item did not induceany systemic toxicity.Complies with ISO 10993-11:2017 | Same | ||
| Shelf-life | 3 years | Not known | Different |
Note 1: Although the shelf-life data of the predicate device are unknown, but the subject device has been validated to the shelf-life of 3 years, so the difference does not affect safety and effectiveness.
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(8) Summary of Non-Clinical Testing:
Powder Free Nitrile Gloves are summarized with the following technological characteristics compared to ASTM or equivalent standard.
| Characteristics | Standard | Result | |
|---|---|---|---|
| Dimension | ASTM D6319-19 | ||
| Small | |||
| Length | $\geq220mm$ | 246mm | |
| Width | 80±10mm | 86.4mm | |
| Thickness Finger | $\geq0.05mm$ | 0.11mm | |
| Palm | $\geq0.05mm$ | 0.08mm | |
| Medium | |||
| Length | $\geq230mm$ | 243mm | |
| Width | 95±10mm | 96.9mm | |
| Thickness Finger | $\geq0.05mm$ | 0.12mm | |
| Palm | $\geq0.05mm$ | 0.09mm | |
| Large | |||
| Length | $\geq230mm$ | 255mm | |
| Width | 110±10mm | 106mm | |
| Thickness Finger | $\geq0.05mm$ | 0.12mm | |
| Palm | $\geq0.05mm$ | 0.09mm | |
| X large | |||
| Length | $\geq230mm$ | 251mm | |
| Width | 120±10mm | 116mm | |
| Thickness Finger | $\geq0.05mm$ | 0.12mm | |
| Palm | $\geq0.05mm$ | 0.08mm | |
| Physical Properties | ASTM D6319-19 | ||
| Before aging | Tensile strength $\geq14MPa$ | 34.56MPa | |
| Ultimate elongation $\geq500%$ | 556% | ||
| After aging | Tensile strength $\geq14MPa$ | 36.34MPa | |
| Ultimate elongation $\geq400%$ | 485% | ||
| Freedom from pinholes | ASTM D5151-19 | Pass, no water leakagePassed Standard Acceptance Criteria, AQL=2.5 | |
| Powder Residual | ASTM D6319-19 and ASTM D6124-06 (Reapproved 2017) | Meets < 2.0 mg/ glove 0.3mg/glove | |
| Biocompatibility | In vitro cytotoxicity ISO 10993-5:2009 | Cytotoxic. Additional test i.e. Acute Systemic Toxicity was tested.The test material demonstrated a cytotoxic effect under the condition of this study | |
| Acute Systemic Toxicity of PowderFree Nitrile Gloves ISO 10993-11:2017 | Under the conditions ofthis study, there was noevidence of systemictoxicity from theextract. The test articleextract met therequirements of thestudy. | Pass | |
| Skin Irritation ISO 10993-10: 2010 | The test result showedthat the response of thetest article extract wascategorized asnegligible under thetest condition. | Pass | |
| Skin sensitization in the guinea pigISO 10993-10: 2010 | Under the conditions ofthis study, the testarticle extract showedno significant evidenceof causing skinsensitization in theguinea pig. | Pass | |
| Shelf-life | ASTM D7160-16The study arefollowing the table 1lists three conditions(0, 50 oC ,70 oC ) foraccelerate agingtesting. | Pass and met 3years of shelf-life. |
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The Powder Free Nitrile Gloves meet requirements per ASTM D6319-19, per ASTM D 5151-19, per ASTM D6124-06 (Reapproved 2017), ISO 10993-11: 2017 and ISO 10993-10: 2010.
(9) Summary of Clinical Testing
Clinical performance testing was not needed for this device.
(10) Conclusion
Based on the nonclinical tests performed, the subject device, Powder Free Nitrile Gloves, are as safe, as effective, and perform as well as the legally marketed predicate device, K210366, Blue Nitrile Powder Free Patient Examination Glove, Non-Sterile.
§ 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.