(98 days)
The Medical Examination Gloves are disposable devices intended for medical purposes that are worn on the examiner's hands to prevent contamination between patient and examiner.
The proposed device is Powder Free Medical Examination Gloves. The proposed device is blue. The design of proposed device is addressing the standards as ASTM D6124, ASTM D5151, and ASTM D6319. The proposed device is non-sterile.
The provided document is a 510(k) summary for Medical Examination Gloves. It details the device's characteristics and compares them to a predicate device to demonstrate substantial equivalence. Since this is an application for a Class I medical device (Medical Examination Gloves), the acceptance criteria and supporting studies are focused on demonstrating that the device performs as intended and is as safe and effective as a legally marketed predicate device, rather than a detailed AI-driven diagnostic or treatment device study. Therefore, many of the requested categories for AI/human reader studies are not applicable.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria (from recognized standards) and Reported Device Performance:
| Acceptance Criteria (from Standards) | Proposed Device Performance | Predicate Device Performance (per submitted document) |
|---|---|---|
| Dimensions (ASTM D6319-19) | ||
| Length, mm (min) | S: 220, M: 230, L: 230, XL: 230 | 230 |
| Width, mm (tolerance) | S: 80 ($\pm 10$), M: 95 ($\pm 10$), L: 110 ($\pm 10$), XL: 120 ($\pm 10$) | XS: 75 ($\pm 5$), S: 85 ($\pm 5$), M: 95 ($\pm 5$), L: 105 ($\pm 5$), XL: 115 ($\pm 5$) |
| Finger Thickness, mm (min) | 0.05 | 0.05 |
| Palm Thickness, mm (min) | 0.05 | 0.05 |
| Note: "Analysis1" states that the proposed device's dimensions meet ASTM D6319-19, despite differences from the predicate. | ||
| Physical Properties (ASTM D6319) | ||
| Before Aging Tensile Strength (min) | 14 MPa | 14 MPa |
| Before Aging Ultimate Elongation (min) | 500% | 500% |
| After Aging Tensile Strength (min) | 14 MPa | 14 MPa |
| After Aging Ultimate Elongation (min) | 400% | 400% |
| Freedom from Holes (ASTM D5151) | AQL=2.5 | AQL=2.5 |
| Powder Content (ASTM D6124) | 0.15 | "Meet the requirements of ASTM D6124" |
| Biocompatibility (ISO 10993-10, -5, -11) | ||
| Irritation (ISO 10993-10) | Not an irritant | Comply with ISO10993-10 |
| Sensitization (ISO 10993-10) | Not a sensitizer | (Not explicitly stated for predicate, but overall compliance implies) |
| Cytotoxicity (ISO 10993-5) | Potentially cytotoxic | Comply with ISO10993-5 |
| Systemic Toxicity (ISO 10993-11) | Does not elicit a systemic toxicity response | Complies with ISO 10993-11 Third edition 2017-09 |
| Material | Nitrile | Nitrile |
| Powdered/Powder-free | Powdered free | Powdered free |
Study Proving Device Meets Acceptance Criteria:
The device's compliance is proven through a series of non-clinical (bench) tests against recognized international and national standards. The document explicitly states:
- "The following tests were performed to evaluate the biocompatibility of the proposed device, the tests' results to show substantial equivalence to the predicate device:"
- ISO 10993-10:2010 Biological Evaluation Of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization.
- ISO 10993-5:2009 Biological Evaluation Of Medical Devices - Part 5: Tests For In Vitro Cytotoxicity
- ISO 10993-11 Third edition 2017-09, Biological evaluation of medical devices -Part 11: Tests for systemic toxicity.
- "In summary, the performance testing of the subject device was conducted to adequately demonstrate the effectiveness of the device in accordance with the relevant test methods cited below:"
- ASTM D6124-06 (Reapproved 2017), Standard Test Method for Residual Powder on Medical Gloves
- ASTM D5151-19, Standard Test Method for Detection of Holes in Medical Gloves.
- ASTM D6319-19, Standard Specification For Medical Examination Gloves For Medical Application.
- ASTM D7160-16, Standard Practice for Determination of Expiration Dating for Medical Gloves
2. Sample Size Used for the Test Set and Data Provenance:
The document does not specify the exact sample sizes for each non-clinical test (e.g., number of gloves tested for holes, number of samples for biocompatibility). These are typically determined by the testing standards themselves.
The data provenance is from testing conducted by the manufacturer (Guangdong Gymda Medical Technology Co., Ltd) or their designated testing facilities in China, as indicated by the company's address and the origin of the submission. These are prospective tests conducted during the device development and submission process.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
Not applicable. For this type of device (medical examination gloves), the "ground truth" for performance is established by the specified standards (ASTM, ISO) and laboratory testing methodologies, not by expert human interpretation of results in the way a diagnostic AI system would require. The tests yield objective, measurable outcomes (e.g., tensile strength, presence of holes, cytotoxicity levels).
4. Adjudication Method for the Test Set:
Not applicable. Adjudication methods (like 2+1 or 3+1) are used for resolving discrepancies in human interpretation of data, typically for clinical studies or image-based diagnostic systems. The non-clinical tests performed here produce direct, quantifiable results.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done:
No. This is not an AI-assisted diagnostic device, so an MRMC comparative effectiveness study is not applicable. The device is a physical barrier (glove).
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done:
Not applicable. The device is not an algorithm or AI system.
7. The Type of Ground Truth Used:
The ground truth is based on objective measurements against established performance specifications and biocompatibility endpoints defined by international and national standards (ASTM and ISO), measured through laboratory testing.
8. The Sample Size for the Training Set:
Not applicable. This device is not an AI/machine learning system that requires a training set. The "training" for such devices involves adherence to manufacturing quality systems and design controls to consistently produce devices meeting specifications.
9. How the Ground Truth for the Training Set Was Established:
Not applicable. As above, there is no "training set" in the context of an AI model for this device.
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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 text logo on the right. The text logo has the FDA acronym in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
October 8, 2021
Guangdong Gymda Medical Technology Co., Ltd % Boyle Wang General Manager Shanghai Truthful Information Technology Co., Ltd. Room 608, No.738, Shangcheng Rd., Pudong Shanghai, Shanghai 200120 China
Re: K212078
Trade/Device Name: Medical Examination Gloves Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I, reserved Product Code: LZA Dated: September 6, 2021 Received: September 10, 2021
Dear Boyle Wang:
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
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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,
For Clarence W. Murray, III, PhD 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) K212078
Device Name Medical Examination Gloves
Indications for Use (Describe)
The Medical Examination Gloves are disposable devices intended for medical purposes that are worn on the examiner's hands 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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510(k) Summary
This summary of 510(k) safety and effectiveness information is being submitted in accordance with 21 CFR 807.92.
1.0 submitter's information
Name: Guanqdong Gymda Medical Technology Co.,Ltd Address: No.13, Quan'an Third Road, Phase 2 of High-tech Zone, Nanxiong City, Shaoguan City, Guangdong Province, 512400, China Phone Number: +86-20-37738661 Contact: Olivia Chen Date of Preparation: 2021.05.27
Designated Submission Correspondent
Mr. Boyle Wang Shanghai Truthful Information Technology Co., Ltd. Tel: +86-21-50313932 Email: Info@truthful.com.cn
2.0 Device information
Trade name: Medical Examination Gloves Common name: Patient Examination Gloves Classification name: Non-powdered patient examination glove Model(s): S, M, L, XL
3.0 Classification
Production code: LZA Regulation number: 21CFR880.6250 Classification: Class I Panel: General Hospital
4.0 Predicate device information
Manufacturer: Ever Global (Vietnam) Enterprise Corp Device: Disposable Powder Free Nitrile Examination Glove, White/ Blue/ Black/ Pink Color 510(k) number: K171422
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5.0 Intended use
The Medical Examination Gloves are disposable devices intended for medical purposes that are worn on the examiner's hands to prevent contamination between patient and examiner.
6.0 Device description
The proposed device is Powder Free Medical Examination Gloves. The proposed device is blue. The design of proposed device is addressing the standards as ASTM D6124, ASTM D5151, and ASTM D6319. The proposed device is non-sterile.
7.0 Summary comparing technological characteristics with predicate device
| Table1-General Comparison | |||
|---|---|---|---|
| Item | Proposed device | Predicated device | Remark |
| 510(k) number | Pending | K171422 | |
| Product Code | LZA | LZA | Same |
| Regulation No. | 21CFR880.6250 | 21CFR880.6250 | Same |
| Class | I | I | Same |
| Intended Use | The Medical ExaminationGloves is a disposabledevice intended formedical purposes that isworn on the examiner'shands to preventcontamination betweenpatient and examiner. | The Disposable PowderFree Nitrile ExaminationGlove, White/ Blue/ Black/Pink Color is a disposabledevice intended formedical purposes that isworn on the examiner'shands to preventcontamination betweenpatient and examiner. | Same |
| Powdered or Powered free | Powdered free | Powdered free | Same |
| Design Feature | ambidextrous | ambidextrous | Same |
| Labeling Information | Single-use indication,powder free, device color,device name, glove sizeand quantity, MedicalExamination Gloves,Non-Sterile | Single-use indication,powder free, device color,device name, glove sizeand quantity, DisposablePowder Free NitrileExamination Glove,Non-Sterile | Same |
Table1-General Comparison
Table2 Device Dimensions Comparison
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| Predicate | Designation | Size | Tolerance | ||||
|---|---|---|---|---|---|---|---|
| Device(K171422) | XS | S | M | L | XL | ||
| Length, mm | 230 | 230 | 230 | 230 | 230 | min | |
| Width, mm | 75 | 85 | 95 | 105 | 115 | $\pm 5$ | |
| Thickness, mm: | |||||||
| Finger | 0.05 | min | |||||
| Palm | 0.05 | min | |||||
| Proposed Device | Designation | Size | Tolerance | ||||
| S | M | L | XL | ||||
| Length, mm | 220 | 230 | 230 | 230 | min | ||
| Width, mm | 80 | 95 | 110 | 120 | $\pm 10$ | ||
| Thickness, mm: | |||||||
| Finger | 0.05 | min | |||||
| Palm | 0.05 | min | |||||
| Remark | Analysis 1 |
Analysis1: The sizes and tolerances of proposed device are different with those of the predicate, but they all meet the requirements of ASTM D6319-19, so the differences do not raise any new safety or performance questions.
| Item | Proposed device | Predicated device | Remark | |
|---|---|---|---|---|
| Colorant | blue | White/ Blue/ Black/ Pink | Analysis2 | |
| PhysicalProperties | BeforeAgingTensileStrength | 14MPa, min | 14MPa, min | SAME |
| UltimateElongation | 500%min | 500%min | SAME | |
| AfterAgingTensileStrength | 14MPa, min | 14MPa, min | SAME | |
| UltimateElongation | 400%min | 400%min | SAME | |
| Comply with ASTM D6319 | Comply with ASTM D6319 | SAME | ||
| Freedom from Holes | Be free from holes when tested in accordance with ASTMD5151 AQL=2.5 | Be free from holes when tested in accordance with ASTMD5151 AQL=2.5 | SAME | |
| Powder Content | 0.15 | Meet the requirements of ASTM D6124 | SIMILAR |
Table3 Performance Comparison
Analysis 2: The proposed device has different color to the predicate device, but all proposed devices are conducted the biocompatibility test, the test results shown that the color difference do not effect the safety of proposed device
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| Item | Proposed device | Predicated device | Remark | |
|---|---|---|---|---|
| Material | Nitrile | Nitrile | SAME | |
| Biocompatibility | Irritation | Under the conditions of the study, not an irritant | Comply with ISO10993-10 | SAME |
| Sensitization | Under conditions of the study, not a sensitizer. | |||
| Cytotoxicity | Under the conditions of the study, the device is potentially cytotoxic | Comply with ISO10993-5 | Analysis3 | |
| Systemic toxicity | Under the conditions of the study, the device does not elicit a systemic toxicity response in the model animal. | Complies with ISO 10993-11 Third edition 2017-09 | ||
| Label and Labeling | Meet FDA's Requirement | Meet Requirement | FDA's SAME |
Table4 Safety Comparison
Analysis3: The proposed device is potentially cytotoxic, but all proposed devices are conducted the systemic toxicity test, the test results show that the proposed device is safe.
8.0 Discussion of non-clinical testing
The following tests were performed to evaluate the biocompatibility of the proposed device, the tests' results to show substantial equivalence to the predicate device:
ISO 10993-10:2010 Biological Evaluation Of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization.
ISO 10993-5:2009 Biological Evaluation Of Medical Devices - Part 5: Tests For In Vitro Cytotoxicity
ISO 10993-11 Third edition 2017-09, Biological evaluation of medical devices -Part 11: Tests for systemic toxicity.
Clinical testing is not needed for this device.
9.0 Discussion of performance testing (Bench)
In summary, the performance testing of the subject device was conducted to adequately demonstrate the effectiveness of the device in accordance with the relevant test methods cited below:
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ASTM D6124-06 (Reapproved 2017), Standard Test Method for Residual Powder on Medical Gloves
ASTM D5151-19, Standard Test Method for Detection of Holes in Medical Gloves.
ASTM D6319-19,Standard Specification For Medical Examination Gloves For Medical Application.
ASTM D7160-16,Standard Practice for Determination of Expiration Dating for Medical Gloves
Conclusion 10.0
The conclusions drawn from the nonclinical tests demonstrate that the proposed device is as safe, as effective, and performs as well as the legally marketed predicated device.
§ 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.