(59 days)
The Nitrile Patient Examination Gloves are non-sterile disposable devices intended for medical purposes that are worn on the examiner's hands or finger to prevent contamination between patient and examiner.
The subject device is powder free nitrile examination gloves. The subject device is blue. The subject device is non-sterile.
This looks like a 510(k) premarket notification for Nitrile Patient Examination Gloves, not an AI/ML medical device. Therefore, the questions about acceptance criteria, study design for AI, sample sizes, expert ground truth, MRMC studies, and standalone performance are not directly applicable.
Instead, the document details the device's adherence to established standards for medical gloves. Here's a breakdown of the relevant information provided:
1. Table of Acceptance Criteria and Reported Device Performance
The document uses a comparison table against a predicate device and adherence to industry standards as its form of "acceptance criteria" and "reported device performance."
| Item | Acceptance Criteria (Predicate Device K171422 or Standard) | Reported Device Performance (Subject Device K211028) |
|---|---|---|
| General Characteristics | ||
| Product Code | LZA | LZA |
| Regulation No. | 21CFR880.6250 | 21CFR880.6250 |
| Class | I | I |
| Intended Use | Prevent contamination between patient and examiner | Prevent contamination between patient and examiner |
| Powdered/Powered free | Powdered free | Powdered free |
| Design Feature | Ambidextrous | Ambidextrous |
| Labeling Information | Single-use, powder free, device color, device name, glove size and quantity | Single-use, powder free, device color, device name, glove size and quantity |
| Physical Dimensions | ||
| Length (XS, S, M, L, XL) | 230mm min | 220-230mm min (XS is 220, others 230) |
| Width (XS, S, M, L, XL) | 75-115mm (±5) | 70-120mm (XS-XL) (±10) |
| Thickness (Finger/Palm) | 0.05mm min | 0.05mm min |
| Overall Dimension Note | All meet ASTM D6319-19 requirements | All meet ASTM D6319-19 requirements |
| Performance (ASTM D6319) | ||
| Tensile Strength (Before Aging) | 14MPa, min | 14MPa, min |
| Ultimate Elongation (Before Aging) | 500% min | 500% min |
| Tensile Strength (After Aging) | 14MPa, min | 14MPa, min |
| Ultimate Elongation (After Aging) | 400% min | 400% min |
| Freedom from Holes (ASTMD5151) | AQL=2.5 | AQL=2.5 |
| Powder Content (ASTM D6124) | Meet requirements of ASTM D6124 | 0.07 mg per glove. Meet requirements of ASTM D6124 |
| Safety/Biocompatibility | ||
| Material | Nitrile | Nitrile |
| Irritation (ISO 10993-10) | Not an irritant | Not an irritant |
| Sensitization (ISO 10993-10) | Not a sensitizer | Not a sensitizer |
| Cytotoxicity (ISO 10993-5) | Not cytotoxic | Not cytotoxic |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Test Set (for performance and safety): The document does not specify exact sample sizes for each test (e.g., how many gloves were tested for holes, tensile strength, or biocompatibility). However, it references conformity to international standards (ASTM and ISO). These standards typically define sampling plans for lot release and quality control.
- Data Provenance: The tests were conducted by the manufacturer, Huayuan Medical Technology (Shangqiu) Co., Ltd. located in China. The data's origin would therefore be from their internal testing processes. The study is prospective in the sense that the tests were performed on the manufactured device to demonstrate compliance.
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 for this type of device. "Ground truth" in the context of medical gloves is established by objective measurements against established physical, chemical, and biological standards (ASTM, ISO). There are no human expert interpretations involved in determining if a glove has a hole or its tensile strength.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. As noted above, the evaluation relies on objective measurement against defined specifications, not subjective interpretation requiring 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/ML device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI/ML device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" (or more accurately, the pass/fail criteria) is based on established international and national consensus standards for medical gloves:
- ASTM D6319-19 (Standard Specification for Nitrile Examination Gloves for Medical Application)
- ASTM D5151-19 (Standard Test Method for Detection of Holes in Medical Gloves)
- ASTM D6124-06 (Reapproved 2017) (Standard Test Method for Residual Powder on Medical Gloves)
- ISO 10993-5:2009 (Biological Evaluation of Medical Devices - Part 5: Tests For In Vitro Cytotoxicity)
- ISO 10993-10:2010 (Biological Evaluation of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization)
These standards define the acceptable physical properties, barrier integrity, and biocompatibility.
8. The sample size for the training set
Not applicable. This is not an AI/ML device. There is no concept of a "training set" for physical products like examination gloves in this context.
9. How the ground truth for the training set was established
Not applicable.
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Image /page/0/Picture/0 description: The image shows 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 4, 2021
Huayuan Medical Technology(Shangqiu) Co., Ltd. % Boyle Wang Official Correspondent Shanghai Truthful Information Technology Co., Ltd. RM.608, No.738, Shangcheng Rd., Pudong Shanghai, Shanghai 200120 China
Re: K211028
Trade/Device Name: Nitrile Patient Examination Gloves Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I, reserved Product Code: LZA Dated: April 2, 2021 Received: April 6, 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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's
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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 (OS) 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,
For Ryan Ortega 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) K211028
Device Name Nitrile Patient Examination Gloves
Indications for Use (Describe)
The Nitrile Patient Examination Gloves are non-sterile disposable devices intended for medical purposes that are worn on the examiner's hands or finger 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 (K211028)
This summary of 510(k) is being submitted in accordance with 21 CFR 807.92.
1.0 Submitter's Information
Name: Huayuan Medical Technology (Shangqiu) Co., Ltd. Address: In The North Yard of West 1000m Road at The Intersection of Zhuangzhou Avenue and Pingyuan Road, Liangyuan District, Shangqiu City, Henan Province,China. Phone Number: +86-13705111918 Contact: Huamei Wang Date of Preparation: Jun.03,2021
Designated Submission Correspondent
Mr. Boyle Wang Shanghai Truthful Information Technology Co., Ltd. Room 608, No. 738 Shangcheng Rd., Pudong,Shanghai 200120 ,China Tel: +86-21-50313932 Email: Info@truthful.com.cn
2.0 Device Information
Trade name: Nitrile Patient Examination Gloves Common name: Patient Examination Gloves Classification name: Non-powdered patient examination glove Model(s): XS、S、M、L、XL、XXL
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 Disposable Powder Free Nitrile Examination Glove, White/ Device: Blue/ Black/ Pink Color
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510(k) number: K171422
5.0 Indication for Use
The Nitrile Patient Examination Gloves are non-sterile disposable devices intended for medical purposes that are worn on the examiner's hands or finger to prevent contamination between patient and examiner.
6.0 Device Description
The subject device is powder free nitrile examination gloves. The subject device is blue. The subject device is non-sterile.
7.0 Technological Characteristic Comparison Table
| Item | Subject Device(K211028) | Predicated Device(K171422) | Remark |
|---|---|---|---|
| Product Code | LZA | LZA | Same |
| Regulation No. | 21CFR880.6250 | 21CFR880.6250 | Same |
| Class | I | I | Same |
| Intended Use | The Nitrile PatientExamination Glovesare non-steriledisposable devicesintended for medicalpurposes that areworn on theexaminer's hands orfinger to preventcontaminationbetween patient andexaminer. | The Nitrile PowderFree patientexamination gloveis a non-steriledisposable deviceintended formedical purposesthat is worn on theexaminer's handsor finger to preventcontaminationbetween patientand examiner. | Same |
| Powdered orPowered free | Powdered free | Powdered free | Same |
| Design Feature | Ambidextrous | Ambidextrous | Same |
| Labeling Information | Single-useindication, powderfree, device color,device name, glovesize and quantity,Nitrile GlovePowder Free, Blue | Single-useindication, powderfree, device color,device name, glovesize and quantity,Disposable PowderFree Nitrile | Same |
Table1-General Comparison
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| Non-Sterile | Examination Glove,Non-Sterile | |
|---|---|---|
| -- | ------------- | ----------------------------------- |
| Size | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| Designation | XS | S | M | L | XL | Tolerance | |||
| PredicateDevice(K171422) | Length, mm | 230 | 230 | 230 | 230 | 230 | min | ||
| Width, mm | 75 | 85 | 95 | 105 | 115 | ±5 | |||
| Thickness, mm: | |||||||||
| Finger | 0.05 | min | |||||||
| Palm | 0.05 | min | |||||||
| Designation | XS | S | M | L | XL | XXL | Tolerance | ||
| Subject Device(K211028) | Length, mm | 220 | 230 | 230 | 230 | 230 | 230 | min | |
| Width, mm | 70 | 80 | 95 | 110 | 120 | 130 | ±10 | ||
| Thickness, mm: | |||||||||
| Finger | 0.05 | min | |||||||
| Palm | 0.05 | min | |||||||
| Remark | Similar |
Table2 Device Dimensions Comparison
Analysis: The physical dimensions are different with that 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.
Table3 Performance Comparison
| Item | Subject device(K211028) | Predicated device(K171422) | Remark | ||
|---|---|---|---|---|---|
| Colorant | Blue | White/ Blue/Black/ Pink | Same | ||
| PhysicalProperties | BeforeAging | TensileStrength | 14MPa, min | 14MPa, min | Same |
| UltimateElongation | 500% min | 500% min | Same | ||
| AfterAging | TensileStrength | 14MPa, min | 14MPa, min | Same | |
| UltimateElongation | 400%min | 400%min | Same | ||
| Comply with ASTM D6319 | Comply withASTMD6319 | Same | |||
| Freedom from Holes | Be free fromholes whentested in | Be free fromholes whentested in | Same |
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| accordancewithASTMD5151AQL=2.5 | accordancewithASTMD5151AQL=2.5 | ||
|---|---|---|---|
| Powder Content | 0.07 mg perglove. Meet therequirementsof ASTMD6124 | Meettherequirementsof ASTMD6124 | Same |
Table4 Safety Comparison
| Item | Subjectdevice(K211028) | Predicateddevice(K171422) | Remark | |
|---|---|---|---|---|
| Material | Nitrile | Nitrile | Same | |
| Biocompatibility | Irritation (ISO10993-10:2010BiologicalEvaluation ofMedical Devices -Part 10: Tests ForIrritation And SkinSensitization) | Under theconditions ofthe study, notan irritant | ||
| Sensitization(ISO 10993-10:2010BiologicalEvaluation ofMedical Devices -Part 10: Tests ForIrritation And SkinSensitization) | Underconditions ofthe study, nota sensitizer. | Comply withISO10993-10 | Same | |
| Cytotoxicity (ISO10993-5:2009BiologicalEvaluation ofMedical Devices -Part 5: Tests ForIn VitroCytotoxicity) | Underconditions ofthe study,deviceextract is notcytotoxic | / | Similar |
8.0 Discussion of Non-clinical and Performance Testing
Non-clinical tests were conducted to verify that the proposed device met all
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design specifications. The test results demonstrated that the proposed device complies with the following standards:
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
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 Nitrile Examination Gloves for Medical Application.
9.0 Discussion of Clinical and Performance Testing
Clinical testing is not needed for this device.
10.0 Conclusion
The conclusions drawn from the nonclinical tests demonstrate that the subject device, Nitrile Patient Examination Gloves ,are as safe, as effective, and perform as well as or better than the legally marketed predicated device in K171422.
§ 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.