(247 days)
Powder Free Vinyl Patient Examination Gloves, Clear (non-colored) 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.
PVC films form a barrier to prevent contamination between patient and examiner. The PVC rubber is water tight under normal conditions of use. It's tensile properties cause it to conform to the hand, allowing movements necessary for a medical procedure. The Poly (vinyl chloride) glove acts as a barrier to prevent contamination between patient and examiner. The glove is manufactured in accordance with the requirements of ASTM D5250 and ASTM D5151.
This document, K182575, is a 510(k) Premarket Notification for "Powder Free Vinyl Patient Examination Gloves, Clear (non-colored)". As such, it does not contain the type of acceptance criteria and study data typically associated with a "device" in the context of an AI/ML medical device, which would involve performance metrics like accuracy, sensitivity, specificity, and a detailed human-in-the-loop (HITL) study.
This submission is for a Class I medical device (patient examination glove), which, by regulation, has a much lower bar for demonstrating substantial equivalence to a predicate device. The "performance data" here refers to physical and biological characteristics of the glove, not diagnostic or predictive performance.
Therefore, I cannot provide the requested information in the format of AI/ML device studies because the provided document does not pertain to such a device. The "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context refer to manufacturing and material standards, not clinical diagnostic accuracy.
However, I can extract the information relevant to this specific device type and its "studies":
Acceptance Criteria and Device Performance (for a physical medical device: Examination Glove)
| Acceptance Criteria Category | Specific Acceptance Criteria (Standard & Value) | Reported Device Performance (Subject Device K182575) |
|---|---|---|
| Dimensions | ASTM D5250-06 (Reapproved 2011) | Meets ASTM D5250-06 (Reapproved 2011) |
| Length | ≥230mm (Predicate) | 231-241mm (Subject Device) - Note: Predicate shown as 232-243mm, Subject shows 231-241mm and a comparison "Same" with Predicate. |
| Width (Small) | 80-90mm (Predicate) | 81-89mm (Subject Device) - Note: Predicate shows 82-88mm, Subject shows 81-89mm and a comparison "Same" with Predicate. |
| Width (Medium) | 90-100mm (Predicate) | 93-99mm (Subject Device) - Note: Predicate shows 93-98mm, Subject shows 93-99mm and a comparison "Same" with Predicate. |
| Width (Large) | 100-110mm (Predicate) | 102-110mm (Subject Device) - Note: Predicate shows 102-109mm, Subject shows 102-110mm and a comparison "Same" with Predicate. |
| Width (X-Large) | 110-120mm (Predicate) | 111-119mm (Subject Device) - Note: Predicate shows 113-118mm, Subject shows 111-119mm and a comparison "Same" with Predicate. |
| Thickness (Finger) | ≥ 0.05mm (Predicate) | 0.05-0.10mm (Subject Device) - Note: Predicate shows 0.08-0.11mm, Subject shows 0.05-0.10mm and a comparison "Same" with Predicate. |
| Thickness (Palm) | ≥ 0.08mm (Predicate) | 0.09-0.13mm (Subject Device) - Note: Predicate shows 0.10-0.11mm, Subject shows 0.09-0.13mm and a comparison "Same" with Predicate. |
| Physical Properties | ASTM D5250-06 (Reapproved 2011) | Meets ASTM D5250-06 (Reapproved 2011) |
| Elongation (Before/After aging) | ≥ 300% (Predicate) | 340-410% (Subject Device) - Note: Predicate shows 350-420%, Subject shows 340-410% and a comparison "Same" with Predicate. |
| Tensile Strength (Before/After aging) | ≥ 14MPa (Predicate) | 15-25 MPa (Subject Device) - Note: Predicate shows 15-20 MPa, Subject shows 15-25 MPa and a comparison "Same" with Predicate. |
| Freedom from Pinholes | ASTM D5151-06 (Reapproved 2015), Holes at Inspection Level I AQL 2.5 (Predicate: LAOL 2.5) | Meets ASTM D5151-06 (Reapproved 2011), Holes at Inspection Level I AQL 2.5 |
| Residual Powder | ASTM D5250-06 (Reapproved 2011) and D6124-06 (Reaffirmation 2011): < 2mg/glove (Predicate: below 2mg of residual powder) | Meets ASTM D5250-06 (Reapproved 2011) and D6124-06 (Reaffirmation 2011) : 0.3mg (Predicate: 0.1mg). Comparison stated as "Same". |
| Biocompatibility | ISO 10993-10:2010 Primary Skin Irritation | Not a primary skin irritant |
| ISO 10993-10:2010 Dermal Sensitization | Not a skin sensitizer | |
| ISO 10993-5:2009 Cytotoxicity | Test article was non-cytotoxicity to L-929 cells |
Since this is for a physical device, the following points are not applicable or interpreted differently than for an AI/ML device:
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Sample sizes used for the test set and data provenance: Not explicitly stated as "sample size" in the context of an AI/ML test set. Performance is stated as meeting ASTM (American Society for Testing and Materials) and ISO (International Organization for Standardization) standards, which implies specific destructive and non-destructive testing on a representative sample of manufactured gloves. The provenance is internal testing by the manufacturer (Jiangxi Jaysun Medcare Co., Ltd., China). The studies are "non-clinical tests" (physical and biological).
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for physical properties (dimensions, tensile strength, pinholes) is established through standardized laboratory testing methods. Biocompatibility (irritation, sensitization, cytotoxicity) is assessed through lab-based biological assays.
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Adjudication method for the test set: Not applicable. Standardized test methods do not typically involve human adjudication in the same way an AI/ML diagnostic output would. Outcomes are based on quantitative measurements and biological assay results.
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If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No. This is a physical product, not an AI/ML diagnostic tool. Human readers are not involved in its performance evaluation in this manner.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: The "standalone" performance here refers to the physical attributes and biocompatibility of the glove itself, as tested independently against the standards. There is no algorithm.
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The type of ground truth used:
- Physical properties (dimensions, tensile strength, elongation): Established by objective measurements against specified values in ASTM standards.
- Freedom from Pinholes: Established by standardized leak tests (e.g., water fill test per ASTM D5151).
- Residual Powder: Established by gravimetric analysis per ASTM D6124.
- Biocompatibility: Established by standardized biological assays (e.g., ISO 10993-5, ISO 10993-10) using in-vitro and in-vivo models (e.g., L-929 cells, animal models for irritation/sensitization).
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The sample size for the training set: Not applicable. This device is not an AI/ML product and does not have a "training set" in that sense. The manufacturing process is refined based on quality testing, but there's no data training of a model.
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How the ground truth for the training set was established: Not applicable for the reasons mentioned above.
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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 and 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.
November 12, 2019
Jiangxi Jaysun Medcare Co., Ltd. % Chu Xiaoan Official Correspondent Beijing Easylink CO., LTD Rm. F302 Bldg., 41, Jing Cheng Ya Ju, Courtyard 6 of Southern Dou Ge Zhuang, Beijing, 100021 Cn
Re: K182575
Trade/Device Name: Jaysun Powder Free Vinyl Patient Examination Gloves, Clear (non-colored) Regulation Number: 21 CFR 880.6250 Regulation Name: Non-powdered patient examination glove Regulatory Class: Class I, reserved Product Code: LYZ Dated: April 11, 2019 Received: April 25, 2019
Dear Chu Xiaoan:
This letter corrects our substantially equivalent letter of May 24, 2019.
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 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
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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 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,
Elizabeth Claverie, M.S. 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)
Device Name
Powder Free Vinyl Patient Examination Gloves, Clear (non-colored)
Indications for Use (Describe)
Powder Free Vinyl Patient Examination Gloves, Clear (non-colored) 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.
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
"The assigned 510(k) number is:___K182575
Premarket Notification [510(k)] Summary
Submitter: 1.0
| Submitter's name : | Jiangxi Jaysun Medcare Co.,Ltd. |
|---|---|
| Submitter's address : | No.1 Jaysun Road,Penghuwan Industrial ParkPengze City, Jiujiang JiangxiProvince,332708,China |
| Phone number : | 0086-0792- 5866108 |
| Fax number : | 0086-0792- 5866108 |
| Name of contact person: | Mr. Zong Run |
| Date of preparation: | 2019-05-15 |
2.0 Name of the Device
| Device Name: | Powder Free Vinyl Patient ExaminationGloves, Clear (non-colored) |
|---|---|
| Proprietary/Trade name: | Powder Free Vinyl Patient ExaminationGloves, Clear (non-colored) |
| Common Name: | Exam gloves |
| Classification Name: | Patient examination glove |
| Device Classification: | I |
| Regulation Number: | 21 CFR 880.6250 |
| Panel: | General Hospital |
| Product Code: | LYZ |
3.0 Predicate device
| Device Name: | Powder Free Vinyl Patient Examination Gloves,Clear (non-colored) |
|---|---|
| Company name: | Zhang Jia Gang Fengyuan Plastic Product Co. Ltd. |
| 510(K) Number: | K091663 |
4.0 Device Description:
4.1 How the device functions:
PVC films form a barrier to prevent contamination between patient and examiner.
4.2 Scientific concepts that form the basis for the device
The PVC rubber is water tight under normal conditions of use. It's tensile properties cause it to conform to the hand, allowing movements necessary for a medical procedure.
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Physical and performance characteristics such as design, materials and 4.3 physical properties:
The Poly (vinyl chloride) glove acts as a barrier to prevent contamination between patient and examiner. The glove is manufactured in accordance with the requirements of ASTM D5250 and ASTM D5151.
5.0 Device Intended Use (Indication for use):
Powder Free Vinyl Patient Examination Gloves, Clear (non-colored) is a non-sterile disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
6.0 Technological Characteristics:
Shown below is a comparison of the technological characteristics of the subject device and the predicate device:
| Features & Description | Predicate Device(K091663) | Subject Device(K182575) | Result ofComparison | ||
|---|---|---|---|---|---|
| Company | Zhang Jia GangFengyuan PlasticProduct Co. Ltd. | Jiangxi JaysunMedcare Co.,Ltd. | -- | ||
| 510(K) Number | K091663 | K182575 | -- | ||
| Product name | Powder Free VinylPatient ExaminationGloves, Clear(non-colored) | Powder Free VinylPatientExaminationGloves, Clear(non-colored) | Same | ||
| Product Code | LYZ | LYZ | Same | ||
| Size | Small/ Medium/Large/X large | Small/ Medium/Large/X large | Same | ||
| Intend for use | Powder Free VinylPatient ExaminationGloves, Clear(non-colored)is a disposabledeviceintended for medicalpurposes that isworn on theexaminer's hand orfinger to preventcontaminationbetween patient andexaminer. | Powder FreeVinylPatientExaminationGloves, Clear(non-colored) is adisposabledeviceintended formedical purposesthat is worn on theexaminer's handor finger topreventcontaminationbetween patientand examiner. | Same | ||
| Device Description andSpecifications | Meets ASTMD5250-06 | Meets ASTMD5250-06(Reapproved 2011) | Same | ||
| DimensionsLength(mm )ILS-2AQL4.0 | ≥230mm | 231-241mm | 232-243mm | Same | |
| DimensionsWidth(mm)IL S-2AQL4.0 | Small | 80-90 | 81-89 | 82-88 | Same |
| Medium | 90-100 | 93-99 | 93-98 | ||
| Large | 100-110 | 102-110 | 102-109 | ||
| X large | 110-120 | 111-1119 | 113-118 | ||
| DimensionsThickness(mm )IL S-2AQL4.0 | Finger | $\ge$ 0.05 | 0.05-0.10 | 0.08-0.11 | Same |
| Palm | $\ge$ 0.08 | 0.09-0.13 | 0.10-0.11 | Same | |
| PhysicalPropertiesIL S-2AQL4.0 | Before aging/after aging | Same | |||
| Elongation $\ge$ 300% | 340-410% | 350-420% | |||
| Tensile Strength$\ge$ 14MPa | 15-25 MPa | 15-20 MPa | |||
| FreedomfromPinholesResidualPowder | Holes atInspection LevelLAOL2.5below 2mg ofresidual powder | Holes atInspectionLevel I | Holes atInspection Level IAOL2.5 | Same | |
| 0.3mg | 0.1mg | Same | |||
| Materials used to fabricatethe devices | PVC | PVC | Same | ||
| Dusting or DonningPowder: name | Surface CoatingAgent | Surface CoatingAgent | Same | ||
| Compare performance datasupporting substantialequivalence | MeetsASTM D5151-06(Reapproved 2011)ASTM D5250-06(Reapproved 2011)ASTM D6124-06(Reaffirmation 2011) | MeetsASTM D5151-06(Reapproved 2011)ASTM D5250-06(Reapproved 2011)ASTM D6124-06(Reaffirmation | Same | ||
| Single Patient Use | Single Patient Use | Single Patient Use | Same | ||
| BiocompatibilityIrritation and Sensitization(ISO 10993-10) | Under the conditionsof this study, not anirritant and Underthe conditions ofthis study, not asensitizer. | Under theconditionsof this study, notan irritant andUnder theconditions of thisstudy, not asensitizer. | Same | ||
| Cytotoxicity(ISO 10993-5) | / | Under theconditions of thisstudy, the testarticle wasnon-cytotoxicityto L-929 cells. | |||
| Labeling. | -Powder Free-PatientExaminationGlove-Single Use Only- Manufactured For:- Lot | -Powder Free-PatientExaminationGlove-Single Use Only- Manufactured For:- Lot | Same |
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7.0 Summary of Non-Clinical Performance Data:
Non-clinical tests were conducted to verify that the proposed device will meet acceptance criteria for each test. The test results demonstrated that the proposed device met the acceptance criteria found in the following standards below:
| Characteristics | Standard |
|---|---|
| Dimension | ASTM D 5250-06(Reapproved 2011). |
| Length | |
| Width | |
| Thickness | |
| PhysicalProperties | |
| Powder Residual | ASTM standard D 5250-06 (Reapproved2011).and D6124-06(Reaffirmation 2011) Meets<2mg/glove |
| Biocompatibility | Primary Skin Irritation - ISO 10993-10:2010 Under the conditions ofthe study, the subjectdevice is not a primaryskin irritant. |
| Dermal Sensitization - ISO 10993-10:2010 Under the conditionsof the study, thesubject device is not askin sensitizer. | |
| Cytotoxicity - ISO 10993-5: 2009 Under the conditionsof this study, the testarticle wasnon-cytotoxicity toL-929 cells. |
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| ISO 10993-5:2009 | Biological Evaluation of Medical Devices - Part 5: TestsFor In Vitro Cytotoxicity |
|---|---|
| ISO 10993-10:2010 | Biological Evaluation of Medical Devices - Part 10: TestsFor Irritation And Skin Sensitization. |
| ASTM D5151-06(Reapproved 2015), | Standard Test Method for Detection of Holes in MedicalGloves. |
| ASTM D5250-06(Reapproved 2015), | Standard specification for poly (vinyl chloride) gloves formedical application. |
| ASTM D6124-06(Reapproved 2017) | Standard Test Method for Residual Powder on MedicalGloves |
Summary of Clinical Performance Data: 8.0
Clinical testing is not needed for this device.
9.0 Conclusion:
The conclusions drawn from the nonclinical tests demonstrate that the proposed device is as safe, as effective, and performs as well as or better than 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.