(60 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.
Poly Vinyl Chloride (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 pertains to the 510(k) premarket notification for Powder Free Vinyl Patient Examination Gloves, Clear (non-colored). The information provided heavily focuses on proving substantial equivalence to a predicate device through non-clinical performance data, primarily compliance with established ASTM and ISO standards for medical gloves.
Here's the breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. A table of acceptance criteria and the reported device performance
| Characteristics | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Dimensions | ASTM D 5250-06 (Reapproved 2015) | Met ASTM D 5250-06 (Reapproved 2015) |
| Length | ≥230mm | Subject Device: 231-241mm (Predicate: 231-242mm) - Stated as "Similar" |
| Width (Small) | 80-90 mm | Subject Device: 81-89mm (Predicate: 82-89mm) - Stated as "Similar" |
| Width (Medium) | 90-100mm | Subject Device: 93-99mm (Predicate: 93-99mm) - Stated as "Similar" |
| Width (Large) | 100-110mm | Subject Device: 102-110mm (Predicate: 103-109mm) - Stated as "Similar" |
| Width (X-Large) | 110-120 mm | Subject Device: 111-119mm (Predicate: 114-119mm) - Stated as "Similar" |
| Thickness (Fingertip) | ≥0.05mm | Subject Device: 0.09-0.10mm (Predicate: 0.05-0.10mm) - Stated as "Similar" |
| Thickness (Palm) | ≥0.08mm | Subject Device: 0.10-0.11mm (Predicate: 0.09-0.13mm) - Stated as "Similar" |
| Physical Properties | ASTM D 5250-06 (Reapproved 2015) | Met ASTM D 5250-06 (Reapproved 2015) |
| Tensile Strength | ≥11MPa (Before & After aging) | Subject Device: 15-22 MPa (Predicate: 16-20 MPa) - Stated as "Similar" |
| Elongation Rate | ≥300% (Before & After aging) | Subject Device: 350-420% (Predicate: 380-410%) - Stated as "Similar" |
| Freedom from Pinholes | 21 CFR 800.20 ASTM D5250-06 (Reapproved 2015) ASTM D5151-19 Holes at Inspection Level I AQL2.5 | Subject Device: "Passed Standard Acceptance Criteria"Holes at Inspection Level I AQL2.5 (Same as predicate) |
| Powder Residual | ASTM D5250-06 (Reapproved 2015) ASTM D6124-06 (Reapproved 2017) <2mg/glove | Subject Device: 0.1mg (Predicate: 0.3mg) - Stated as "Similar" and "Meets <2mg/glove" |
| Biocompatibility | ISO 10993-5:2009 (Cytotoxicity) ISO 10993-10:2010 (Irritation & Sensitization) | Primary Skin Irritation: Passed (Not a primary skin irritant). Met ISO 10993-10: 2010-08-01. Dermal Sensitization: Passed (Not a skin sensitizer). Met ISO 10993-10: 2010-08-01. Cytotoxicity: Passed (Non-cytotoxicity to L-929 cells). Met ISO 10993-5: 2009. All stated as "Same" or fully compliant with standards. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: The document does not explicitly state the sample sizes used for each specific test (e.g., how many gloves were tested for dimensions, pinholes, tensile strength). It refers to compliance with standards like ASTM D5250. These standards typically define the sampling plans.
- Data Provenance: The tests were conducted by the manufacturer, Shandong Jieshi Medical Products Co.,Ltd, located in China. The data would be considered prospective, as it was generated to support the 510(k) submission for this specific device.
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 document concerns medical device performance testing, not diagnostic AI. Therefore, the concept of "experts establishing ground truth" in the context of clinical interpretation (like radiologists for imaging) is not applicable here. The "ground truth" for these tests is defined by established regulatory standards (ASTM, ISO) and the laboratory methods prescribed within them. The "experts" would be the qualified laboratory personnel performing these physical and chemical tests. Their specific qualification details are not provided in this regulatory summary but are presumed to be in compliance with good laboratory practices.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This is not a study involving human interpretation or subjective judgment that would require an adjudication process. The tests are objective measurements against defined physical and chemical criteria.
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 document is for a physical medical device (examination gloves), not an AI diagnostic algorithm. Clinical testing was explicitly stated as "not needed for this device."
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is for a physical medical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" here is defined by established consensus standards from organizations like ASTM (American Society for Testing and Materials) and ISO (International Organization for Standardization). These standards specify physical properties, test methods, and acceptable limits for medical gloves. This includes:
- ASTM D5250 (Standard specification for poly (vinyl chloride) gloves for medical application)
- ASTM D5151 (Standard Test Method for Detection of Holes in Medical Gloves)
- ASTM D6124 (Standard Test Method for Residual Powder on Medical Gloves)
- ISO 10993-5 (Biological Evaluation of Medical Devices - Part 5: Tests For In Vitro Cytotoxicity)
- ISO 10993-10 (Biological Evaluation of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization)
8. The sample size for the training set
Not applicable. This is for a physical medical device, not an AI/machine learning model. There is no concept of a "training set" for this type of submission. The manufacturing process itself (Good Manufacturing Practices) would ensure consistent product quality, but there's no data training aspect.
9. How the ground truth for the training set was established
Not applicable, as there is no training set for a physical 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). 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.
May 14, 2021
Shandong Jieshi Medical Products Co.,Ltd % Chu Xiaoan Official Correspondent Beijing Easy-Link Company Rm. F302 Bldg., 41, Jing Cheng Ya Ju, Courtyard 6 of Southern Dou Ge Zhuang, Chaoyung District Beijing, 100121 China
Re: K210774
Trade/Device Name: 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: February 8, 2021 Received: March 15, 2021
Dear Chu Xiaoan:
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 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,
Clarence W. Murray, III, PhD 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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
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: K210774
Premarket Notification [510(k)] Summary
1.0 Submitter:
| Submitter's name : | Shandong Jieshi Medical Products Co.,Ltd |
|---|---|
| Submitter's address : | North Road, Fumin Avenue, Qinghe Street,Caoxian County,Heze City, ShandongProvince, 274400,P.R. China |
| Phone number : | 0086-530-20611570086-530-2069778 |
| Name of contact person: | Ms.Li Biao |
| Date of preparation : | 2021-02-08 |
2.0 Name of the Device
| Device Name: | Powder Free Vinyl Patient Examination Gloves, Clear (non-colored) |
|---|---|
| Proprietary/Trade name: | Powder Free Vinyl Patient Examination Gloves, Clear (non-colored) |
| Common Name: | Vinyl Patient Examination Glove |
| Classification Name: | Non-powdered patient examination glove |
| Device Classification: | I |
| Regulation Number: | 21 CFR 880.6250 |
| Panel: | General Hospital |
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:
Poly Vinyl Chloride (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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4.3 Physical and performance characteristics such as design, materials and 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.
Indications for Use Statement: 5.0
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 Summary of the Technological Characteristics of the Device:
Provided below is the Technological Characteristics Comparison Table that provides a comparison between the subject device and the predicate device.
| Features & Description | Predicate Device | Subject Device | Result of Comparison | ||
|---|---|---|---|---|---|
| Company | Zhang Jia GangFengyuan PlasticProduct Co. Ltd. | Shandong JieshiMedical ProductsCo.,Ltd | -- | ||
| 510(K) Number | K091663 | K210774 | -- | ||
| Product name | Powder Free VinylPatient ExaminationGloves, Clear(non-colored) | Powder Free VinylPatient ExaminationGloves, Clear(non-colored) | Similar | ||
| 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 adisposable deviceintended for medicalpurposes that is wornon the examiner's handor finger to preventcontaminationbetween patient andexaminer. | Powder Free VinylPatient ExaminationGloves,Clear(non-colored) is adisposable deviceintended for medicalpurposes that is wornon the examiner'shand or finger topreventcontaminationbetween patient andexaminer. | Same | ||
| Device Description andSpecifications | Meets ASTMD5250-06 | Meets ASTMD5250-06(Reapproved 2015) | Same | ||
| Dimensions Length(mm)ILS-2 AQL4.0 | $ ≥ $ 230mm | 231-241mm | 231-242mm | Similar | |
| Features & Description | Predicate Device | Subject Device | Result ofComparison | ||
| DimensionsWidth(mm) | Small | 80-90 | 81-89 | 82-89 | Similar |
| Medium | 90-100 | 93-99 | 93-99 | ||
| IL S-2 | Large | 100-110 | 102-110 | 103-109 | |
| AQL4.0 | X large | 110-120 | 111-1119 | 114-119 | |
| DimensionsThickness(mm ) | Finger | ≥0.05 | 0.05-0.10 | 0.09-0.10 | Similar |
| IL S-2AQL4.0 | Palm | ≥0.08 | 0.09-0.13 | 0.10-0.11 | |
| Physical | Before aging/after aging | ||||
| Properties | Elongation ≥300% | 380-410% | 350-420% | Similar | |
| IL S-2 AQL4.0 | Tensile Strength≥ 14MPa | 16-20 MPa | 15-22 MPa | ||
| Freedom fromPinholes | Holes atInspection LevelI AQL2.5 | Holes atInspection Level IAQL2.5 | Holes atInspection Level IAQL2.5 | Same | |
| ResidualPowder | below 2mg ofresidual powder | 0.3mg | 0.1mg | Similar | |
| Materials used to fabricatethe devices | PVC | PVC | Same | ||
| Performance data | MeetsASTM D5151-06(Reapproved 2011)ASTM D5250-06(Reapproved 2011)ASTM D6124-06(Reaffirmation 2011) | MeetsASTM D5151-19ASTM D5250-06(Reapproved 2015)ASTM D6124-06(Reapproved 2017) | Same | ||
| Single Patient Use | Single Patient Use | Single Patient Use | Same | ||
| Biocompatibility | Under the conditionsof this study, not anirritant and Under theconditions of thisstudy, not a sensitizer. | Under the conditionsof this study, not anirritant and Underthe conditions ofthis study, not asensitizer. | Same | ||
| SKIN IRRITATIONDERMAL andSENSITIZATIONSTUDIES Meets ISO10993-10:2002/Amd.1:2006 | SKIN IRRITATIONDERMAL andSENSITIZATIONSTUDIES MeetsISO 10993-10 ThirdEdition 2010-08-01Under the conditionsof this study, the testarticle wasnon-cytotoxicity toL-929 cells. | ||||
| Labeling | -Powder Free-Patient ExaminationGlove-Single Use Only- Manufactured For:- Lot | -Powder Free-Patient ExaminationGlove-Single Use Only- Manufactured For:- Lot | Same |
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Summary of Non-Clinical Performance Data: 7.0
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:
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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 D5151-19 | 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 |
| Characteristics | Standard |
|---|---|
| Dimension | ASTM D 5250-06(Reapproved 2015). |
| Length ≥230mm | |
| WidthSmall 80-90 mmMedium 90-100mmLarge 100-110mmX large 110-120 mm | |
| ThicknessFingertip ≥0.05mmPalm ≥0.08mm | |
| PhysicalProperties | ASTM D 5250-06(Reapproved 2015). |
| Tensile strength (Before & After aging) ≥11MPa | |
| Elongated rate (Before & After aging) ≥300% | |
| Freedom frompinholes | 21 CFR 800.20 ASTM D5250-06(Reapproved 2015) ASTM D5151-19 Passed Standard Acceptance Criteria |
| Powder Residual | ASTM standard D 5250-06 (Reapproved 2015).and D6124-06(Reapproved 2017)Meets <2mg/glove |
| Biocompatibility | Primary Skin Irritation in rabbitsISO 10993-10: 2010-08-01PassesUnder the conditions of the study, the subject device is not a primary skin irritant. |
| Dermal sensitization in the guinea pigISO 10993-10: 2010-08-01PassesUnder the conditions of the study, the subject device is not a skin sensitizer. | |
| The test article was added to L929 cellsmeasured by MTT assayISO 10993-5: 2009PassUnder the conditions of this study, the test article was non-cytotoxicity to L-929 cells. |
Summary of Clinical Performance Data: 8.0
Clinical testing is not needed for this device.
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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.