(187 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.
The subject device is disposable medical PVC gloves that made from PVC compound, Clear (non-colored), powder free and nonsterile. The device meets the specifications in ASTM D5250-06(Reapproved 2015) Standard specification for poly (vinyl chloride) gloves for medical application.
This document is a 510(k) Premarket Notification summary for "Powder Free Vinyl Patient Examination Gloves, Clear (non-colored)". It describes the device, its intended use, and the studies conducted to demonstrate substantial equivalence to a predicate device.
Here's an analysis of the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance:
| Test Methodology | Purpose | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| ASTM D5250-06 (Reapproved 2015) | Dimension (mm) IL S-2 AQL4.0 | ||
| Length | $\geq$ 230 | 233-241 | |
| Width (Small) | 80-90 | 81-89 | |
| Width (Medium) | 90-100 | 92-99 | |
| Width (Large) | 100-110 | 102-109 | |
| Width (X-Large) | 110-120 | 112-119 | |
| Thickness (Fingertip) | $\geq$ 0.05 | 0.09-0.11 | |
| Thickness (Palm) | $\geq$ 0.08 | 0.10-0.11 | |
| ASTM D5250-06 (Reapproved 2015) | Physical Properties IL S-2 AQL4.0 | ||
| Tensile strength | $\geq$ 14MPa (Before & After aging) | 17-25 MPa (implicitly for before & after, as it covers the range) | |
| Elongation (Before aging) | $\geq$ 500% | 560-610% | |
| Elongation (After aging) | $\geq$ 400% | 460-570% | |
| 21 CFR 800.20, ASTM D5250-06 (Reapproved 2015), ASTM D5151-19 | Freedom from pinholes | Waterleakage test: Inspection Level I, AQL2.5, and Accept/Reject criteria of 10/11. (5 noncompliance is allowed.) | Pass |
| ASTM D5250-06 (Reapproved 2015), ASTM D6124-06 (Reapproved 2017) | Powder Residual | $<$ 2mg/glove | Mean: 0.1mg/pcs (Pass) |
| ISO 10993-10: 2010-08-01 | Biocompatibility (Primary Skin Irritation in rabbits) | Under the conditions of the study, the subject device is not a primary skin irritant. | Passes |
| ISO 10993-10: 2010-08-01 | Biocompatibility (Dermal sensitization in the guinea pig) | Under the conditions of the study, the subject device is not a skin sensitizer. | Passes |
| ISO 10993-5: 2009 | Biocompatibility (Cytotoxicity - L929 cells measured by MTT assay) | Under the conditions of this study, the test article was non-cytotoxicity to L-929 cells. | Pass |
2. Sample size used for the test set and the data provenance:
The document does not explicitly state the specific sample sizes for each non-clinical test (e.g., number of gloves tested for dimensions, physical properties, pinholes). However, the tests are based on recognized standards (ASTM, ISO), which typically specify sample sizes or sampling plans (e.g., AQL levels).
- Data Provenance: The studies are non-clinical (laboratory/bench testing, and animal studies for biocompatibility). The document does not specify the country of origin of the test data but implies it was conducted by or for the manufacturer. All tests are retrospective, meaning they were performed on already manufactured product or materials to demonstrate compliance with standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This is not applicable to this type of device and study. The "ground truth" for non-clinical performance and biocompatibility relies on objective measurements according to standardized test methods, not expert consensus or clinical interpretation.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
Not applicable. This is not a study involving human subjective assessment where adjudication would be necessary. The results are objective measurements from laboratory tests.
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 device is a medical glove, not an AI-powered diagnostic or assistive technology. Therefore, an MRMC study and AI assistance are irrelevant.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Not applicable. This device is a medical glove and does not involve an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The "ground truth" for the performance of these gloves is defined by the acceptance criteria specified in internationally recognized standards (ASTM and ISO). These standards establish objective parameters and methods for evaluating physical properties (dimensions, tensile strength, elongation), integrity (pinholes), material properties (powder residual), and biological safety (biocompatibility).
8. The sample size for the training set:
Not applicable. This is a physical medical device, not a machine learning algorithm, so there is no concept of a "training set."
9. How the ground truth for the training set was established:
Not applicable, as there is no training set 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: a symbol on the left and the FDA name on the right. The symbol on the left is a stylized image of a human figure, while the FDA name on the right is written in blue letters. The words "U.S. FOOD & DRUG ADMINISTRATION" are written in a clear, sans-serif font.
December 20, 2021
Liao Ning Shangwei 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,Chaoyang District Beijing, 100121 China
Re: K211865
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: October 18, 2021 Received: December 17, 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 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) K211865
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: K211865
Premarket Notification [510(k)] Summary
1.0 Submitter:
| Submitter's name : | Liao Ning Shangwei Medical ProductsCo.,Ltd. | ||||
|---|---|---|---|---|---|
| Submitter's address : | No.210 Management CommitteeOffice,Economic DevelopmentZone,Diaobingshan City,Tieling City,LiaoningProvince,112700,P.R. China | ||||
| Phone number : | 0086-024-765188880086-024-76518888 | ||||
| Name of contact person: | Mr. Zhu Hongqing | ||||
| Date of preparation : | 2021-10-18 |
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 Classifications: | 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:
The subject device is disposable medical PVC gloves that made from PVC compound, Clear (non-colored), powder free and nonsterile.
The device meets the specifications in ASTM D5250-06(Reapproved 2015) Standard specification for poly (vinyl chloride) gloves for medical application.
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5.0 Indications for Use Statement:
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:
The Poly (vinyl chloride) glove made of Poly Vinyl Chloride (PVC) rubber. The PVC film is water tight under normal conditions of use and its tensile properties cause it to conform to the hand, allowing movements necessary for a medical procedure, so PVC glove can form a barrier to prevent contamination between patient and examiner worn them on his hand or finger.
Powder Free Vinyl Patient Examination Gloves, Clear (non-colored) are summarized with the following technological characteristics compared to ASTM or equivalent standard.
| 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 Passed Standard Acceptance Criteria ASTM D5250-06(Reapproved 2015) ASTM D5151-19 |
| Powder Residual | ASTM standard D 5250-06(Reapproved 2015).andD6124-06(Reapproved 2017) Meets<2mg/glove |
| Biocompatibility | Primary Skin Irritation in rabbits PassesISO 10993-10: 2010-08-01 Under the conditionsof the study, thesubject device is nota primary skinirritant. |
| Dermal sensitization in the guinea pig PassesISO 10993-10: 2010-08-01 Under the conditionsof the study, thesubject device is nota skin sensitizer. | |
| The test article was added to L929 Passcells measured by MTT assay Under the conditionsISO 10993-5: 2009 of this study, the testarticle wasnon-cytotoxicity to |
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7.0 Technological Characteristic Comparison:
| Features & Description | Predicate Device | Subject Device | Result of Comparison | |
|---|---|---|---|---|
| Company | Zhang Jia Gang Fengyuan Product Co. Ltd. | Liao Ning Shangwei Medical Products Co.,Ltd. | -- | |
| 510(K) Number | K091663 | K211865 | -- | |
| Product name | Powder Free Vinyl Patient Examination Gloves, Clear (non-colored) | Powder Free Vinyl Patient Examination Gloves, 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 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. | 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. | Same | |
| Device Description and Specifications | Meets ASTM D5250-06 | Meets ASTM D5250-06 (Reapproved 2015) | Similar | |
| Dimensions Length (mm) ILS-2 AQL4.0 | ≥230mm | 231-241mm | 233-241mm | Similar |
| Dimensions Width (mm) IL S-2 AQL4.0 | Small 80-90 | 81-89 | 81-89 | Similar |
| Medium 90-100 | 93-99 | 92-99 | ||
| Large 100-110 | 102-110 | 102-109 | ||
| X large 110-120 | 111-119 | 112-119 | ||
| Dimensions Thickness (mm) IL S-2 AQL4.0 | Finger ≥0.05 | 0.05-0.10 | 0.09-0.11 | Similar |
| (mm) IL S-2 AQL4.0 Palm | ≥0.08 | 0.09-0.13 | 0.10-0.11 | Similar |
| Before aging/after aging | ||||
| Physical Properties IL S-2 AQL4.0 | Elongation ≥300% | 380-410% | 350-420% | Similar |
| Tensile Strength ≥ 14MPa | 16-20 MPa | 16-22 MPa | ||
| Freedom from Pinhole S | Holes at Inspection Level I AQL2.5 | Holes at Inspection Level I AQL2.5 | Holes at Inspection Level I AQL2.5 | Similar |
| Residual Powder | below 2mg of residual powder | 0.3mg | 0.1mg | Similar |
| Materials used tofabricate the devices | PVC | PVC | Same | |
| Compare performancedata supportingsubstantial equivalence | 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) | Similar | |
| 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.SKIN IRRITATIONDERMAL andSENSITIZATIONSTUDIES Meets ISO10993-10:2002/Amd.1:2006 | Under the conditionsof this study, not anirritant and Under theconditions of thisstudy, not a sensitizer.SKIN IRRITATIONDERMAL andSENSITIZATIONSTUDIES Meets ISO10993-10 ThirdEdition 2010-08-01Under the conditionsof this study, the testarticle wasnon-cytotoxicity toL-929 cells. | Same | |
| Labeling for the legallymarketed device to whichsubstantial equivalence isclaimed. | -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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For all above differences (state "similar" in the right column on above table) between the subject and predicate devices, they are derived from individual product differentiation, those differences are not critical to the intended use and the differences do not affect the safety and effectiveness of the subject device when used as labeled, due to each items belonged to the product performance are within the range of the standard requirement (ASTM D6319-10) at that time.
8.0 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:
| 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. |
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| ASTM D6124-06(Reapproved 2017) | Standard Test Method for Residual Powder on MedicalGloves |
|---|---|
| ------------------------------------ | --------------------------------------------------------------- |
Summary of the non-clinical testing is shown as below:
| Test Methodology | Purpose | Acceptance Criteria | Results |
|---|---|---|---|
| ASTM D5250-06(Reapproved 2015) | Dimension(mm)IL S-2AQL4.0 | Length $\geq$ 230 | 233-241 |
| WidthSmall 80-90 | 81-89 | ||
| Medium 90-100 | 92-99 | ||
| Large 100-110 | 102-109 | ||
| X large 110-120 | 112-119 | ||
| ThicknessFingertip $\geq$ 0.05Palm $\geq$ 0.08 | 0.09-0.110.10-0.11 | ||
| ASTM D5250-06(Reapproved 2015) | PhysicalPropertiesIL S-2AQL4.0 | (Before & After aging) | |
| Tensilestrength $\geq$ 14MPa | 17-25 | ||
| BeforeagingElongation $\geq$ 500%After agingElongation $\geq$ 400% | 560-610460-570 | ||
| 21 CFR 800.20•ASTM D5250-06•(Reapproved 2015)ASTM D5151-19• | Freedom frompinholes | Waterleakage test:Inspection Level I, AQL2.5, andAccept/Reject criteria of 10/11. | 5noncomplianceis allowed. |
| Pass | |||
| ASTM•D5250-06(Reapproved 2015)ASTM D6124-06•(Reapproved2017), | Powder Residual | Meets$<$ 2mg/glove | Mean: 0.1mg/pcsPass |
| Primary SkinIrritation in rabbitsISO 10993-10:2010-08-01 | Biocompatibility | Under the conditions of the study,the subject device is not a primaryskin irritant. | Passes |
| Dermal sensitizationin the guinea pig ISO10993-10: 2010-08-01 | Under the conditions of the study,the subject device is not a skinsensitizer. | Passes | |
| The test article wasadded to L929 cellsmeasured by MTTassay ISO 10993-5:2009 | Under the conditions of this study,the test article was non-cytotoxicityto L-929 cells. | Pass |
Summary of Clinical Performance Data: 9.0
Clinical testing is not needed for this device.
10.0 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.