(132 days)
DAIYANG 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.
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.
The provided document is a 510(k) summary for the "DAIYANG Powder Free Vinyl Patient Examination Gloves, Clear (non-colored)". It describes the device, its intended use, and a comparison to a predicate device to establish substantial equivalence.
Here's an analysis 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 | Standard / Acceptance Criteria | Reported Device Performance (DAIYANG Powder Free Vinyl Patient Examination Gloves) | Predicate Device Performance (K091663) | Result of Comparison (DAIYANG vs. Predicate) |
|---|---|---|---|---|
| Dimension: | ASTM D 5250-06(Reapproved 2011) | Meets ASTM D5250-06 | Similar | |
| Length | ≥230mm | 231-241mm | 232-240mm | Similar |
| Width (Small) | 80-90 mm | 81-89 | 81-87 | Similar |
| Width (Medium) | 90-100mm | 93-99 | 93-98 | Similar |
| Width (Large) | 100-110mm | 102-110 | 102-109 | Similar |
| Width (X Large) | 110-120 mm | 111-1119 (likely typo, should be 111-119) | 113-118 | Similar |
| Thickness (Fingertip) | ≥0.05mm | 0.05-0.10 | 0.08-0.11 | Similar |
| Thickness (Palm) | ≥0.08mm | 0.09-0.13 | 0.10-0.12 | Similar |
| Physical Properties: | ASTM D 5250-06(Reapproved 2011) | Before aging/after aging: Elongation ≥300%, Tensile Strength ≥ 14MPa | Similar | |
| Tensile strength | ≥11MPa (Before & After aging) | 15-25 MPa | 15-20 MPa | Similar |
| Elongation rate | ≥300% (Before & After aging) | 340-410% | 350-420% | Similar |
| Freedom from pinholes | 21 CFR 800.20 Passed Standard Acceptance Criteria; ASTM D5250-06; ASTM D5151-06 | Holes at Inspection Level I AQL2.5 | Holes at Inspection Level I AQL2.5 | Similar |
| Powder Residual | ASTM standard D 5250-06 (Reapproved 2011) and D6124-06 (Reaffirmation 2011). Meets <2mg/glove | 0.3mg | 0.1mg | Similar |
| Biocompatibility | ISO 10993-10: 2010-08-01 | Primary Skin Irritation: Passes (Not a Primary Skin Irritation); Dermal sensitization: Passes (Not a Dermal sensitization) | Under the conditions of this study, not an irritant and not a sensitizer. Meets ISO 10993-10:2002/Amd.1:2006 | Similar |
| Other: | ||||
| Materials used | N/A (implicit that it should be appropriate given the predicate) | PVC | PVC | Similar |
| Dusting or Donning Powder | N/A | Surface Coating Agent | Surface Coating Agent | Similar |
| Single Patient Use | N/A (Standard for examination gloves) | Single Patient Use | Single Patient Use | Similar |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
The document does not explicitly state the sample sizes used for each test. It refers to established ASTM and 21 CFR standards (e.g., AQL levels for pinholes) which would imply specific sampling plans, but the actual number of gloves tested is not provided. The data provenance is linked to Zibo Daiyang Plastic Company, which is located in China. The studies are non-clinical performance tests conducted to demonstrate that the device meets the specified standards. It does not mention if the data is retrospective or prospective, but since it's testing a manufactured product against specified standards, it would be considered prospective testing of batches for quality control and regulatory submission.
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 information is not applicable to this type of device and study. The "ground truth" for vinyl examination gloves is defined by well-established international standards (ASTM, ISO) and FDA regulations (21 CFR 800.20). These standards specify objective physical and chemical properties and testing methodologies rather than requiring expert interpretation for "ground truth." The tests are typically performed by trained technicians in a laboratory setting.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This information is not applicable as the evaluation of examination gloves against physical and chemical standards does not involve adjudication by multiple experts in the way clinical diagnostic studies might. The results are typically quantitative measurements or pass/fail criteria 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:
This information is not applicable. An MRMC study is relevant for diagnostic devices that involve human interpretation (e.g., radiologists reading medical images, with or without AI assistance). This device is a patient examination glove, and its performance is assessed through physical, chemical, and biocompatibility testing, not through human reader interpretation of cases.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
This information is not applicable. This device is a physical product (a glove), not an algorithm or AI system. Its performance is assessed through direct testing of its material and physical properties, not through standalone algorithm performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
The "ground truth" for this device's performance is based on established industry standards (ASTM D5250, ASTM D5151, ASTM D6124) and regulatory requirements (21 CFR 800.20, ISO 10993-10). These standards define objective pass/fail criteria for dimensions, physical properties (tensile strength, elongation), freedom from pinholes, powder residue, and biocompatibility.
8. The sample size for the training set:
This information is not applicable. This device is a physical product and the submission describes non-clinical performance testing. The concept of a "training set" typically applies to machine learning or AI models, which are not involved here. The manufacturer would have internal quality control and product development processes which involve testing, but these are not referred to as a "training set" in the context of this submission.
9. How the ground truth for the training set was established:
This information is not applicable for the same reasons as point 8.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 21, 2016
Zibo Daiyang Plastic Company % Chu Xiaoan Official Correspondent Beijing Easylink Co., LTD Rm. F302 Bldg., 41, Jing Cheng Ya Ju, Courtyard 6 of Southern Dou Ge Zhuang, Beijing, CN 100121
Re: K162259
Trade/Device Name: DAIYANG Powder Free Vinyl Patient Examination Gloves, Clear (non-colored) Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LYZ Dated: November 8, 2016 Received: November 22, 2016
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. 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
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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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely,
Michael J. Ryan -S
for Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K162259
Device Name
DAIYANG Powder Free Vinyl Patient Examination Gloves, Clear (non-colored)
Indications for Use (Describe)
DAIYANG 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.
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:______K162259
Premarket Notification [510(k)] Summary
1.0 Submitter:
| Submitter's name : | Zibo Daiyang Plastic Company |
|---|---|
| Submitter's address : | North of Shiji Rd,Zhuangyuan Industrial Park,Zhangdian,Zibo,Shandong,255087,China |
| Phone number : | 0086-533-3813666 |
| Fax number : | 0086-533-3811696 |
| Name of contact person: | Yang Yan Hong |
| Date of preparation : | 2016-12-16 |
2.0 Name of the Device
| Device Name: | Powder Free Vinyl Patient ExaminationGloves, Clear (non-colored) |
|---|---|
| Proprietary/Trade name: | DAIYANG Powder Free Vinyl PatientExamination Gloves, 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 Glove(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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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.
5.0 Device Intended Use (Indication for use):
DAIYANG 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:
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 2011). |
| Length ≥230mm | |
| WidthSmall 80-90 mmMedium 90-100mmLarge 100-110mmX large 110-120 mm | |
| Thickness Fingertip ≥0.05mm | |
| Palm ≥0.08mm | |
| PhysicalProperties | ASTM D 5250-06(Reapproved 2011).Tensile strength (Before & After aging) ≥11MPaElongated rate (Before & After aging) ≥300% |
| Freedom frompinholes | 21 CFR 800.20 Passed Standard Acceptance CriteriaASTM D5250-06(Reapproved 2011)ASTM D5151-06(Reapproved 2011) |
| Powder Residual | ASTM standard D 5250-06 (Reapproved 2011).and D6124-06(Reaffirmation 2011) Meets <2mg/glove |
| Biocompatibility | Primary Skin Irritation in rabbits PassesISO 10993-10: 2010-08-01 Not a Primary Skin Irritation |
| Dermal sensitization in the guinea pig PassesISO 10993-10: 2010-08-01 Not a Dermal sensitization |
7.0 Substantial Equivalent Based on Assessment of Non-Clinical Performance Data:
DAIYANG Powder Free Vinyl Patient Examination Gloves, Clear (non-colored), meet requirements per ASTM D5250-06 (Reapproved 2011), per ASTM D6124-06 Reaffirmation 2011), per 21 CFR 800.20 and ISO 10993-10:2010-08-01.
The performance test data of the nonclinical tests that support a determination of substantial equivalent is the same as mentioned immediately above.
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8.0 Substantial Equivalent Based on Assessment of Clinical Performance Data:
Clinical data was not needed to demonstrate that the subject glove is substantially equivalent to the predicate glove.
| Features & Description | Predicate Device | Subject Device | ResultofComparison | ||
|---|---|---|---|---|---|
| Company | Zhang Jia GangFengyuan PlasticProduct Co.Ltd. | Zibo Daiyang PlasticCompany | -- | ||
| 510(K) Number | K091663 | K162259 | -- | ||
| Product name | Powder Free VinylPatient ExaminationGloves, Clear(Non-colored) | Powder Free VinylPatient ExaminationGloves, 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)isa disposable deviceintended for medicalpurposes that is wornon the examiner'shand or finger topreventcontaminationbetween patient andexaminer. | DAIYANG Powderfree VinylPatient ExaminationGloves, Clear(non-colored) is anon-sterile disposabledevice intended formedical purposes thatis worn on theexaminer's hand orfinger to preventcontaminationbetween patient and | Similar | ||
| Device Description andSpecifications | Meets ASTMD5250-06 | Meets ASTMD5250-06(Reapproved 2011) | Similar | ||
| DimensionsLength (mm)ILS-2AQL4.0 | ≥230mm | 231-241mm | 232-240mm | Similar | |
| DimensionsWidth (mm)IL S-2AQL4.0 | Small 80-90Medium 90-100Large 00-110X large 110-120 | 81-8993-99102-110111-1119 | 81-8793-98102-109113-118 | Similar | |
| DimensionsThickness(mm)IL S-2AQL4.0 | Finger ≥0.05Palm ≥0.08 | 0.05-0.100.09-0.13 | 0.08-0.110.10-0.12 | Similar | |
| PhysicalPropertiesIL S-2AQL4.0 | Before aging/after agingElongation ≥300%Tensile Strength≥ 14MPa | 340-410%15-25 MPa | 350-420%15-20 MPa | Similar | |
| Freedomfrom Pinholes | Holes atInspection LevelI AQL2.5 | Holes atInspection Level IAQL2.5 | Holes atInspection Level IAQL2.5 | Similar | |
| ResidualPowder | below 2mg ofresidual powder | 0.3mg | 0.1mg | Similar | |
| Materials used to fabricate thedevices | PVC | PVC | Similar | ||
| Dusting or Donning Powder:name | Surface CoatingAgent | Surface CoatingAgent | Similar | ||
| 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 2011) | Similar | ||
| Single Patient Use | Single Patient Use | Single Patient Use | Similar | ||
| Biocompatibility | Under the conditionsof this study, not anirritant and Under theconditions of thisstudy, not asensitizer.SKIN IRRITATIONDERMAL andSENSITIZATIONSTUDIES Meets ISO10993-10:2002/Amd.1:2006 | Under the conditionsof this study, not anirritant and Under theconditions of thisstudy, not asensitizer.SKIN IRRITATIONDERMAL andSENSITIZATIONSTUDIES Meets ISO10993-10 ThirdEdition 2010-08-01 | Similar | ||
| Labeling for the legally marketeddevice to which substantialequivalence is claimed. | -Powder Free-Patient ExaminationGlove-Single Use Only- Manufactured For:- Lot | -Powder Free-Patient ExaminationGlove-Single Use Only- Manufactured For:- Lot | Similar |
9.0 Substantial Equivalence Comparison:
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10.0 Substantial Equivalence Comparison:
Discussion: The Powder Free Vinyl Patient Examination Gloves, Clear (non-colored) meet the ASTM standard or equivalent standard and FDA requirements for waterleak test on pinhole AQL., meeting labeling claims.
The subject device The Powder Free Vinyl Patient Examination Gloves, Clear (non-colored) has the same intended use and technological and performance characteristics as the predicate device Powder-Free Vinyl Patient Examination Glove (Non-colored) Zhang Jia Gang Plastic Product Co., Ltd. K091663, and therefore the devices are substantially equivalent.
Conclusion: Based on the nonclinical tests data, it can be concluded that the Powder Free Vinyl Patient Examination Gloves, Clear (non-colored) is as safe, as effective, and performs as well as the predicate device, Powder-Free Vinyl Patient Examination Glove (Non-colored) Zhang Jia Gang Plastic Product Co., Ltd. K091663.
§ 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.