(273 days)
Powder Free Yellow Synthetic Vinyl Patient Examination Gloves 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 Yellow Synthetic Vinyl Patient Examination Gloves that meets all of the requirements of ASTM standard D 5250-06(Reaffirmation 2011).
Please find the acceptance criteria and study details based on the provided text. Due to the nature of the device (patient examination gloves), the "study" is a series of performance tests against established standards, rather than a clinical study involving human readers or AI.
Device: Powder Free Yellow Synthetic Vinyl Patient Examination Gloves (K131341)
1. Table of Acceptance Criteria and Reported Device Performance
The device's performance is gauged against established ASTM standards for patient examination gloves, primarily ASTM D5250-06 (Reaffirmation 2011), ASTM D5151-06 (Reaffirmation 2011), and ASTM D6124-06 (Reaffirmation 2011). The acceptance criteria are the minimum requirements specified by these standards.
| Feature & Description | Acceptance Criteria (from ASTM Standard) | Reported Device Performance (Subject Device) | Result of Comparison |
|---|---|---|---|
| Intended Use | Disposable device for medical purposes, worn to prevent contamination between patient and examiner. | Disposable device for medical purposes, worn to prevent contamination between patient and examiner. | Substantially equivalent |
| Length | ≥230mm min. (ASTM D5250-06) | 230mm min for all sizes | Substantially equivalent |
| Width | Meets ASTM D5250-06 specifications: Small 80-90 mm, Medium 90-100mm, Large 100-110mm, X large 110-120 mm | Small 80-85 mm, Medium 95-97 mm, Large 102-108mm, X large 114-118 mm | Substantially equivalent |
| Thickness | Finger 0.05mm min., Palm 0.08mm min. (ASTM D5250-06) | Finger 0.05mm min., Palm 0.08mm min. | Substantially equivalent |
| Physical Properties (Before aging/after aging) | Elongation ≥300%, Tensile Strength ≥14MPa (ASTM D5250-06) | Elongation ≥300%, Tensile Strength ≥ 14MPa | Substantially equivalent |
| Freedom from Pinholes | Meets 21 CFR 800.20, ASTM D5250-06, ASTM D5151-06 (Inspection Level I, AQL 2.5) | Meets ASTM D5151 (Holes Inspection Level I, AQL 2.5) | Substantially equivalent |
| Residual Powder | Meets ASTM D6124-06 (≤2mg of residual powder, for powder-free classification) | Results generated values below 2mg of residual powder | Substantially equivalent |
| Materials Used | PVC | PVC | Substantially equivalent |
| Dusting/Donning Powder | PU (as surface coating agent) | PU (as Surface Coating Agent) | Substantially equivalent |
| Performance Data Supporting Substantial Equivalence | Meets ASTM D5151-06, ASTM D5250-06, ASTM D6124-06 | Meets ASTM D5151-06, ASTM D5250-06, ASTM D6124-06 | Substantially equivalent |
| Single Patient Use | Single Patient Use | Single Patient Use | Substantially equivalent |
| Biocompatibility | (Expected to be non-irritant/non-sensitizer per ISO 10993-10) | SKIN IRRITATION DERMAL and SENSITIZATION STUDIES Meets ISO 10993-10. The test article was a non-irritant or non-sensitizer. | Substantially equivalent |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the specific sample sizes used for each physical and performance test (e.g., number of gloves tested for tensile strength, pinholes, etc.). However, it indicates that the tests were conducted in accordance with ASTM standards. These standards typically specify the sampling plans and test methods.
Data Provenance: The tests are implied to be conducted by the manufacturer, Shijiazhuang Winful Plastic Co., Ltd. The data is retrospective, as it pertains to measurements taken on the manufactured gloves to demonstrate compliance with standards for the 510(k) submission. The company's address is listed as: No.6 Cangshi Road, Jinzhou City, Hebei, 052260, China. Therefore, the data originates from China.
3. Number of Experts Used to Establish Ground Truth and Qualifications
This section is not applicable as the device is a medical glove, not an AI/imaging device requiring expert interpretation for ground truth establishment. The "ground truth" for the performance characteristics of the gloves is established by the specified ASTM standards and the validated methodologies for performing the tests detailed within those standards.
4. Adjudication Method for the Test Set
This is not applicable. The "adjudication method" concept is relevant for studies involving subjective human interpretation or AI outputs, where multiple experts might disagree on a "ground truth" label. For this device, the tests involve objective measurements against quantitative physical and chemical specifications from established standards.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
This is not applicable. An MRMC study is designed to evaluate the diagnostic performance of a system (often AI-assisted) compared to human readers. This device is a physical product (medical glove) and does not involve diagnostic interpretation or human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
This is not applicable. This concept applies to AI algorithms. The device is a physical product.
7. The Type of Ground Truth Used
The ground truth used for proving the device meets acceptance criteria is compliance with established national and international consensus standards:
- ASTM D5250-06 (Reaffirmation 2011) - Standard Specification for Poly(vinyl chloride) Patient Examination Gloves
- ASTM D5151-06 (Reaffirmation 2011) - Standard Test Method for Detection of Holes in Medical Gloves
- ASTM D6124-06 (Reaffirmation 2011) - Standard Test Method for Residual Powder on Medical Gloves
- 21 CFR 800.20 - General provisions regarding medical devices. (specifically for waterleak test on pinhole AQL)
- ISO 10993-10: 2002/Amd. 1:2006(E) - Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization (for biocompatibility).
These standards define the acceptable physical properties, performance, and safety requirements for patient examination gloves.
8. The Sample Size for the Training Set
This is not applicable. This device is a physical product, not a machine learning model, so there is no "training set."
9. How the Ground Truth for the Training Set was Established
This is not applicable. As there is no training set for a physical product, there is no corresponding ground truth establishment process. The "ground truth" for the product's design and manufacturing quality is derived from its adherence to the aforementioned ASTM and ISO standards.
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Section C
510(k) Summary
"This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92."
"The assigned 510(k) number is:_______________________________________________________________________________________________________________________________________________
Premarket Notification [510(k)] Summary
[(a)(1)]. The summary contains on the first page, preferably on your letterhead paper, the submitter's name, address, phone and fax numbers, name of contact person, and date the summary was prepared :
| Submitter's name : | Shijiazhuang Winful Plastic Co., Ltd. |
|---|---|
| Submitter's address : | No.6 Cangshi Road, Jinzhou City, Hebe i, 052260, China |
| Phone number : | (86) 31184320503 |
| Fax number : | (86) 31184311294 |
| Name of contact person: | Yin Mingfei |
| Date the summary was prepared: | January 27, 2014 |
[(a)(2)]. The name of the device, including the trade or proprietary name if applicable, the common or usual name, and the classification name, if known
| Device Name: | Powder Free Yellow Synthetic Vinyl Patient Examination Gloves |
|---|---|
| Proprietary/Trade name: | Powder Free Yellow Synthetic Vinyl Patient Examination Gloves |
| Common Name: | Patient examination glove |
| Classification Name: | Patient examination glove |
| Device Classification: | I |
| Regulation Number: | 21 CFR 880.6250 |
| Panel: | General Hospital (80) |
| Product Code: | LYZ |
[(a)(3)]. An identification of the legally marketed device to which your firm is claiming substantial equivalence .
Class I* Powder Free Yellow Synthetic Vinyl Patient Examination Gloves that meets all of the requirements of ASTM standard D 5250-06 (Reaffirmation 2011).
Predicate device : POWDER-FREE YELLOW SYNTHETIC VINYL PATIENT EXAMINATION GLOVES, ZHAOYANG PLASTIC CO., LTD K110945
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|(a)(4)| A description of the device
Device Description : Powder Free Yellow Synthetic Vinyl Patient Examination Gloves that meets all of the requirements of ASTM standard D 5250-06(Reaffirmation 2011).
-- How the device functions:
PVC films form a barrier to body fluids and bloodborne Pathogens
-- Scientific concepts that form the basis for the device The PVC rubber is water tight under normal conditions of use. Its tensile properties cause it to conform to the hand, allowing movements necessary for a medical procedure.
-- Physical and performance characteristics such as design, materials and physical properties: PVC gloves are known to create a barrier to bloodborne pathogens and body fluids. ASTM conforming tensile properties create a glove that is strong and flexible. The glove is manufactured in accordance with the requirements of ASTM D5250 and ASTM D5151 requirements.
[{a)(5)} The summary describes the intended use of the device
Device Intended Use: Powder Free Yellow Synthetic Vinyl Patient Examination Gloves 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)(6)] A summary of the technological characteristics of new device compared to the predicate device.
The Powder Free Yellow Synthetic Vinyl Patient Examination Gloves, non sterile are summarized with the following technological characteristics compared to ASTM or equivalent standard.
| Features &Description | Predicate Device | Subject Device | Result ofComparison |
|---|---|---|---|
| 510(k) Number | K110945 | K131341 | -- |
| Company | ZHAOYANG PLASTIC CO.,LTD | Shijiazhuang Winful PlasticCo., Ltd. | -- |
| Product name | POWDER-FREE YELLOWSYNTHETICVINYL PATIENTEXAMINATIONGLOVES | Powder Free YellowSynthetic Vinyl PatientExamination Gloves | -- |
| Product Code | LYZ | LYZ | Same |
| Size | Small/ Medium/Large/X large | Small/ Medium/Large/X large | Small/ Medium/Large/X large |
| Intend for use | POWDER-FREE YELLOWSYNTHETIC VINYLPATIENT EXAMINATIONGLOVES is a disposable deviceintended for medical purposes thatis worn on the examiner's hand orfinger to prevent contaminationbetween patient and examiner. | Powder Free YellowSynthetic Vinyl PatientExamination Gloves is adisposable device intendedfor medical purposes that isworn on the examiner's handor finger to preventcontamination betweenpatient and examiner. | Substantiallyequivalent |
| DeviceDescription andSpecifications | Meets ASTM D5250-06(Reapproved 2011) | Meets ASTM D5250 -06(Reapproved 2011) | Substantiallyequivalent |
| Dimensions-- Length | Meets ASTM D5250-06(Reapproved 2011)≥230mm min. | 230mm min for all sizes | Substantiallyequivalent |
| Dimensions-- Width | Meets ASTM D5250-06(Reapproved 2011) | Small 80-85 mmMedium 95-97 mmLarge 102-108mm | Substantiallyequivalent |
| Small 80-90 mm |
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| X large 114-118 mm | |||||||
|---|---|---|---|---|---|---|---|
| Medium 90-100mmLarge 100-110mmX large 110-120 mm | |||||||
| Dimensions-- Thickness | Meets ASTM D5250-06(Reapproved 2011) | ||||||
| Finger 0.05mm min.Palm 0.08mm min. | Finger 0.05mm min.Palm 0.08mm min. | ||||||
| Physical Properties | Meets ASTM D5250-06(Reapproved 2011) | Before aging/after aging | Substantiallyequivalent | ||||
| Before aging/after agingElongation ≥300%Tensile Strength≥14MPa | Elongation ≥300%Tensile Strength≥ 14MPa | ||||||
| Freedom fromPinholes | Meets21 CFR 800.20ASTM D5250-06(Reapproved 2011)ASTM D 5151-06-(Reapproved 2011) | Meets ASTMD5151HolesInspection Level IAQL2.5 | Substantiallyequivalent | ||||
| Residual Powder | Meets ASTMD 6124-06(Reapproved 2011) | D 6124-06(Reapproved 2011)Results generated valuesbelow 2mg of residual powder | Substantiallyequivalent | ||||
| Compare allmaterials used tofabricate thedevices | PVC | PVC | Substantiallyequivalent | ||||
| Dusting orDonningPowder: | PU | PU | Substantiallyequivalent | ||||
| Dusting orDonningPowder: name | PU | Surface Coating Agent | Substantiallyequivalent | ||||
| Compareperformance datasupportingsubstantialequivalence | MeetsASTM D5151-06(Reapproved 2011)ASTM D5250-06(Reapproved 2011)ASTM D6124-06(Reapproved 2011) | MeetsASTM D5151-06(Reapproved 2011)ASTM D5250-06(Reapproved 2011)ASTM D6124-06(Reapproved 2011) | Substantiallyequivalent | ||||
| Single PatientUse | Single Patient Use | Single Patient Use | Substantiallyequivalent | ||||
| Biocompatibility | Labeling for thelegally marketeddevice to whichsubstantialequivalence isclaimed. | SKIN IRRITATION DERMALand SENSITIZATION STUDIESMeets ISO 10993-10 | -Powder-free-Patient Examination Glove- Yellow color-non sterile-Single Use Only- Manufactured For:- Lot | The test article was anon-irritant ornon-sensitizer.SKIN IRRITATIONDERMAL and | DERMAL andSENSITIZATIONSTUDIES Meets ISO10993-10-Powder-free-Patient Examination Glove- Yellow color-non sterile-Single Use Only- Manufactured For:- Lot | Substantiallyequivalent | Substantiallyequivalent |
(b)(1)) A brief discussion of the non-clinical submitted, reference, or relied on in the premarket
notification submission for a determination of substantial equivalence
Section C (rev.03)
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Powder Free Yellow Synthetic Vinyl Patient Examination Gloves meet requirements per ASTM D5250-06(Reaffirmation 2011), per ASTM D6124-06(Reaffirmation 2011), per 21 CFR 800.20 and ISO 10993-10: 2002/Amd. 1:2006(E).
((b)(2)) A brief discussion of the clinical submitted, reference, or relied on in the premarket notification submission for a determination of substantial equivalence.
Clinical data is not needed for gloves or for most devices cleared by the 510(k) process.
[(b)(3)] The conclusions drawn from the non-clinical tests that demonstrate that the device is as safe, as effective, and performed as well or better than the legally marketed device identified in (a)(3).
It can be concluded that the Powder Free Vinyl Patient Examination Gloves meet the ASTM standard or equivalent standard and FDA requirements for waterleak test on pinhole AQL., meet labeling claims and the Powder Free Yellow Synthetic Vinyl Patient Examination Gloves is as safe, as effective, and performs as well as the predicate device, POWDER-FREE YELLOW SYNTHETIC VINYL PATIENT EX AMINATION GLOVES, ZHAOYANG PLASTIC CO., LTD K110945
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 6, 2014
Shijiazhuang Winful Plastic Company, Limited C/O Mr. Chu Xiaoan Room 1606 Bldg 1 Jianxiang Yuan #209 Bei Si Huan Zhong Road, Haidian District Beijing 100083 CHINA
Re: K131341
Trade/Device Name: Powder Free Yellow Synthetic Vinyl Examination Gloves Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LYZ Dated: December 19, 2013 Received: December 30, 2013
Dear Mr. 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.
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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 (reporting of medical device-related 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 Small Manufacturers, International and Consumer Assistance at its tollfree 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" (21CFR 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/ReportalProblem/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 Small Manufacturers, International and Consumer Assistance 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 yours,
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Erin I. Keith, M.S. 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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510{k) Number (if known) K 131341
Device Name
Powder Free Yellow Synthetic Vinyl Patient Examination Gloves
Indications for Use (Describe)
Powder Free Yellow Synthetic Viryl Patient Examination Gloves 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.
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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CHE CONNECT CALL CORTED LOSE ONLY PART ALL ALL AND CALL AND CALL AND CALL COLLECT COLLECT COLLECT C Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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FORM FDA 3881 (9/13)
Form Approved: OMB No. 0910-0120 Expiration Date: December 31, 2013 See PRA Statement on last page.
PSC Publishing Services (101) 44)-6740 EF
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§ 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.