(319 days)
Powder Free Vinyl Patient Examination Gloved) is a non-sterile disposable device intended for medical purposs 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) that meets all of the requirements of ASTM standard D 5250-06(Reaffirmation 2011).
Here's a breakdown of the acceptance criteria and the study verifying the performance of the "Powder Free Vinyl Patient Examination Gloves, Clear (Non-colored)" based on the provided text.
1. Table of Acceptance Criteria and Reported Device Performance
| Feature & Description | Acceptance Criteria (from ASTM D5250-06 unless specified) | Reported Device Performance |
|---|---|---|
| Dimensions | ||
| -- Length | ≥ 230mm for all sizes (ASTM D5250) | Meets ASTM D5250-06 (Reapproved 2011) |
| -- Width (Small) | 80-90 mm (ASTM D5250) | 80-85 mm |
| -- Width (Medium) | 90-100 mm (ASTM D5250) | 95-97 mm |
| -- Width (Large) | 100-110 mm (ASTM D5250) | 102-108 mm |
| -- Width (X-Large) | 110-120 mm (ASTM D5250) | 114-118 mm |
| -- Thickness (Finger) | ≥ 0.05 mm | 0.05 mm min. |
| -- Thickness (Palm) | ≥ 0.08 mm | 0.08 mm min. |
| Physical Properties | ||
| -- Elongation | ≥ 300% (before/after aging, ASTM D5250) | ≥ 300% (before/after aging) |
| -- Tensile Strength | ≥ 14 MPa (before/after aging, ASTM D5250) | ≥ 14 MPa (before/after aging) |
| Freedom from Pinholes | ||
| -- AQL | 2.5 (Inspection Level I, ASTM D5151-06, 21 CFR 800.20) | Meets ASTM D5151-06 (Reapproved 2011) |
| Residual Powder | ASTM D6124-06 | Below 2mg of residual powder (meets ASTM D6124-06) |
| Material/Composition | PVC | PVC |
| Donning Lubricant | If used, composition and biocompatibility data (ISO 10993-10) should be provided | PU / Surface Coating Agent |
| Biocompatibility | Skin Irritation, Dermal, and Sensitization Studies (ISO 10993-10:2002/Amd.1:2006) | Meets ISO 10993-10:2002/Amd.1:2006 |
| Sterility Status | Non-sterile | Non-sterile |
| Single Patient Use | Single Patient Use | Single Patient Use |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size used for each specific test (e.g., number of gloves tested for pinholes, tensile strength, etc.). However, it indicates that the device "meets 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)." This implies that the testing was conducted according to these established standards, which would have their own specified sample size requirements.
The data provenance is not explicitly mentioned as retrospective or prospective, or country of origin for the specific test data. However, the submitter is Hope Plastic Co., Ltd. from China, suggesting the testing was likely performed by or for the manufacturer.
3. Number of Experts Used to Establish Ground Truth and Qualifications of Experts
This information is not applicable to this type of device and study. The "ground truth" for medical gloves is established by objective physical and chemical testing against recognized consensus standards (ASTM, ISO, CFR) rather than expert interpretation of images or clinical outcomes.
4. Adjudication Method for the Test Set
This information is not applicable. Adjudication methods like 2+1 or 3+1 are used for studies involving subjective human interpretation (e.g., radiologists reviewing images) to resolve discrepancies. For objective physical testing of medical gloves, the results are typically quantitative and directly compared to the specified criteria in the standards.
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 comparative effectiveness study is used to evaluate the performance of AI-assisted diagnostic devices, often comparing human reader performance with and without AI. This device is a physical medical glove and does not involve AI or human "readers" in a diagnostic capacity.
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, not an algorithm, and therefore does not have standalone algorithm performance.
7. The Type of Ground Truth Used
The ground truth used for verifying the device's performance is based on objective measurements and laboratory testing results compared against established consensus standards. Specifically:
- ASTM D5250-06 (Reaffirmation 2011) for physical properties (dimensions, tensile strength, elongation).
- ASTM D5151-06 (Reaffirmation 2011) for freedom from pinholes.
- ASTM D6124-06 (Reaffirmation 2011) for residual powder.
- 21 CFR 800.20 for water leak tests (related to pinholes).
- ISO 10993-10: 2002/Amd. 1:2006 (E) for biocompatibility (skin irritation, dermal, and sensitization studies).
8. The Sample Size for the Training Set
This information is not applicable. This device is a physical product and does not involve machine learning algorithms that require a "training set."
9. How the Ground Truth for the Training Set Was Established
This information is not applicable as there is no training set for this device.
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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: _K130807 ." (applicant leave blank)
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 : | Hope Plastic Co., Ltd. |
|---|---|
| Submitter's address : | #22 Ti Yu St., Shijiazhuang, 050000, China |
| Phone number : | (86) 311-67699608 |
| Fax number : | (86) 311-67699906 |
| Name of contact person: | Mr. ZHANG Haidong |
| Date the summary was prepared: | Mar. 11th, 2013 |
[(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 Vinyl Patient Examination Gloves, Clear (Non-colored) |
|---|---|
| Proprietary/Trade name: | Powder Free Vinyl Patient Examination Gloves, Clear (Non-colored) |
| 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 Vinyl Patient Examination Gloves, Clear (Non-colored) that meets all of the requirements of ASTM standard D 5250-06 (Reaffirmation 2011).
Predicate device: Powder free Vinyl Patient Examination Gloves, Clear (Non-colored), Shijiazhuang Fuguan Plastic Products Co., Ltd. K032908.
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[(a)(4)] A description of the device
Device Description: Powder Free Vinyl Patient Examination Gloves, Clear (Non-colored) 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. It's 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 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.
[(a)(6)] A summary of the technological characteristics of new device compared to the predicate device.
The Powder Free Vinyl Patient Examination Gloves, Clear (Non-colored) non sterile are summarized with the following technological characteristics compared to ASTM or equivalent standard.
| Features &Description | Predicate Device | Medical GloveGuidanceManual (1661) | Subject Device | Result ofComparison |
|---|---|---|---|---|
| Company | Shijiazhuang FuguanPlastic Products Co., Ltd. | Hope Plastic Co., Ltd. | -- | |
| 510(K) Number | K032908 | -- | ||
| Product name | Powder Free Vinyl PatientExamination Gloves,Clear(Non-colored) | Powder Free VinylPatient ExaminationGloves, Clear(Non-colored) | Same | |
| Product Code | LYZ | LYZ | LYZ | Same |
| Size | Small/ Medium/Large/X large | Small/ Medium/Large/X large | Substantiallyequivalent | |
| Intend for use | Powder free Vinyl PatientExamination Gloves,Clear(Non-colored)is adisposable deviceintended for medicalpurposes that is worn onthe examiner's hand orfinger to preventcontamination betweenpatient and examiner. | Powder FreeExaminationGloves:A powder-freepatient examinationglove is adisposable deviceintended formedical purposesthat is worn on theexaminer's hand orfinger to preventcontaminationbetween patient andexaminer. | Powder free VinylPatient ExaminationGloves, Clear(Non-colored) is adisposable deviceintended for medicalpurposes that is worn onthe examiner's hand orfinger to preventcontamination betweenpatient and examiner. | Substantiallyequivalent |
| DeviceDescription andSpecifications | Meets ASTM D5250-06 (Reapproved 2011) | If vinyl:Do the vinylexamination glovesmeet all the currentspecifications listedunder ASTMSpecification D5250 | Meets ASTM D5250-06 (Reapproved 2011) | Substantiallyequivalent |
Section C(rev.01)
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| or an equivalentconsensus standard? | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| Dimensions-- Length | Meets ASTM D5250-06 (Reapproved 2011) | ASTM D5250 | 230mm min for all sizes | Substantiallyequivalent | |||||
| Dimensions-- Width | Meets ASTM D5250-06 (Reapproved 2011)Small 80-90 mmMedium 90-100mmLarge 100-110mmX large 110-120 mm | Small 80-85 mmMedium 95-97 mmLarge 102-108mmX large 114-118 mm | Substantiallyequivalent | ||||||
| Dimensions-- Thickness | Meets ASTM D5250-06 (Reapproved 2011) | Finger 0.05mm min.Palm 0.08mm min. | |||||||
| PhysicalProperties | Meets ASTM D5250-06 (Reapproved 2011)Before aging/after agingElongation ≥300%Tensile Strength≥14MPa | ASTM D5250 | Before aging/after agingElongation ≥300%Tensile Strength≥ 14MPa | Substantiallyequivalent | |||||
| Freedom fromPinholes | Meets21 CFR 800.20ASTM D5250-06(Reapproved 2011)ASTM D 5151-06(Reapproved 2011) | 21 CFR 800.20ASTM D5250ASTM D 5151 | Meets ASTM D5151-06(Reapproved 2011)HolesInspection Level IAQL2.5 | Substantiallyequivalent | |||||
| ResidualPowder | Meets ASTM D 6124-06(Reapproved 2011) | ASTM D 6124 | Meets ASTM D 6124-06(Reapproved 2011)Results generatedvalues below 2mg ofresidual powder | Substantiallyequivalent | |||||
| Compare allmaterials usedto fabricate thedevices | PVC | If the glove is madeof a polymer orother type ofmaterial. identifythe material. | PVC | Substantiallyequivalent | |||||
| Dusting orDonningPowder: | PU | If a donninglubricant is used,state thecomposition andincludebiocompatibilitydata for thelubricant in anidentifiedattachment; alsostate the name,manufacturer, andaddress below | PU | Substantiallyequivalent | |||||
| Dusting orDonningPowder: name | PU | LubricantGeneric Name/LubricantBrand Name | Surface Coating Agent | Substantiallyequivalent | |||||
| Compareperformancedata supportingsubstantialequivalence | equivalence | MeetsASTM D5151-06(Reapproved 2011)ASTM D5250-06(Reapproved 2011)ASTM D6124-06 | (Reapproved 2011)ASTM D6124-06 | At this time FDArecognizes thefollowing standards:Patient ExaminationGloves(PVC)ASTMD5151(Detection ofHoles in MedicalGloves)ASTM | Gloves(PVC)ASTMD5151(Detection ofHoles in MedicalGloves)ASTM | MeetsASTM D5151-06(Reapproved 2011)ASTM D5250-06(Reapproved 2011)ASTM D6124-06 | (Reapproved 2011)ASTM D6124-06 | Substantiallyequivalent |
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| D6124(ResidualPowder on MedicalGloves)ASTMD5250(Poly(vinylchloride) Gloves) | ||||
|---|---|---|---|---|
| Sterility status | Non sterile | -- | Non sterile | Substantiallyequivalent |
| SinglePatientUse | Single Patient Use | Single Patient Use | Single Patient Use | Substantiallyequivalent |
| Biocompatibility | SKIN IRRITATIONDERMAL andSENSITIZATIONSTUDIES Meets ISO10993-10 :2002/Amd.1:2006 | SKIN IRRITATIONDERMAL andSENSITIZATIONSTUDIESISO 10993-10 | SKIN IRRITATIONDERMAL andSENSITIZATIONSTUDIES Meets ISO10993-10 :2002/Amd.1:2006 | Substantiallyequivalent |
| Labeling for thelegallymarketeddevice to whichsubstantialequivalence isclaimed. | -Powder Free-Patient ExaminationGlove-Single Use Only- Manufactured For:- Lot | Chapter 4 | -Powder Free-Patient ExaminationGlove-Single Use Only- Manufactured For:- Lot | Substantiallyequivalent |
[(b)(1)| A brief discussion of the nonclinical submitted, reference, or relied on in the premarket notification submission for a determination of substantial equivalence.
Powder Free Vinyl Patient Examination Gloves, Clear (Non-colored) 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 nonclinical 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 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 Gloves, Clear(Non-colored), Shijiazhuang Fuguan Plastic Products Co., Ltd. K032908 .
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring MD 20993-0002
February 7, 2014
Hope Plastic Co., Ltd Mr. Chu Xiaoan Rm. 1606 Bldg.1 Jianxiang Yuan No.209 Bei Si Huan Zhong Road, Haidian District Beijing, 100083 CHINA
Re: K130807
Trade/Device Name: 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: December 24, 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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Page 2 – Mr. Xiaoan
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
Sincerely yours.
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Image /page/5/Picture/7 description: The image contains a combination of text and abstract shapes. The text includes "Tejashri Purohit-Sheth, M.D." and "Clinical Deputy Director", suggesting a medical context. The word "DAGRID" is also present, possibly an acronym or name. The image also contains the word "FOR" at the bottom right.
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) K130807
Device Name
Powder Free Vinyl Patient Examination Gloves, Clear (Non-colored)
Indications for Use (Describe)
Powder Free Vinyl Patient Examination Gloved) is a non-sterile disposable device intended for medical purposs 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)
Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
CHART WARRETT PROPERTY FOR FOR FOR FOR FOR FOR THE FOR THE FOR THE FOR THE FOR THE FOR THE FOR Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
FORM FDA 3881 (9/13)
Form Approved: OMB No. 0910-0120 Expiration Date: December 31, 2013 See PRA Statement on last page.
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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.