(166 days)
Powder-Free Yellow Vinyl 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.
Powder-Free Yellow Vinyl Patient Examination Gloves that meets all of the requirements of ASTM standard D 5250-06(Reaffirmation 2011).
The provided text is a 510(k) summary for the Hongyun Powder-Free Yellow Vinyl Patient Examination Gloves. It focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study report of a device's performance against specific acceptance criteria in the context of an AI/ML algorithm.
Therefore, many of the requested elements for describing the acceptance criteria and study that proves an AI device meets acceptance criteria simply do not apply to this document, as it concerns a medical glove and not an AI/ML device.
However, I can extract the relevant information from the document that is analogous to "acceptance criteria" and "reported device performance" for this specific product, a patient examination glove.
Here's the closest interpretation of your request based on the provided text:
Acceptance Criteria and Reported Device Performance
1. Table of Acceptance Criteria and Reported Device Performance:
The "acceptance criteria" for the Hongyun Powder-Free Yellow Vinyl Patient Examination Gloves are defined by their conformance to specific ASTM standards and FDA regulations. The "reported device performance" is the statement that the device meets these standards.
| Feature / Performance Metric | Acceptance Criteria (Standard) | Reported Device Performance |
|---|---|---|
| Dimensions - Length | Meets ASTM D5250-06 (Reapproved 2011) >230mm min. | Meets ASTM D5250-06 (Reapproved 2011) 230mm min for all sizes |
| Dimensions - Width | Meets ASTM D5250-06 (Reapproved 2011) (Specific ranges for S, M, L, XL) | Meets ASTM D5250-06 (Reapproved 2011) (Specific ranges for S, M, L, XL) |
| Dimensions - Thickness | Meets ASTM D5250-06 (Reapproved 2011) Finger 0.05mm min., Palm 0.08mm min. | Meets ASTM D5250-06 (Reapproved 2011) Finger 0.05mm min., Palm 0.08mm min. |
| Physical Properties | Meets ASTM D5250-06 (Reapproved 2011) Before aging/after aging Elongation ≥300% | Meets ASTM D5250-06 (Reapproved 2011) Before aging/after aging Elongation ≥300% |
| Physical Properties | Meets ASTM D5250-06 (Reapproved 2011) Before aging/after aging Tensile Strength ≥11MPa | Meets ASTM D5250-06 (Reapproved 2011) Before aging/after aging Tensile Strength ≥11MPa |
| Freedom from Pinholes | Meets 21 CFR 800.20, ASTM D5250-06 (Reapproved 2011), ASTM D 5151-06 (Reapproved 2011) | Meets ASTM D5151-06 (Reapproved 2011) Holes Inspection Level I, AQL 2.5 |
| Residual Powder | Meets ASTM D6124-06 (Reaffirmation 2011) | ASTM D6124-06 (Reaffirmation 2011) Results generated values below 2mg of residual powder |
| Biocompatibility | Meets ISO 10993-10:2002/Amd.1:2006 (for Skin Irritation and Sensitization) | Under the conditions of the study, not an irritant and not a sensitizer. Meets ISO 10993-10 Third Edition 2010-08-01 |
The study proving the device meets these criteria is an internal non-clinical testing program conducted by the manufacturer, Tangshan Hongyun Plastic Products Co.,ltd, to ensure compliance with the referenced ASTM standards and ISO standard for biocompatibility.
Regarding the requested information for AI/ML devices (which are not applicable to this document):
- Sample size for the test set and data provenance: Not applicable. The "test set" here refers to samples of gloves tested according to ASTM standards. The document does not specify exact sample sizes for each test, but rather refers to conformance with standards which typically define sampling plans. The data provenance is internal testing by the manufacturer in China.
- Number of experts used to establish the ground truth for the test set and their qualifications: Not applicable. Ground truth for a physical product like a glove is established by standardized measurement methods defined in ASTM standards, not by expert consensus in the way an AI algorithm's output might be.
- Adjudication method for the test set: Not applicable. Testing for physical properties follows specific protocols defined by the ASTM and ISO standards.
- Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable. This type of study is for evaluating human performance, often with and without AI assistance, which is not relevant for a medical glove.
- Standalone (algorithm only) performance study: Not applicable. This device is not an algorithm.
- Type of ground truth used: For physical properties, the "ground truth" is the quantitative measurement obtained through standardized tests (e.g., length in mm, thickness in mm, tensile strength in MPa, AQL for pinholes, residual powder in mg/glove, biological response for biocompatibility).
- Sample size for the training set: Not applicable. This concept is for AI/ML models. For manufacturing, there are quality control processes, but not a "training set" in this context.
- How the ground truth for the training set was established: Not applicable.
In summary, this document is a regulatory submission for a physical medical device (gloves), not an AI/ML device. Therefore, most of the questions relating to AI/ML study design are not addressed. The "acceptance criteria" are the established ASTM and ISO standards, and the "study" is the non-clinical testing performed by the manufacturer to demonstrate compliance with these standards.
{0}------------------------------------------------
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a symbol. The symbol is a stylized representation of three human profiles facing to the right, stacked on top of each other. The profiles are black against a white background.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 24, 2014
Tangshan Hongyun Plastic Products Company Limited C/O Mr. Chu Xiaoan Room 1606 Bldg. 1 Jianxiang Yuan No. 209 Bei Si Huan Zhong Road Haidian Distict, Beijing 100083 CHINA
Re: K141878
Trade/Device Name: Hongyun Powder Free Vinyl Patient Examination Gloves Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Gloves Regulatory Class: I Product Code: LYZ Dated: November 5, 2014 Received: November 17, 2014
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.
{1}------------------------------------------------
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/Resourcesfor You/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/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 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,
Erin | Keith -S
Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{2}------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K141878
Device Name
Hongyun Powder-Free Yellow Vinyl Patient Examination Gloves
Indications for Use (Describe)
Powder-Free Yellow Vinyl 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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
{3}------------------------------------------------
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: " (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 : | Tangshan Hongyun Plastic Products Co.,ltd |
|---|---|
| Submitter's address : | South Shenggezhuang Village, Pachigang Town, LuannanCounty, 063502, Hebei Province,China |
| Phone number : | (86)315-4169377 |
| Fax number : | (86)315-4169377 |
| Name of contact person: | RJ Wang |
| Date the summary was prepared: | 2014-11-05 |
[(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 Vinyl Patient Examination Gloves |
|---|---|
| Proprietary/Trade name: | "Hongyun Powder-Free Yellow Vinyl Patient ExaminationGloves" |
| 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 Vinyl Patient Examination Gloves that meets all of the requirements of ASTM standard D 5250-06 (Reaffirmation 2011).
Predicate device: Powder Free Vinyl Patient Examination Gloves. Colored (Yellow), Hebei Leader Plastic Co., Ltd. K122920.
{4}------------------------------------------------
[(a)(4)] A description of the device
Device Description: Powder-Free Yellow 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: Hongyun Powder-Free Yellow 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 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 of Comparison |
|---|---|---|---|
| Company | Hebei Leader Plastic Co., Ltd. | Tangshan Hongyun PlasticProducts Co.,ltd | -- |
| 510(K) Number | K122920 | K141878 | |
| Product name | Powder-Free Vinyl PatientExamination Gloves, YellowColor | Powder-Free Yellow VinylPatient Examination Gloves | Same |
| Product Code | LYZ | LYZ | Same |
| Size | Small/ Medium/Large/X large | Small/ Medium/Large/X large | Similar |
| Intend for use | Powder Free Vinyl PatientExamination Gloves. Colored(Yellow) is a disposable deviceintended for medical purposesthat is worn on the examiner'shand or finger to preventcontamination between patientand examiner. | Powder-Free Yellow SyntheticVinyl Patient ExaminationGloves is a disposable deviceintended for medical purposesthat is worn on the examiner'shand or finger to preventcontamination between patientand examiner. | Similar |
| DeviceDescription andSpecifications | Meets ASTM D5250-06(Reapproved 2011) | Meets ASTM D5250 -06(Reapproved 2011) | Similar |
| Dimensions-- Length | Meets ASTM D5250-06(Reapproved 2011)>230mm min. | Meets ASTM D5250-06(Reapproved 2011)230mm min for all sizes | Similar |
| Dimensions-- Width | Meets ASTM D5250-06(Reapproved 2011)Small 80-90 mmMedium 90-100mmLarge 100-110mmX large 110-120 mm | Meets ASTM D5250-06(Reapproved 2011)Small 83-86 mmMedium 94-97 mmLarge 104-107mmX large 113-115 mm | Similar |
| Dimensions-- Thickness | Meets ASTM D5250-06(Reapproved 2011) | Meets ASTM D5250-06(Reapproved 2011) | Similar |
| Finger 0.05mm min.Palm 0.08mm min.Meets ASTM D5250-06(Reapproved 2011)Before aging/after agingElongation ≥300%Tensile Strength≥11MPa | Finger 0.05mm min.Palm 0.08mm min.Meets ASTM D5250-06(Reapproved 2011)Before aging/after agingElongation ≥300%Tensile Strength≥ 11MPa | Similar | |
| Physical Properties | |||
| Freedom fromPinholes | Meets• 21 CFR 800.20• ASTM D5250-06(Reapproved 2011)• ASTM D 5151-06(Reapproved 2011) | Meets ASTMD5151-06 (Reapproved 2011)HolesInspection Level IAQL2.5 | Similar |
| Residual Powder | Meets ASTMD6124-06 (Reaffirmation2011) | ASTM D6124-06(Reaffirmation 2011)Results generated valuesbelow 2mg of residual powder | Similar |
| Compare allmaterials used tofabricate thedevices | PVC | PVC | Similar |
| Dusting orDonning Powder: | PU | PU | Similar |
| Dusting orDonning Powder:name | PU | Surface Coating Agent | Similar |
| Compareperformance datasupportingsubstantialequivalence | 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 | SKIN IRRITATION DERMALand SENSITIZATIONSTUDIES Meets ISO10993-10:2002/Amd.1:2006 | Under the conditions of thestudy, not an irritant andunder conditions of thestudy, not a sensitizer.SKIN IRRITATIONDERMAL andSENSITIZATION STUDIESMeets ISO 10993-10 ThirdEdition 2010-08-01 | Similar |
| Labeling for thelegally marketeddevice to whichsubstantialequivalence isclaimed. | -Powder Free-Devices color: Yellow-Patient Examination Glove-Non sterile-Single Use Only | -Powder Free-Devices color: Yellow-Patient Examination Glove-Non sterile-Single Use Only | Similar |
{5}------------------------------------------------
[(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 Yellow Vinyl Patient Examination Glovesmeet requirements per ASTM D5250-06(Reaffirmation 2011), per ASTM D6124-06(Reaffirmation 2011), per 21 CFR 800.20 and ISO 10993-10 Third Edition 2010-08-01.
[(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.
{6}------------------------------------------------
[(b)(3)] The conclusions drawn from the nonclinical test 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 Vinyl Patient Examination Gloves is as effective, and performs as well as the predicate device Powder Free Vinyl Patient Examination Gloves. Colored (Yellow), Hebei Leader Plastic Co., Ltd. K122920.
§ 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.