(59 days)
Powder free vinyl 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.
Powder Free Vinyl Patient Examination Gloves, Clear (non-colored)that meets all of the requirements of ASTM standard D 5250-06.
This document describes the acceptance criteria and study for the "Powder Free Vinyl Patient Examination Gloves, Clear (non-colored)" manufactured by SHANDONG JUNFENG INDUSTRIES CO., LTD.
1. Table of Acceptance Criteria and Reported Device Performance
| Characteristics | Acceptance Criteria (Standard) | Reported Device Performance |
|---|---|---|
| Dimension | ASTM standard D 5250-06 | Meets |
| Physical Properties | ASTM standard D 5250-06 | Meets |
| Freedom from pinholes | 21 CFR 800.20 | Meets |
| Powder Residual | ASTM standard D 5250-06 and D6124-06 | <2mg/glove (Meets) |
| Biocompatibility (Primary Skin Irritation) | ISO 10993-10 (Primary Skin Irritation in rabbits) | Passes (Not a Primary Skin Irritation) |
| Biocompatibility (Dermal Sensitization) | ISO 10993-10 (Dermal sensitization in the guinea pig) | Passes (Not a Dermal sensitization) |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample sizes used for each specific test within the ASTM standards or the biocompatibility tests. However, the tests performed (e.g., freedom from pinholes, powder residual, primary skin irritation, dermal sensitization) imply that samples of the gloves were rigorously tested according to the specified international and national standards.
The data provenance is not explicitly stated as "country of origin" or "retrospective/prospective," but the testing was conducted to meet established standards like ASTM and ISO, which are internationally recognized. The testing would have been prospective in nature, as the device was manufactured and then tested against these criteria to demonstrate compliance.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This section is not applicable in the context of device performance testing against established standards for patient examination gloves. The "ground truth" here is defined by the objective metrics and thresholds set out in the ASTM and ISO standards themselves, not by expert consensus on qualitative observations. The product simply had to "meet" the quantitative or qualitative pass/fail criteria of these standards.
4. Adjudication Method for the Test Set
Adjudication methods like "2+1" or "3+1" are typically used in clinical studies involving interpretation of medical images or subjective assessments by multiple experts. This is not relevant for the objective performance testing described for these gloves. The device performance was evaluated directly against the quantitative and qualitative requirements of the listed standards.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices where human readers interpret results, often with and without AI assistance, to assess the impact of AI on diagnostic accuracy. This is not applicable to patient examination gloves, which are physical barrier devices.
6. If a Standalone (i.e., algorithm only without Human-in-the-Loop performance) Was Done
No, a standalone (algorithm-only) performance study was not done. This concept is applicable to AI/ML software devices. The device in question is a physical medical device (gloves) and its performance is evaluated through material and physical property tests, not algorithmic performance.
7. The Type of Ground Truth Used
The ground truth used for this device's performance evaluation comprises:
- Objective Standards: Defined by international and national consensus standards such as ASTM D5250-06, ASTM D6124-06, 21 CFR 800.20, and ISO 10993-10. These standards specify precise methodologies for testing and define quantifiable pass/fail criteria (e.g., maximum allowable pinholes, maximum powder residual, specific methods for biocompatibility testing).
- Laboratory Testing Results: The "Meets" or "Passes" reported for each characteristic directly reflects the results of laboratory tests conducted in accordance with these objective standards.
8. The Sample Size for the Training Set
This document does not describe a "training set" in the context of machine learning or AI. The device is a physical product (gloves), not an AI algorithm. Therefore, the concept of a training set is not applicable. The manufacturer produces the gloves, and then tested samples from production lots against the outlined standards.
9. How the Ground Truth for the Training Set Was Established
As explained in point 8, the concept of a "training set" is not applicable to this device. Therefore, no ground truth was established for a training set. The "ground truth" for the device's acceptable performance is derived from the established and publicly available standards it must meet.
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510(K)Summary
SEP 27 2012
"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: ماصل " (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 : | SHANDONG JUNFENG INDUSTRIES CO., LTD |
|---|---|
| Submitter's address : | No.899 ,Hengtong Road, Zhoucun,Zibo ,Shandong,255300, China |
| Phone number : | (86) 533-6537122 |
| Fax number : | (86) 533-6537122 |
| Name of contact person: | Ms. BIAN Qinyu |
| Date the summary was prepared: | Jul. 04th, 2012 |
[(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 |
| 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.
Predicate device : FUGUAN (Brand) Powder-Free Vinyl Patient Examination Gloves, Shijiazhuang Fuguan Plastic Products Co., Ltd.. K032908 .
{(a)(4)] A description of the device
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Device Description : Powder Free Vinyl Patient Examination Gloves, Clear (non-colored)that meets all of the requirements of ASTM standard D 5250-06.
[(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, non sterile are summarized with the following technological characteristics compared to ASTM or equivalent standard.
| Characteristics | Standard | Device performance |
|---|---|---|
| Dimension | ASTM standard D 5250-06 | Meets |
| Physical Properties | ASTM standard D 5250-06 | Meets |
| Freedom from pinholes | 21 CFR 800.20 | Meets |
| Powder Residual | ASTM standard D 5250-06 | Meets |
| and D6124-06 | <2mg/glove | |
| Biocompatability | Primary Skin Irritation inrabbits | Passes |
| Not a Primary Skin Irritation | ||
| Dermal sensitization in theguinea pig | Passes | |
| Not a Dermal sensitization |
[(b)(1)] A brief discussion of the non-clinical testing data that was submitted, referenced or relied on to demonstrate that the Subject Device is safe and effective, and whose performance meets the requirements of its pre-defined acceptance criteria and intended uses.
Powder Free Vinyl Patient Examination Gloves, Clear (non-colored)meet requirements per ASTM D5250-06, per ASTM D6124-06, per 21 CFR 800.20 and ISO10993-10. , it is safe and effective, and it's performance meets the requirements of its pre-defined acceptance criteria and intended uses.
[(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 and 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 . It is as safe,as effective, and performed as well the legally marketed device identified in (a)(3).
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Section 15
Substantial Equivalence Discussion
The Powder Free Vinyl Patient Examination Gloves, Clear (non-colored) made by SHANDONG JUNFENG INDUSTRIES CO., LTD, have the same intended use and technological characteristics as the Predicate devices, FUGUAN (Brand) Powder-Free Vinyl Patient Examination Gloves made by Shijiazhuang Fuguan Plastic Products Co., Ltd. K032908. The Subject Device is substantially equivalent to the predicate devices with regard to technologies, in design and very similar construction, material, function, and application. More detail information on the Table 1.
Based on the information in following Table I, the Subject Device (Powder Free Vinyl Patient Examination Gloves, Clear (non-colored)) has the same technological characteristics as the predicate device. The Powder Free Vinyl Patient Examination Gloves, Clear (non-colored) made by SHANDONG JUNFENG INDUSTRIES CO., LTD, are substantially equivalent to the predicate devices.
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| Table 1 Substantial Equivalence Comparison with predicate devices | ||||
|---|---|---|---|---|
| Features & Description | Predicate Device | Medical Glove GuidanceManual (1661) | Subject Device | Result of Comparison |
| Intend for use | Powder free vinyl 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. | Powder-FreeExamination Gloves:A powder-free 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. | Powder-Free 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. | Substantially equivalent |
| Device Description and Specifications | Meets ASTM D5250 | If vinyl:Do the vinyl examination gloves meet all the current specifications listed under ASTM Specification D5250 or an equivalent consensus standard? | Meets ASTM D5250 | Substantially equivalent |
| Compare all materials used to fabricate the devices | PVC | If the glove is made of a polymer or other type of material. identify the material. | PVC | Substantially equivalent |
Table 1 Substantial Equivalence Comparison with predicate devices
Section 15.2
Section 15 -2
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| usting or DonningPowder: | If a donning lubricant isused, state thecomposition andinclude biocompatibilitydata for the lubricant inan identified attachment;also state thename, manufacturer,and address below | Lubricant•Generic Name/LubricantBrand Name | Compare productspecifications | Compare performancedata supportingsubstantial equivalence |
|---|---|---|---|---|
| PU | PU | PU | Meets ASTM D5250 | MeetsASTM D5151ASTM D5250ASTM D6124 |
| Surface Coating AgentPU-120-C. | We recommend youcertify that your finished"powder-free" glovesmeet the following:•ASTM D 5250 standardor an equivalentstandard for vinyl | At this time FDArecognizes the followingstandards:Patient ExaminationGlovesASTM D5151(Detectionof Holes in Medical | ||
| Substantially equivalent | ||||
| Substantially equivalent | ||||
| Substantially equivalent | ||||
| Substantially equivalent |
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Section 15 -3
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| Single Patient UseBiocompatibility | Gloves)ASTM D6319(NitrileExamination Gloves)ASTM D6124(ResidualPowder on MedicalGloves) | ASTM D5250(Poly(vinylchloride) Gloves)ASTM D3578(RubberExamination Gloves)ASTM D3772(RubberFinger Cots) | Single Patient UseSKIN IRRITATIONDERMAL andSENSITIZATIONSTUDIESMeets ISO 10993-10-Powder-Free-Patient ExaminationGlove-Single Use Only- Manufactured For:- Lot | Single Patient UseSKIN IRRITATIONDERMAL andSENSITIZATIONSTUDIESISO 10993-10Chapter 4 | Single Patient UseSKIN IRRITATIONDERMAL andSENSITIZATIONSTUDIESMeets ISO 10993-10-Powder-Free-Patient ExaminationGlove-Single Use Only- Manufactured For:- Lot | Substantially equivalent |
|---|---|---|---|---|---|---|
| Labeling for the legallymarketed device towhich substantialequivalence is claimed. | Substantially equivalent | |||||
| Substantially equivalent |
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Section 15 -4
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Section 13
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Image /page/6/Picture/0 description: The image shows the seal of the Department of Health & Human Services USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. In the center of the seal is an abstract symbol that resembles a stylized caduceus or a stylized representation of a human figure.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Shandong Junfeng Industries Company, Limited Mr. Chu Xiaoan Room 1606 Building 1, Jianxiang Yuan No. 209 Bei SI Huan Zhong Road Haidian District Beijing 100083, P.R. China
SEP 2 7 2012
Re: K122266
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: September 6, 2012 Received: September 13, 2012
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 go to
http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
For
Anthony D. Watson, B.S., M.S., M.B.A. Director
Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and
Radiological Health
Enclosure
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INDICATIONS FOR USE
Applicant: SHANDONG JUNFENG INDUSTRIES CO., LTD
K122266 510(k) Number (if known):_*
Device Name: Powder Free Vinyl Patient Examination Gloves, Clear (non-colored)
Indications For Use:
Powder free vinyl 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.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use ਮ (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Elishth F. Claire-Willis
sthesiology, General Hospital
510(k) Number: K122266
§ 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.